In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-2001V
UNPUBLISHED
Filed: September 2, 2021
LESLIE KRAUS,
Chief Special Master Corcoran
Petitioner,
v. Special Processing Unit (SPU);
Entitlement; Ruling on the Record;
SECRETARY OF HEALTH Decision Without a Hearing;
AND HUMAN SERVICES, Causation-In-Fact; Influenza (Flu)
Vaccine; Shoulder Injury Related to
Respondent. Vaccine Administration (SIRVA)
Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
Petitioner.
Jennifer Leigh Reynaud, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT1
On December 21, 2017, Leslie Kraus filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa–10, et seq.2 (the
“Vaccine Act” or “Program”), alleging that she suffered from a shoulder injury related to
vaccine administration (“SIRVA”) after receiving an influenza (“flu”) vaccination on
September 26, 2016. Petition at 1 (Preamble). The case was assigned to the Special
Processing Unit of the Office of Special Masters. For the reasons discussed herein, I find
that Petitioner is entitled to compensation.
1
Because this unpublished ruling contains a reasoned explanation for the action in this case, I am required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). I intend 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 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).
I. Procedural History
Ms. Kraus filed her petition on December 21, 2017. (ECF No. 1). She filed the
relevant medical records and a Statement of Completion over the next four months. (ECF
Nos. 6-7, 9-10, 12-13). By September 2018, Respondent had reviewed all the records in
the case and filed a status report stating that he was amenable to settlement discussions.
(ECF No. 19). Settlement discussions broke down in the summer of 2019, however, and
a deadline was set for the filing of Respondent’s Rule 4(c) report to identify the areas of
disagreement. (ECF Nos. 35, 37).
Respondent filed his Rule 4(c) Report on August 29, 2019, in which he argued that
“[t]he current record does not establish by preponderant evidence that petitioner
developed SIRVA as a result of her alleged September 26, 2016 flu vaccination, as there
are insufficient records substantiating that the onset of petitioner’s right shoulder pain
began within forty-eight hours of vaccination.” (ECF No. 40). The parties agreed to brief
the case (including any disputed factual issues) and requested a ruling on the record. The
parties have completed briefing, and this case is now ripe for adjudication. After a review
of the entire record, I find that Petitioner is entitled to compensation.
II. Factual History
On September 26, 2016, Ms. Kraus (a 54-year-old disability claims adjuster at
Prudential Insurance Company) received a flu vaccine in her right deltoid at the office of
her primary care provider, Dr. Victoria Borgia, located in Bensalem, Pennsylvania. Exhibit
(“Ex.”) 1 at 1; Ex. 2 at 46. Although there is a mention of a fall in her medical notes that
may have impacted her right shoulder, that fall took place 15 years prior. Ex. 4 at 21.
There is no other documented history of any right shoulder injuries in the three years prior
to September 26, 2016.3 See generally Exs. 4 at 19, Ex. 23 at 1, ¶2.
In her affidavit, Ms. Kraus describes the circumstances of the vaccination, stating:
[a]n assistant of Dr. Borgia’s gave me the shot in my right shoulder. Within
two days, my arm was sore with an inflammatory type pain. I did not think
anything of it because it had only been a couple of days after the shot and
I felt that type of pain could happen. I went through my daily life but noticed
right away that the soreness was not going away.
Ex. 9 at ¶1.
3
Ms. Kraus’s medical history included allergic rhinitis, arthritis, backache, bronchitis, GERD, “neck burn,”
sleep apnea, tendinitis of the ankle), Ex. 4 at 10, 35-41 (clogged right ear), 42-50 (coccyx pain and low
back pain); Ex. 6 at 9-15, 23 (ankle contusion).
2
On October 17, 2016 (three weeks after her vaccination), Ms. Kraus presented to
Dr. Bindu Mathew as a new patient for left foot and ankle pain that had been present for
a number of months. Ex. 4 at 24-26. Dr. Mathew noted joint pain and back pain under
“Review of Systems,” but did not record any shoulder complaints. Id. at 25.
Approximately two months later, on December 20, 2016, Ms. Kraus presented to
Dr. Borgia with complaints of right shoulder pain. Ex. 4 at 19-21. The note from this visit
states “right shoulder pain x years but in the past month its [sic] become more painful.”
Id. at 19. Under history of present illness, Dr. Borgia noted, “R[ight] shoulder pain
intermittent x years, increasing in frequency,” no decreased range of motion, and
referenced a fall Ms. Kraus had 15 years prior. Id. No abnormal findings are noted on the
physical exam. Id. at 21. The assessment was tendinopathy, and Dr. Borgia prescribed
Naproxen and referred Ms. Kraus to physical therapy (“PT”). Id.
Approximately one month later, on January 16, 2017, Dr. Borgia amended this
record to include:
Addendum … amended 1/16/17: per p[atien]t report, had flu shot in affected
shoulder and on exam, did have area of thickened tissue at site on deltoid.
However, exam consistent with a tendonitis with ratiation [sic]. THIS
DOCUMENT HAS BEEN AMENDED.
Ex. 4 at 19. To explain this addendum, Ms. Kraus in her affidavit stated:
On December 20, 2016, I went to see Dr. Borgia and I expressed that I
couldn’t understand why I was having so much pain in my shoulder joint
since I had not injured myself. I indicated that the only thing that ever
happened to me was around 12-15 years ago, I fell on my neighbor’s
driveway. I put ice on my right hip and right arm, and called it a day. The
pain I experienced as a result of that fall was not nearly as painful as the
pain I was having presently…
I later learned that Dr Borgia had failed to note in the records of my
December 20, 2016, office visit where I stated that the vaccine injection site
was still painful. She also embellished what I stated about my reported fall
years ago. I asked her to correct my office visit note and she, once again,
put statements that did not correlate with what I reported and what we
discussed… On my next office visit, she apologized for the incorrect
information noted in my record of December 20, 2016. She stated her
medical assistant put the inaccurate information in my office visit note and
3
she often doesn’t check the notes. She further advised that she would
correct that information in the office note for January 20, 2017. She made
note in the January 20, 2017 office visit note that the prior office visit note
had erroneous information.
Ex. 9 at 1-2, ¶¶4-5.
Ms. Kraus returned to Dr. Borgia on January 20, 2017, about four days after Dr.
Borgia amended the December 20, 2016 visit note. Ex. 4 at 15-18. Ms. Kraus reported
“she is here because in September she got a flu shot in her right arm and ever since then
she has had pain in her upper arm that goes up to her shoulder.” Id. at 15. She also stated
that she had “no issue until 2 day[s] after.” Id. Ms. Kraus explained that she “felt some
soreness which she attributed to customary soreness [that] did not resolve.” Id. She had
full range of motion, but the pain was worse when she lifted her arm to use her computer
and when drying her hair. Id. Dr. Borgia noted that at the prior visit she had “erroneously
attributed this new pain to exacerbation of an old injury” to the same shoulder after a fall
many years ago. Id. Dr. Borgia prescribed a course of oral steroids and ordered an MRI.
Id. at 13-18; Ex. 5 at 5; Ex. 6 at 16-17.
Ms. Kraus underwent the MRI of her right shoulder on February 17, 2017. Ex. 2 at
23; Ex. 4 at 13-14. The impression was a “[t]iny high-grade insertional infraspinatus
tendon tear. 2. No evidence of soft tissue collection or signs of septic arthritis.” Id. The
indication on the MRI report stated, “Pain after a flu shot.” Id.
Ms. Kraus met with Dr. Borgia on February 20, 2017, to review the results of her
MRI. Dr. Borgia explained that the MRI showed a “tiny tear” of the infraspinatus tendon.
Ex. 4 at 10, 13. Dr. Borgia also noted that she “found other examples of [rotator cuff]
problems after flu [immunization],” and she planned to report Ms. Kraus’s reaction to
VAERS. Id. at 10, 12. During this visit, Ms. Kraus receive a steroid injection to her right
shoulder to treat the pain and inflammation. Id. at 10-12. She was also referred to PT. Id.
Ms. Kraus began physical therapy for her right shoulder on March 8, 2017. Ex. 2
at 8-15. She described her pain as a 5, on a 0 to 10 scale. Ex. 4 at 7. Ms. Kraus was
discharged after seven sessions. Ex. 2 at 8-15. Then, on April 3, 2017, Ms. Kraus
presented to Julie Todd, D.O., at Bucks Family Medicine for a “general physical exam.”
Ex. 5 at 3. The history of present illness section of the note states “[c]omplains of right
shoulder pain since 9/26/174 after receiving flu shot in her right arm.” Id. The “Nurse Note”
on the same page states “P[atien]t has r[igh]t delt/shoulder pain since receiving flu shot
4
This date is a typo. There is no dispute that Ms. Kraus received the flu vaccine on September 26, 2016.
See Ex. 1 at 1.
4
on 9-26-16. P[atien]t states pain started 2 days after injection.” Id. Ms. Kraus reported
that her symptoms had not improved with PT and a steroid injection. Id. Dr. Todd
encouraged her to continue with PT and referred her to an orthopedist. Id.
A week later, on April 10, 2017, Ms. Kraus presented to Dr. Steven A. Caruso at
Trenton Orthopaedic Group. Ex. 6 at 4-8. She had seen another orthopedist in this
practice group in the past for a right ankle problem. Id. at 9-11, 14-15, 19, 22-23. Under
History of Present Illness, Dr. Caruso notes
Leslie is a pleasant 55-year-old left-had dominant female who presents
today with right shoulder pain. She has this pain since September. She is
[sic] obtained a flu shot and she states that she has had this pain since this
flu shot. . .
Id. On exam, Ms. Kraus exhibited pain to palpitation of her right shoulder and pain at the
end of full range of motion. Id. at 4-8. When Ms. Kraus inquired, “whether or not the flu
shot [was] the reason for her pain,” Dr. Caruso stated that he could not confirm it. Id. at
7. He continued, “I believe it is possible and the axillary nerve does cross the anterior and
lateral shoulder and I believe it depends on where the injection is,” noting further,
however, “I have never seen this or what this does in my practice before.” Id. The
assessment was right shoulder pain and “partial thickness rotator cuff tear.” Id. Dr. Caruso
echoed Dr. Todd’s recommendation that Ms. Kraus continue with PT. Id. That same day
she began physical therapy at NovaCare Rehabilitation. Ex. 7 at 7-9. When her condition
did not notably improve after nine sessions, her therapy was suspended on May 16, 2017,
pending further evaluation by a doctor. Id. at 36.
On June 6, 2017, Ms. Kraus presented orthopedic surgeon Dr. George Russell
Huffman, who diagnosed Petitioner with right shoulder bursitis. Ex. 8 at 1-3. Ms. Kraus
reported having “had pain at the time of vaccination and within two days, the pain
escalated and increased to the point that she could not sleep at night, could not use her
arm for activities of daily living.” Id. at 2. Dr. Huffman recommended a second steroid
injection in her right shoulder, which Ms. Kraus received roughly two months later, on
August 15, 2017. Id. at 2-4. By October 3, 2017, however, Ms. Kraus exhibited good range
of motion and minimal signs of impingement. Ex. 8 at 6. Dr. Huffman prescribed Voltaren
gel and advised that she return in three months. Id.
A year later, on October 4, 2018, Ms. Kraus was seen at Bucks Family Medicine,
P.C. by Dr. David E. Lewis for “ongoing right arm/shoulder pain.” Ex. 13 at 1. Dr. Lewis
noted that Ms. Kraus “had previously followed with Ortho who recommended [follow up]
in 1/2018 but she was not able to go. She is now doing more lifting as a result of her job.
5
This increased lifting is worsening the shoulder pain with radiation into her arm (these are
what the symptoms had been).” Id. The physical examination showed decreased right
shoulder range of motion, and assessments included “Pain in right shoulder” and
“incomplete rotator cuff tear or rupture of right shoulder.” Id. at 2. Ms. Kraus later saw Dr.
Huffman, on November 20, 2018, for “SIRVA reaction to a flu vaccination into her deltoid
on 09/26/2016. She continues to have pain and discomfort.” Ex. 12 at 1. Physical
examination showed “pain around the deltoid tuberosity…positive Jobe’s and very mild
impingement.” Id.
On April 12, 2019, Ms. Kraus was seen at Penn Orthopaedic Institute by Dr.
Huffman for a follow up on her right shoulder. Ex. 12 at 4. The record from this visit reflects
the following:
[Petitioner] had a SIRVA reaction to a flu vaccination in the right delta on
09/26/2016. She had a course of physical therapy early on, but said that her
shoulder was too painful for the therapy to have been effective. She points
to the range from the lateral aspect of the acromion down to the deltoid
tuberosity for the preponderance of her pain. She rates her pain as 3/10
today.
Id. The plan was to for Ms. Kraus to resume physical therapy, and “[i]f she is still
struggling, a bursectomy decompression may be warranted.” Id. at 4.
Ms. Kraus completed 11 physical therapy sessions at NovaCare Rehabilitation,
from May 9, until June 27, 2019. Ex. 16. She returned to Dr. Huffman, on July 16, 2019,
for a follow up on her right shoulder pain. Ex. 15 at 1. Dr. Huffman noted Petitioner “had
a SIRVA reaction to a flu vaccination in the right deltoid on 09/26/2016…I did give her a
corticosteroid injection at one point that helped. She has done physical therapy, which
helped to a point but now has continued pain. Now, her pain is not in the shoulder as
much, which feels good.” Id. Petitioner was instructed to continue using Voltaren Gel to
“break the cycle of inflammation in [the deltoid] region,” and to return as needed. Id.
No additional medical records have been filed. However, Ms. Kraus filed two
affidavits and three witness affidavits, which include her husband, Cliff Kraus, her
daughter, Kristin Kraus, and a work colleague, Catherine Barbagallo. Exs. 17-20. Each
of these witnesses describe conversations or personal recollections to help substantiate
Ms. Kraus claims of shoulder pain within the 48-hour period after her vaccination.
6
III. Parties’ Arguments
Ms. Kraus requests that I issue a ruling determining that: (1) she experienced the
onset her right shoulder pain within 48 hours of receiving the flu vaccine on September
26, 2016, and (2) she has otherwise established entitlement to compensation for her
SIRVA injury. Petitioner’s Motion for Ruling on the Record (“Mot.”) at 1-2, ECF No. 47.
Respondent argues that Petitioner has failed to satisfy the criteria for a Table
SIRVA because she “has failed to provide preponderant evidence that her right shoulder
pain began within 48 hours of vaccine administration.” Respondent’s Brief (“Opp.”) at 6
(citing 42 C.F.R. § 100.3(a)(XIV)(B) (Table entry for SIRVA following the influenza
vaccine) and (c)(10) (additional criteria for SIRVA set forth in the QAI)). Respondent
maintains that the medical records are unclear as to when Petitioner’s right shoulder pain
began, and therefore, criterion (ii) under the QAI for SIRVA has not been met. Opp. at 6-
7, ECF No. 54.
Ms. Kraus filed a Reply reiterating that the medical records and witness affidavits
all support a finding that her shoulder pain began within 48 hours of vaccination and she
is therefore entitled to compensation. Petitioner’s Reply to Motion for Ruling on the
Record (“Reply”) at 4-5, ECF No 55. The parties’ positions and evidence are considered
below.
IV. Fact Findings and Ruling on Entitlement
a. Legal Standards
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
of Health & Human 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 & Human Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a
7
petitioner may present testimony which is “consistent, clear, cogent, and compelling.”
Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human 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,5 a petitioner must
establish that he suffered an injury meeting the Table criteria, in which case causation is
presumed, or an injury shown to be caused-in-fact by the vaccination he received. 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 an influenza 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:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
5
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 his injury. See § 11(c)(1)(A)(B)(D)(E).
8
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).
If, however, petitioner suffered an injury that either is not listed in the Table or did
not occur within the prescribed time frame, he must prove that the administered vaccine
caused injury to receive Program compensation. Section 11(c)(1)(C)(ii) and (iii). In such
circumstances, petitioner asserts a “non-Table or [an] off-Table” claim and to prevail,
petitioner must prove her claim by preponderant evidence. Section 13(a)(1)(A). The
Federal Circuit has held that to establish an off-Table injury, petitioner must “prove . . .
that the vaccine was not only a but-for cause of the injury but also a substantial factor in
bringing about the injury.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1351 (Fed. Cir 1999). The received vaccine, however, need not be the predominant cause
of the injury. Id. at 1351.
The Circuit Court has indicated that a petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[t]here must be a ‘logical sequence of cause and effect showing
that the vaccination was the reason for the injury.’” Id. The Federal Circuit subsequently
reiterated these requirements in a three-pronged test set forth in Althen v. Sec’y of Health
& Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this test, a petitioner is
required
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
9
of a proximate temporal relationship between vaccination and
injury.
Id. All three prongs of Althen must be satisfied. Id. Circumstantial evidence may be
considered, and close calls regarding causation must be resolved in favor of the
petitioner. Id. at 1280.
A. Factual Findings Regarding QAI Criteria for Table SIRVA
After a review of the entire record, I find that a preponderance of the evidence
demonstrates that Petitioner has satisfied the QAI requirements for a Table SIRVA.
1. Prior Condition
The first requirement under the QAIs for a Table SIRVA is a lack of a history
revealing problems associated with the affected shoulder which were experienced prior
to vaccination and would explain the symptoms experienced after vaccination. 42 C.F.R.
§ 100.3(c)(10)(i). Although Respondent noted that the December 20, 2016 medical record
from Dr. Borgia notes that Ms. Kraus had a fall that may have affected her right shoulder
15 years prior, Respondent has not formally contested that Petitioner meets this criterion.
I also have found no evidence in the records that Ms. Kraus had any evidence of a right
shoulder injury in the years prior to her September 16, 2016 vaccination. I therefore find
that Ms. Kraus has satisfied the first SIRVA requirement.
2. Onset of Pain
In order to meet the definition of a Table SIRVA, a petitioner must show that she
experienced the first symptom or onset (here, pain) within 48 hours of vaccination (42
C.F.R. §§ 100.3(a)(XIV)(B)) and 100.3(c)(10)(ii) (QAI criteria)).
Respondent argues that Ms. Kraus did not report her shoulder pain to a medical
provider until nearly three months after her vaccination, and in the interim, made no
mention of such pain when she saw Dr. Mathew concerning a chronic ankle problem.
Opp. at 6. Respondent also notes that at Ms. Kraus’s initial visit to Dr. Borgia, she
complained of “right shoulder pain x years” that had “become more painful” in the past
month, and referenced a fall Ms. Kraus had 15 years prior. Id. Respondent states that the
physical exam was “poorly described” but no abnormal findings were noted. Dr. Borgia
later amended her note to relate Ms. Kraus’s shoulder pain to her vaccine, rather than a
past fall. Respondent further cites to a number of notations in the record where Ms. Kraus
states that her pain began two days “after vaccination,” which Respondent interprets to
10
mean outside the Table time period of 48 hours. Notably, however, Respondent also cites
to the records where Ms. Kraus reports that her shoulder pain began “within two days”.
Opp at 7. Respondent thus claims these references make it “unclear” when Petitioner’s
shoulder pain began – meaning that Table onset cannot be demonstrated.
Respondent has reasonably raised questions about the extent to which this record
establishes Table onset. In particular, the amended statements in Dr. Borgia’s records
are grounds for concern (although the fact that the record was amended not long after
the visit, and many months prior to the case’s initiation, diminishes my concerns
somewhat). Nevertheless, the overall record permits the conclusion that onset “more
likely than not” occurred within 48 hours of vaccination.
First, Respondent unpersuasively maintains that the various instances in the
medical records where Ms. Kraus reported that her shoulder pain began two days “after”
vaccination do not make the onset of her shoulder pain unclear. In fact, my interpretation
of these statements is exactly the opposite of what Respondents wants me to infer.
Presumably, an individual seeking medical treatment is unaware of the 48-hour
onset requirement for shoulder pain to satisfy the SIRVA QAI when he or she is presenting
to a medical provider to be treated for shoulder pain. As a result, an approximation of “two
days” after vaccination is reasonable, if imprecise, evidence that shoulder pain began in
the day or two after vaccination – especially when (as here) it is coupled with statements
that do put the onset of her shoulder pain squarely within the 48 hour onset window. See
e.g., Ex. 8 at 2 (June 6, 2017 note by Dr. Huffman states “pain began within a day or two
after an influenza vaccination.”); Ex. 4 at 15 (Dr. Borgia’s note states “flu shot in her right
arm and ever since then she has had pain in her upper arm that goes up to her shoulder.”);
Ex. 5 at 3 (Dr. Todd notes “has rt (right) delt [deltoid] /shoulder pain since receiving flu
shot on 9-26-16”); Ex. 6 at 7 (Orthopedist Steven Caruso noted that petitioner had right
shoulder pain beginning in September since receiving “a flu shot and she states that she
has had this pain since this flu shot”); Ex. 7 at 34 (Physical therapist Brendan Cummings
noted “shoulder pain that began in late September after patient received flu shot.”); Ex. 8
at 2 (Orthopedist G. Russell Huffman noted “pain began within a day or two after an
influenza vaccination and within two days, the pain escalated and increased to the point
that she could not sleep at night”); Ex. 16 at 1 (Petitioner presented to NovaCare
Rehabilitation for an evaluation and it was noted, “Presents with s/o pain in R shoulder
after receiving flu vaccine 2016”). The totality of this evidence is favorable to Petitioner
despite the presence of some record instances that are more vague or imprecise.
Second, I am not persuaded by Respondent’s argument that because Ms. Kraus
did not complain to her podiatrist, Dr. Mathew, on October 17, 2016, about her shoulder
11
pain, she must not have been experiencing shoulder pain at that time. As Petitioner notes
in her brief, it is entirely understandable why Ms. Kraus would not have reported her
shoulder pain to a podiatrist, whom she sought for evaluation of left foot and ankle pain.
There is no reason for her to have informed a specialist of all of her concurrent or
comorbid issues that that time.
Third, delay in treatment in this case does not preclude a finding of Table onset.
As I have previously explained in other SIRVA onset rulings, it is common for petitioners
to delay seeking treatment, thinking the injury will resolve on its own, since patients are
often told by medical providers at the time of vaccination to expect some soreness and
pain for a period of time after. Indeed, Ms. Kraus confirmed in her affidavit that she
expected to have some shoulder pain immediately after receiving her vaccination. Ex. 9
at 1, ¶1; Ex. 17 at 1, ¶2. Thus, I find the length of time Ms. Kraus waited before contacting
her physician’s office to report her shoulder pain to be entirely reasonable in these
circumstances.
Finally, I note that proof of onset need not come from records created within the
relevant onset period – as Respondent often seems to assume. 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. Section 13(b)(2). In this case, there are medical records created in a generally-
contemporaneous time to the reporting of shoulder pain6 that clearly relate onset of
Petitioner’s shoulder pain to the 48-hour time period after vaccination. While evidence of
post-vaccination pain from a record created no more than two days post-vaccination
would constitute particularly strong evidence of onset, it is not the only form of persuasive
evidence to establish onset.
Based upon the above, I find there is preponderant evidence which establishes the
onset of Ms. Kraus’s right shoulder pain was more likely than not within 48-hours of
vaccination.
3. Scope of Pain and Limited ROM
I likewise find that the scope of pain and limited range of motion was limited to
Petitioner’s right shoulder. To establish a Table SIRVA, a petitioner’s pain and reduced
6
As the Federal Circuit has noted, it is appropriate for a special master to give greater weight to evidence
contained in medical records created closer in time to the vaccination, even if the information is provided
as part of a medical history. Cucuras, 993 F.2d at 1528 (medical records are generally trustworthy
evidence).
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ROM must be limited to the shoulder in which the vaccination alleged as causal was
administered. 42 C.F.R. § 100.3(c)(10)(iii).
Ms. Kraus was diagnosed and treated solely for pain and limited range of motion
to her right shoulder and Respondent does not contest that Petitioner fails to meet this
criterion. I therefore find that there is preponderant evidence to support a finding that
Petitioner’s pain and reduced range of motion was limited to her right shoulder. Thus, she
satisfies the third criterion for a SIRVA injury.
4. Other Condition or Abnormality
The last QAI criterion for a Table SIRVA states that there must be no other
condition or abnormality which would explain a petitioner’s current symptoms. 42 C.F.R.
§ 100.3(c)(10)(iv). Respondent has likewise not contested that Petitioner meets this
criterion and I have found no evidence in the record of any other condition or abnormality
that would explain Ms. Kraus’s right shoulder pain and symptomology.
Thus, the record contains preponderant evidence establishing that there is no
other condition or abnormality which would explain the symptoms of Petitioner’s right
shoulder injury.
A. Other Requirements for Entitlement
In addition to establishing a Table injury, a petitioner must also provide
preponderant evidence of the additional requirements of Section 11(c). Respondent does
not dispute that Petitioner has satisfied these requirements in this case, and the overall
record contains preponderant evidence to fulfill these additional requirements.
The record shows that Petitioner received the flu vaccine intramuscularly in her
right shoulder on September 26, 2016. Ex. 1 at 1; Ex. 2 at 46; see Section 11(c)(1)(A)
(requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i)(I) (requiring administration
within the United States or its territories). There is no evidence that Petitioner has
collected a civil award for her injury. Petition at 2; Section 11(c)(1)(E) (lack of prior civil
award).
As stated above, I have found that the onset of Petitioner’s right shoulder pain was
within 48 hours of vaccination. See 42 C.F.R. § 100.3(c)(10)(ii) (setting forth this QAI
requirement). This finding also satisfies the requirement that Petitioner’s first symptom or
manifestation of onset occur within the time frame listed on the Vaccine Injury Table. 42
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C.F.R. § 100.3(a)(XIV)(B) (listing a time frame of 48 hours for a Table SIRVA following
receipt of the influenza vaccine).
The next criteria which must be satisfied by Petitioner involves the duration of her
SIRVA. For compensation to be awarded, the Vaccine Act requires that a petitioner suffer
the residual effects of her shoulder injury for more than six months. See Section
11(c)(1)(D)(i) (statutory six-month requirement). The records demonstrate, and
Respondent does not contest, that Ms. Kraus suffered the residual effects of her shoulder
injury for more than six months. See, e.g., Ex. 12 at 4; Ex. 15 at 1, Ex. 16. Thus, this
requirement is also met.
In view of the evidence of record, I find that Petitioner is entitled to
compensation.
V. Conclusion
For all of the reasons discussed above and based on consideration of the record
as a whole, I find that Petitioner’s right shoulder injury meets the definition for a
Table SIRVA. Thus, causation is presumed, and Petitioner is entitled to
compensation in this case. A separate damages order will be issued.
IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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