Ervin-Spencer v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-314V

TRACEY ERVIN-SPENCER, Chief Special Master Corcoran

Petitioner,

v. Filed: December 8, 2023

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for

Petitioner.

Ronalda Elnetta Kosh, U.S. Department of Justice, Washington, DC, for Respondent.

RULING ON ENTITLMENT 1

On January 8, 2021, Tracey Erwin-Spencer filed a petition for compensation under

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

“Vaccine Act”). Petitioner alleges a Table injury - that she suffered a shoulder injury

related to vaccine administration (“SIRVA”) after receiving an influenza (“flu”) vaccine on

1 Because this Ruling contains a reasoned explanation for the action taken in this case, it must be made

publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at

https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of

2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government

Services). This means the Ruling will be available to anyone with access to the internet. In accordance with

Vaccine Rule 18(b), 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, upon review, I agree that the

identified material fits within this definition, I will redact such material from public access.

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

of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §

300aa (2012).

October 2, 2019. Petition at 1. The case was assigned to the Special Processing Unit of

the Office of Special Masters (the “SPU”).

After a full review of the evidence, I find that Petitioner has satisfied all Table

requirements for a SIRVA Table injury and is otherwise entitled to compensation for her

injury.

I. Relevant Procedural History

On May 13, 2022, Petitioner filed a Motion for a Ruling on the Record (hereinafter

“Motion”), at my invitation after Respondent failed to provide his position in this case for

more than following the claim’s assignment to SPU. ECF No. 23. In her Motion, Petitioner

argues that she has satisfied all requirements under the Vaccine Act and established

entitlement to compensation for a Table SIRVA injury. Id. Respondent reacted to

Petitioner’s Motion (hereinafter “Response”) on July 27, 2022, recommending that

entitlement to compensation be denied under the terms of the Vaccine Act. ECF No. 27. 3

Specifically, Respondent argues that the evidence preponderates against a finding that

the onset of Petitioner’s shoulder pain occurred within 48 hours of her vaccination. ECF

No. 27 at 8-9. Additionally (and although this argument is not fully developed),

Respondent appears to assert that Petitioner’s pain is not limited to the shoulder in which

she was vaccinated. Id. at 9.

On August 10, 2022, Petitioner filed a Reply brief addressing Respondent’s

objections to compensation and arguing that she has established a SIRVA Table case.

ECF No. 28. This matter is ripe for my resolution.

II. Authority

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

demonstrate, by a preponderance of evidence, all matters required under Section

11(c)(1), including the factual circumstances surrounding his claim. Section 13(a)(1)(A).

In making this determination, the special master or court should consider the record as a

whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or

by medical opinion. Id.

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

which may include contemporaneous medical records and testimony. See Burns v. Sec'y

3During the interim between the filing of Petitioner’s Motion and Respondent’s Response the parties

engaged in discussions to informally resolve this case. ECF Nos. 22, 25 -26. I offered to stay the briefing

deadlines at the parties’ joint request, if further time to engage in settlement discussions would be fruitful,

but no request was made. Scheduling Order (Non-PDF) filed June 7, 2022.

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of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special

master must decide what weight to give evidence including oral testimony and

contemporaneous medical records). Contemporaneous medical records are presumed to

be accurate. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed.

Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a

petitioner may present testimony which is “consistent, clear, cogent, and compelling.”

Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.

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

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

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

severity of petitioner’s injury, and the lack of other award or settlement, 4 a petitioner must

establish that she suffered an injury meeting the Table criteria, in which case causation

is presumed, or an injury shown to be caused-in-fact by the vaccination she received.

Section 11(c)(1)(C).

The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,

identifies the vaccines covered under the Program, the corresponding injuries, and the

time period in which the particular injuries must occur after vaccination. Section 14(a).

Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48

hours of the administration of a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria

establishing a SIRVA under the accompanying QAI are as follows:

Shoulder injury related to vaccine administration (SIRVA). 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 (even if the condition causing the neurological

abnormality is not known). A vaccine recipient shall be considered to have

suffered SIRVA if such recipient manifests all of the following:

4 In summary, a petitioner must establish that he received a vaccine covered by the Program, administered

either in the United States and its territories or in another geographical area but qualifying for a limited

exception; suffered the residual effects of his injury for more than six months, died from his injury, or

underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected

an award or settlement for her injury. Section 11(c)(1)(A)(B)(D)(E).

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

prior to intramuscular vaccine administration that would explain the alleged

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

after vaccine injection;

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

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

the intramuscular vaccine was administered; and

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

patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,

brachial neuritis, mononeuropathies, or any other neuropathy).

42 C.F.R. § 100.3(c)(10).

III. Relevant Factual Evidence

I have fully reviewed the evidence, including all medical records and affidavits, and

the parties’ briefing. I find most relevant the following:

A. Records

• Prior to her vaccination, Petitioner suffered some significant non-contributory

comorbidities, including myelodysplastic syndrome (“MDS”) with sideroblastic

anemia which necessitated frequent blood transfusions, aortic regurgitation, and

common variable immunodeficiency. See generally Ex. 2.

• On October 2, 2019, Petitioner received the flu vaccine in her left deltoid. Ex. 1 at

1.

• On October 21, 2019, Petitioner made a telephone call to her primary care

provider’s (“PCP”) office, the Polyclinic, in regard to an MRI order for brain imaging

that took place later that same day. Ex. 4 at 30; 57-59.

• On October 23, 2019, Petitioner underwent a blood transfusion at Seattle Cancer

Care Alliance (“SCCA”). Ex. 2 at 264.

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• On October 31, 2019, Petitioner was seen by her cardiologist for a follow-up

appointment. Ex. 5 at 43-49.

• On November 14, 2019, Petitioner underwent another blood transfusion at SCCA.

Ex. 2 at 266. A nursing note states that Petitioner reported “new” left deltoid pain

“post flu shot.” Id. Petitioner’s pain score was 2/10, and up to 7/10 with movement.

Id.

• On November 21, 2019, Petitioner was evaluated by hematologist Janice L.

Abkowitz, M.D., at SCCA. Ex. 2 at 397. Dr. Abkowitz’s record memorializes that

Petitioner’s “only complaint in [a] complete review of systems,” except as noted in

her history, was that “after her flu vaccination, she has had some nerve pain in her

left arm. She does not want physical therapy or other intervention for this. Rather

she has been doing stretching and has been placing heat on it at home.” Id.

• On December 3, 2019, Petitioner was seen by her PCP, Dr. Cynthia Smyth, with

a “complain[t] of a 2-month history of worsening left shoulder pain.” Ex. 4 at 33.

Petitioner reported to Dr. Smyth that “[s]he feels as though her symptoms started

after getting a flu shot in the left upper arm. She has been giving it time but her

symptoms have not improved but have worsened.” Id. Petitioner also informed Dr.

Smyth that she “had not had a fall or any trauma to the area,” and that she had a

“mass near her left elbow which [has] gotten bigger which she would like

evaluated,” that she continued to receive blood transfusions every three weeks for

her MDS and that she had not suffered any recent infections. Id.

On exam, Petitioner exhibited reduced range of motion of her left arm, strength in

her left upper extremity of 4/5, and “tenderness over her biceps and supraspinatus

tendon.” Id. at 34. Dr. Smyth also recorded Petitioner had a “2 x 2 centimeter raised

palpable mass” on her left elbow. Id. Dr. Smyth ordered an MRI’s of Petitioner’s

left shoulder and elbow, and referred her to orthopedics. Id.

• On December 9, 2019, Petitioner underwent an MRI of her left shoulder, and the

findings included: an “abnormal low T1 signal throughout the proximal humerus

extending from the head to the metadiaphysis” with “similar changes” in the

acromion and the clavicle; a “[t]race amount of bursal inflammation and fluid;” a

“[q]uestion [of] mild inflammation of the anterior band of the inferior glenohumeral

ligament and thickening of the coracoid humeral ligament;” “[m]inor marrow edema

and cyst formation;” a “partial footprint attachment tear of the far anterior

supraspinatus” that “probably has bursal extension;” an “[a]bnormal signal in the

biceps anchor;” and an “irregularity of the posterosuperior labral contour.” Ex. 4 at

5

60. An MRI was also conducted that same day of Petitioner’s left elbow. Id. at 61-

62.

• Petitioner was seen by orthopedist Dr. Daniel G. Schwartz on December 13, 2019.

Ex. 6 at 4. Petitioner reported to Dr. Schwartz that her “symptoms have been

ongoing [since] 10/2/19. She states that there was a flu shot injury – states that

she felt them hit a nerve.” Ex. 6 at 4. Dr. Schwarz diagnosed Petitioner with

impingement syndrome of the left shoulder and a traumatic incomplete tear of the

left rotator cuff. Id. at 3.

• On December 20, 2019, Petitioner began physical therapy. Ex. 3 at 245.

Petitioner’s initial evaluation history records “Date of Injury: date symptoms began:

10/2/19.” Id. The history further provides “61 year old female who present[s] to

therapy with L[eft] sided shoulder pain that resulted after a flu shot was injected

into the subacromial bursa.” Id.

• Subsequently, Petitioner continued to treat with Dr. Schwartz and undergo physical

therapy for her left shoulder pain. In April of 2020, Petitioner reported at a physical

therapy session, that she could not get her “arm up any higher.” Ex. 3 at 180. She

stated that the “inside of the shoulder feels pinching and sharp nerve pain that

goes down the arm and across her chest,” she elaborated that “if she tries to use

the arm too much then she gets radiating pain.” Id. At another physical therapy

session a few days later, she reported that the previous day she had received a

blood transfusion and “from the wrist up into the shoulder was miserable but is

much better today.” Id. at 178.

• After undergoing physical therapy for approximately 17 months, Petitioner was

discharged on May 18, 2021. Ex. 8 at 1. She was described as “90% better with

some ROM loss still and minor pain in bicep but otherwise doing well functionally.”

Id. at 6.

B. Declaration

Petitioner executed a signed and sworn declaration on January 25, 2021

addressing her October 2, 2019 vaccination and alleged shoulder injury. Ex. 7. In regard

to the administration of her vaccination, Petitioner states she received the vaccination at

SCCA on October 2, 2019 following her receipt of a blood transfusion. Id., ¶ 1. Petitioner

recounts that when the vaccine needle was inserted into her left shoulder that her “left

shoulder and [her] left arm flew straight up to the ceiling and fell back down.” Id. She

recalls the “pain I felt was immediate.” Id. The nurse requested that she “relax and

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completed the injection.” Id. She advised the nurse that she thought he “hit a nerve.” Id.

Petitioner states that night she had a fever and called the after-hours line at SCCA to

speak with a nurse – Petitioner was not sure if the fever was due to her vaccination or her

transfusion. Id., ¶ 2. Petitioner reported her arm pain and fever to the nurse and it was

“decided” both were due to her injection as she had a fever the prior year after her

vaccination. Id. The next morning Petitioner states that she could not “move [her] arm

without extreme pain” and required assistance from her husband showering and dressing.

Id.

Petitioner states that her pain persisted, and she required continued assistance

from her husband. Id., ¶ 3. Petitioner avers that she had another blood transfusion on

October 24, 2019 5 and when asked if she was currently in any pain she reported that her

left arm had “been extremely painful since [her] flu shot.” Id., ¶ 4. Petitioner states that

thereafter she subsequently reported her pain at every blood transfusion visit. Id.

Petitioner provides in her affidavit that after the pain persisted for several weeks,

she began to think it was not normal pain and that she had nerve damage. Id., ¶ 5. She

states that by mid-November after “getting no relief from extreme pain” she scheduled an

appointment with her primary care provider, Dr. Smyth, and that the first appointment

available was in early December. Id. Petitioner states Dr. Smyth thought she had a left

rotator cuff tear and referred her to orthopedics. Id.

Petitioner’s affidavit describes her subsequent treatment, and the limitations that

she suffered in her daily activities due to her shoulder pain.

IV. Findings of Fact

A. Onset

The primary disputed factor in this case is whether Petitioner’s first post-

vaccination symptom or manifestation of onset (specifically pain) of her shoulder injury

occurred within 48 hours of her flu vaccination as set forth in the Vaccine Injury Table and

Qualifications and Aids to Interpretation (“QAI”) for a Table SIRVA. 42 C.F.R. §

100.3(a)(XIV)(B) (seasonal influenza vaccines); 42 C.F.R. § 100.3(c)(10)(ii) (required

onset for pain listed in the QAI); ECF No. 27 at 8-9. Based upon a review of the entire

record, and for the reasons set forth below, I find that it more likely than not did.

5 This appears to be a typographical error as Petitioner’s blood transfusion occurred on October 23, 2019,

not October 24, 2019. Ex. 2 at 264.

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In this case, as correctly pointed out by Respondent, the records corresponding to

Petitioner’s first several encounters with medical providers following her October 2, 2019

vaccination contain no reference to Petitioner’s shoulder pain at all. These encounters

consist of a phone call on October 21, 2019 to her PCP in regard to an unrelated MRI

scheduled for later that day, Petitioner’s actual MRI imaging visit that same day, an

appointment on October 23, 2019 at SCCA for a blood transfusion, and a cardiology

appointment on October 31, 2019. ECF No. 27 at 8 (citing Ex. 2 at 264; Ex. Ex. 4 at 30,

58; Ex. 5 at 43-49).

Petitioner, however, asserts in her declaration that she called an after-hours line

at SCCA the night she received her vaccination and reported her shoulder pain and a

fever. Ex. 7, ¶ 2. Petitioner also states that she reported her shoulder pain at her October

23, 2019 SCCA appointment for a blood transfusion. Ex. 7, ¶ 4. I cannot conclude per se

that Petitioner reported her shoulder pain to SCCA on the evening of October 2, 2019, or

at her October 23, 2019 appointment. However, as I have observed in other cases, it

would not be uncommon for either a patient to fail to report, or for a provider to fail to

document, symptoms outside the primary purpose of a medical visit – as would be the

case for Petitioner’s medical encounters regarding her October 21, 2019 MRI, October

23, 2019 SCCA blood transfusion, and cardiology appointment on October 31, 2019.

The fact that references to onset are not precise in terms of time or date does not

prevent a favorable finding. As I have previously observed, “the Vaccine Act clearly does

not require that symptoms be recorded within a specific timeframe to be preponderantly

established. Rather, it requires only that onset occurs in the relevant timeframe.” Niemi v.

Sec'y of Health & Hum. Servs., No. 19-1535V, 2021 WL 4146940, at *4 (Fed. Cl. Aug.

10, 2021) (citing Section 13) (emphasis in original). Neither does the Act require that the

medical records document an exact date that the onset of a petitioner’s shoulder pain

began. A special master may thus find that the first symptom or manifestation of onset of

an injury occurred “within the time period described in the Vaccine Injury Table even

though the occurrence of such symptom or manifestation was not recorded or was

incorrectly recorded as having occurred outside such period.” Section 13(b)(2).

In this case, Petitioner’s allegation that her shoulder pain occurred within 48 hours

of her vaccination is supported by many contemporaneous treatment records close-in-

time to her vaccination – even if the medical records most contemporaneous to her

October 2, 2019 vaccination do not. In particular, the records corresponding to Petitioner’s

November 13, 2019 appointment for a blood transfusion at SCCA – which occurred only

42 days after her vaccination (and only a few weeks after her first post-vaccination

medical encounter) - specifically document that Petitioner suffered “new pain” in her left

shoulder “post flu shot.” Ex. 2 at 266.

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Thereafter, Petitioner consistently reported to her providers at numerous

appointments that she experienced the onset of her shoulder pain contemporaneous with

her October 2, 2019 flu vaccination. See, e.g., Ex. 2 at 397 (November 21, 2019 complaint

to Dr. Abkowtiz that “after her flu vaccination, she has had some nerve pain in her left

arm. She does not want physical therapy or other intervention for this. Rather she has

been doing stretching and has been placing heat on it at home.”); Ex. 4 at 33 (December

3, 2019 PCP record a documenting a “complain[t] of a 2-month history of worsening left

shoulder pain” and report that “[s]he feels as though her symptoms started after getting a

flu shot in the left upper arm. She has been giving it time but her symptoms have not

improved but have worsened.”); Ex. 6 at 4 (December 13, 2019 complaint to orthopedist

Dr. Schwartz that her “symptoms have been ongoing [since] 10/2/2019. She states that

there was a flu shot injury – states that she felt them hit a nerve.”); Ex. 3 at 25 (Petitioner’s

initial physical therapy evaluation history states, “Date of Injury: date symptoms began:

10/2/19” and provides “L[eft] sided shoulder pain after a flu shot was injected into the

subacromial bursa.”).

Based on the record as a whole, I find that Petitioner has established the onset of

her injury occurred within 48 hours of her vaccination. Of course, Petitioner’s short delay

in seeking medical treatment specific to her shoulder pain demonstrates that she was

able to tolerate the pain initially and is indicative of a somewhat less severe SIRVA – a

factor I will consider in awarding damages for pain and suffering in this case.

B. Injury Limited to Shoulder

The second disputed issue is whether Petitioner’s “[p]ain and reduced range of

motion are limited to the [left] shoulder in which the intramuscular vaccine was

administered.” 42 C.F.R. § 100.3(c)(10)(iii).

Preliminarily, Respondent has not explicitly contested that Petitioner has failed to

satisfy this SIRVA Table requirement – or any SIRVA Table requirement aside from onset.

Nonetheless, Respondent seemingly calls the third SIRVA QAI factor into question in his

Response. Thus, Respondent has generally maintained that “[P]etitioner’s complaints

indicate that she was also experiencing radiating pain that she described as ‘nerve pain

in her left arm,’ wrist pain, ‘a mass near her left elbow which [had] gotten bigger,’ and her

left shoulder MRI showed a minor marrow edema and cyst formation.” ECF No. 27 at 9

(citing Ex. 2 at 397; Ex. 3 at 178, 180; Pet. Ex. 4 at 33, 60).

Respondent fails to further develop this argument, however. And Petitioner

correctly points out that her “treatment records have consistently confirmed a left shoulder

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injury,” and that after thorough examinations of both her complete left shoulder and arm,

the subsequent assessment of her injury and focus of her treatment was on her left

shoulder. ECF No. 28 7-8 (citing Ex. 3 at 185, 245; Ex. 4 at 33; Ex. 6 at 3, 8). While

Petitioner on several occasions described her left shoulder and arm pain as nerve pain

collectively, and stated when her vaccination was administered that she thought a nerve

had been hit, these appear to be Petitioner’s subjective descriptions of her injury and pain

as a lay person (and there is no evidence in the record that Petitioner suffered any

neurological injury from her vaccination).

Additionally, some of the symptoms and findings cited by Respondent do not

actually appear to be related to Petitioner’s shoulder injury or vaccination, but instead

appear to constitute, or be reflective of, comorbidities – for example her elbow mass (Ex.

4 at 33). To be clear, a petitioner must establish pain and reduced ROM were “limited to

the shoulder in which the intramuscular vaccine was administered” in order to

demonstrate a Table SIRVA. 42 C.F.R. § 100.3(c)(10)(iii). However, this requirement

“does not prevent a petitioner with simultaneous areas of pain due to unrelated conditions

from also meeting the Table SIRVA definition.” Rodgers v. Sec’y of Health & Hum. Servs.,

No. 18-0559V, 2021 WL 4772097, at *8 (Fed. Cl. Spec. Mstr. Sept. 9, 2021).

To the extent that any pain did radiate from Petitioner’s shoulder to other part of

her body, I have previously found that claims involving musculoskeletal pain primarily

occurring in the shoulder are valid under the Table even if there are additional allegations

of pain extending to adjacent parts of the body, since the essence of the claim is that a

vaccine administered to the shoulder primarily caused pain there. Cross v. Sec'y of Health

& Hum. Servs., No. 19-1958V, 2023 WL 120783, at *7 (Fed. Cl. Spec. Mstr. Jan. 6, 2023).

This reading is consistent with the determinations of other special masters. Grossmann

v. Sec’y of Health & Hum. Servs., No. 18-0013V, 2022 WL 779666, at *15 (Fed. Cl. Spec.

Mstr. Feb. 15, 2022) (explaining that the criterion is intended 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”) (emphasis added). Here, despite some notations of pain extending beyond the

shoulder, Petitioner’s injury is consistent with the definition of SIRVA and there is not

preponderant evidence of another etiology.

V. Other Table Requirements and Entitlement

Petitioner has established all other requirements for a Table SIRVA claim. 42

C.F.R. § 100.3(c)(10). There is no history of shoulder pain, inflammation, or dysfunction

that would explain the post-vaccination injury. 42 C.F.R. § 100.3(c)(10)(i). And there is

not preponderant evidence of another condition that would explain the symptoms. 42

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C.F.R. § 100.3(c)(10)(iv). 6 However, even if a petitioner has satisfied the requirements of

a Table injury or established causation-in-fact, he or she must also provide preponderant

evidence of the additional requirements of Section 11(c), i.e., receipt of a covered

vaccine, residual effects of injury lasting six months, etc. See generally Section

11(c)(1)(A)(B)(D)(E). But those elements are established or undisputed in this claim. I

therefore find that Petitioner is entitled to compensation in this case.

Conclusion

Based on the entire record, I find that Petitioner has provided preponderant

evidence satisfying all requirements for a Table SIRVA. Petitioner is entitled to

compensation. A Damages Order will issue.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

6 To the extent that Respondent may have argued that Petitioner suffered any other condition that would

explain her condition/SIRVA, I explicitly find, as discussed above, that Petitioner did not. See supra section

IV B.

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