Layne v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-57V

Filed: July 12, 2022

PUBLISHED

Special Master Horner

BECKY LAYNE,

Petitioner, Shoulder Injury Related to

v. Vaccine Administration

(“SIRVA”); Influenza (“Flu”)

SECRETARY OF HEALTH AND Vaccine; Ruling on the Record

HUMAN SERVICES,

Respondent.

Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner.

Jamica M. Littles, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT 1

On January 11, 2018, petitioner, Becky Layne, filed a petition under the National

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

of an influenza vaccination on November 2, 2016, caused a left shoulder injury. (ECF

Nos. 1, 30.)3 For the reasons set forth below, I conclude that petitioner is entitled to an

award of compensation.

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.

2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-

10-34.

3 Petitioner’s original petition alleges “left shoulder injuries resulting from the adverse effects of the

influenza vaccination…received on November 2, 2016.” (ECF No. 1 (emphasis added).) While

petitioner’s amended petition simply alleges “injuries related to vaccine administration (“SIRVA”) as a

result of an influenza vaccination…received on November 2, 2016.” (ECF No. 30 (emphasis added).) As

petitioner’s motion for a ruling on the record makes clear, petitioner alleges that she suffered a left-sided

shoulder injury meeting all four criteria demonstrating a SIRVA Table injury, (ECF No. 49, p. 9) or

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I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation

awards are made to individuals who have suffered injuries after receiving vaccines. In

general, to gain an award, a petitioner must make a number of factual demonstrations,

including showing that an individual received a vaccination covered by the statute;

received it in the United States; suffered a serious, long-standing injury; and has

received no previous award or settlement on account of the injury. Finally – and the key

question in most cases under the Program – the petitioner must also 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 other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-

11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).

As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to

Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours

of administration of an influenza vaccine. § 300aa-14(a) as amended by 42 CFR §

100.3. Table Injury cases are guided by statutory “Qualifications and aids in

interpretation” (“QAIs”), which provides more detailed explanation of what should be

considered when determining whether a petitioner has actually suffered an injury listed

on the Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,”

petitioner must show that his injury fits within the following definition:

SIRVA manifests as shoulder pain and limited range of motion occurring

after the administration of a vaccine intended for intramuscular

administration in the upper arm. These symptoms are thought to occur as a

result of unintended injection of vaccine antigen or trauma from the needle

into and around the underlying bursa of the shoulder resulting in an

inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal

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

not a neurological injury and abnormalities on neurological examination or

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

would not support SIRVA as a diagnosis . . . . 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

alternatively, that reliable medical evidence supports a non-Table injury that was caused-in-fact by her

vaccination (Id. at 15).

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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 CFR §100.3(c)(10).

Alternatively, if no injury falling within the Table can be shown, the petitioner may

still demonstrate entitlement to an award by showing that the vaccine recipient’s injury

or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); §

300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must demonstrate that the

vaccine was “not only [the] but-for cause of the injury but also a substantial factor in

bringing about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs.,

592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human

Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human

Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). In particular, a petitioner must show by

preponderant evidence: (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 in order to prove causation-in-fact. Althen v. Sec’y of Health &

Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)

For both Table and Non–Table claims, Vaccine Program petitioners must

establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a

petitioner must present evidence sufficient to show “that the existence of a fact is more

probable than its nonexistence . . . .” Moberly, 592 F.3d at 1322 n.2. Proof of medical

certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873

(Fed. Cir. 1991). However, a petitioner may not receive a Vaccine Program award

based solely on his assertions; rather, the petition must be supported by either medical

records or by the opinion of a competent physician. § 300aa-13(a)(1).

In this case, petitioner stresses that she suffered a left-sided shoulder injury

meeting all four criteria demonstrating a SIRVA Table injury. (ECF No. 49, p. 9.)

Alternatively, petitioner asserts that reliable medical evidence supports a non-Table

injury was caused-in-fact by her vaccination. (Id. at 15.)

II. Procedural History

Petitioner filed her petition, affidavit, and medical records on January 11, 2018.

(ECF No. 1.) This case was initially assigned to the Court’s Special Processing Unit

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(“SPU”) on January 16, 2018. (ECF Nos. 5, 6.) On January 17, 2018, petitioner filed

additional medical records and a statement of completion. (ECF Nos. 7-8.) An initial

status conference was held on March 1, 2018. (ECF No. 12.) Subsequently, petitioner

filed a supplemental affidavit, further medical records, and an amended statement of

completion. (ECF Nos. 13, 14, 17-18.)

On December 3, 2018, respondent filed his Rule 4(c) report recommending

against compensation. (ECF No. 26.) Thereafter petitioner was ordered to file an

amended petition clarifying the nature of her claim, any outstanding physical therapy

records, and an expert report. (ECF No. 27.) On January 10, 2019, petitioner filed

updated physical therapy records. (ECF No. 28.) On February 15, 2019, petitioner filed

an expert report authored by Naveed Natanzi, D.O. as well as the supporting medical

literature. (ECF No. 29.) Petitioner filed her amended petition on March 11, 2019.

(ECF No. 30.)

On February 15, 2019, respondent filed a responsive expert report from Geoffrey

Abrams, M.D., with accompanying medical literature. (ECF No. 34.) Thereafter this

case was reassigned to Special Master Mindy Roth on July 2, 2019. (ECF No. 37.) On

October 17, 2019, a status conference was held and petitioner was ordered to submit a

reasonable settlement demand to respondent. (ECF No. 38.) After settlement

negotiations were unsuccessful, petitioner elected to file to a responsive supplemental

expert report from Dr. Natanzi on March 23, 2020. (ECF No. 42.)

Subsequently, the parties filed a joint status report on June 22, 2020, electing to

proceed with motions for a ruling on the record. (ECF No. 44.) Concurrently, petitioner

requested the opportunity to file a responsive expert report in conjunction with her

motion. (Id.) On September 15, 2020, petitioner filed a second supplemental expert

report from Dr. Natanzi, as well as an expert report authored by Tinoosh Zand, M.D.,

regarding petitioner’s MRI arthrogram of the left shoulder. (ECF No. 47.) On October

20, 2020, petitioner filed her motion for a ruling on the record. (ECF No. 49.) On

February 5, 2021, respondent filed his responsive brief. (ECF No. 51.) Petitioner filed

her reply to respondent’s response on February 12, 2021. (ECF No. 52.)

Subsequently, this case was reassigned to my docket on February 4, 2022.

(ECF No. 55.) In light of the posture of the case upon reassignment, I issued a NON-

PDF Order on February 8, 2022, advising the parties that “[a]t the time of reassignment,

a ripe motion for a ruling on the written record [] remained pending” and “[a]bsent further

action from the parties, I intend to act on the pending motion in due course without

further proceedings.” (Dkt Text 2/8/22.) On March 21, 2022, petitioner filed Dr.

Natanzi’s CV. (ECF No. 56.) However, neither party took any further action in

response to my Order of February 8, 2022.

On May 2, 2022, I instructed petitioner to file a complete copy of Dr. Cincere’s

record of December 20, 2016, a request that had been made in respondent’s brief.

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(Sched. Order (Non-PDF), 5/2/2022 (citing ECF No. 51, p. 3, n. 1). Petitioner filed the

required records on June 29, 2022. (ECF No. 58; Ex. 25.)

I have determined that the parties have had a full and fair opportunity to present

their cases and that it is appropriate to resolve this issue without a hearing. See

Vaccine Rule 8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health & Human

Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must

determine that the record is comprehensive and fully developed before ruling on the

record.”). Accordingly, this matter is now ripe for resolution.

III. Factual History

a. As reflected in the medical records

On November 2, 2016, petitioner received an influenza vaccination in her left

arm. (Ex. 1, p. 1.) An undated handwritten note on the vaccination record states that

“she had a severe reaction to the flu shot. Very sore arm (the shot site) a week later.

Reported CDC.” (Id.) Prior to this vaccination, petitioner had no history of injury to her

left shoulder. (Ex. 2, pp. 18, 22-34; Ex. 11, pp. 1-12.)

On November 11, 2016, petitioner presented to her primary care provider

(“PCP”) Teresa Regan, D.O. (Ex. 2, p. 18.) Petitioner reported that her arm was red,

swollen, and warm to the touch since receiving a flu shot on November 2nd. (Id.) The

note states that “they told her it was a bad reaction to the Flu VACC” and the shot “was

given supposedly im [intramuscular] but appears to have been given near the superior

deltoid tendon.” (Id.) Petitioner reported significant pain, significant decreased range of

motion, and an audible click in the “rotator cuff area.” (Id.) Dr. Regan noted “severe

point tenderness in [the rotator cuff] region and over acj [acromioclavicular joint], short

head of biceps and supraspinatus and joint capsule.” (Id.) Additionally, petitioner

reported numbness, tingling, and pain to the left hand. (Id.) On physical examination,

Dr. Regan observed decreased range of motion with abduction and external rotation

greater than internal rotation to less than 90 degrees from the horizontal plain. (Ex. 2,

p. 18.) Petitioner also indicated that she “may have had some chills immediately after

the injection.” (Id.) Dr. Regan administered an injection of Ketorolac Tromethamine 4 in

her right gluteus and prescribed Diclofenac5 and Percocet. 6 (Id. at 20.) Dr. Regan also

4 “a nonsteroidal anti-inflammatory drug administered intramuscularly, intravenously, or orally for

short=term management of pain[.]” Ketorolac Tromethamine, DORLAND’ MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=26960&searchterm=ketorolac%20tromethamine

(last accessed Mar. 23, 2022.)

5 “a nonsteroidal anti-inflammatory drug derived from phenylacetic acid.” Diclofenac, DORLAND’S MEDICAL

DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=13937&searchterm=diclofenac

(last accessed Mar. 23, 2022).

6“Trademark for a combination preparation of oxycodone hydrochloride and acetaminophen.” Percocet,

DORLAND’S MEDICAL DICTIONARY ONLINE,

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ordered an ultrasound to rule out septic joint versus an injury to the left rotator cuff. (Id.

at 18.) That same day, petitioner underwent a CT scan of her left shoulder. (Ex. 2, p.

47.) The history indicates “joint pain” and “patient reports injection complications of the

flu shot.” (Id.) The CT scan showed normal findings, including no acute fracture or

evidence of osteomyelitis, no significant arthritic changes, no radiopaque foreign body,

edema, inflammation, fluid collection, or appreciable glenohumeral joint effusion. (Id.)

A VAERS report was filed on November 18, 2016. (Ex. 1, p. 2.) On November

30, 2016, petitioner underwent an MRI of the left shoulder. (Ex. 13.) The history

indicated “[l]eft shoulder pain following a flu shot in November 2016” and “[p]ain

radiating into the left hand.” (Id.) The MRI showed no evidence of a rotator cuff tear,

labral injury, or occult bone injury, and no abnormality in the subcutaneous or deltoid

muscles surrounding the left humerus. (Id.)

On December 20, 2016, petitioner presented to Brandon Cincere, M.D., an

orthopedist. (Ex. 25, pp. 15-18; see also Ex. 14, pp. 2-3; Ex. 3, p. 2.) Petitioner

reported that her therapeutic injection had not provided relief and that she “is having

sharp and achey pains” as well as pain radiating to her fingers. 7 On examination

petitioner’s passive range of motion was “limited and guarded, improved,” and empty

can and full can tests were positive. (Ex. 25, p. 16.) Upon reviewing petitioner’s MRI,

Dr. Cincere indicated that he disagreed with the radiologist’s report on the axial images.

(Id.) Dr. Cincere’s impression was left shoulder pain with “limited ROM after flu shot, no

relief with IA injection, MRI with RTC tendinosis and bursitis.” (Id. at 17.) Petitioner was

diagnosed with pain, bursitis, and unspecified mononeuropathy of the left shoulder.

(Id.) Petitioner was given a steroid injection and Dr. Cincere ordered an

electromyogram (“EMG”) with the note “please evaluate suprascapular nerve.” (Id.)

On January 3, 2017, petitioner was seen at Ocoee Regional Health for

musculoskeletal pain and an adverse reaction to a flu shot. (Ex. 10, pp. 1-3.) Under the

heading “musculoskeletal pain,” petitioner reported severe pain in her neck and

shoulders that began three days earlier; she reported no injuries; and described waking

up with a “crick in her neck.” (Id.) Under the heading “adverse reaction to flu shot,”

petitioner reported constant, severe pain in her left shoulder that began two months

prior. (Id.) In the review of systems, petitioner reported extremity weakness with no

numbness. (Id.) On examination, PAC Caleb Rae noted a “right muscle spasm” and

painful range of motion in the cervical spine, and moderately reduced range of motion in

https://www.dorlandsonline.com/dorland/definition?id=37652&searchterm=Percocet (last accessed Mar.

23, 2022.)

7 The record indicates in the narrative that this history was provided relative to the right shoulder. (Ex. 25,

p. 15.) However, the record is clear in indicating petitioner was presenting with a chief complaint relative

to her “left shoulder.” Moreover, the record as a whole is clearly focused on petitioner’s left shoulder and

the resulting diagnoses all specifically relate to the left shoulder. (Id. at 17.) Accordingly, it appears this

isolated reference to the right shoulder is an error within the record.

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the left shoulder. (Id.) The assessment was cervicalgia and petitioner was advised to

continue heating, massaging, and stretching. (Id.)

On January 4, 2017, petitioner returned to Dr. Regan complaining of neck and

shoulder pain. (Ex. 2, p. 14.) Petitioner reported that she had started developing neck

pain, worse on the left, on Sunday at dinner and it had gotten worse, radiating down her

left shoulder and right shoulder. (Id.) She also described numbness and tingling to the

2nd, 3rd, and 4th digits of the left hand “but this is not new or worse.” (Id.) Petitioner

reported a headache in the back of the head. (Id.) She indicated that she received a

steroid shot and Robaxin 8 at the clinic the previous day and was “getting no better but

worse.” (Id.) On examination petitioner had tenderness to palpation over the left and

right paracervical areas and bilateral trapezius, as well as decreased range of motion in

her neck and in all plains and tenderness of paracervical muscles. (Id. at 15.)

Petitioner was assessed with headache and “joint pain – neck pain.” (Ex. 2, pp. 15-16.)

She was advised to apply moist to the neck area and to avoid taking Robaxin. (Id. at

17.)

On February 1, 2017, petitioner underwent an EMG which showed evidence of

left suprascapular neuropathy. (Ex. 4, pp. 24-25.) The history indicates that petitioner

had persistent left shoulder and left upper extremity pain and weakness; with

numbness, tingling and “paresthesias in her left arm that radiated down her arm and

affect digits 3 through 5.” (Id. at 24.) On limited examination, petitioner had somewhat

limited mobility in her neck and left shoulder, secondary to pain; and the right shoulder

mobility was normal. (Id.) The impression indicates that “[t]his is an abnormal study,”

finding evidence of left suprascapular neuropathy, affecting both the left supraspinatus

and left infraspinatus; however, there was no evidence of right suprascapular

neuropathy, cervical radiculopathy, brachial plexopathy, left median neuropathy, left

ulnar neuropathy, or left radial neuropathy. (Id.)

On February 7, 2017, petitioner returned to Dr. Cincere. (Ex. 4, pp. 26-29; Ex.

14, pp. 4-8.) Petitioner reported that the injection from her previous visit did not help

much. (Ex. 4, p. 26.) She indicated that she saw her PCP and “believes she has nerve

damage.” (Id.) She described constant pain which she rated as 7/10. (Id.) Petitioner’s

left shoulder passive range of motion was 170-90-90-30-40, her empty can test was

negative and full can test was positive, her infraspinatus was weak, her Hawkins and

Neer’s tests were positive, and her O’Brien’s test was negative. (Id. at 28.) She was

diagnosed with suprascapular nerve compression, pain in the left shoulder, incomplete

rotator cuff tear/ruptured left shoulder (not traumatic), impingement syndrome and

bursitis in the left shoulder, and other specified mononeuropathies in the left upper limb.

8 “Trademark for preparation of methocarbamol.” Robaxin, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=44009&searchterm=Robaxin (last accessed Mar.

23, 2022). “a skeletal muscle relaxant, administered orally, intramuscularly, or intravenously in the

treatment of painful musculoskeletal conditions.” Methocarbamol, DORLAND’S MEDICAL DICTIONARY

ONLINE, https://www.dorlandsonline.com/dorland/definition?id=30925 (last accessed Mar. 23, 2022.)

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(Id.) The note states that an MRI showed bursal signal changes and rotator cuff signal

changes. (Id. at 29.) Petitioner elected to undergo surgery. (Id.)

On February 22, 2017, petitioner underwent left shoulder surgery. (Ex. 4, pp. 21-

23; Ex. 14, pp. 17-19.) Petitioner’s preoperative diagnoses were: 1) left shoulder

subacromial impingement bursitis; 2) left shoulder rotator cuff tendinitis; and 3) left

shoulder suprascapular neuropathy. (Ex. 4, p. 21.) Petitioner’s postoperative

diagnoses were the same, with the addition of left humeral head chondromalacia. (Id.)

In the findings Dr. Cincere reported

extensive subacromial bursitis and anterolateral acromial overhanging with

intact bursal-sided rotator cuff partial, small tearing of the anterior fibers of

the supraspinatus articulated with an associated chondral flap injury in this

area, and completely intact biceps in the groove portion and superior

labrum. [Petitioner] [had] some mild fraying of the anterior labrum. Intact

remaining cartilage with significant subacromial narrowing.

(Id. at 21-22.)

Thereafter petitioner underwent her initial physical therapy evaluation on

February 23, 2017. (Ex. 5, pp. 318-22.) In the history of present condition, Ann Miller-

Talent, PT, DPT, noted that petitioner “reports having an adverse reaction to a flu shot,

which resulted in bursitis, nerve damage, and difficulty moving and using the LUE [left

upper extremity].” (Id. at 318.) On examination, petitioner’s left shoulder active range of

motion was not tested, and her passive range of motion was 60 degrees flexion, 35

degrees abduction, 10 degrees external rotation in neutral position, and 50 degrees in

internal rotation in neutral position. (Id. at 319.) In her assessment, DPT Miller-Talent

noted that petitioner presented with “signs and symptoms consistent with status post

arthroscopic repair.” (Id. at 320.) She further observed decreased range of motion,

decreased strength, swelling, and pain. (Id.) Thereafter petitioner attended sixty-five

sessions of physical therapy through December 8, 2017. (See Ex. 5.)

Petitioner presented to Dr. Cincere for a follow-up on March 3, 2017. (Ex. 4, pp.

31-33; Ex. 14, pp. 9-11.) She described a constant pain for the past nine days in the

side and top of her shoulder that also “radiates to the arm,” which she rated as a 7/10.

(Ex. 4, p. 31.) Her “status [wa]s reported as improving.” (Id.) On examination

petitioner’s left shoulder range of motion was limited and painful. (Id. at 32.) She

returned to see Dr. Cincere again on April 6, 2017. (Ex. 4, pp. 35-37; Ex. 14, pp. 13-

15.) Petitioner was taking Vimovo and stated that it was helping. (Ex. 4, p. 35.)

Petitioner described constant, “sharp, stabbing, radiating and throbbing” shoulder pain

for four months. (Id.) The pain “radiates to the shoulder, fingers, and hand.” (Id.) She

rated the pain as 6/10. (Id.) On examination, petitioner’s left shoulder passive range of

motion was 150-90-80-10-30. (Id. at 36.) Empty and full can tests were positive,

petitioner’s infraspinatus was weak. (Id.) Dr. Cincere noted that she was “over worked

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in PT with increased pain, good motion, [rotator cuff] weak.” (Id. at 37.) Petitioner

received a subacromial bursa injection. (Id.)

On May 18, 2017, petitioner again returned to Dr. Cincere for a follow-up. (Ex. 4,

pp. 7-10; Ex. 14, pp. 30-35.) At three months post-surgery, petitioner voiced

improvement with her therapy. (Ex. 4, pp. 7-8.) She also indicated that she was still

taking Vimovo which helped. (Id. at 8.) Furthermore, petitioner suggested that the

swelling had decreased greatly. (Id.) On examination petitioner had weak empty and

full can tests. (Id. at 9.) Petitioner’s infraspinatus was intact, and her bear hug and

O’Brien’s tests were negative. (Id.) Petitioner received another subacromial bursa

injection in her left shoulder. (Id. at 10.)

On June 27, 2017, petitioner presented to Dr. Cincere for a follow-up. (Ex. 4, pp.

4-6; Ex. 14, pp. 27-30.) Petitioner was attending physical therapy twice a week, and

said it was effective. (Ex. 4, p. 4.) She indicated that she was “experiencing numbness

and tingling from the shoulder down to the left hand.” (Id.) On examination Dr. Cincere

observed tenderness in the ac joint, acromion, biceps tendon, and clavicle. (Id. at 5.)

Petitioner’s Hawkin’s and impingement tests were positive. (Id. at 6.) Petitioner’s left

shoulder passive range of motion was 170-90-90-30-50. (Id.) Empty and full can tests

were painful, petitioner’s infraspinatus was intact, and her bear hug, O’Brien’s and

Speeds tests were negative. (Id.) In his assessment Dr. Cincere noted that “since

February surgery she [ha]s improvement continue[s] has pain rated radicular type

symptoms of paresthesias down into her hand[.]” (Id.) Dr. Cincere ordered a repeat

EMG. (Id.)

On June 28, 2017, petitioner presented to Dr. Regan for pain in her right-side rib

cage radiating to the back for the last month causing shortness of breath. (Ex. 2, p. 2.)

Dr. Regan ordered a CTA of her lungs to rule out any pulmonary embolus. (Id.)

On July 19, 2017, petitioner underwent another EMG. (Ex. 4, pp. 13-14.) On

examination, petitioner had limited range of motion in her left shoulder and left neck.

(Ex. 4, p. 13.) There was no evidence of cervical radiculopathy, brachial plexopathy,

suprascapular neuropathy, left median neuropathy, left ulnar neuropathy, or left radial

neuropathy. (Id.) The report further indicated that “[petitioner’s] previously seen left

suprascapular neuropathy based on studies of 02/01/2017 has physiologically resolved

following surgery” and “full clinical correlation is suggested.” (Id.) The same day,

petitioner underwent a cervical spine MRI which showed minimal C3-C4 canal and

bilateral foraminal stenosis, mild right C4-C5 canal and foraminal stenosis, and mild

right and minimal left C5-C6 canal and foraminal stenosis. (Ex. 4, pp. 19-20.)

Furthermore, disc desiccation was noted at levels C2-C3, C6-C7, and C7-T1 and disc

osteophyte complex were noted at C3-C4, C4-C5, and C5-C6. (Id.)

On July 27, 2017, petitioner returned to Dr. Cincere to review her MRI and EMG

studies, complaining of left shoulder and neck pain. (Ex. 4, pp. 1-3.) Petitioner rated

her pain as 7/10, aggravated by range of motion, associated with weakness, numbness,

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tingling, and popping/clicking that “radiates to: down the arm.” (Id. at 1.) On

examination, petitioner experienced tenderness in the cervical region though her left

shoulder range of motion was normal. (Id. at 2.) Dr. Cincere noted that her c-spine MRI

showed “mild degenerative changes foraminal disease C3 through C6 bilaterally.” (Id.

at 3.) In his assessment, Dr. Cincere observed that petitioner continued to complain of

neck and trapezial pain, meanwhile “radicular type symptoms improved[,] paresthesias

in her left hand[,] complains of swelling around her neck despite shoulder arthroscopy

debridement subscapular nerve release.” (Id. at 3.) Dr. Cincere noted that petitioner’s

EMG demonstrated “no injuries and resolution of left subscapular neuropathy,” and he

was referring petitioner to Dr. Keueter for cervical radiculopathy. (Id.) Dr. Cincere

indicated that “the initial process of how this all started[,] does not seem to make a lot of

sense[,] there is no further structural injury of her shoulder that I feel like I can help her

with[,] she may need to be referred to a rheumatologist or pain management.” (Id.)

On September 19, 2017, petitioner presented to Dr. Regan complaining of

chronic left shoulder pain and requesting a referral back to physical therapy. (Ex. 2, p.

4.) On examination petitioner had decreased range of motion and tenderness in the left

shoulder. (Id. at 5.)

On November 8, 2017, petitioner underwent an unrelated sleep apnea

consultation. (Ex. 9, pp. 1-3.) Petitioner returned on November 16, 2017, after

undergoing a sleepy study, showing accentuated obstructive sleep apnea. (Id. at 5-7.)

Petitioner continued physical therapy for her left shoulder and neck pain through

approximately February 22, 2018. 9 (Ex. 15.)

b. As reflected in petitioner’s affidavits

Petitioner filed her first affidavit on January 11, 2018. (Ex. 8.) Petitioner states

that she received a flu shot on November 2, 2016, and sustained shoulder injuries

caused by the administration of the vaccine. (Ex. 8, p. 1.)

On March 20, 2018, petitioner filed a supplemental affidavit. (Ex. 12.) Petitioner

avers that she felt pain when the pharmacist stuck the needle in her arm. (Id. at 1.)

“Within 30 minutes” petitioner states that “the pain was so bad and [her] arm was

swelling and [she] could not even raise [her] arm.” (Id.) Having received flu shots in the

past, petitioner states that she hoped her arm would get better with ice packs. (Id.)

Thereafter petitioner called the pharmacy “and explained how [her] arm was swelling

and in excruciating pain,” such that she could not raise her arm. (Id.) Petitioner was

advised to fill out a VAERS report. (Id.)

On November 11, 2016, petitioner presented to Dr. Teresa Regan, and petitioner

recalls that Dr. Regan indicated that “someone had screwed up [her] arm.” (Ex. 12, p.

9 Petitioner’s Alliance Physical Therapy billing records, filed as Exhibit 15, indicate that petitioner attended

physical therapy through February 22, 2018, although petitioner’s updated Alliance Physical Therapy

records only provide Daily Notes through December 27, 2018. (See Exs. 15, 17.)

10

1.) Petitioner avers that Dr. Regan wanted to “rule out if it [] caused MRSA so she sent

[petitioner] to Erlanger hospital for a CT scan.” (Id.) Dr. Regan referred petitioner to an

orthopedic physician, Dr. Brandon Cincere. (Id.)

On November 18, 2016, petitioner presented to Dr. Cincere. (Ex. 12, p. 2.) She

states that she was in “excruciating pain” and cried when Dr. Cincere tried to raise her

arm. (Id.) Dr. Cincere ordered x rays and an MRI. (Id.) Petitioner avers that she was

“having bad pain in [her] left shoulder arm, hand, and fingers and had pain in [her]

neck.” (Id.) Petitioner was experiencing “tingling all the way down her arm, and into

[her] fingers, so they moved [her] MRI with contrast up to November 30, 2016.” (Id.)

Petitioner presented to Dr. Cincere again on December 20, 2016, for a follow-up visit

after her MRI, at which point petitioner avers that she “still couldn’t use [her] left arm.”

(Id.)

On January 3, 2017, petitioner presented to a walk-in clinic and she avers that

her arm was swelling “so badly that [she] couldn’t move [her] neck.” (Ex. 12, p. 2.) Dr.

Rae prescribed petitioner Robaxin. (Id.) The next day petitioner called Dr. Regan who

advised her to come in immediately and “said the flu shot has set up bursitis.” (Id.)

Petitioner “couldn’t move [her] arm and [her] neck was stiff.” (Id.)

On February 1, 2017, petitioner presented to Chattanooga Imaging for an EMG

and Dr. Kadrie “said it had caused nerve damage in [her] left shoulder.” (Ex. 12, p. 2.)

On February 7, 2017, petitioner presented to Dr. Cincere, who scheduled surgery “due

to the nerve damage, muscle weakness, and pain” in her left shoulder. (Id.) At the time

petitioner needed assistance with dressing, household chores, and driving. (Id.)

Petitioner underwent left shoulder surgery on February 22, 2017. (Id.) After surgery,

petitioner was told by Dr. Cincere “not to lift more than a pencil” and to wear a brace for

six weeks. (Id.) Petitioner attended physical therapy 2x a week, and later returned to

work as a nurse two days a week because she still experienced “a lot of shoulder and

neck pain[.]” (Id.)

IV. Summary of Expert Opinions

a. Petitioner’s expert Naveed Natanzi, D.O.

Dr. Natanzi currently serves as the Medical Director for Tova Surgical Center and

as the Staff Physician for the VA Long Beach Healthcare System. (Ex. 24, p. 1.) He is

also a founder at Regenerative Sports and Spine Institute. (Id.) Dr. Natanzi received

his medical degree from Western University of Health Sciences in 2012. (Id. at 2.) Dr.

Natanzi completed his residency at the University of California Irvine Physical Medicine

and Rehabilitation department. (Id. at 1.) He was also an attending physician in

Interventional Regenerative Sports and Spine medicine at the Bodor Clinic. (Id.) Dr.

Natanzi was trained by Dr. Marko Bodor, the first to describe shoulder injuries related to

vaccine administration in medical literature. (Ex. 18, p. 1.) Dr. Natanzi is board certified

by the American Academy of Physical Medicine and Rehabilitation as well as the

11

American Board of Pain Management. (Ex. 24, p. 1.) On average, he diagnoses and

treats 40 to 50 shoulder and 200 to 300 cervical and lumbar pathologies per month.

(Ex. 19, p. 1.)

Dr. Natanzi opines that there is a clear temporal relationship between vaccination

and onset of petitioner’s symptoms; and her clinical scenario is well in line with the

generally accepted timeframe in SIRVA cases. (Ex. 18, p. 7.) He observes that

petitioner first presented to Dr. Regan on November 11, 2016, nine days post-

vaccination with limited range of motion which began shortly after vaccination. (Id.) Dr.

Regan noted the injection site to be “to[o] far superior,” which Dr. Natanzi explains is

known to increase the likelihood of vaccine overpenetration. 10 (Id.) On December 20,

2016, petitioner was diagnosed with shoulder impingement, rotator cuff tendinosis, and

subacromial bursitis by Dr. Cincere. (Id.) Petitioner’s bursitis diagnosis was further

confirmed by Dr. Cincere intraoperatively on February 22, 2017, where he identified

thickened bursal tissue, Dr. Natanzi explains. (Id.) Dr. Natanzi highlights three key

points in petitioner’s case: her prior influenza vaccination on October 21, 2015, the

onset of her symptoms immediately after vaccination, and petitioner’s prolonged

inflammatory-like clinical reaction—which all suggest a causal relationship between

petitioner’s November 2, 2016 vaccination and her symptoms. (Id.)

Dr. Natanzi observes that Dr. Cincere offered a possible diagnosis of cervical

radiculopathy on June 27, 2017. (Ex. 18, p. 8.) However, Dr. Natanzi stresses that an

MRI of petitioner’s cervical spine (7/19/2017) and two NCS/EMGs (2/1/2017; 7/19/2017)

revealed no signs of radiculopathy or cervical spine pathology that would explain

petitioner’s symptoms. (Ex. 18, p. 8.) Given petitioner’s lack of any history of cervical

symptoms, her benign diagnostic testing, and the acute development of her symptoms

after vaccination, he opines that contribution of symptoms from the cervical spine (i.e.

cervical radiculopathy or facet syndrome) are “exceedingly unlikely.” (Id.)

Dr. Natanzi acknowledged that on November 11, 2016, Dr. Regan noted

numbness and tingling in the left hand, beginning along with the shoulder symptoms

after vaccination. (Ex. 18, p. 8.) Dr. Natanzi explains that “[r]adiating pains associated

with numbness and tingling are common findings in cases of SIRVA.” (Id.) In fact, he

notes that Atanasoff et al. recorded altered sensation in the ipsilateral limb after SIRVA

in four patients out of a cohort of thirteen. (Id. (see S. Atansoff et al., Shoulder injury

related to vaccine administration (SIRVA), 28 VACCINE 8049 (2010) (Ex. 18.5).)

Likewise, Dr. Natanzi points to Okur et al., who described a cool, numb, and heavy

sensation with radiating pains along the affected limb in SIRVA patients immediately

10Dr. Nantanzi further observes that overpenetration is increasingly likely in petitioner’s case given the

proximal injection site, as witnessed by Dr. Regan, the standing position of the injector while petitioner

was seated, and her resting (non-abducted left arm position). (Ex. 18, p. 9 (citing Ian cook, An evidence

based protocol for the prevention of upper arm injury related to vaccine administration (UAIRVA), 7.8

Human Vaccines 845 (2011) (Ex. 18.4); Atanasoff et al., supra, at Ex. 18.5; Gail Cross et al., Don’t aim

too high: Avoiding shoulder injury related to vaccine administration, 45.5 Australian Family Phys. 303

(2016) (Ex. 18.11).))

12

after vaccination. (Ex. 18, p. 8 (see Gokcan Okur et al., Magnetic resonance imaging of

abnormal shoulder pain following influenza vaccination, 43 SKELETAL. RADIOL. 1325

(2014) (Ex. 18.8).) Without any objective findings to suggest otherwise, either in

petitioner’s MRI or EMG/NCS, Dr. Natanzi opines that petitioner’s hand numbness and

tingling were “related directly to SIRVA.” (Ex. 18, p. 8.)

Dr. Natanzi observed that petitioner’s NCS/EMG on February 1, 2017, revealed

signs of a left suprascapular neuropathy. (Ex. 18, p. 8.) According to Dr. Natanzi,

suprascapular neuropathy is a relatively rare diagnosis that often presents in athletes or

heavy laborers. (Ex. 18, p. 8.) The mechanism of injury is typically related to a traction

type injury related to trauma, or as a result of anatomical compression. (Id. (citing

Anthony Romeo et al., Suprascapular Neuropathy, 7 J. AM. ACAD. ORTHOP. SURG. 358

(1999) (Ex. 18.14)).) Dr. Natanzi finds that petitioner had no history of such injuries in

the clinical history, or evidence of an anatomical compression in the MRI or operative

report by Dr. Cincere. (Ex. 18, p. 8.) Despite a surgical release by Dr. Cincere on

February 22, 2017, and resolution of the previously identified suprascapular neuropathy

on a follow-up EMG (7/19/2017), Dr. Natanzi notes that there were no signs of clinical

improvement in petitioner’s symptoms. (Id.) He opines that the findings of

suprascapular neuropathy were subclinical and unrelated to petitioner’s shoulder

symptoms—and thus does not preclude a SIRVA diagnosis. (Ex. 18, p. 8.)

b. Respondent’s Expert, Geoffrey Abrams, M.D.

Dr. Abrams currently serves as Assistant Professor of Orthopedic Surgery at the

Stanford University School of Medicine. (Ex. A, p. 1.) He also holds the appointment

of Staff Physician at the Veterans Administration Palo Alto Health Care Division. (Id.)

Dr. Abrams is the Director of Sports Medicine for Stanford University Varsity Athletics as

well as Director of the Lacob Family Sports Medicine Center at Stanford University.

(Id.) He also serves as Team Physician for numerous professional and collegiate sports

teams in the San Francisco Bay Area. (Id.) Dr. Abrams received his medical degree

from the University of California San Diego. (Ex. C, p. 1.) He competed a surgical

internship at Stanford University Hospital and Clinics from 2007 to 2008; and completed

his residency in 2012 at the same hospital in the Department of Orthopedic Surgery.

(Id.) Dr. Abrams also has a subspecialty certificate in Orthopedic Sports Medicine. (Id.

at 2.) He has a surgical practice focused on orthopedic conditions of the shoulder and

authored or co-authored over sixty peer-reviewed medical articles on various orthopedic

topics. (Ex. A, p. 1; Ex. C, pp. 2-8.)

Dr. Abrams observes that petitioner experienced pain not only in the shoulder,

but also numbness, pain and tingling into the left hand as well as pain in the neck. (Ex.

A, p. 3 (citing Ex. 2, p. 18; Ex. 10, p. 3).) While some suspected cases of SIRVA can

have pain in the shoulder area that may radiate to the upper arm, Dr. Abrams explains

that numbness and tingling are classic findings of a neurogenic pathology. (Id. (citing P.

Marchettini et al., Painful Peripheral Neuropathies, 4 CURRENT NEUROPHARM. 175 (2006)

(Ex. A.10)).) In contrast, Atanasoff et al. reported that “sensory symptoms such as

13

tingling and numbness in the affected extremity were uncommon” among SIRVA cases.

(Ex. A, p. 3-4 (quoting Atanasoff et al., supra, at Ex. A.1).)

Dr. Abrams acknowledges that suprascapular neuropathy is not likely to cause

numbness and tingling to the hand. (Ex. A, p. 4.) However, he opines that there is

another reason to suspect that petitioner’s pain, numbness, and tingling may be related

to another neurogenic cause – her cervical spine. (Id.) Given her neck and shoulder

pain, as well as numbness and tingling into the hand, Dr. Abrams stresses that a

number of petitioner’s providers suspected and evaluated her for cervical spine

pathology. (Id.) Dr. Abrams notes that petitioner’s MRI of the cervical spine

demonstrated C4/5 bilateral narrowing and stenosis as well as C5/6 left foraminal and

canal stenosis from paracentral disc osteophyte complex. (Ex. A, p. 4 (citing Ex 4, p.

19; Ex 14, p. 36.).) In radicular symptoms originating from the cervical spine, Dr.

Abrams explains that the exiting nerve root is often involved, which is the lower number

of the disc complex at any particular level. 11 (Ex. A, p. 4.) He observes that petitioner’s

MRI from July 19, 2017, indicated left sided pathology at both of these levels. (Id.) Dr.

Abram further explains that “the C5 nerve root gives a sensation and/or pain to the

shoulder and lateral upper extremity while the C6 nerve root gives sensation and/or pain

pattern to the lateral forearm and digits (hand).” (Ex. A, p. 4.) These pain patterns are

consistent with the petitioner’s stated location of her symptoms, Dr. Abrams opines.

(Id.)

Furthermore, Dr. Abrams notes evidence of spondylosis, or degenerative

changes, in petitioner’s cervical MRI taken on July 19, 2017. (Ex. A, p. 4.) According to

Dr. Abrams, this is evidenced in the MRI report as “disc desiccation” and reported at

nearly all levels. He explains that cervical spondylosis is a well-documented cause of

neck pain. (Id. (citing Ginger Evans, Identifying and Treating the Causes of Neck Pain,

98 MED. CLIN. N. AM. 645 (2014) (Ex. A.6)).) Furthermore, he suggests that cervical

spondylosis can also lead to referred pain to the upper extremities – including the

shoulder area. (Ex. A, p. 4 (citing Evans, supra, at Ex. A.6).) Dr. Abrams explains that

the mechanism of this “stems from nociceptive afferents from facet joints that converge

in the spinal cord with nociceptive afferents from other distal sites.” (Ex. A, p. 4 (citing

Nikolai Bogduk, The Anatomy and Pathophysiology of Neck Pain, 22 PHYS. MED.

REHABIL. CLIN. N. AM. 367 (2011) (Ex. A.3); Grant Cooper et al., Cervical

Zygaphophysial Joint Pain Maps, 8(4) PAIN MEDICINE 344 (2007) (Ex. A.5); Nalini Sehgal

et al., Systematic Review of Diagnostic Utility of Facet (Zygapophysial) Joint Injections

in chronic Spinal Pain: An Update, 10 PAIN PHYS. 213 (2007) (Ex. A.13)).) Moreover,

Dr. Abrams notes that Cooper et al. reported over half of their patients with cervical

spondylosis at C5/6 suffered shoulder/lateral arm/deltoid pain in addition to neck pain.

(Ex. 8, pp. 4-5 (citing Cooper et al., supra, at Ex. A.13).)

Regarding petitioner’s diagnosis of left suprascapular neuropathy, Dr. Abrams

opines that suprascapular neuropathy is a source of shoulder pain, one where patients

11For instance, Dr. Abram explains that at the C4/5 level the C5 nerve root would most often be affected

while at the C5/6 level the C6 nerve root is involved. (Ex. A, p. 4.)

14

often present with pain to the superior and posterolateral aspect of the shoulder, often

radiating to the neck or lateral arm. (Ex. A, p. 5 (citing Lazaros Kostretzis et al.,

Suprascapular Nerve Pathology: A Review of the Literature, 11 Open Ortho. J. 140

(2017) (Ex. A.9)).) Dr. Abrams disagrees with Dr. Natanzi’s assessment that

suprascapular neuropathy is an uncommon diagnosis. Rather, Dr. Abrams stresses

that suprascapular neuropathy is actually a well-documented source of shoulder pain.

(Ex. A, p. 5 (citing Neil Ghodadra et al., Arthroscopic Decompression of the

Suprascapular Nerve at the Spinoglenoid Notch and Suprascapular Notch Through the

Subacromial Space, 25(4) J. ARTHROSCOPIC AND RELATED SURG. 439 (2009) (Ex. A.8);

Amit Momaya, et al., Clinical outcomes of suprascapular nerve decompression: a

systematic review, 27 J. SHOULDER ELBOW SURG. 172 (2018) (Ex. A.11); Dana Piasecki,

Suprascapular Neuropathy, 17(11) J. AM. ACAD. ORTHOP. SURG. 665 (2009) (Ex. A.12)).)

Rarely is there a history of acute trauma in those with a diagnosis of suprascapular

neuropathy, Dr. Abrams stresses. (Ex. A, p. 5 (citing Ghodara et al., supra, at Ex. A.8;

Momaya et al., supra, at Ex. A.11).) Furthermore, Dr. Abrams suggests that it is

expected that some patients with suprascapular neuropathy will have normal MRIs.

(Ex. A, p. 5.) There are three typical sources of suprascapular nerve compression: 1)

space occupying lesion such as a paralabral cyst, 2) traction injury, and 3) hypertrophic

suprascapular ligament and/or narrowed suprascapular notch. (Id. (citing Piasecki,

supra, at Ex. A.12).) In the latter two scenarios, Dr. Abrams stresses that MRIs will not

have any direct finding of suprascapular nerve pathology in the early stages of the

disease. (Ex. A, p. 5.) Instead, the EMG results are used to diagnose the disorder.

Therefore, in petitioner’s case, Dr. Abrams opines that the results of petitioner’s

first EMG on February 1, 2017, as well as the MRI of the shoulder on November 30,

2016, suggest that petitioner’s suprascapular neuropathy was present only for a

relatively short time. (Ex. A, p. 5.) In fact, Dr. Abrams opines that “it would be

reasonable to conclude that this nerve pathology may have arisen around the time of

the injection.” (Id.) Dr. Abrams draws this conclusion based on the abnormal muscle

response of the supraspinatus and infraspinatus on the EMG evaluation 12 combined

with the finding of no significant loss of muscle bulk/mass and/or fatty infiltration seen

within these muscles on the MRI. (Id.) In the setting of chronic muscle denervation (in

this instance, the supraspinatus and infraspinatus muscles of the rotator cuff), Dr.

Abrams opines that “one would expect to see loss of muscles mass and fatty

infiltration/atrophy on the MRI.” (Ex. A, p. 5.) However, he notes that this is not noted in

the MRI report, indicating that the motor endplates and synaptic connections between

the nerve and muscle had not fully degenerated. (Id. (citing Meredith Wilson & Michael

Deschenes, The neuromuscular junction: Anatomical features and adaptations to

various forms of increased, or decreased neuromuscular activity, 115 INTERN. J.

12 Furthermore, Dr. Abrams opines, that a patient may experience clinical symptoms of shoulder pain

despite having a normal EMG/NCS evaluation for suprascapular neuropathy. (Ex. A, p. 5.) Citing Freehill

et al., Dr. Abrams notes that while electromyography and nerve conduction velocity studies are the “gold

standard for confirmation of the diagnosis of suprascapular neuropathy…nerve pain may occur even in

the setting of a negative electromyography.” (Id. (citing Michael Freehill, Suprascapular Neuropathy:

Diagnosis and Management, 40(1) PHYS. AND SPORTSMEDICINE 72 (2012) (Ex. A.7)).) This would provide

a plausible explanation for petitioner’s continued pain following her suprascapular nerve decompression

performed by Dr. Cincere, Dr. Abrams opines. (Ex. A, p. 5.)

15

NEUROSCIENCE 803 (2005) (Ex. A.14)).) Therefore, he concludes that “the

suprascapular nerve pathology had been present over a time period of months, not

years, and certainly could have begun to manifest itself around the time of the 2016

vaccination.” (Ex. A, p. 5.)

Dr. Abrams further disagrees with Dr. Nantanzi’s theory of over-penetration of the

needle into petitioner’s shoulder, leading to an inflammatory reaction in the subacromial

space. (Ex. A, p. 6.) First, Dr. Abrams stresses that petitioner did not experience pain

relief with the pre-operative subacromial bursa injections or the shoulder arthroscopy,

both meant to address the location of the alleged SIRVA insult. (Id.) This offers an

alternative explanation for petitioner’s shoulder pain: either cervical etiology and/or

residual suprascapular nerve disfunction even after the surgical decompression. (Id.)

Second, Dr. Abrams suggests that the medical literature cited by Dr. Nantanzi is not

persuasive. (Id.) In both cases of needle over-penetration studied by Bodor et al., the

patients experienced complete pain relief with subacromial bursa-directed corticosteroid

injections. (Id. (citing Bodor et al., supra, at Ex. A.2).) This was not the case with

petitioner. (Ex. A, p. 6.) Trollmo et al. examined systemic inflammatory effect of intra-

articular injection to the knee and wrist in experimental and control subjects. (Id. (citing

Trollmo et al., supra, at Ex. 18.1).) However, Dr. Abrams stresses that there is no

evidence that petitioner received an intra-articular injection; and according to Dr.

Nantazi, petitioner received, possibly, a sub-deltoid or subacromial vaccination. (Ex. A,

p. 6.) Even still, Dr. Abrams notes that the intra-articular space of the glenohumeral

joint differs substantially in anatomy and composition from the subacromial space. (Id.)

Finally, Dr. Abrams observes that Barnes et al., Uchida et al., and Okur et al. report that

patients in their case series had MRI findings of either bone bruising, subacromial

effusion, and/or fluid signal in the deep muscular layers. (Id.) According to Dr. Abrams,

there is no evidence of any of these findings in the radiology report from petitioner’s

November 30, 2016 MRI. 13 (Id.)

c. Dr. Natanzi’s First Supplemental Expert Report

As is common in SIRVA cases, Dr. Natanzi notes that secondary compensational

issues may develop as a result of “favoring the shoulder.” (Ex. 19, p. 2.) In petitioner’s

case, Dr. Natanzi opines that her shoulder pain and reduced glenohumeral joint range

of motion have resulted in overuse, malpositioning, and imbalance of the

scapulothoracic joint. (Id.) As a result, muscles of this joint that have attachments to

the cervical spine (namely the levator scapulae and upper trapezius) exert altered and

atypical forces/strain on the cervical spine and cause cervical mediated signs,

symptoms, and pathology. (Id.) Dr. Natanzi opines that this phenomenon is particularly

13 In petitioner’s shoulder MRI, Dr. Cincere reported evidence of “left shoulder bursal signal changes RTC

signal changes.” (Ex. A, p. 6 (citing Ex. 4, p. 29).) However, Dr. Abrams highlights the operative report,

which states that the bursal side of the rotator cuff was “completely intact.” (Ex. A, p. 6 (citing (Ex. 4, p.

23).) According to Dr. Abrams, many of the SIRVA cases in the literature that claim needle over-

penetration result in bursal-sided rotator cuff pathology. (Ex. A, p. 6 (citing Bodor et al., supra, at Ex.

18.2; Atanasoff et al., supra, at Ex. 18.1).) These findings were not seen in petitioner’s MRI or noted by

Dr. Cincere during surgery.

16

likely in petitioner’s case given the delayed onset of cervical symptoms, beginning

approximately 2 months post-vaccination on January 3. (Id. (citing Ex. 10, p. 4).) Dr.

Natanzi opines that petitioner “likely experienced myofascial and facet sprain/strain

symptoms as a result of favoring her shoulder.” (Ex. 19, p. 2.) In support, Dr. Natanzi

cites a case study by Escobar et al., who described a trigger point in a part of the rotator

cuff (teres minor) with radiating symptoms into the ring and little fingers. (Ex. 19, p. 2

(citing Pedro Luis Escobar & Julian Ballesteros, Teres Minor: Source of Symptoms

Resembling Ulnar Neuropathy or C8 Radiculopathy, 67.3 Am. J. Physical Med. &

Rehab. 120 (1988) (Ex. 19.3)).) Although the teres minor was not the specific rotator

cuff muscle affected in petitioner’s case, Dr. Natanzi opines that “there are likely other

rotator cuff ‘trigger points’ that may account for additional anomalous neuropathic pain

referral patterns as experienced by [petitioner].” (Ex. 19, p. 2.) Thus, he opines that the

paresthesia-like sensations petitioner felt immediately post-vaccination in the ipsilateral

limb were “related to a rotator cuff referral pattern” and therefore “unrelated to the

cervical spine.” (Id.)

Lastly, based on his experience and discussions with Dr. Bodor, Dr. Natanzi

explains that he has seen cases similar to petitioner’s, and attributes the refractory

symptoms to the vaccine remaining embedded in the rotator cuff tendons. (Ex. 19, p. 2-

3.) Dr. Natanzi explains that the vaccine can become lodged within the tendon itself—

and would be invisible to the naked eye or an arthroscopy camera and therefore

undetectable and untreatable with arthroscopic surgery. 14 (Id.) Ultimately, he explains

that “shoulder pain associated with compensatory neck pain” can exist and does not

preclude a SIRVA diagnosis. (Id.)

d. Dr. Abrams’ Supplemental Expert Report

In his supplemental expert, Dr. Abrams stresses that there are irrefutable facts

that argue against a SIRVA related diagnosis. (Ex. C, p. 1.) First, Dr. Abrams observes

once again that petitioner’s MRI taken approximately four weeks post-vaccination did

not show any of the signs of SIRVA—bursitis, bursal sided rotator cuff pathology, bone

edema, etc. (Id.) Dr. Abrams notes that Dr. Natanzi relies on Dr. Cincere’s report (Ex.

14, p. 2), concluding that there are objective signs of bursitis and tendinopathy on

petitioner’s MRI. (Id. (citing Ex. 19, p. 1).) Closer examination reveals that Dr. Cincere

disagreed with the radiologist’s report on the axial images, a series of images that are

rarely utilized for viewing bursitis, according to Dr. Abrams. (Ex. C, p. 1 (citing Ex. 14,

p. 2).) Moreover, Dr. Abrams stresses that Dr. Cincere used the term “bursal changes”

but nowhere in his note from this visit does he state that he sees inflammation or fluid in

the bursa. (Ex. C, p. 1.)

14 Dr. Natanzi further describes a procedure known as the Tenex procedure, an ultrasound guided

percutaneous tenotomy, in which the vaccine is “cleaned out” of the tendon. (Ex. 19, p. 3.) Dr. Natanzi

observes that Dr. Bodor’s preliminary data has shown a near-complete resolution of shoulder pain in

similar cases after this procedure—lending further supporting to this theory. (Id.)

17

Second, Dr. Abrams disputes the onset of petitioner’s neck pain and cervical-

related symptoms. (Ex. C, p. 1.) Dr. Abrams points to records indicating that

petitioner’s “numbness, pain and tingling to the left hand” began five days following the

injection, not two months later (as Dr. Natanzi proposes). (Id. (citing Ex. 2, p. 18).) This

would make Dr. Natanzi’s mechanism for a compensational pattern of shoulder pain

less likely, according to Dr. Abrams. (Ex. C, p. 1.) Furthermore, Dr. Abrams stresses

that there are several other possible sources for petitioner’s neck pain that are

objectively documented in her medical history, including C5/6 left foraminal and canal

stenosis from paracentral disc osteophyte complex, spondylosis or “disc desiccation,”

and negative EMG (with suprascapular nerve findings). (Ex. C, p. 1 (citing Ex. 4, pp.

19, 24-25; Ex. 14, pp. 19, 36).)

Third, Dr. Abrams maintains that petitioner did not receive any improvement in

symptoms with the administration of a corticosteroid injection. (Ex. C, p. 3.) Dr. Abrams

disagrees with Dr. Natanzi’s theory suggesting the vaccine could be lodged in the

tendon itself; and Dr. Abrams stresses the lack of objective evidence supporting this

theory. (Id.) Nonetheless, Dr. Abrams stresses that if Dr. Natanzi’s theory is possible, it

would likely incite some inflammatory process within the tendon itself—which again was

not seen on the shoulder MRI four weeks post-vaccination. (Id.)

Lastly, Dr. Abrams emphasizes the record from petitioner’s visit with Dr. Regan

nine days post-vaccination. (Ex. C, p. 3 (citing Ex. 2, p. 18).) Dr. Regan offered

statements about the location of the injection in the history of present illness section;

however, the section memorializing the physical exam did not include any evidence that

the examiner was able to see the location of the injection. (Ex. C, p. 3 (citing Ex. 2, p.

18).) Furthermore, Dr. Abrams suggests that the outside of a skin reaction to the

injection (of which there was no mention) and the location of needle penetration to the

skin would be difficult to visualize nine days following vaccination. (Ex. C, p. 3.)

e. Dr. Natanzi’s Second Supplemental Expert Report

In his second supplemental expert report, Dr. Natanzi suggests that “Dr. Abrams

agrees that TOS [thoracic outlet syndrome] is not the source of [petitioner’s] ongoing

shoulder pain given his comments on page 3 of his supplemental expert report (Exhibit

C).” 15 (Ex. 20, p. 1.) He further finds that Dr. Abrams “[e]ssentially agrees that given

the ongoing pain – despite surgical decompression of the suprascapular nerve in

conjunction with the subsequent negative (normal) EMG – the suprascapular nerve

cannot be a source of ongoing pain.” (Id.)

Dr. Natanzi agrees that a sensory radiculopathy could be the source of radicular

symptoms in light of a negative EMG; and that cervical radiculopathy can cause

shoulder pain and upper limb paresthesia. (Ex. 20, p. 1.) However, Dr. Natanzi

maintains that cervical radiculopathy was not the likely cause of petitioner’s pain, for

15Dr. Abrams does not appear to discuss thoracic outlet syndrome on page 3 of Exhibit C or otherwise.

(See Ex. C.)

18

three reasons. (Id. at 2.) First, he stresses that petitioner never had any history of neck

pain or upper limb symptoms prior to the date of vaccination. (Id.) For symptoms of a

neck disorder (cervical radiculopathy) to have surfaced spontaneously after five

decades of life, and coincidentally days after a shoulder injection (that can

independently explain petitioner’s symptoms), is very unlikely—Dr. Natanzi explains.

(Id.) Second, Dr. Natanzi suggests that multiple physical exams demonstrate signs of

impingement and a restricted shoulder range of motion, which are indicative of a

shoulder pathology, and would not be expected in the context of a cervical issue like

radiculopathy. (Id.) Lastly, he emphasizes the fact that an orthopaedic surgeon

performed surgery on the shoulder, and “[c]learly he would not have done so if he even

suspected the pain was stemming from her neck.” (Ex. 20, p. 2.)

Dr. Natanzi again stresses that trigger points in the rotator cuff can cause

symptoms that extend into the hand. (Ex. 20, p. 2 (citing Escobar et al., supra, at Ex.

19.3; Okur et al., supra, at Ex. 18.8; Atanasoff et al., supra, at Ex. 18.5).) To

demonstrate, Dr. Natanzi cites a study of 94 patients with various shoulder pathologies

where the authors mapped out pain symptom patterns from the level of the shoulder all

the way to the hand. (Ex. 20, p. 2 (citing Levent Bayam et al., Pain Mapping for

Common Shoulder Disorders, 40(7) AM. J. ORTHOP. 353 (2011) (Ex. 20.3)).) Similar to

petitioner’s case, Dr. Natanzi identifies 28 patients in that study who were diagnosed

with impingement syndrome, of which 9 of 28 (32%) had a sense of dull aching pain

below the elbow (forearm and hand) and 7 of 28 (25%) had pins and needles

sensations in the hand. (Ex. 20, p. 2 (citing Bayam et al., supra, at Ex. 20.3).) Although

symptoms radiating to the hand is more commonly seen in the setting of cervical

radiculopathy, Dr. Natanzi explains that these symptoms can also be seen in the setting

of rotator cuff-mediated pain. (Ex. 20, p. 2.)

Lastly, Dr. Natanzi indicates that he reviewed the MRI images and opines that

“there are clear signs of subacromial fluid accumulation (bursitis) [and] these findings

complement Dr. Cincere’s 12/20/16 clinical findings of impingement.” (Ex. 20, p. 3

(citing Ex. 14, p. 2).) In response to Dr. Abrams, Dr. Natanzi stresses that “this is one

piece of data that is clearly objective and not left to interpretation.” (Ex. 20, p. 3.) This

finding, Dr. Natanzi adds, complements Dr. Cincere’s intraoperative findings of 2/22/17

in which Dr. Cincere identified thickened bursal tissue, which is expected in bursitis.

(Id.) Reviewing Dr. Zand’s report (discussed below), Dr. Natanzi notes that Dr. Zand

traced the distance from the skin to the subacromial space (the path the needle would

travel) and measured it to be 18 to 20 millimeters. (Ex. 20, p. 3 (citing Ex. 21).)

According to Dr. Natanzi, a typical vaccination needle measures 25.4 mm. (Ex. 20, p.

3.) He explains that with an improper technique, it is clear that the vaccine needle is

long enough to have caused penetration into the subacromial bursa and underlying

rotator cuff, causing petitioner’s bursitis and rotator cuff tendinopathy. (Id.)

19

f. Petitioner’s expert, Tinoosh Zand, M.D.

Dr. Zand currently serves as a Senior Partner radiologist and Director of the

quality control committee at Focus Medical Imaging. (Ex. 22, p. 2.) He is a board-

certified diagnostic radiologist in private practice since 2020. (Ex. 21, p. 1.) Dr. Zand

received his medical degree from Rosalind Franklin University at the Chicago Medical

School in 2003. (Ex. 22, p. 1.) He did his diagnostic radiology residency at Harvard

Medical School / Mount Auburn Hospital and his subspeciality fellowship training in

musculoskeletal imaging at the University of Southern California. (Ex. 21, p. 1.) Dr.

Zand interprets approximately 3000-4000 MRI examinations a year; and the majority of

the examinations are of the shoulder, knee, cervical spine, and lumbar spine. (Id.)

Dr. Zand reviewed petitioner’s MRI arthrogram of the left shoulder taken on

November 30, 2016, as well as the MRI results by John Nelson, M.D. (Ex. 21, p. 1.)

Dr. Zand explained that the MRI arthrogram of the left shoulder included the following

sequences: axial T1 and T2 DE3D WE, coronal oblique T1, T1FS and T2FS, sagittal

oblique T2. (Id.) Dr. Zand observed the following: 1) mild acromioclavicular joint

arthrosis with capsular hypertrophy and edema; 2) mild subacromial / subdeltoid

bursitis; 3) moderate thickening and intermediate signal in the supraspinatus tendon

representing tendinosis; 4) thickening and intermediate signal in the intra-articular

portion of the long head of the biceps tendon representing tendinosis; 5) thinning of the

posterior labrum which may be secondary to a chronic labral tear; 6) adequate joint

distention without extravasation of contrast into the subacromial / subdeltoid bursa. (Id.)

Lastly, Dr. Zand measured the deltoid fat pad and muscle thickness at the level of the

greater tuberosity of the humeral head from the skin to the lateral aspect of the

subacromial / subdeltoid and found the distance to be 18-20 mm on the coronal oblique

T2 FS sequence depending on the angle of measurement. (Id. at 2.)

V. Party Positions

a. Petitioner’s contentions

Petitioner stresses that she suffered a left-sided shoulder injury meeting all four

criteria demonstrating a SIRVA Table injury. (ECF No. 49, p. 9.) Alternatively,

petitioner asserts that reliable medical evidence supports a non-Table injury was

caused-in-fact by her vaccination. (Id. at 15.)

In support of her Table claim, petitioner stresses that her symptoms were limited

to the left shoulder and that no other condition or abnormality would explain her

symptoms. (ECF No. 49, p. 10.) Specifically, petitioner suggests that this is a “classic

left SIRVA injury with symptoms limited to the left shoulder, and a subsequent, distinct

cervical injury beginning on or around December 31, 2016.” (Id.) Petitioner “does not

dispute that she suffered from cervical symptoms throughout her course of treatment for

the SIRVA injury.” (Id.) Rather, petitioner asserts that symptoms radiating into the hand

can be seen in a SIRVA injury and petitioner’s complaints of cervical issues developed

20

in January 2017 when she developed neck pain after waking up with a “crick” in her

neck. (Id. at 11.) Furthermore, petitioner posits that the language “limited to the

shoulder” was not meant to bar a case with a “clear root shoulder injury with associated

radiating symptoms[.]” (Id. at 12 (citing 42 C.F.R. § 100.3(c)(10)).) Next, petitioner

argues that neither cervical radiculopathy nor suprascapular neuropathy were the cause

of petitioner’s left shoulder pain. (ECF No. 49, p. 12.) In support of petitioner’s

argument, her expert opines that petitioner’s suprascapular neuropathy was subclinical

and unrelated to the shoulder symptoms experienced by petitioner post-vaccination and

diagnosed by MRI. (Id. at 12-13.) Moreover, petitioner’s expert explains that her

cervical symptoms were not the likely cause of her shoulder pain because petitioner did

not have a prior history of neck or upper limb pain, petitioner’s EMG results were

negative, and petitioner’s physical examinations demonstrated signs of impingement

and reduced range of motion—which strongly point to shoulder pathology as the source

of her pain. (Id. at 13-14.)

In support of her causation-in-fact claim, petitioner asserts that she has satisfied

all three Althen prongs. (ECF No. 49, pp. 15-20.) Under prong one, petitioner requests

that this Court take judicial notice that SIRVA has been added to the Vaccine Injury

Table for the influenza vaccine, and therefore petitioner has met her burden under

prong one requiring preponderant evidence of a medical theory connecting the flu

vaccine to SIRVA. (Id. at 15.) Alternatively, petitioner relies on the medical literature

cited by Dr. Natanzi—describing over 80 cases of immune-mediated inflammatory

reactions as a result of vaccination. (Id. (citing Ex. 18.1-18.11.)) The proposed

mechanism of injury, petitioner alleges, “is the unintentional injection of antigenic

material into synovial tissues and / or the subdeltoid bursa causing an immune-

mediated inflammatory reaction.” (ECF No. 49, p. 15 (quoting Atanasoff et al., supra,

Ex. 18.5).) Under prong two, petitioner stresses that she had no prior history of injury to

her left upper extremity and presented to her primary care physician nine days post-

vaccination with redness, swelling, and limited range of motion. (ECF No. 49, p. 16.)

Moreover, petitioner’s PCP observed that the injection site was “too far superior.” (Id.)

Petitioner was subsequently diagnosed with impingement syndrome, rotator cuff

tendonitis, and bursitis by her orthopedist Dr. Cincere. (Id.) Taken together, petitioner

asserts that she has demonstrated a logical sequence of cause and effect showing that

the vaccination was the cause of her injuries. (Id.) Finally, under the third prong,

petitioner stresses that she presented to her PCP nine days post-vaccination reporting

shoulder pain and limited range of motion since receiving her flu shot. (Id. at 19.)

Petitioner suggests that the Vaccine Table and SIRVA QAI establish a 48-hour

medically acceptable timeframe for the onset of symptoms. (Id.) Furthermore,

petitioner cites her affidavit, where she described pain when the vaccine was

administered and swelling within 30 minutes after her vaccination. (Id.)

In response to respondent’s contentions, petitioner stresses that she has

preponderantly demonstrated a logical sequence of cause and effect showing that the

vaccination was the cause of her injuries. (ECF No. 57, pp. 2-3.) Petitioner stresses

21

that Dr. Cincere’s July 27, 2017, report noted that there was no further structural

damage to the shoulder—because her left shoulder was surgically repaired five months

prior to this visit. (Id. at 2.) Additionally, petitioner argues that she demonstrated

improvement following surgery, albeit inconsistently. (Id.) Therefore, petitioner argues

that it is speculative to conclude that because petitioner continued to have symptoms

following surgery that the shoulder injury was not a continual source of those symptoms.

(Id.) Finally, petitioner maintains that petitioner was diagnosed with subacromial bursitis

and tendonitis. (Id. at 3.) While respondent argues that the bursal side of petitioner’s

rotator cuff was found intact during surgery, petitioner highlights the February 22, 2017,

surgical report which indicates “extensive subacromial bursitis.” (Id.) Petitioner

stresses that these diagnoses are “hallmark SIRVA diagnoses.” (Id.)

b. Respondent’s contentions

Respondent argues that petitioner is not entitled to compensation because she

has not met the elements for a Table SIRVA nor has she presented preponderant

evidence showing that her injury was caused-in-fact by her influenza vaccination. (ECF

No. 51, pp. 6, 8.)

Specifically, respondent stresses that petitioner’s pain was not limited to her left

shoulder, and that other conditions explain her symptoms. (ECF No. 51, pp. 6-7.)

Respondent suggests that petitioner likely experienced numbness and tingling in her

hand in her first visit with her PCP on November 11, 2016, and later records specifically

indicate that petitioner had numbness and tingling in the second, third, and fourth digits

of the left hand. (Id. at 6-7.) Moreover, respondent argues that the fact that pins-and-

needles sensations in the hand have been reported with shoulder impingement is not

relevant. (Id. at 7 (citing ECF No. 49, p. 11).) Respondent contends that petitioner has

failed to satisfy the criteria set forth in the Vaccine Injury Table QAIs that would entitle

her to a presumption of vaccine causation. (ECF No. 51, p. 7.)

Respondent emphasizes the fact that petitioner also reported pain in her neck

(Id.) Though petitioner claims that her neck pain stems from a distinct injury,

respondent argues that her medical records indicate that her neck pain was related to

her left-hand paresthesia—prompting Dr. Cincere to order an EMG/NCS to evaluate

petitioner for cervical radiculopathy. (Id.) Respondent also asserts that petitioner

suffered from suprascapular neuropathy and cervical-spine pathology, either of which

could explain her symptoms. (Id. at 7-8.) Suprascapular neuropathy causes shoulder

pain, and respondent stresses that while this condition “may not explain all of

petitioner’s symptoms,” respondent suggests that petitioner’s theory that this

neuropathy was “subclinical” is unconvincing. (Id.) Notably, respondent asserts that the

QAIs specifically identify neuropathies as “conditions that preclude a Table SIRVA.” (Id.

(citing 42 C.F.R. § 100.3(b)(10)(iv)).) Furthermore, petitioner’s cervical spine MRI

showed disc desiccation at all levels, explaining the numbness and tingling that

petitioner reported in her initial visit nine days post-vaccination. (ECF No. 51, p. 8.)

22

Respondent further contends that petitioner has not established causation in fact.

(ECF No. 51, p. 8.) Under Althen prong one, respondent stresses that petitioner has

not offered a persuasive medical theory linking the vaccination to her condition. (Id. at

9.) Respondent argues that prong one cannot be met simply by pointing to the fact that

SIRVA is a Table injury. (Id.) Likewise, respondent asserts that the only support for Dr.

Natanzi’s needle over-penetration theory are case reports—which are weak evidence of

causation. (Id. at 10.) Under prong two, respondent contends that there is no logical

sequence of cause and effect showing that the vaccination caused petitioner’s injury

where the record indicates that petitioner’s symptoms cannot be attributed to the type of

mechanical shoulder injury that Dr. Natanzi claims is caused by the vaccine

(impingement, bursitis, or capsulitis). (Id. at 11.) Specifically, respondent’s expert

explains that the pain petitioner suffered in her neck and in her left hand are indicative

of cervical radiculopathy. (Id.) Moreover, petitioner received no benefit from

subacromial steroid injection—suggesting that inflammation was not the cause of her

pain. (Id. at 11-12.) Finally, respondent stresses that none of petitioner’s treating

doctors attributed her condition to the vaccine. (Id. at 12.) In fact, petitioner’s

orthopedic surgeon indicated that “the initial process of how this all started does not

seem to make a lot of sense to me.” (Id. (citing Ex. 4, p. 3).) Respondent did not

address prong three, a proximate temporal relationship between vaccination and injury.

(See ECF No. 51, pp. 8-13.)

VI. Analysis

a. Petitioner’s Table Injury claim

As explained above, the Vaccine Injury Table lists SIRVA as a compensable

injury if it occurs within 48 hours of administration of a vaccine containing the influenza

virus. § 300aa-14(a) as amended by 42 C.F.R. § 100.3(a). To be considered a Table

“SIRVA,” petitioner must show: (i) there is “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) that “onset of pain occurred within the

specified timeframe,” i.e. within 48 hours; (iii) that “pain and reduced range of motion

are limited to the shoulder in which the intramuscular vaccine was administered”; and

(iv) that “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(a); 42 C.F.R. §

100.3(c)(10).

In this case there is no dispute as to the first and second QAI SIRVA criteria.

Respondent raises no argument in either his Rule 4 report or his response to

petitioner’s motion for a ruling on the record that petitioner had a prior history of

shoulder dysfunction, or that petitioner’s injury arose outside of the 48-hour timeframe

identified by the Vaccine Injury Table. (ECF Nos. 26, 51.) My own review of the record

23

confirms these points. Based on the record as a whole, petitioner has preponderantly

established that she suffered onset of new shoulder pain within 48 hours of the

vaccination at issue in this case. Rather, respondent’s defense against petitioner’s

Table Injury claim hinges on the third and fourth SIRVA QAI prongs. Respondent

contends that petitioner’s pain was not limited to the shoulder in which she received her

vaccination and also that her condition is better explained by suprascapular neuropathy

and cervical-spine pathology. (ECF No. 51, pp. 6-8.) In this case, respondent’s

arguments regarding these two prongs are closely related.

With regard to the third SIRVA criterion, “the gravamen of this requirement is to

guard against compensating claims involving patterns of pain or reduced range of

motion indicative of a contributing etiology beyond the confines of a musculoskeletal

injury to the affected shoulder.” Grossmann v. Secretary of Health & Human Services,

18-13V, 2022 WL 779666, at *15 (Fed. Cl. Spec. Mstr. Feb. 15, 2022) (citing Werning v.

Sec'y of Health & Human Servs., No. 18-0267V, 2020 WL 5051154, at *10 (Fed. Cl.

Spec. Mstr. July 27, 2020) (finding that a petitioner satisfied the third SIRVA QIA

criterion where there was a complaint of radiating pain, but the petitioner was

“diagnosed and treated solely for pain and limited range of motion to her right

shoulder.”)) Relatedly, the fourth QAI SIRVA criteria requires petitioner to demonstrate

that no other condition or abnormality is present that would explain her symptoms.

Important to this case, the SIRVA QAI’s specifically identify evidence of neuropathy and

radiculopathy, rather than confirmed diagnoses, as conditions which preclude a Table

SIRVA. 42 C.F.R. § 110.3(b)(10(iv) (petitioner must have “No other condition or

abnormality that would explain the patient’s symptoms (e.g. NCS/EMG or clinical

evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other

neuropathy)”).

Here, petitioner voiced subjective complaints demonstrating that she experienced

pain beyond the left shoulder, including numbness and tingling to her left arm and hand

at the outset and later onset of neck pain. (Ex. 2, pp. 14, 18; Ex. 4, pp. 1, 4, 24; Ex. 5,

pp. 11, 48, 73; Ex. 10, p. 1.) Additionally, her medical records include two separate and

potentially confounding diagnoses – suprascapular neuropathy and cervical

radiculopathy. For all the reasons discussed by the experts there are substantial

questions surrounding both diagnoses; however, each is supported by at least some

objective evidence. Petitioner’s February 1, 2017, EMG showed evidence of left

suprascapular neuropathy. (Ex. 4, pp. 24-25.) Suprascapular neuropathy was also

among her surgical findings. (Id. at pp. 21-23.) Additionally, petitioner’s cervical spine

MRI showed mild right C4-C5 canal and foraminal stenosis and mild right and minimal

left C5-C6 canal and foraminal stenosis. 16 (Ex. 4, pp. 19-20.) Numbness and tingling

are hallmark symptoms associated with radiculopathy. (Evans, supra, at Ex. A.6, p.

16 Spinal stenosis is “the narrowing of the vertebral canal, nerve root canals or intervertebral foramina of

the lumbar spine caused by encroachment of bone upon the space” and symptoms are caused

compression of the cauda equina and include “pain paresthesias, and neurogenic claudication.” Spinal

stenosis, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=108389 (last accessed Apr. 27, 2022).

24

648; Caridi et. al., supra, at Ex. A.4, 266.) Cervical radiculopathy is caused by

compression of a cervical nerve root, and depending on the location of that

compression, patients experience varying patterns of pain, weakness, and absent

reflexes. (Caridi et al., supra, at Ex. A.4.) C5 radiculopathy, in particular, is associated

with pain “in the shoulder and radiates down the ventral arm to below the elbow.”17 (Id.

at 266.) Dr. Natanzi stresses that these initial numbness and tingling symptoms were

more likely than not related to petitioner’s SIRVA injury. (Ex. 18, p. 8 (“Radiating pains

associated with numbness and tingling are common findings in cases of SIRVA.”); Ex.

20, p.2.) However, he also acknowledges that cervical radiculopathy can cause

shoulder pain and upper limb paresthesia. (Ex. 20, pp. 1-2; Caridi et al., supra, at Ex.

A.4, p. 266.) He also agrees that a sensory radiculopathy could be the source of

radicular symptoms in light of a negative EMG. (Id.)

As discussed further below in the cause-in-fact context, petitioner continued to

complain of shoulder pain and reduced range of motion throughout her course of

treatment and showed objective shoulder pathology on MRI consistent with bursitis and

rotator cuff tendinitis. (Ex. 4, p. 29; Ex. 21, pp 1-2.) Thus, it does not appear that

petitioner’s neurologic conditions wholly explain her presentation. However, there is still

significant evidence suggesting that one or both of petitioner’s diagnosed cervical

radiculopathy and/or suprascapular neuropathy presented as comorbid conditions that

contributed to petitioner’s overall presentation, with the cervical radiculopathy further

standing as likely explanation of additional symptoms of numbness and tingling that

extended beyond the confines of petitioner’s musculoskeletal injury to her left shoulder.

Petitioner therefore has not satisfied either the third or fourth SIRVA QAI criteria. Even

if it is possible that petitioner’s numbness and tingling might alternatively be explained

by her shoulder pathology as Dr. Natanzi suggests, this evidence is enough to deprive

petitioner of a causal presumption and require that petitioner’s claim be assessed on a

cause-in-fact basis.

b. Petitioner’s Cause-in-Fact Claim

i. Medical theory causally connecting the vaccination and the

injury (Althen prong one)

The first Althen prong requires petitioner to present a persuasive medical theory

of causation demonstrating that the influenza vaccine could have caused her alleged

17 Cervical radiculopathy was not seen on two different EMG procedures, on February 1, 2017 (Ex. 4, p.

24) and on July 19, 2017 (Ex. 4, p. 13). However, Dr. Abrams explains that patients with normal EMGs

with known cervical pathology can demonstrate pain patterns in the neck and upper extremity. (Ex. C, p.

2.) Lazaro et al. studied 75 patients who had MRI confirmed spinal degermation, bulging discs, and facet

hypertrophy with neck and upper extremity pain (with non-dermatomal paresthesias) who had normal

EMG studies. (Lazaro et al., supra, at Ex. C.1.) The authors concluded that the utility of the EMG

procedure is limited to pathology in the motor unit and “cannot assess the function of the sensory

components of the spinal roots, small-diameter sensory nerves, and the sensory innervation of the spine

via sinuvertebral nerve,” strongly suggesting that a normal EMG does not rule out the presence of

cervical spine mediated pain patterns. (Id. at 1.)

25

shoulder injury. Althen, 418 F.3d at 1278. It is well-established in the Vaccine Program

that compensation may be awarded for shoulder injuries on a cause-in-fact basis. See,

e.g., A.P. v. Sec'y of Health & Human Servs., No. 17-784V, 2022 WL 275785 (Fed. Cl.

Spec. Mstr. Jan. 31, 2022); L.J. v. Sec'y of Health & Human Servs., No. 17-0059V, 2021

WL 6845593 (Fed. Cl. Spec. Mstr. Dec. 2, 2021); Tenneson v. Sec'y of Health & Human

Servs., No. 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018) rev. den.,

142 Fed. Cl. 329 (2019). However, petitioner’s medical theory must be supported by

“reputable” scientific evidence and must “pertain[] specifically to the petitioner’s case.”

Moberly, 592 F.3d at 1322.

In her motion petitioner asks this Court to take judicial notice that SIRVA was

added to the Vaccine Injury Table for the influenza vaccine effective March 21, 2017.

(ECF No. 49, p. 15.) However, where a petitioner alleges both an on-Table SIRVA and

off-Table shoulder injury, she must set forth a theory of causation to meet her burden for

the off-Table claim. Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1147-48

(Fed. Cir. 1992) (explaining with respect to cause-in-fact claims that “[s]imple similarity

to conditions or time periods listed in the Table is not sufficient evidence of causation;

evidence in the form of scientific studies or expert medical testimony is necessary to

demonstrate causation for such a petitioner.”). “The Act relaxes proof of causation for

injuries satisfying the Table in § 300aa–14, but does not relax proof of causation in fact

for non-Table injuries.” Id. at 1148. The government’s recognition of “SIRVA” as a

vaccine-caused injury was limited by the accompanying QAI criteria and for the reasons

discussed above, I have already concluded that petitioner has not met those criteria.

Importantly, however, petitioner’s expert cites three key articles concerning

shoulder dysfunction post-vaccination. 18 (Ex. 18, p. 10.) Atanasoff et al., and Bodor

and Montalvo were both cited as support for the addition of SIRVA to the Vaccine Injury

Table. Proposed Rulemaking, 2015 WL 4538923, at *45136 (citing Atanasoff et al.,

supra, at Ex. 18.5; Bodor & Montalvo, supra, at Ex. 18.2). As petitioner posits, the

mechanism set forth in Atanasoff is described as “the unintentional injection of antigenic

material into synovial tissues resulting in an immune-mediated inflammatory reaction.”

(ECF No. 49, p. 15; Atanasoff et al., supra, at Ex. 18.5, p. 8049.) This results in an

inflammatory response which may be prolonged due to pre-existing antibody in the

synovial tissue from an earlier, naturally occurring infection or vaccination. (Id. at 8051.)

Atanasoff et al. further observed that bursitis and greater fluid in the bursa were two of

the findings often seen in MRI studies of vaccine injured shoulders. (Id. at 8050.) The

authors speculated that the patients they studied may have had prior conditions such as

rotator cuff tears which only became symptomatic following the improper vaccine

injection. (Id. at 8051.) Notably, Atanasoff et al. distinguished vaccine-related shoulder

injuries from conditions caused by a mechanical injury or overuse by “the rapid onset of

pain with limited range of motion following vaccination.” (Id.) Arias et al., lent additional

support for this proposed mechanism in a large systematic review, with a majority of

18 Dr. Natanzi additionally cites Trollmo et al., a study addressing immune reaction without specific

reference to SIRVA or SIRVA-like presentations, as well the study conducted by Cook, which sought to

develop a specific protocol for the safe intramuscular vaccination of the deltoid muscle in adults. (Trollmo

et al., supra, at Ex. 18.1; Cook, supra, at Ex. 18.4.)

26

cases reporting pain within 48 hours, and many reporting a high injection location.

(Arias et al., supra, at Ex. 18.10.)

This medical literature provides preponderant evidence supporting the conclusion

that the influenza vaccine can, when administered intramuscularly, cause an

inflammatory response resulting in shoulder injury.

ii. Logical sequence of cause and effect showing that the

vaccination was the reason for the injury (Althen prong 2)

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

effect showing that the vaccine was the reason for the injury, usually supported by facts

derived from a petitioner's medical records. Althen, 418 F.3d at 1278; Andreu ex rel.

Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375–77 (Fed. Cir. 2009);

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006);

Grant, 956 F.2d at 1148. However, medical records and/or statements of a treating

physician do not per se bind the special master to adopt the conclusions of such an

individual, even if they must be considered and carefully evaluated. See 42 U.S.C.

§300aa-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”); Snyder v. Sec'y

of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing ... that

mandates that the testimony of a treating physician is sacrosanct—that it must be

accepted in its entirety and cannot be rebutted”).

As previously noted, relative to the Table claim, prior to her November 2, 2016,

vaccination petitioner had no prior history of pain or dysfunction in her upper left

extremity or left shoulder. (Ex. 2, pp. 22-34; Ex. 11, p. 1-12.) Respondent raises no

argument in either his Rule 4 report or his response to petitioner’s motion for a ruling on

the record to the contrary. (ECF Nos. 26; 51.) My own review of the record confirms

these points.

Petitioner’s presentation to Dr. Regan nine-days post-vaccination is strong

evidence in support of a logical sequence of cause and effect showing that petitioner’s

shoulder injury was caused by her influenza vaccination. The history of present illness

from that visit indicates that:

[Petitioner] got a F[l]u shot last week on 11/02 an[d] her arm was red an[d]

swollen and even warm to the touch an[d] they told her it was a bad reaction

to the Flu VACC. [Petitioner] had flu vac 11/2/16 in the pm and was given

supposedly im [intramuscular] but appears to have been given near the

superior deltoid tendon…[B]y direct observation the injection site was to[o]

far superior and not given IM.

(Ex. 2, p. 18.) An undated, handwritten note on petitioner’s vaccine record reads “she

had a severe reaction to flu shot – very sore arm (the shot site) – a week later reported

CDC.” (Ex. 1, p. 1.) In her affidavit petitioner described pain and swelling within thirty

minutes after the vaccination. (Ex. 12, p. 1.)

27

Atanasoff et al. explain that the simple act of inserting a needle into the deltoid

muscle would not be expected to cause an immune-mediated inflammatory response.

(Atanasoff et al., supra, at Ex. 18.5, p. 8051.) Even when an individual is vaccinated in

the deltoid muscle with a previously administered vaccine, “any local injection site

reaction caused by vaccine-antigen antibody interaction is expected to be relatively brief

and resolve as the antigen is clear from the soft tissues over a period of several days.”

(Id.) If, however, “a vaccine is injected into the synovial space of the shoulder (bursa or

joint), pre-existing antibody in the synovial tissues…may lead to a more prolonged

inflammatory response.” (Id.) In “a great number of cases,” Arias et al. found that “the

vaccine had been administered into a ‘very high site’ in the arm, at a distance between

1 and 3 cm from the acromion.” (Arias et al., supra, at Ex. 18.10, p. 4874.)

Dr. Regan’s observation that petitioner’s injection site was “to[o] far superior and

not given IM [intramuscularly]” thus supports petitioner’s theory that her influenza

vaccination was injected into the synovial space of the shoulder, superior to the deltoid

muscle. 19 (Id.; Ex. 2, p. 18.) Additionally, with regard to overpenetration, Dr. Zand’s

report traced the distance from the skin to the subacromial space (the path the needle

would travel, according to petitioner’s theory), and measured it to be between 18-20

millimeters. (Ex. 21, pp. 2, 7.) As Dr. Natanzi explains, a typical needle measures 25.4

mm, which is “plenty long enough to have caused penetration into the subacromial

bursa and underlying rotator cuff.” (Ex. 20, p. 3.)

There is some debate as to whether or not petitioner suffered from subacromial

impingement bursitis and rotator cuff tendinitis. (Ex. 4, p. 21.) Dr. Abrams challenges

Dr. Cincere’s diagnoses based on Dr. Cincere’s interpretation of petitioner’s MRI and

based on Dr. Cincere’s operative findings from petitioner’s left shoulder surgery. (Ex. C,

p. 1.) However, the evidence preponderates in favoring of a finding that these

conditions were present.

First, Dr. Abrams challenges petitioner’s diagnosis of bursitis. Petitioner

underwent a left-shoulder MRI on November 30, 2016. (Ex. 13.) The MRI report

indicated (1) no evidence of rotator cuff tear, labral injury, or occult bone injury and (2)

no abnormality in the subcutaneous or deltoid muscles surrounding the left humerus

with “[n]o focal inflammatory process or free fluid.” (Id.) Based on the radiologist’s

findings, Dr. Abrams opines that petitioner’s MRI did not show any signs of bursitis.

(Ex. C, p. 1.) However, petitioner’s orthopedist, Dr. Cincere, reviewed her MRI on

19 Dr. Abrams challenges the accuracy of Dr. Regan’s observation of an incorrect vaccine location and

argues that “the location of needle penetration to the skin would be difficult to visualize five [sic] days

following vaccination.” (Ex. C, p. 3.) For satisfying the second Althen prong, however, “medical records

and medical opinion testimony are favored in vaccine cases, as 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 (quoting Althen, 418 F.3d at 1280). Dr.

Abrams may be correct that it is unlikely Dr. Regan would be able to confidently visualize the point of

needle penetration himself. However, especially given that petitioner reported a reaction at the injection

site itself, Dr. Regan’s record is nonetheless in keeping with the taking of a careful history of present

illness based on his in-person interaction with petitioner. This is exactly the type of issue for which

contemporaneous treatment records are valued, given the accuracy warranted by the treatment context.

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December 20, 2016, and “disagree[d] with [the] radiologist findings.” (Ex. 14, p. 2.) Dr.

Cincere noted “RTC [rotator cuff] signal changes: tendinosis, AC joint arthrosis, [and]

bursal changes.” (Id.) Dr. Abrams stresses that Dr. Cincere never specifically noted

any inflammation or fluid in the bursa in his operative findings. 20 (Ex. C, p. 1; Ex. 4, pp.

22-23.) However, the first finding in Dr. Cincere’s February 22, 2017, surgical report is

“extensive subacromial bursitis.” (Ex. 4, p. 21.) In his description of the procedure, Dr.

Cincere observed “thick bursal tissue overlying the rotator cuff.” (Ex. 4, p. 23.) Dr.

Natanzi explains that this is expected for bursitis. (Ex. 20, p. 3.) Dr. Cincere further

remarked that “the similar findings on the MRI were consistent with what was found with

extensive bursitis” during petitioner’s surgery. (Ex. 4, p. 23.) Dr. Zand, a diagnostic

radiologist, additionally reviewed petitioner’s MRI films and also agreed that petitioner’s

left shoulder revealed mild subacromial / subdeltoid bursitis. (Ex. 21, pp. 1-2.)

Second, Dr. Abrams challenges Dr. Cincere’s diagnosis of rotator cuff tendinitis.

Rotator cuff tendinitis is “an overuse injury consisting of inflammation of tendons of one

or more of the muscles forming the rotator cuff[.]” 21 Dr. Abrams suggests that while

many cases of SIRVA presented in the literature claim that needle over-penetration

results in rotator cuff pathology, petitioner’s bursal side of the rotator cuff was

“completely intact,” according to Dr. Cincere’s operative report. (Ex. C, p. 1; Ex 4, p.

23.) In his operative report, Dr. Cincere identified “mild fraying” of the supraspinatus–

one of the muscles that comprises the rotator cuff. 22 (Ex. 4, p. 22.) Additionally, Dr.

Zand observed “moderate thickening and intermediate signal in the supraspinatus

tendon representing tendinosis” in petitioner’s MRI of her left shoulder. (Ex. 21, p. 1

(emphasis added).)

Overall, nothing in the record of this case calls into question Dr. Cincere’s clinical

care and, given his in-person treatment of petitioner and first-hand observation of her

shoulder during surgery, he is better positioned than Dr. Abrams to make judgments as

to the clinical significance of his own operative findings. E.g., Capizzano, 440 F.3d at

1326 (“medical records and medical opinion testimony are favored in vaccine cases, as

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’”); see contra Schmidt v. Sec’y of Health & Human Servs., 17-1530V, 2021 WL

5226494 (Fed. Cl. Spec. Mstr. Oct. 7, 2021)(Chief special master finding Dr. Abrams

20 Bursitis is “inflammation of a bursa, occasionally accompanied by a calcific deposit in the underlying

tendon” and “the most common site is the subdeltoid bursa.” Bursitis, DORLAND’S MEDICAL DICTIONARY

ONLINE, https://www.dorlandsonline.com/dorland/definition?id=7315&searchterm=bursitis (last accessed

Apr. 13, 2022).

21 Rotator cuff tendinitis, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=112296&searchterm=rotator+cuff+tendinitis (last

accessed Apr. 13, 2022).

22 The rotator cuff is “a musculotendinous structure about the capsule of the shoulder joint, formed by the

inserting fibers of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles[.]” Rotator

cuff, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=67782&searchterm=rotator+cuff (last accessed

Apr. 13, 2022).

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persuasive where treating physician’s affidavit was inconsistent with his own operative

report showing no rotator cuff tear and MRI showing no bursal fluid). Although Dr.

Cincere clearly felt petitioner had a complex history (see, e.g. Ex. 4, p. 3), it is also clear

that he felt that history included shoulder pathology inclusive of bursitis.

In the cause-in-fact context, respondent also renews his argument that

petitioner’s symptoms cannot be attributed to the type of mechanical shoulder injuries

discussed above. (ECF No. 51, p. 11.) Instead, respondent maintains that petitioner’s

pain in her left shoulder, neck, and left hand are indicative of cervical radiculopathy and

suprascapular neuropathy. (Id. (Ex. A, pp. 4-5; Ex. C, pp. 1-2.)) Petitioner’s

presentation of symptoms and subsequent diagnoses complicate the matter; and a

close look at the experts’ reports and medical literature reveals why. As discussed

above, petitioner has offered persuasive evidence in the medical records that she

suffered some of the “classic” SIRVA injuries. (Arias et al., supra, at Ex. 18.10, p. 4873,

Tab. 2; Ex. 4, p. 28; Ex. 14, pp. 17-19.) Impingement and bursitis could have likely

caused petitioner’s shoulder pain and limited range of motion. (Atanasoff et al., supra,

at Ex. 18.5.) Separately, cervical radiculopathy could have likely caused the numbness

and tingling in petitioner’s left arm, hand, and fingers. (Caridi et al., supra, at Ex. A.4;

Evans, supra, at Ex. A.6; Bogduk, supra, at Ex. A.3.)

However, Dr. Natanzi maintains that cervical radiculopathy was not the likely

cause of petitioner’s pain, for three reasons. (Id. at 2.) First, he stresses that petitioner

never had any history of neck pain or upper limb symptoms prior to the date of

vaccination. (Id.) For symptoms of a neck disorder (cervical radiculopathy) to have

surfaced spontaneously after five decades of life, and coincidentally days after a

shoulder injection (that can independently explain petitioner’s symptoms), is very

unlikely—Dr. Natanzi explains. (Id.) Second, multiple physical exams demonstrate

signs of impingement and a restricted shoulder range of motion, which are indicative of

a shoulder pathology, and would not be expected in the context of a cervical issue like

radiculopathy. (Id.) Lastly, Dr. Cincere emphasizes the fact that an orthopedic surgeon

performed surgery on the shoulder, and “[c]learly he would not have done so if he even

suspected the pain was stemming from her neck.” (Ex. 20, p. 2.)

Dr. Natanzi also opines that suprascapular neuropathy more than likely did not

cause petitioner’s shoulder pain because petitioner continued to experience clinical

symptoms for more than two years after a normal NCS and surgical suprascapular

nerve decompression. (Ex. 19, p. 2; Ex. 4, p. 13.) Dr. Abrams argues that if petitioner’s

numbness and tingling were a radiating symptom of her impingement syndrome or

bursitis, petitioner would have likely shown post-operative improvement in her

symptoms, or at least some clinical improvement with the anti-inflammatory injections.

(Ex. A, p. 6; (citing Bodor et al., supra, at Ex. 18.2 (reporting both cases of SIRVA had

complete pain relief after subacromial bursa-directed corticosteroid injections)).)

Petitioner did demonstrate improvement, albeit inconsistently, following surgery. During

her March 3, 2017, post-operative appointment, petitioner reported that “she goes to PT

twice a week and noticed improvement.” (Ex. 4, p. 31.) During a May 18, 2017, visit

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with Dr. Cincere petitioner “voice[d] improvement with her therapy” and “state[d] the

swelling [] decreased greatly.” (Ex. 4, pp. 6-7.)

As the SIRVA medical literature indicates, orthopedic surgery is not a guaranteed

remedy, and some patients suffer residual pain and limited joint movement for years.

(Cross, supra, at Ex. 19.1, p. 305; Atanasoff, supra, at Ex. 18.5, p. 8050.) Ultimately,

petitioner’s MRI and multiple physical exams preponderantly demonstrate signs of

bursitis, tendinitis, and restricted shoulder range of motion, which are indicative of a

shoulder pathology and would not be expected in the context cervical radiculopathy and

suprascapular neuropathy. (See infra.) Thus, petitioner’s diagnoses of cervical

radiculopathy and suprascapular neuropathy do not wholly explain petitioner’s condition

and do not preclude a finding that petitioner’s November 2, 2016, influenza vaccination

more likely than not caused her to suffer shoulder dysfunction, especially in light of her

initial post-vaccination presentation. Therefore, petitioner has satisfied her burden

under Althen prong 2.

iii. Proximate temporal relationship between vaccination and injury

(Althen prong 3)

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.” de Bazan v. Sec'y of Health & Human Servs.,

539 F.3d 1347, 1352 (Fed. Cir. 2008).

Respondent raises no argument in either his Rule 4 report or his response to

petitioner’s motion for a ruling on the record that petitioner’s injury arose outside of the

48-hour timeframe identified by the Vaccine Injury Table. (ECF Nos. 26, 51.) Nor does

Respondent contest that the medically accepted timeframe for the onset of a shoulder

injury caused-in-fact by vaccination is within 48 hours of vaccination. (Id.) Additionally,

the Atanasoff study relied upon by petitioner supports 48 hours as the relevant onset

period. In that study, 12 subjects (92% of the study population) experienced their

symptoms within 48 hours of injection. (Atanasoff et al., supra, at Ex. 18.5, p. 8050.)

My own review of petitioner’s medical records confirms that her symptoms began

within 48 hours of vaccination. Petitioner presented to her primary care provider, Dr.

Regan, nine days after receiving an influenza vaccination. She reported that her “arm

was red and swollen and even warm to the touch and [that] they told her it was a bad

reaction to the Flu VACC.” (Ex. 2, p. 18.) Likewise, in her subsequent visits, petitioner

continued to report shoulder pain and limited range of motion since receiving the

influenza vaccination. (Ex. 14, pp. 2-3.) Petitioner’s affidavit corroborates this account,

When the pharmacist stuck the needle in my arm, I felt pain. Within 30

minutes the pain was so bad and my arm was swelling and I could not even

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raise my arm. I have had the flu shot in the past so I was trying to think the

best and hope it would get better with ice packs, however, it did not.

(Ex. 12, p. 1.)

Dr. Natanzi opines that, given the medical understanding of a shoulder injury

related to vaccine administration, the onset of petitioner’s left shoulder pain, beginning

shortly after receipt of the influenza vaccination on November 2, 2016, it is medically

acceptable to infer causation-in-fact. (Ex. 18, p. 7.) Accordingly, petitioner has

preponderantly demonstrated that the onset of her left shoulder symptoms occurred

within a time frame for which, given the medical understanding of shoulder dysfunction,

it is medically acceptable to infer causation-in-fact.

iv. Factors Unrelated

Once petitioner has met her prima facie burden of demonstrating a Table Injury,

respondent may still prove the condition is “due to factors unrelated to the

administration of the vaccine described in the petition.” § 300aa-13(a)(1)(B). However,

while petitioner’s comorbid diagnoses of suprascapular neuropathy and cervical

radiculopathy may have caused some contributing neck pain and numbness and

tingling, respondent has not shown, for the reasons detailed above, that these

conditions explain petitioner’s subacromial impingement bursitis and rotator cuff

tendinopathy, identified on MRI and in Dr. Cincere’s operative report. Thus, respondent

cannot preponderantly establish under his shifted burden that these conditions wholly

explain petitioner’s alleged vaccine injury. Additionally, diagnoses of cervical spine

radiculopathy and suprascapular neuropathy do not readily explain the specific

circumstances of this case where petitioner experienced an abrupt onset of left shoulder

pain within 48 hours of her November 2, 2016, influenza vaccination, nor do they

explain the objective decrease in the range of motion of her left shoulder after

vaccination that was not present previously. (Ex. 2, p. 18; Ex. 13; Ex. 14, p. 2; Ex. 4,

pp. 21-23, 29.)

VII. Conclusion

For all the reasons discussed above, after weighing the evidence of record within

the context of this Program, I find by preponderant evidence that petitioner suffered

subacromial impingement bursitis and rotator cuff tendinitis caused-in-fact by her

November 2, 2016, influenza vaccination. A separate damages order will be issued.

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

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