# In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18

- 0226 V

Filed: June 7, 2019

UN PUBLISHED

KIMBERLY RAYBORN

,

Petitioner,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent. Special Processing Unit (SPU) ; Findings of Fact; Onset; Influenza (Flu) Vaccine; Shoulder Injury

Related to Vaccine Administration (SIRVA)

Amy A. Senerth, Muller Brazil, LLP, Dresher, PA , for petitioner. Ryan Daniel Pyles , U.S. Department of Justice, Washington, DC, for respondent.

FACT RULING AND SCHEDULING ORDER

– SPECIAL PROCESSING UNIT 1

Dorsey

, Chief Special Master:

On February 14, 2018

, Kimberly Rayborn (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa

- 10, et seq

. , 2 (the “Vaccine Act” or “the Act” ). Petitioner alleges that she
suffered a left shoulder injury related to vaccine administration (“SIRVA”) as a result of

an influenza (“flu”) vaccine she received on September 21, 2016 . Petit ion at 1

. The

case was assigned to the Special Processing Unit of the Office of Special Masters.

1 The un dersign ed intends to post this ruling on the United States Court of Federal Claims' website. 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 invasio n of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. Because this published ruling contains a reasoned explanation for the action in t his case, undersigned is required to post it on the United States Court of Federal Claims' website in accordance

with the E

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

.

2 Natio nal Childhood Vaccine Injury Act of 1986, Pub. L. No. 99

- 660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subpara graph of 42 U.S.C. § 300aa (2012 ).2

Petitioner now moves for a ruling on the record making a finding of fact that the onset of petitioner’s shoulder injury was within 48 hours of receiving the flu vaccination.
ECF No. 25 , Petitioner’s Mot ion for a Fact Ruling on the Issue of Onset (“Motion”). For the reasons discussed below, the undersigned grants p etitioner’s M otion and finds that the onset of petitioner’s shoulder injury was within 48 hours of her September 21, 2016
flu vaccination.

I. P rocedural History

On February 14, 2018, in addition to the petition, petitioner filed medical records

as Exhibits 1

- 3 and an affidavit as Exhibit 4. (ECF No. 1). On February 20, 2018, petitioner filed the vaccine administration record as Exhibit 5 and, on February 26, 2018

, filed a statement of completion. (ECF Nos. 6, 8). Immediately following the March 20,

2018 initial status conference, petitioner filed additional medical records as Exhibits 6

and 7. (ECF No. 10). O n April 10, 2018, petitioner filed an amended petition in which

the date of vaccination was corrected. (ECF No . 11 ). Petitioner ’s second affidavit and a

more detailed record of vaccine a dministration were filed on April 13 and April 23, 2018

as Exhibits 8 and 9. (ECF Nos. 13 , 14 ).

On November 14, 2018, respondent filed the Rule 4(c) Report asserting that petitioner had not demonstrated entitlement to compensation. Respondent’s Report (ECF No. 23). S pecifically, respondent argued that the record is insufficient to substantiate that the onset of petitioner ’ s left sh oulder symptoms began within forty

eight hours of vaccination because “ petitioner di d not seek care for her alleged injury

until . . . almost four months after the vaccination. ” Id . at 3.

On November 20, 2018, the undersigned ordered petitioner to file a detailed

affidavit and Motion for a Ruling on the Record regarding onset. See Scheduling Order at 1 (ECF No. 24). Petitioner filed her Motion on January 14, 2019 wi thout an affidavit. (ECF No. 25). Respondent filed his response on March 5, 2019. (ECF No. 26). Thus, petitioner’s Motion is now ripe for adjudication.

II. Relevant Factual History

On September 21, 2016, petitioner received a flu vaccination in her left arm. Ex.

9 . Petitioner’s medical history does not appear to be contributory to her claim in this

case. See generally Ex. 7 at 34

- 35 (listing petitioner’s past medical history and “active problems.”).

Approximately 4 months later , o n January 18, 2017

, petitioner first presented to

Nurse Practi tioner ( “ NP ” ) Anne Musgrove at Memorial Southern Coast Family Medicine with complaints of left shoulder pain. Ex. 3 at 4. According to the clinical record, petitioner’s pain “began in September on the evening she received her flu vaccine at

work.” Id

. It is n oted that petitioner initially attempted to treat her shoulder with

nonsteroidal anti

- inflammatory drugs (“NSAIDs”) and sought to alleviate pain through the strategic placement of pillows during the night and limiting weight

- bearing activities.

Id

. D espi te these measures, petitioner’s shoulder pain continued. Id

. It was also noted3

that “abduction of the left arm is limited to approximately 85 [degrees] actively and 94 [degrees] passively. There is some weakness in her left hand, sometimes losing her grip streng th.” Id

. T h e clinical notes reflect “ constant 2/10 dull aching with episodes of 6/10 pain with ab duction of L[eft] ar m. ” Id

. NP Musgrove diagnosed petitioner with a vaccine reaction and referred her for magnetic resonanc e imaging ( “ MRI ” ). Id . at 5.

On January 22, 2017, petitioner underwent an MRI of her left shoulder. Id . at 1

- 2. T he MRI report notes petitioner’s “[l]imited ra ng e of motion of the shoulder since the fluid [sic] shot.” Id

. at 1 . The MRI revealed “some mild thickening of the joint capsule at the axillary recess which can be seen with adhesive capsulitis.” Id . at 2.

On February 2, 2017, petitioner presented to Dr. Arthur D. Black, an orthopedist.

Ex. 6 at 1

- 2. P etitioner reported left shoulder pain “that started approximately 4 months ago after receiving a flu shot in the same shoulder.” Id . at 1. Peti tioner further reported having had “some relief [of] some of the symptoms with activity modification and anti

inflammatories however they have not completely resolved.” Id

. Petitioner was assessed with “left shoulder bursitis, slow to resolve,” and was g iven a cortisone injection. Id

. at 2.

Petitioner returned to Dr. Black on March 21, 2017 to follow

- up on her left shoulder pain. Id

. at 3

- 4. The clinical notes indicate that while the previously administered cortisone injection had initial ly provided pain relief, petitioner’s symptoms

were beginning to return. Id . at 3. Petitioner was assessed with having left shoulder impingement symptoms and petitioner was prescribed physical therapy. Id . at 4.

On April 21 , 2017, petition completed a Vaccine Adverse Event Reporting System form (“VAERS Report”) indicating “left shoulder pain onset [illegible] injection.” Ex. 1 at 2. The date of onset is listed as September 21, 2016. Id

. Petitioner participated in 13 sess ions of occupational therapy from March 30, 2017 through June 20, 2017. E x . 2 at 40

- 68. The outpatient evaluation note states that petitioner “has a history of approximately 6 months of left shoulder pain.” Id . at 68.

In petitioner’s second affid avit, petitioner states that she began experiencing left shoulder pain following her September 21, 2016 flu shot. Ex. 8 at ¶ 3. Petitioner explain s that, “[i]n the past with vaccination, I had often experienced some mild soreness typically resolving with in a few days.” Id

. Petitioner explained that, unlike the

soreness she experienced following previous vaccinations, the pain that followed her September 21, 2016 vaccination persisted

. Id

. Petitioner noted that as “a nurse practitioner and busy mom I continued to just treat su pportively. Once I began having limited range of motion as well as continued pain, I knew there was something more wrong.” Id

.

III. Discussion

a. Applicable Legal Standard4

Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and aids to interpretation. 42 C.F.R. § 100.3(c)(10). Therefore, the undersigned’s findings are informed by the Qualifications and Aids to Interpretation for SIRVA criteria used to

evaluate such claims. The criteria are as follows:

A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time

frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symp toms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy).

Id.; see also National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Prop osed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann

- Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA) , Vaccine 28(51):8049

- 8052). The criteria at issue in this

case is whether petitioner’s pain occurr ed within the specified time

- frame of 48 hours or

less after administration of her September 2 1 , 201 6 flu vaccination. The undersigned

finds that it does.

b. Evaluation of the Evidence

The parties dispute whether petitioner has satisfied her burden of proof as to the second SIRVA criteria: “[pain occur[ring] within the specified time

- frame.” To meet this

criterion , petitioner must show by preponderant evidence that her left shoulder pain began within 48 hours of her September 2 1, 2016 flu vaccination. 42 U.S.C. § 300aa

– 13(a)(1)(A) ; 42 C.F.R. § 100.3(c)(10 )

. Petitioner has the burden of demonstrating the

facts nec essary for entitlement to an award by a “preponderance of the evidence.” §

300aa

- 12(a)(1)(A). Under that standard, the existence of a fact must be shown to be “more probable than its nonexistence.” In re Winship , 397 U.S. 358, 371 (1970) (Harlan, J., co ncurring). In light of all of the above record evidence and for the reasons described below, the undersigned finds that there is preponderant evidence that the onset of petitioner’s alleged shoulder pain occurred within 48 hours of petitioner’s September 2 1 , 201 6 flu vaccination.

It is undisputed that petitioner was no t seen by a healthcare provider until January 18, 2017

, almost four months after her September 2 1 , 201 6 flu shot. H owever, the medical records provide preponderant evidence demonstrating that the onset of her shoulder pain began within 48 hour s of the administration of the flu vaccine. On the first

occasion that petitioner sought treatment for her left shoulder injury, she reported that

her shoulder pain “ began in September on the evening she recei ved her flu vaccine

. ” Ex. 7 at 10. Moreover, in recounting petitioner’s history of shoulder pain, the report5

documenting petitioner’s January 22, 2017 MRI indicates that she experienced limited range of motion in her left shoulder since the “fluid [sic] shot.” Id . at 4. Consistent with this timeline is petitioner’s February 2, 2017 report to her orthopedist that her shoulder pain “ started approximately 4 months ago after receiving a flu shot in the same shoulder.” Ex. 6 at 1. Petitioner’s subsequent o ccupational therapy evaluation on March 30, 2017 further corroborates petitioner’s claim that her shoulder pain began

within 48 hours of t he flu vaccination: It is noted that petitioner “has a history of approximately 6 months of left shoulder pain

. ” Ex. 2 at 68. Moreo ver, petitioner’s VAERS Report indicates an onset date of September 21, 2016, the date of petitioner’s

vaccination.

The undersigned recognizes that some of the aforementioned medical records are imprecise regarding onset (e.g.

, “ approximately 4 months ag o ”); however, it would be a mistake to overanalyze these notations in search of a precise onset date when

th ese notes were provided as generalizations

. T he reported ti meframe reflected by the record as a whole encompass the 48

- hour post

- vaccination period. Moreover, it is significant that on January 18, 201 7 , the first time petitioner s ought treatment for her

shoulder , she reported that her pain began “on the evening she received the flu

vaccine

. ” Ex. 7 at 10.

Additionally, the undersigned finds petitioner’s second affidavit explaining her delay in seeking treatment to be reasonable and credible. See, e.g.

, Stevens v. Sec’y

of Health & Human Servs. , 90

- 221V, 1990 WL 608693, *3 (Cl. Ct. Spec . Mstr. 1990)(noting that clear cogent, and consistent testimony can overcome missing or contradictory medical records). Petitioner indicate d that sh e had previously experienced mild soreness after vaccinations that typically resolved within a few days. Ex. 8 at 1. Petitioner also indicated that, as a nurse and busy mom, she initially sought to treat the pain with ibuprofen and by applying ice. Id . at 2. Given that petitioner was

noted to have had “ some relief [of] symptoms with activity modification and anti

inflammatories,” (Ex. 6 at 1) petitioner’s decision not to seek immediate attention was

reasonable. Further, because petitioner is a nurse, and it is typical for many medical professionals to self

- treat , they often wait before seeking formal medical treatment. I n the undersigned’s experience, petitioner’s affidavit s and medical records as a whole

reflec t a pattern of treatment consistent with and similar to many other compensat ed
SIRVA claims.

Based on the record as a whole , the undersigned finds that there is preponderant proof that the onset of petitioner’s left sh oulder pain occurred within 48 hours of her September 21, 2016 flu vaccination.

IV. Conclusion

The undersigned finds , based on the record as a whole, that the onset of petitioner’s left shoulder pain was within forty

- eight ( 48 ) hours of her September

2 1, 2016 influenza vaccination.

The parties are encouraged to consider an informal resolution of this claim. Petitioner shall file a joint status report by no later than Monday, July 8, 2019

,6

updating the court on the status of the parties’ progress informally resolving t his

claim.

IT IS SO ORDERED.

s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master