VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-01077
Package ID: USCOURTS-cofc-1_18-vv-01077
Petitioner: Terry Pedri
Filed: 2018-07-24
Decided: 2023-06-27
Vaccine: influenza
Vaccination date: 2015-10-14
Condition: left shoulder injury related to vaccine administration (SIRVA)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Terry Pedri, a 55-year-old adult, received an influenza vaccine on October 14, 2015. She filed a petition alleging a left shoulder injury related to vaccine administration (SIRVA). Pedri claimed the injury occurred immediately after the vaccination, causing severe pain and loss of range of motion. She submitted an affidavit detailing her symptoms and an expert report from Dr. Naveed Natanzi, who opined that Pedri suffered from SIRVA due to potential needle overpenetration and an inflammatory response. The respondent, the Secretary of Health and Human Services, argued that Pedri's claim did not meet the criteria for a Table SIRVA. The respondent pointed to the delayed onset of symptoms reported in medical records (approximately seven weeks post-vaccination), the presence of widespread pain in other joints (back, knees, hands, hips), and the diagnosis of fibromyalgia by her treating physicians, including Dr. Bruce Cohn and Dr. Maika Del Mar. Respondent's expert, Dr. Geoffrey Abrams, supported the fibromyalgia diagnosis based on the American College of Rheumatology criteria. The Special Master reviewed the evidence and found that Pedri did not establish a Table SIRVA claim because her symptom onset was not clearly within 48 hours, her pain was not limited to the shoulder, and an alternative condition (fibromyalgia) was present. The Special Master also found that Pedri failed to prove an off-Table claim, as her symptoms extended beyond the shoulder and the medical records overwhelmingly supported a fibromyalgia diagnosis, not the alleged SIRVA. Consequently, Pedri's petition was dismissed.

Theory of causation field:
unclear

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-01077-0
Date issued/filed: 2023-08-01
Pages: 24
Docket text: PUBLIC DECISION (Originally filed: 06/27/2023) regarding 38 DECISION of Special Master. Signed by Special Master Herbrina Sanders. (rig) Service on parties made.
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Case 1:18-vv-01077-UNJ Document 40 Filed 08/01/23 Page 1 of 24
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: June 27, 2023
TERRY PEDRI,
No. 18-1077V
Petitioner,
Special Master Sanders
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner.
Sarah C. Duncan, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION ON ENTITLEMENT1
On July 24, 2018, Terry Pedri (“Petitioner”), filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2018)2 alleging “a left shoulder injury related to
vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered on
October 14, 2015.” Pet. at 1, ECF No. 1. For the reasons set forth below, I conclude that Petitioner
is not entitled to compensation.
I. Procedural History
Petitioner filed her vaccination record, medical records, and an affidavit along with her
initial petition. Pet’r’s Exs. 1–3, ECF No. 1. This case was originally assigned to the Special
Processing Unit (“SPU”) for expedited resolution based on the allegations in the petition. ECF No.
5. On July 26, 2018, Petitioner filed her statement of completion. ECF No. 7. Petitioner filed a
supplemental affidavit on October 24, 2018. Pet’r’s Ex. 4, ECF No. 11-2. A detailed vaccination
record was filed on January 11, 2019, along with a second statement of completion. Pet’r’s Ex. 5,
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 (2018) (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 I, upon review, agree that the identified material fits within this definition, it will be redacted
from public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
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ECF No. 13-1; ECF No. 14. Petitioner filed additional medical records on June 26, 2019, and an
amended statement of completion. Pet’r’s Ex. 6, ECF No. 19-2; ECF No. 20.
Respondent filed his Rule 4(c) report on August 26, 2019. Resp’t’s Report, ECF No. 22.
The same day, Respondent filed a motion to reassign the case and argued that, after his “review of
the case, complicating factors do exist which suggest that the case should be removed from the
SPU.” Resp’t’s Mot. at 1, ECF No. 23. The case was transferred to me on September 17, 2019.
ECF Nos. 24–25. On December 5, 2019, Petitioner filed an expert report from Dr. Naveed Natanzi,
his curriculum vitae, and medical literature. Pet’r’s Exs. 7, 8A–T, ECF No. 27. Respondent filed
his responsive expert report from Dr. Geoffrey Abrams, his curriculum vitae, and medical
literature on April 10, 2020. Resp’t’s Exs. A, A1–6, B, ECF No. 29. On May 18, 2020, Petitioner
filed a supplemental expert report with medical literature. Pet’r’s Exs. 9, 9A–B, ECF No. 30.
Respondent filed a supplemental report with medical literature on July 16, 2020. Resp’t’s Exs. C,
C1–C3, ECF No. 31.
On March 18, 2022, the parties indicated a desire to proceed with a ruling on the record.
Informal Comm., docketed Mar. 18, 2022. The same day, I ordered Petitioner to file said motion
by April 18, 2022. Sched. Order, ECF No. 33. Petitioner filed her motion for a ruling on the record
on April 18, 2022. Pet’r’s Mot. for Ruling [hereinafter “Pet’r’s Mot.”], ECF No. 34. Respondent
filed his response on May 18, 2022. Resp’t’s Resp., ECF No. 35. Petitioner did not file a reply.
I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where, in the exercise
of their discretion, they conclude that doing so will properly and fairly resolve the case. See 42
U.S.C. § 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has
been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed.
Cir. 2020); Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
cases on the papers in lieu of hearing and those decisions were upheld). Accordingly, this matter
is now ripe for resolution.
II. Factual History
a. Medical Records
Petitioner’s pre-vaccination medical history is significant for right leg pain and swelling
associated with lower extremity deep venous thrombosis (“DVT”)3 and obesity. Pet’r’s Ex. 2 at 1–
2, ECF No. 1-5; Pet’r’s Ex. 6 at 57, ECF No. 19-2. On October 14, 2015, at age 55, she received
a flu vaccine in her left deltoid. Pet’r’s Ex. 2 at 6.
Approximately seven weeks post vaccination, on December 4, 2015, Petitioner saw her
primary care physician (“PCP”), Dr. Bruce Cohn. Id. at 10–11. She reported a “[four] week
3 Deep venous thrombosis (or deep vein thrombosis) is “thrombosis of one or more deep veins, usually of
the lower limb, characterized by swelling, warmth, and erythema[.]” Dorland’s Illustrated Medical
Dictionary 1, 1923 (32nd ed. 2012) [hereinafter “Dorland’s”]. Thrombosis refers generally to the
formation of a “thrombus” or blood clot in the veins that impedes blood flow. Id.
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‘aching’ in [her] shoulder [more than in] other joints[.]” Id. at 10. She complained that she “[h]ad
been awaken [sic] at night due [to] shoulder, back[,] and knees” pain. Id. She did not report
limitations in movement but stated that she had “pain with changing position at night.” Id. A
physical examination revealed no tenderness to palpation, full range of motion (“ROM”), and no
synovitis.4 Id. Dr. Cohn assessed Petitioner with joint pain and prescribed nabumetone.5 Id. at 11.
On January 25, 2016, Petitioner emailed Dr. Cohn complaining that her “[u]pper left arm
ache[d] constantly in [the] muscle about where you would receive a shot.” Id. at 35. She explained
that it was “[p]ainful to raise [her] arm over head or [to] bend [her arm] to [the] middle of [her]
back – still.” Id. Petitioner also described right hand stiffness at night and in the morning that
improved with flexing exercises. Id. She reported additional complaints including pain in her right
thigh and hip that self-resolved and pain on the lower left side of her spine. Id. She also reported
that the previous week, she experienced pain on the upper, right side of her chest, followed by
heartburn. Id. Lastly, Petitioner reported achy knees and sore wrists. Id. She said, “most of this
came on mid-Oct[tober].” Id.
The next day, on January 26, 2016, Dr. Cohn responded that Petitioner’s last exam and lab
tests were all normal, which was “obviously good news but d[id] not give [Petitioner and Dr. Cohn]
an answer to why [Petitioner] fe[lt] so poorly.” Id. at 36. Petitioner immediately replied to his
email and added that she experienced pain in the lower left side of her spine to the lower right side.
Id. She continued that after her flu shot, all of her issues started, including bilateral hand pain and
right arm pain. Id. Petitioner also reported feelings of melancholy beginning “last week[,] as pain
[and limited ROM] in [her right] arm [was] not getting better, [and] now [her right] side of [the]
middle chest [was] aching and fe[lt] bruised.” Id. Dr. Cohn responded on January 28, 2016, and
asked Petitioner if she had “ever heard of ‘fibromyalgia’?”6 Id. at 34. He continued, “[Petitioner’s]
symptoms may fit with this diagnosis, based on [her] prior normal labs and exam.” Id.
Petitioner emailed Dr. Cohn the next day, on January 29, 2016, and noted that she was
going through menopause. Id. She reported that “[t]he night before last[, she] woke up [with three]
of [her] toes stiff [with] a burning sensation until [she] worked it out. Yesterday, midday [her right]
temple was tender and [] late in the day the whole top – back and around the skull was tender and
hurt.” Id. On January 30, 2016, Dr. Cohn responded and explained that “[w]e can treat this like
fibromyalgia” and if Petitioner had fibromyalgia, “there is no[] blood test or x-ray to prove that
diagnosis[,and] the best treatment is daily aerobic type exercise.” Id. He also recommended
possible physical therapy (“PT”) and daily medication. Id. Petitioner responded that she would try
aerobic exercise and asked if there are “any foods or diet changes that help or hinder this
condition.” Id. at 35, 51.
On February 6, 2016, Petitioner emailed Dr. Cohn with complaints of “a lot of pain” in the
4 Synovitis is “inflammation of a synovial membrane; it is usually painful, particularly on motion, and is
characterized by a fluctuating swelling due to effusion within a synovial sac.” Dorland’s at 1856.
5 Nabumetone is “a nonsteroidal anti-inflammatory drug used in the treatment of osteoarthritis and
rheumatoid arthritis.” Dorland’s at 1229.
6 Fibromyalgia is defined as “pain and stiffness in the muscles and joints that either is diffuse or has
multiple trigger points.” Dorland’s at 703.
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left shoulder area and requested an x-ray. Id. at 33. She reported that she had been
doing aerobic exercises for the past five days but still had hand stiffness and soreness along with
left shoulder and right lower back pain. Id. A February 10, 2016 x-ray of Petitioner’s left shoulder
was normal. Id. at 66.
Petitioner presented to Dr. Maika Del Mar, a new PCP, with complaints of joint pain on
February 23, 2016. Id. at 80–82. Petitioner reported increased pain and limited ROM in her left
shoulder, beginning in October of 2015 after a flu shot. Id. at 80. She described pain in her right
hip, bilateral knee pain, and occasional weakness in her left hand. Id. During a physical exam,
Petitioner exhibited mild point tenderness in her right hip and lower lumbar and buttocks area with
difficulty reaching back and over with her left shoulder. Id. at 81. Dr. Del Mar assessed Petitioner
with adhesive capsulitis7 of the left shoulder, lumbar radiculopathy,8 and “joint pain—
fibromyalgia [versus] other, supportive care.” Id. at 82. Dr. Del Mar recommended PT for
Petitioner’s fibromyalgia, but Petitioner declined, stating that her “shoulder appear[ed] to be
getting better slowly.” Id. Petitioner’s prescription for nabumetone was renewed for her back pain.
Id. Dr. Del Mar also ordered a lumbar spine x-ray that revealed mild facet arthropathy9 at L4–L5
and L5–S1. Id. at 88.
Between March 10 and May 25, 2016, Petitioner attended four PT appointments. Id. at 98–
101, 118–29, 145–47. During her initial evaluation on March 10, 2016, Petitioner complained of
left shoulder pain when reaching behind and overhead and when lifting baggage overhead on an
airplane. Id. at 99. She also complained of right hip and low back pain that was aggravated by
sitting or driving for more than thirty minutes, bilateral knee pain when standing up and squatting,
and left elbow and hand stiffness in the morning. Id. The visit record noted in the “mechanism of
injury, history and progression” section that “onset [occurred] the day after [she received a] flue
[sic] shot [and] started with left shoulder” pain. Id. Petitioner’s therapist observed shoulder flexion
of 170 degrees, external rotation of 50 degrees, and functional internal rotation to L5. Id. at 100.
Petitioner’s elbow and knee movement were within functional limits, but supination was painful
in the shoulder, and she experienced internal and external hip rotation stiffness. Id.
Following her initial PT visit, on March 13, 2016, Petitioner emailed Dr. Del Mar and
requested a cortisone10 shot in her left shoulder because she could not reach behind her back or
pull on a seatbelt “without severe pain.” Id. at 90. She also reported that nabumetone was no longer
working, but she had taken 200mg of ibuprofen the night before and only “woke up once.” Id. at
91. Petitioner presented to Dr. Del Mar the next day and reported that PT had not helped. Id. at
110–12. Dr. Del Mar administered a steroid injection on March 14, 2016. Id. at 112.
7 Adhesive capsulitis is “adhesive inflammation between the joint capsule and the peripheral articular
cartilage of the shoulder with obliteration of the subdeltoid bursa, characterized by shoulder pain of
gradual onset, with increasing pain, stiffness, and limitation of motion. Called also adhesive bursitis and
frozen shoulder.” Dorland’s at 286.
8 Lumbar radiculopathy is a “disease of the lumbar nerve roots, such as from disc herniation or
compression by a tumor or bony spur, with lower back pain and often paresthesias.” Dorland’s at 1571.
9 Arthropathy refers to “any joint disease[,]” generally. Dorland’s at 158.
10 Cortisone is “a natural glucocorticoid [a corticosteroid] that is metabolically convertible to cortisol[.]”
Dorland’s at 422.
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A PT record dated April 1, 2016, noted that “[a]ll [of Petitioner’s] symptoms were
resolving.” Id. at 119. Petitioner reported that her recent cortisone injection had helped. Id. On
April 22, 2016, Petitioner reported that she was having “very little pain at this time, only with
certain positions in the shoulder,” and some weakness when playing tennis. Id. at 126. A physical
exam revealed that Petitioner’s ROM was normal, and she reported a return to normal activity with
mild symptoms. Id. Petitioner attended her last PT session on May 25, 2016. Id. at 145–47. She
reported very little pain, only with certain hip positions. Id. at 146. Petitioner was discharged with
a home exercise program after having met her PT goals. Id. at 147.
The same day as her last PT session, on May 25, 2016, Petitioner presented to Dr. Del Mar
with upper respiratory infection symptoms, and she reported right hip pain. Id. at 151. In an email
dated June 7, 2016, Petitioner reported to Dr. Del Mar that during her last PT session on May 25,
2016, she utilized “two new additional exercises for the right hip along with the same strengthening
exercises for the left shoulder joint where [she] received the original flu shot. All other joints
[we]re back to normal.” Id. at 173.
Petitioner continued to complain of right hip pain throughout 2017. See, e.g., id. at 207,
218–19, 225, 234–36. On November 28, 2017, Petitioner was seen by an orthopedist and reported
that following her 2015 flu shot, she experienced “multiple joint pain the next day, including the
hips.” Id. at 234. She stated that “[a]ll other joints improved over time except her right hip.” Id.
Petitioner received a steroid injection in her hip and re-entered PT for said hip pain through January
of 2018. See id. at 234, 241–43, 253–54, 286–87. On March 7, 2018, Petitioner told her
gynecologist that “[s]he had a severe systemic reaction with her last flu shot and has not been
working since that time but is considering going back now.” Pet’r’s Ex. 6 at 517.
b. Petitioner’s Affidavit
Petitioner described her vaccination and injury in a detailed affidavit filed on October 24,
2018. Pet’r’s Ex. 4, ECF No. 11-2.11 Petitioner stated that “[t]he shot was administered late
afternoon, and [she] was standing at the time.” Id. at 1. Petitioner described the shot as feeling like
a “bite, it stung.” Id. She noted that “[i]mmediately following [her] vaccination, [she] felt pain in
[her] left shoulder.” Id. Petitioner described a “knot at the injection site” and stated that her arm
was sore that evening. Id. The next day, Petitioner was “extremely sore” and “all [her] joints [were]
aching – stiff, inflamed.” Id. Her symptoms reminded her of a “very bad case of the flu.” Id.
Petitioner stated that she could not move her left arm to reach or pull, because “[i]t was extremely
painful and locked up – ached – would[ not] move.” Id. She “felt like [she] turned 90 [years] old
overnight.” Id. She recalled a “total[] los[s of ROM] and [said] it was crazy painful.” Id. Petitioner
stated she was still suffering symptoms after Halloween of 2015 and that she “rested a lot to get
over the flu, and was waiting for [her] left shoulder and arm pain to go away.” Id. at 2. Unable to
get comfortable, Petitioner reported that she could not sleep with her “muscles aching.” Id. She
was unable to fasten her seatbelt with her left arm and her shoulder muscles were “screaming and
refusing to move.” Id. Petitioner stated that she was convinced a doctor would tell her “to let this
flu vaccine work out of [her] system[,]” so she did not initially seek treatment. Id.
11 Petitioner’s first affidavit merely stated the date and location of the vaccination at issue; that her left
shoulder pain began “immediately[;]” and the pain persisted for more than six months. See Pet’r’s Ex. 3,
ECF No. 1-6. Its contents will therefore not be discussed in more detail.
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After Thanksgiving of 2015, when her “symptoms did not resolve,” Petitioner sought
medical care. Id. She noted her inability to continue with hobbies, including tennis, kayaking,
fishing, hiking, and bowling.” Id.
III. Expert Reports
a. Petitioner’s Expert, Naveed M. Natanzi, D.O.
Dr. Natanzi received his undergraduate degree from University of California, Santa
Barbara in 2007. Pet’r’s Ex. 8A at 2, ECF No. 27-3. He attended Western University of Health
Sciences and received his Doctor of Osteopathy degree in 2012. Id. From 2013–2016, Dr. Natanzi
completed his residency and a fellowship in physical medicine and rehabilitation at the University
of California, Irvine. Id. Dr. Natanzi worked as an attending physician in interventional medicine
and pain management before founding the Regenerative Sports and Spine Institute in 2017. Id. at
1. He is board certified by the American Academy of Physical Medicine and Rehabilitation.12 Id.
Topics of Dr. Natanzi’s publications include vasoactive intestinal peptide tumors and thalamic
lacunar infarction. Id. He issued two expert reports in the case. See Pet’r’s Ex. 7; ECF No. 27-2;
Pet’r’s Ex. 9; ECF No. 30-2.
Dr. Natanzi discussed his qualifications to opine in this matter. He noted his training by
Dr. Marko Bodor, “who[, according to Dr. Natanzi,] was the first to describe [SIRVA] in medical
literature.” Pet’r’s Ex. 7 at 1. He also noted that he “almost exclusively treat[s] musculoskeletal
issues[,] including but not limited to[,] the shoulder joint.” Id. Over the previous five years, Dr.
Natanzi has provided an expert opinion in “approximately [thirty] medico-legal matters.” Id. He
currently diagnoses and treats forty to fifty shoulder pathologies per month. Id.
Following a summary of Petitioner’s factual evidence and the medical literature filed in
support of his opinions, Dr. Natanzi began his analysis with the temporal relationship between
Petitioner’s vaccination and pain onset. Id. at 7–8. Cautioning that SIRVAs are often believed to
be the typical, self-resolving pain associated with vaccinations, he asserted that a patient’s delay
in seeking treatment is common. Id. at 8. Furthermore, the condition is rare and largely unknown
to treaters, and Dr. Natanzi opined that the condition is often misdiagnosed. Id. at 7. In Petitioner’s
case, a medical record documenting a visit in mid-December of 2016 placed the onset of
Petitioner’s shoulder pain four weeks prior, beginning in November of 2016. Id. at 8 (citing Pet’r’s
Ex. 2 at 10). However, Dr. Natanzi characterized this account of pain onset as “a
misdocumentation.” Id. He argued that Petitioner’s affidavit and emailed communications with
providers establish that Petitioner’s pain occurred immediately following vaccination. Id. at 7
(citing Pet’r’s Ex. 2 at 35, 80; Pet’r’s Exs. 3–4). Furthermore, “given the lack of any alternative
etiology for the acute development of shoulder pain in the peri-vaccination period,” Dr. Natanzi
argued that the temporal relationship between Petitioner’s vaccine and injury is consistent with a
SIRVA. Id. at 8.
12 Dr. Natanzi’s curriculum vitae indicates that he is board eligible for certification by the American
Board of Pain Management, and there is a “planned for 2018” notation. Pet’r’s Ex. 8A at 1. However, his
curriculum vitae was filed on December 5, 2019, and it is not clear if this was completed. See id.
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Dr. Natanzi identified Petitioner’s “immediate bite-like sensation,” limited ROM the
morning after vaccination, and adhesive capsulitis diagnosis as clinical and diagnostic evidence of
her SIRVA. Id. Petitioner’s account that she and the vaccine administrator were standing at the
time of her injection, “coupled with the subjective and objective signs of SIRVA,” support Dr.
Natanzi’s opinion of “a strong causal relationship between [Petitioner’s October 14, 2015 flu]
vaccination and [the onset of her] symptoms.” Id.
He further explained the “course of events in [Petitioner’s] case [that] are consistent with
SIRVA.” Id. at 9. In Dr. Natanzi’s opinion, the vaccine administrator “[i]nadvertent[ly]
overpenetrat[ed Petitioner’s skin with] the vaccination needle resulting in [b]ursal and rotator cuff
penetration causing [Petitioner] to experience immediate pain, limited [ROM], and discomfort.”
Id. He continued that meanwhile, the “[v]accine interact[ed] with naturally-occurring antibodies
from a prior vaccination [Petitioner received], resulting in an exaggerated, robust, and prolonged
inflammatory response[,] resulting in [a]dhesive capsulitis and rotator cuff mediated pain.” Id. In
support, Dr. Natanzi submitted medical literature including an article by Bodor and Montalvo,13
who Dr. Natanzi claimed “[h]ypothesized that [a vaccine injected into the subdeltoid bursa in two
patients caused] a robust inflammatory mediated response.” Id. at 4 (citing Pet’r’s Ex. 8C, ECF
No. 27-5). He also submitted an article by Atanasoff et al.,14 which Dr. Natanzi asserted
“[d]escribed that if a vaccine is injected inadvertently into a synovial space (bursa or joint); a
prolonged inflammatory response may be initiated.” Id. (citing Pet’r’s Ex. 8J, ECF No. 27-12). Dr.
Natanzi noted that his “report is based on many of [Petitioner’s] recollections of events, which are
presumed to be accurate and were taken at face value.” Id. at 10.
Dr. Natanzi also discussed Petitioner’s possible fibromyalgia diagnosis. Id. at 8. According
to Dr. Natanzi, Petitioner’s “focal and isolated” shoulder pain is inconsistent with Dr. Del Mar’s
differential fibromyalgia diagnosis because fibromyalgia presents with “diffuse musculoskeletal
achiness, stiffness, and tenderness at specific points.” Id. Other symptoms that are also sometimes
seen with fibromyalgia, such as sleep, memory, and mood changes, are also not present in
Petitioner’s case. Id. Dr. Natanzi acknowledged that Petitioner experienced “other peripheral pain
conditions” in both of her knees, right hip, and left foot. Id. at 9 (citing Pet’r’s Ex. 6 at 601; Pet’r’s
Ex. 2 at 80). He argued that “these complaints are episodic and consistently secondary to the
primary complaint of shoulder pain.” Id. Furthermore, he opined that such symptoms are
“completely unrelated to each other, fibromyalgia, or [her] SIRVA injury.” Id. Dr. Natanzi asserted
instead that they “are the result of the typical wear and tear pains that surface in the latter decades
of life.” Id.
In his supplemental expert report, Dr. Natanzi identified potential etiologies for Petitioner’s
non-shoulder pain. Pet’r’s Ex. 9 at 2. He attributed Petitioner’s lower back pain to radiculopathy,
her left foot pain to tendinitis15 or a fracture, and her right hip pain to bursitis.16 Id. at 2–3. He also
discounted Dr. Del Mar’s February 23, 2016 adhesive capsulitis diagnosis because it was not
13 M. Bodor & E. Montalvo, Vaccination-related shoulder dysfunction, 25 VACCINE 585–87 (2007).
14 S. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 VACCINE 8049–52
(2010).
15 Tendinitis is “inflammation of tendons and of tendon-muscle attachments[.]” Dorland’s at 1881.
16 Bursitis is “inflammation of a bursa, occasionally accompanied by a calcific deposit in the underlying
tendon; the most common site is the subdeltoid bursa.” Dorland’s at 264.
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supported by a “documented physical exam.” Id. at 2. Rather, Petitioner’s PT notes show she had
“grossly preserved flexion and significant limitation in internal rotation.” Id. (citing Pet’r’s Ex. 2
at 100, 120). He then noted the Saleh et al.17 article that “described a case of SIRVA-mediated
capsulitis in a 30-year-old with preserved flexion and limited external and internal rotation.” Id.
(citing Pet’r’s Ex. 9B at 2, ECF No. 30-4). The study, according to Dr. Natanzi, revealed “findings
[that] almost identically mimic” those in Petitioner’s PT notes, if her arm was tested from the
abducted position. Id. Saleh et al. defined adhesive capsulitis as a “diagnosis of exclusion[,
meaning] other diagnoses need to be ruled out.” Pet’r’s Ex. 9B at 4. Patients within the study had
negative radiological findings and had ruled out other possible causes, such as rotator cuff tears,
tendonitis, and bursitis. Id.
Dr. Natanzi also discussed why patients may not seek medical care right after suffering an
injury. Pet’r’s Ex. 9 at 1. He filed an article by Taber et al.18 that “present[ed] a comprehensive
description and conceptual categorization of reasons people avoid medical care.” Pet’r’s Ex. 9A
at 1, ECF No. 30-3. The study identified three main categories: 1) unfavorable evaluations; 2) low
perceived need for care; and 3) traditional barriers to care. Id. at 6. Dr. Natanzi asserted that
Petitioner’s belief that her condition would self-improve over time is a common example of a low
perceived need to seek care. Pet’r’s Ex. 9 at 4 (citing Pet’r’s Ex. 4; Pet’r’s Ex. 9A at 5). Despite
Petitioner’s delay in seeking care, her specific descriptions of the pain immediately post
vaccination and the morning after “suggests [to Dr. Natanzi,] a clear temporal relationship between
vaccination and the onset of her symptoms.” Id. at 1.
b. Respondent’s Expert, Geoffrey D. Abrams, M.D.
Dr. Abrams received his undergraduate degree from Stanford University and his medical
degree from University of California, San Diego. Resp’t’s Ex. B at 1, ECF No. 29-8. He completed
his internship and residency at Stanford University School of Medicine in the departments of
general surgery and orthopedic surgery, respectively. Id. Since 2013, Dr. Abrams has been
employed as an assistant professor at Stanford University School of Medicine and as an attending
physician at the Veterans Administration Hospital in Palo Alto. Id. He is also currently the director
of the Lacob Family Sports Medicine Center at Stanford and “serve[s] as the [t]eam [p]hysician
for numerous professional and collegiate sports teams in the San Francisco Bay Area.” Resp’t’s
Ex. A at 1, ECF No. 29-1. Dr. Abrams is board certified in orthopedic surgery with a subspecialty
in orthopedic sports medicine. Resp’t’s Ex. B at 2. He has published articles on rotator cuff injuries,
arthroscopy, and synovial inflammation. Id. at 2–8. He issued two expert reports in this case. See
Resp’t’s Ex. A; Resp’t’s Ex. C, ECF No. 31-1.
He began by arguing Petitioner did not suffer from a SIRVA. Resp’t’s Ex. A at 4.
Petitioner’s failure to seek medical care immediately post vaccination is the first indicator for Dr.
Abrams that the onset for her shoulder pain was “well outside the 48-hour window typically seen
for consideration of a SIRVA diagnosis.” Id. Furthermore, Dr. Abrams asserted that in SIRVA
cases, “pain and reduced [ROM] should be limited to the shoulder in which the vaccine was
17 Z. Saleh et al., Onset of Frozen Shoulder Following Pneumococcal and Influenza Vaccinations, 14 J.
CHIRO. MED. 285–89 (2015).
18 J. Taber et al., Why do People Avoid Medical Care? A Qualitative Study Using National Data, 30(3) J.
GEN. INT. MED. 290–97 (2015).
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administered.” Id. at 5. However, Petitioner had “numerous musculoskeletal complaints in the
months following the injection.” Id. He noted simultaneous complaints of aching in Petitioner’s
shoulder, back, and knees during her initial visit with her PCP, seven weeks post vaccination. Id.
(citing Pet’r’s Ex. 2 at 10). He also noted Petitioner’s complaints in January of 2016, three months
post vaccination, of “right hand stiffness, right thigh into hip pain, lower left of spine upper hip
soreness (later corrected to the right side), right upper chest pain, achy knees, and wrist soreness.”
Id. (citing Pet’r’s Ex. 2 at 36–37).
In light of these complaints, Dr. Abrams agreed with Dr. Del Mar’s fibromyalgia
assessment. Id. at 6. He used The American College of Rheumatology’s (“ACR”) classification
criteria to evaluate Petitioner’s presentation and reach his conclusion. Id. (citing Resp’t’s Ex. A3,
ECF No. 29-4).19 The ACR “develop[ed] simple, practical criteria for [the] clinical diagnosis of
fibromyalgia that are suitable for use in primary and specialty care.” Resp’t’s Ex. A3 at 10. The
patient must have a widespread pain index (“WPI”) of 7 or greater and a symptom severity (“SS”)
scale score greater than 5. Resp’t’s Ex. A at 6. Symptoms must be present for at least three months,
and the patient cannot have a disorder that would otherwise explain the pain. Id. at 7.
Dr. Abrams determined that Petitioner would have a WPI of 10, based on her description
of pain in ten of nineteen possible locations on the body.20 Id. at 6. Dr. Abrams calculated
Petitioner’s total SS score at 5–8. Id. at 7. He broke the SS total down into three components:
fatigue, waking un-refreshed, and cognitive symptoms. Id. According to the classification system,
1 indicates slight or mild, intermittent problems; 2 indicates moderate, considerate problems; and
3 indicates severe and continuous, life-disturbing problems. Id. at 7. First, he assigned Petitioner a
score of 2–3 for fatigue due to her reports of waking up at night from hand and foot pain. Id. (citing
Pet’r’s Ex. 2 at 2–3). Dr. Abrams also assigned Petitioner a score of 2–3 for waking un-refreshed,
due to the same reports. Id. Lastly, Petitioner reported feeling melancholy, which Dr. Abrams
recorded as a cognitive symptom, and he assigned a severity score of 1–2. Id. (citing Pet’r’s Ex. 2
at 36). Dr. Abrams argued that at a minimum, Petitioner would have a SS scale score of 5. Id.
He noted that Petitioner’s symptoms had been present “at a similar level” for at least three
months, therefore satisfying the ACR’s three-month severity requirement for a fibromyalgia
diagnosis. Id. Citing the medical record, Dr. Abrams argued that Petitioner’s fibromyalgia
symptoms “began [four] weeks prior to her visit with Dr. Cohn on December 4, 2015,” or during
October of 2015, immediately post vaccination. Id. (citing Pet’r’s Ex. 2 at 10, 80). Dr. Abrams
wrote that this therefore places the duration of symptoms “from approximately late October/early
November until at least late January – the time of the emails – a time period of [three] months.”
Id. (citing Pet’r’s Ex. 2 at 34–36). Lastly, Dr. Abrams noted that he and Petitioner’s expert agree,
“no other objective medical conditions would explain the multiple musculoskeletal complaints of
[ P]etitioner at th[at] time.” Id. at 7–8. He opined that Petitioner’s clinical presentation is consistent
with fibromyalgia, and she did not suffer from SIRVA. Id. at 8.
19 F. Wolfe et al., The American College of Rheumatology Preliminary Diagnostic Criteria for
Fibromyalgia and Measurement of Symptom Severity, 62(5) ARTHR. CARE & RES. 600–10 (2010).
20 Petitioner reported pain in her left shoulder girdle, left lower arm/wrist, right lower arm/hand/wrist,
right hip, upper right leg/thigh, lower right leg/knee, toes, lower left leg/knee/toes, right jaw/temple, and
right upper chest. Resp’t’s Ex. A at 6 (citing Pet’r’s Ex. 2 at 35–37).
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In support of his argument that Petitioner did not have SIRVA, Dr. Abrams filed articles
to rebut Dr. Natanzi’s opinion that Petitioner suffered from “SIRVA [m]ediated [c]apsulitis.” See
Resp’t’s Exs. C2–C3, ECF Nos. 31-3–31-4.21 The Erickson et al. article noted that adhesive
capsulitis patients, “depending on the stage of the disease process at presentation, may present
with pain, pain and loss of motion, or loss of motion with minimal pain.” Resp’t’s Ex. C2 at 1. The
inclusion criteria for the study included “active and passive restriction of ROM of 20 [degrees] or
more in any plane compared with the contralateral shoulder.” Id. Patients in the study with
adhesive capsulitis “had average forward flexion of the shoulder of 114 [+/-33] degrees (and
external rotation of 29 [+/-14] degrees with the arm at the side.” Id. at 2. The Rundquist et al.
article analyzed frozen shoulder “characterized by the spontaneous onset of pain in the shoulder
with restriction of movement in every direction.” Resp’t’s Ex. C3 at 1. The authors identified
adhesive capsulitis as a subset of frozen shoulder. Id. They noted that “[q]uantifying the ROM
diagnostic of frozen shoulder has not been consistent,” and “[m]aximal abduction and maximal
external rotation reported vary considerably.” Id. Rundquist et al.’s “[i]nclusion criteria for the
study required subjects to have a maximum elevation angle relative to the trunk of less than 120
[degrees].” Id. at 4. The Rundquist et al. article noted “average flexion of 117 degrees” (and
external rotation of 35 degrees with the arm abducted). Resp’t’s Ex. C at 2. Both averages are
“well below [ P]etitioner’s documented range” of 170 degrees of shoulder flexion and 50 degrees
of external rotation. Id. at 3. Dr. Abrams also noted that an MRI was not done in Petitioner’s case.
Resp’t’s Ex. A at 8. Without an MRI, “[t]here is no objective evidence of SIRVA in this case.” Id.
He then disputed Dr. Natanzi’s description of the course of events and his theory that
overpenetration of the needle into Petitioner’s shoulder resulted in a SIRVA. Id. Dr. Abrams
argued that, despite the assertions Dr. Natanzi used to support his theory, there is no objective
evidence of the injection location (high versus low), the position of Petitioner’s arm at the time of
vaccination, or the posture of Petitioner and the administrator during vaccination. Id. Petitioner’s
recount “given during an affidavit nearly three years after the injection in question,” is not reliable
in Dr. Abrams’ opinion. Id. He questioned the reliability of Petitioner’s memory and, in support,
filed articles on the accuracy of memory recall. Resp’t’s Exs. A1–A2, ECF Nos. 29-2–29-3.22
Finally, Dr. Abrams argued that Petitioner’s higher-than-average body mass index (“BMI”)
made it unlikely that the needle could have reached her subacromial space. Resp’t’s Ex. A at 9. He
filed the Nakajima et al.23 article, which endeavored “to identify a safer intramuscular (“IM”)
injection site in the deltoid muscle because of possible complications following the vaccine
administration of IM injections.” Resp’t’s Ex. A4, ECF No. 29-5. As part of their foundational
research, the authors identified the thickness of skin and muscle in “a limited number of [healthy]
subjects in terms of [BMI,] as well as the small sample size and age.” Id. at 5. They used these
21 B. Erickson et al., Adhesive Capsulitis: Demographics and Predictive Factors for Success Following
Steroid Injections and Surgical Intervention, 1(1) ARTHROP, SPORTS MED. & REHABIL. 35–40 (2019); P.
Rundquist, et al., Shoulder Kinematics in Subjects with Frozen Shoulder, 84 ARCH. PHYS. MED.
REHABIL. 1473–81 (2003).
22 J. Lacy, et al., The Neuroscience of Memory: Implications for the Courtroom, 14(9) NAT. REV.
NEUROSCI. 649–58 (2013); E. Loftus, Planting misinformation in the human mind: A 30-year
investigation of the malleability of memory, 12 LEARNING & MEMORY 361–66 (2005).
23 Y. Nakajima et al., Establishing a new appropriate intramuscular injection site in the deltoid muscle,
13(9) HUM. VACC. & IMMUNOTHER. 2123–29 (2017).
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numbers as a basis to calculate the “appropriate depth and angle of needle insertion” to minimize
injury due to overpenetration. Id. The authors cautioned that while they “guess [their newly
proposed injection site] is also applicable to obese subjects[, they] do not have any data on the
location of axillary nerve, [posterior circumflex humeral artery (“PCHA”)] and subcutaneous
thickness, [and] further studies are required to identify safer sites for IM injection in obese
subjects.” Id. Based on the Nakajima et al. article, Dr. Abrams opined that “the needle would have
to transverse a distance (skin plus deltoid thickness) of up to approximately 28 mm in order to
minimally reach the bursa. The rotator cuff would be even further.” Resp’t’s Ex. A at 9. Based on
Petitioner’s weight, Dr. Abrams estimated that the standard needle for a flu vaccination for her
would be 25.4 mm. Id. He asserted that “over penetration is more likely in patients with lower
BMI,” unlike in Petitioner’s case. Id. (citing Pet’r’s Ex. 8M at 5, ECF No. 27-15).24 He concluded
that the needle length, the target distance, and Petitioner’s anatomy do not support Dr. Natanzi’s
contention that over penetration occurred. Id.
IV. Ruling on the Record
a. Petitioner’s Motion
Petitioner maintained in her motion for a ruling on the record “that she has suffered a
‘Table’ injury through her satisfaction of the Qualifications and Aids to Interpretation [(“QAIs”)]
criteria for SIRVA.” Pet’r’s Mot. at 8. She asserted that Respondent does not dispute that Petitioner
had no medical history indicative of “pain, inflammation, or dysfunction of the affected shoulder
prior to intramuscular vaccine administration.” Id. Petitioner also stated that Respondent did not
contest her assertion “that no other condition or abnormality is present that would explain [her]
symptoms.” Id. Petitioner focused her argument on the remaining two Table SIRVA criteria: 1)
symptoms occurring within forty-eight hours of vaccination and 2) injury limited to the shoulder
of vaccination. Id.
Regarding the onset of her symptoms, Petitioner relied on her affidavit wherein she
described pain that occurred “immediately” post vaccination. Id. (citing Pet’r’s Ex. 4 at 1).
Petitioner referred to this recounting, the multiple instances in which she related her pain to
vaccination in communications with her medical providers, and her recount of the sore knot at the
injection site as evidence that is “strongly supportive of forty-eight (48) hour onset.” Id. Although
Petitioner acknowledged that she suffered from pain in areas other than her shoulder, including
her back, knees, hands, and hip, she argued that the QAIs “cannot be read so strictly as to require
a [p]etitioner to be free of any and all painful ailments at the time of vaccination in order to
establish a Table injury.” Id. at 9. Petitioner continued that “she sought treatment for her shoulder
more consistently and more often” than for pain in any other area. Id. She also maintained that her
shoulder pain occurred first. Id. She contended that her complaints of “peripheral pain were
unrelated to each other, unrelated to any potential diagnosis of fibromyalgia, and unrelated to [her]
SIRVA.” Id. As additional support, Petitioner noted that her expert characterized her peripheral
pain as “episodic and consistently secondary.” Id.
24 G. Okur et al., Magnetic resonance imaging of abnormal shoulder pain following influenza
vaccination, 43 SKELETAL RADIOL. 1325–31 (2014).
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Table claim notwithstanding, Petitioner submitted arguments in support of a but-for
causation claim. Id. at 9–12. She first asserted that “Althen prong one is not at issue.” Id. at 9. She
continued that due to “extensive medical literature causally relating shoulder injuries to
vaccinations,” her causation theory “regarding shoulder injuries has become well established.” Id.
at 9–10. According to Petitioner, Dr. Natanzi explained this mechanism as an “inadvertent
overpenetration of the vaccination needle,” that is accompanied by the chemical interaction of the
vaccine “with naturally-occurring antibodies from prior vaccinations.” Id. at 10. This led “to an
exaggerated and prolonged inflammatory response” in Petitioner. Id.
To satisfy Althen prong two’s requirement to present a logical sequence of cause and effect,
Petitioner argued that “the entirety of [her] treatment course, when viewed together with her
testimony, support a development of left shoulder symptoms immediately following vaccination.”
Id. at 11. She acknowledged that she “experienc[ed] a plethora of symptoms throughout her
treatment course, and the records most contemporaneous to the vaccination, viewed alone, are
unclear as to when each symptom began.” Id. at 10. However, she stated that “in her message to
Dr. Cohn on January 26, 2016, [she] seemed to clarify her onset, noting that she ‘got a flu shot
[and] all this started.” Id. at 11. Petitioner continued that her later complaints “all refer back to the
flu vaccination as the event that spurred onset of her symptoms.” Id. (citing Pet’r’s Ex. 2 at 44, 80,
98, 110).
Finally, Petitioner noted that “it is not a requirement that a petitioner specify the date of
vaccination when reporting onset of pain to a provider or third-party, nor is it a requirement that a
petitioner accurately recall the month or day of their vaccination.” Id. at 11–12 (citing Williams v.
Sec’y of Health & Hum. Servs., No. 17-1046V, 2020 WL 3579763, at *5 (Fed. Cl. Spec. Mstr.
Apr. 1, 2020)). She reiterated that “[e]ven if [her] complaints at her first [doctor’s] visit [post
vaccination] are read to place onset of her shoulder pain three weeks post vaccination, this
particular record is heavily outweighed by [her] testimony.” Id. at 12.
b. Respondent’s Response
Respondent relied heavily on Petitioner’s December 4, 2015 medical exam record to place
“onset [of her symptoms at] approximately three weeks after vaccination.” Resp’t’s Resp. at 10.
Furthermore, Respondent argued that at that time, Petitioner did not specifically “attribute her
shoulder pain (or other complaints) to the flu vaccine.” Id. at 11 (citing Pet’r’s Ex. 2 at 35).
Respondent continued that in February, four months post vaccination, “[P]etitioner presented to
her new PCP and reported left shoulder pain ‘after’ a flu shot but did not specify when after the
vaccine her pain began.” Id. (citing Pet’r’s Ex. 2 at 80–82). Ultimately, “Petitioner’s claims in her
affidavits that the onset of her pain was immediate and persisted thereafter are not corroborated by
the contemporaneous medical records, were created years after the events in question, and amount
to her word alone.” Id.
In response to Petitioner’s assertion that delayed reporting is common, Respondent
contended that in Petitioner’s case, a delay in seeking treatment is “difficult to fathom.” Id. As
support for this opinion, Respondent cited Petitioner’s claims that “she could not reach over her
head or back to dress herself, she could not buckle her seatbelt or sleep on her left side, she felt
like she ‘turned 90 years old overnight,’ her left arm ached severely just to move it, and it was
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crazy painful.” Id. at 11–12. Despite these extreme symptoms, Petitioner “waited seven weeks to
seek medical care because she ‘thought it was just going to work itself out.’” Id. at 12 (citing
Pet’r’s Ex. 4 at 2). Respondent argued that the severity and scope of Petitioner’s described
symptoms undercut this claim, and therefore, “[P]etitioner has not established by preponderant
evidence that the onset of her left shoulder pain occurred within forty-eight hours of her October
14, 2015 vaccination.” Id.
In direct disagreement with Petitioner, Respondent argued that “the medical records
establish that from her first complaint, [P]etitioner described back, knee, hand, and hip pain,
beginning in the same time frame” as her purported shoulder pain. Id. Respondent continued that
Petitioner’s medical records refute her arguments “that her other musculoskeletal complaints were
‘episodic,’ ‘consistently secondary’ to her shoulder pain, and that ‘the onset of these other
conditions is unclear.’” Id. (citing Pet’r’s Mot. at 9). He quoted Petitioner’s affidavit stating that
“she woke up the next morning after her vaccination with all of her joints aching – stiff, inflamed
– extremely sore.” Id. (citing Pet’r’s Ex. 4 at 1). Her report of “multiple musculoskeletal
complaints beginning in the same time frame,” precludes a Table claim because “the language of
the QAI specifies that pain outside the shoulder in which the vaccine was administered is [a]
sufficient” disqualifier. Id. at 13.
Consistent with Respondent’s argument that Petitioner’s pain was not limited to her
shoulder, Respondent further argued that Petitioner cannot successfully assert a Table claim
because fibromyalgia is another “condition or abnormality [] present that would explain her
symptoms.” Id. As support, Respondent reiterated Dr. Abrams’ point that Petitioner “meets the
[ACR] criteria for fibromyalgia, a diagnosis also raised by her treating medical providers.” Id.
Additionally, Dr. Abrams also noted that “[P]etitioner never had an MRI, so there is no imaging
to support her alleged SIRVA.” Id. at 14.
Regarding Petitioner’s off-Table claim, Respondent cited the legislative history that is
discussed in Grant v. Sec’y of Health & Hum. Servs., wherein the Federal Circuit noted that in off-
Table cases, “[s]imple similarity to conditions or time periods listed in the Table is not sufficient
evidence of causation[.]” Id. at 15 (citing Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144
(Fed. Cir. 1992)). The Circuit continued, “evidence in the form of scientific studies or expert
medical testimony is necessary to demonstrate causation for such a petitioner.” See id. Respondent
contended that Petitioner has not identified “a medically recognized injury” for a medical causation
theory to be applicable. Id. at 16. Petitioner relied on limited ROM to support her SIRVA claim.
Id. However, Respondent argued that a non-specific injury “to the bursa, ligaments, and tendons
of the shoulder” is not a diagnosis. Id. He further noted Dr. Abrams’ assertion that Dr. Natanzi’s
adhesive capsulitis diagnosis is inconsistent with Petitioner’s “normal shoulder flexion to 170
degrees and external rotation to 50 degrees.” Id.
Pursuant to Althen, Petitioner must establish “a medical theory causally connecting
vaccination and the injury.” Id. (citing Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005)). In tandem with Respondent’s contention that Petitioner has not established
a specific diagnosis, he further argued “Petitioner has not set forth a reliable medical theory” of
causation. Id. at 17. Respondent summarized Petitioner’s theory as “over penetration of the needle
into the deep structures of the shoulder.” Id. He acknowledged that “medical literature supports
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that vaccination can be associated with shoulder injuries,” but he argued that the case studies filed
do “not provide preponderant evidence of a mechanism for how vaccinations can cause shoulder
injuries.” Id. at 17–18 (emphasis in original). Respondent then discounted the mechanism
mentioned in the articles Petitioner filed. Id. at 18. Specifically, he contended that while a
prolonged inflammatory response following an inadvertent injection into the shoulder joint is
plausible, plausibility is not the standard. Id.
Every aspect of Petitioner’s claim is disputed by Respondent. See generally id. Respondent
asserted that Petitioner’s injury is not consistent with SIRVA and that unrelated, contemporaneous
complaints of pain in other areas preclude a Table claim. Id. at 20–21. Furthermore, Respondent
argued that Petitioner did not present preponderant evidence of a general causation theory, nor did
she provide preponderant evidence that her causation theory is consistent with the facts in her case.
Id. Respondent requested dismissal of Petitioner’s claim. Id. at 21.
V. Applicable Statutory Scheme
The Vaccine Act provides petitioners with two avenues to receive compensation for their
injuries resulting from vaccines or their administration. First, a petitioner may demonstrate that
she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table that occurred
within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is presumed.”
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006); § 13(a)(1)(B).
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 a vaccination.
§ 300aa-14(a) as amended by 42 C.F.R. § 100.3. Table Injury cases are guided by statutory QAIs,
which provide 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 C.F.R. § 100.3(c).
To be considered a “Table SIRVA,” a petitioner must show that her injury fits within the following
definition:
SIRVA manifests as shoulder pain and limited [ROM] 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 signs,
symptoms, examination findings, and/or diagnostic studies occurring after vaccine
injection;
(ii) Pain occurs within the specified time-frame;
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(iii) Pain and reduced [ROM] 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).
Alternatively, if a petitioner is unable to establish a Table claim, she may bring an “off-
Table” claim. § 11(c)(1)(C)(ii). An “off-Table” or cause-in-fact claim requires that the petitioner
“prove by a preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano,
440 F.3d at 1320; see 42 U.S.C. § 300aa-13(a)(1)(A); see § 11(c)(1)(C)(ii)(II). A petitioner must
show that the vaccine was “not only a 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 & Hum. Servs., 592 F.3d
1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006) (citations omitted).
In the seminal case of Althen v. Sec’y of the Dept. of Health & Hum. Servs., the Federal
Circuit set forth a three-pronged test used to determine whether a petitioner has established a causal
link between a vaccine and the claimed injury. See 418 F.3d at 1278–79. The Althen test requires
petitioners to set forth: “(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 a proximate temporal relationship between vaccination and injury.”
Id. at 1278. To establish entitlement to compensation under the Program, a petitioner is required
to establish each of the three prongs of Althen by a preponderance of the evidence. See id.
Under the first prong of Althen, a petitioner must offer a scientific or medical theory that
answers in the affirmative the question: “can the vaccine[] at issue cause the type of injury
alleged?” See Pafford v. Sec’y of Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *4
(Fed. Cl. Spec. Mstr. July 16, 2004), mot. for rev. denied, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d
1352 (Fed. Cir. 2006). To satisfy this prong, a petitioner’s theory must be based on a “sound and
reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Knudsen, 35 F.3d at 548–49. Petitioners are not required to identify
“specific biological mechanisms” to establish causation, nor are they required to present
“epidemiologic studies, rechallenge[] the presence of pathological markers or genetic disposition,
or general acceptance in the scientific or medical communities.” Capizzano, 440 F.3d at 1325
(quoting Althen, 418 F.3d at 1280). Scientific and “objective confirmation” of the medical theory
with additional medical documentation is also unnecessary. Althen, 418 F.3d at 1278–81; Moberly,
592 F.3d at 1322. However, as the Federal Circuit has made clear, “simply identifying a ‘plausible’
theory of causation is insufficient for a petitioner to meet her burden of proof.” LaLonde v. Sec’y
of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322).
Rather, “[a] petitioner must provide a reputable medical or scientific explanation that pertains
specifically to the petitioner’s case.” Moberly, 592 F.3d at 1322. In general, “the statutory standard
of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely
than not caused the condition alleged.” LaLonde, 746 F.3d at 1339.
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Under the second prong of Althen, a petitioner must prove that the vaccine actually did
cause the alleged injury in a particular case. See 418 F.3d at 1279. The second Althen prong
requires proof of a logical sequence of cause and effect, usually supported by facts derived from a
petitioner’s medical records. Id. at 1278; Capizzano, 440 F.3d at 1326; Grant, 956 F.2d at 1148.
A petitioner does not meet this obligation by showing only a temporal association between the
vaccination and the injury; instead, the petitioner “must explain how and why the injury occurred.”
Pafford, 2004 WL 1717359, at *4 (emphasis in original). The special master in Pafford noted
petitioners “must prove [] both that [the] vaccinations were a substantial factor in causing the
illness . . . and that the harm would not have occurred in the absence of the vaccination.” See 2004
WL 1717359, at *4 (citing Shyface, 165 F.3d at 1352). A reputable medical or scientific
explanation must support this logical sequence of cause and effect. Hodges v. Sec’y of Health &
Hum. Servs., 9 F.3d 958, 961 (Fed Cir. 1993) (citation omitted). Nevertheless, “[r]equiring
epidemiologic studies . . . or general acceptance in the scientific or medical communities . . .
impermissibly raises a claimant’s burden under the Vaccine Act and hinders the system created by
Congress . . . .” Capizzano, 440 F.3d at 1325–26. “[C]lose calls regarding causation are resolved
in favor of injured claimants.” Althen, 418 F.3d at 1280.
In Program cases, contemporaneous medical records and the opinions of treating
physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen, 418 F.3d at 1280). Indeed,
when reviewing the record, a special master must consider the opinions of treating physicians. Id.
This is because “treating physicians are likely to be in the best position to determine whether ‘a
logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’”
Id. In addition, “[m]edical records, in general, warrant consideration as trustworthy evidence. The
records contain information supplied to or by health professionals to facilitate diagnosis and
treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an
extra premium. These records are also generally contemporaneous to the medical events.” Cucuras
v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). While a special master
must consider these opinions and records, they are not “binding on the special master or court.” 42
U.S.C. § 300aa-13(b)(1). Rather, when “evaluating the weight to be afforded to any such . . .
[evidence], the special master . . . shall consider the entire record . . . .” Id.
To satisfy the third Althen prong, a petitioner must establish a “proximate temporal
relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This
“requires preponderant proof that the onset of symptoms occurred within a timeframe for which,
given the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir.
2008). Typically, “a petitioner’s failure to satisfy the proximate temporal relationship prong is due
to the fact that onset was too late after the administration of a vaccine for the vaccine to be the
cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case, the
temporal relationship is not such that it is medically acceptable to conclude that the vaccination
and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Hum. Servs., 685
F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was administered,
logically, the vaccine could not have caused the illness.”).
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Although a temporal association alone is insufficient to establish causation, under the third
prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory.
See Althen, 418 F.3d at 1278. The special master cannot infer causation from temporal proximity
alone. See Thibaudeau v. Sec’y of Health & Hum. Servs., 24 Cl. Ct. 400, 403–04 (1991); see also
Grant, 956 F.2d at 1148 (“[T]he inoculation is not the cause of every event that occurs within the
ten[-]day period . . . [w]ithout more, this proximate temporal relationship will not support a finding
of causation.” (quoting Hasler v. United States, 718 F.2d 202, 205 (6th Cir. 1983))).
Once a petitioner has established her prima facie case, the burden then shifts to Respondent
to prove, also by preponderant evidence, that the alleged injury was caused by a factor unrelated
to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa-13(a)(1)(B). The Vaccine Act
requires Respondent to establish that the factor unrelated to the vaccination is the more likely or
principal cause of the injury alleged. Deribeaux v. Sec'y of Health & Hum. Servs., 717 F.3d 1363,
1369 (Fed. Cir. 2013). Such a showing establishes that the factor unrelated, not the vaccination,
was “principally responsible” for the injury. See § 300aa-13(a)(2)(B). The factor unrelated must
be the “sole substantial factor[;]” therefore, Respondent must establish that the factor unrelated,
not the vaccination, actually caused the injury alleged. See de Bazan, 539 F.3d at 1354.
VI. Discussion
In the present case, the parties are unable to agree on any material fact or legal conclusion,
save that Petitioner’s flu vaccination occurred on October 14, 2015. Petitioner maintains that she
suffered a left-sided shoulder injury that satisfies the QAI criteria for a SIRVA. Pet’r’s Mot. at 8.
Alternatively, Petitioner asserts that she “can demonstrate entitlement on a cause-in-fact theory.”
Id. at 9. Respondent, however, disputes the characterization of the claim as on-Table, the timing
of onset, the nature of Petitioner’s symptoms, and the diagnosis. See generally Resp’t’s Resp.
Respondent also argues that Petitioner has not presented preponderant evidence of general or
specific causation to satisfy an off-Table claim. Id. After a thorough review of the record, I find
that Petitioner has not presented preponderant evidence of a Table claim. Additionally, Petitioner
has submitted evidence in support of a theory of causation, a logical sequence of cause and effect,
and an appropriate temporal relationship. However, Petitioner has not presented preponderant
evidence that she suffered from an off-Table shoulder injury caused by vaccination. 25
a. Table Claim
i. No History of Pain, Inflammation, or Dysfunction
Respondent as much as conceded that Petitioner’s claim satisfies the first of the four QAI
factors for a Table SIRVA, that Petitioner did not suffer from prior pain, inflammation, or
dysfunction of the shoulder. In Petitioner’s motion for a ruling on the record, she noted the absence
of history of pain, inflammation, or dysfunction of her left shoulder that would explain her post-
vaccination injuries. While Petitioner has therefore satisfied the first QAI criterion, Petitioner must
25 All shoulder injuries that are alleged to have been caused by a vaccine are by definition related to
vaccine administration. In order to distinguish between the Table defined SIRVA and all other vaccine-
caused shoulder injuries that do not fit within the parameters for the Table presumption, I refer to the
shoulder injuries alleged as part of a causation-in-fact claim as off-Table shoulder injuries caused by
vaccination.
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still establish that her pain onset occurred within the specified timeframe, that her injury was
localized to her shoulder, and a lack of an alternative condition to explain her symptoms.
ii. 48-Hour Symptom Onset
A review of Petitioner’s medical record does not provide a clear or consistent account of
her shoulder pain onset. Petitioner’s first post-vaccination doctor’s visit occurred on December 4,
2015, approximately seven weeks after her injection. At that time, she reported a four-week aching
in her left shoulder and other joints. Pet’r’s Ex. 2 at 10–11. That would place symptom onset
relevant to SIRVA in early November of 2015, more than two weeks after her October 14, 2015
vaccination. In an email dated January 25, 2016, Petitioner complained to Dr. Cohn of pain in her
left arm “about where you would receive a shot.” 26 Id. at 35. She also stated that her pain began
in mid-October. Id. This account is more consistent with Petitioner’s later assertion in her
affidavits, authored in 2018, that her pain began immediately after vaccination. See Pet’r’s Exs. 3–
4. Petitioner did not mention any belief that the vaccine and her symptoms were related in her
January 25, 2016 email to Dr. Cohn, but in a follow-up the next day, she stated that all of her
symptoms started after her flu shot. Pet’r’s Ex. 2 at 36. These symptoms included bilateral hand
pain and right arm pain. Id. Even in these excerpted communications, Petitioner did not indicate if
her symptoms began immediately after her injection, later the same day, or in the following days.
Petitioner eventually saw a new PCP on February 23, 2016, and described left shoulder pain and
limited ROM after her flu shot in October of 2015. Id. at 80–82. This is her first account of a
clinical presentation that is consistent with a Table SIRVA in scope of injury, timeframe, and with
a direct reference to her vaccination. Although Petitioner initially described symptoms beginning
in November of 2015, thereafter, she consistently referred to the flu shot as a landmark for the
onset of her pain.
For instance, in her detailed affidavit authored in October of 2018, Petitioner described a
previously unreported knot at the injection site, accompanied by pain immediately post vaccination
and soreness later in the day. Pet’r’s Ex. 4 at 1. These symptoms were not reported to any of her
treaters at any time post vaccination. Petitioner also noted that she had a “total” loss of ROM and
that she was unable to sleep or participate in any hobbies. See id. at 1–2. Again, she did not report
this to her treaters. I do not find it more likely than not that Petitioner’s presentation as described
in her October 2018 affidavit is more credible than her contemporaneous reports to her PCP made
closer in time to the date of her vaccination. It is true that Petitioner consistently stated that her
pain began post vaccination, but she did not specify if the onset of that pain was in the hours or
days immediately thereafter. Furthermore, if during her initial complaint to treaters on December
4, 2015, she misremembered the specific onset date, it is unlikely she would also have forgotten
pain and a knot that occurred in the few hours or days immediately following vaccination. Based
on the above, I do not find preponderant evidence that Petitioner experienced shoulder pain within
48 hours of vaccination. As Petitioner cannot satisfy the second QAI criterion, she cannot establish
a Table SIRVA. However, for the sake of completeness, I will discuss the remaining QAI criteria.
iii. Nature of Symptoms
26 Petitioner’s description of her arm pain, without an association to her actual October 14, 2015
vaccination, could merely be a reference to location.
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Petitioner conceded that she had contemporaneous pain in areas other than her shoulder
post vaccination but argued that the QAI should not be read so strictly as to preclude “any and all
painful ailments at that time of vaccination.” Pet’r’s Mot. at 8. However, the QAI factor that
informs this analysis is succinct. For Petitioner’s Table SIRVA claim to be successful, she must
submit preponderant evidence that her “pain and reduced [ROM] are limited to the shoulder in
which the intramuscular vaccine was administered.” 42 C.F.R. §100.3(c)(10). Petitioner is correct
that the QAI does not preclude any and all ailments. For example, it is possible that someone who
went on a hike the day after a vaccination and suffered a minor fall and an ankle fracture could
also have a viable, unrelated SIRVA claim. The defining factor in that hypothetical is the ability
to separate and account for the vaccine-related shoulder pain in onset and scope. In the
hypothetical, the petitioner’s SIRVA would, presumably, have manifested in the hours or day after
vaccination, and the ankle fracture would have caused immediate pain following the fall. The
hypothetical petitioner would therefore be able to differentiate the pain in terms of onset and scope.
In Petitioner’s case, she associated all of her ailments, including her shoulder pain, with a
common manifestation period and cause. Despite her expert’s assertion that her peripheral pain
was “episodic” and “unrelated to [her] SIRVA,” her medical records do not support that such pain
should be separately considered. For example, her initial December 4, 2015 complaint described
aching and pain in her back and knees, and an exam revealed no ROM loss. Pet’r’s Ex. 2 at 11.
The following January, Petitioner complained that her “[u]pper left arm ache[d] constantly in [the]
muscle about where you would receive a shot” and that she had hand stiffness, right thigh and hip
pain, achy knees, and sore wrists. Id. at 35. Petitioner continued to complain of left shoulder pain
through early February of 2016, but she also reported hand stiffness and lower right back pain. Id.
at 33. After changing to a different PCP in late February, she specified that her left shoulder pain
and limited ROM began in October post vaccination, but she also complained of right hip pain,
bilateral knee pain, and left-hand weakness. Id. at 80. In March of 2016, Petitioner complained of
left shoulder pain, right hip and low back pain, bilateral knee pain, and left elbow and hand
stiffness. Id. at 98–101. PT records also suggest that Petitioner considered her multiple ailments
related. An April 1, 2016 record included Petitioner’s statement that “[a]ll symptoms were
resolving.” Id. at 119. During an orthopedic appointment on November 28, 2017, Petitioner stated
that following a “flu shot two years ago” she had experienced “multiple joint pain the next day,
including the hips.” Id. at 234. It is clear from the record that Petitioner’s left shoulder aches and
pain were accompanied by pain and stiffness in most of her other joints. Petitioner only
distinguished her shoulder pain from her other complaints in her affidavit and motion pursuant to
adjudicating this claim. Therefore, I do not find preponderant evidence that Petitioner’s pain was
limited to her left shoulder.
iv. Lack of Alternative Condition
Petitioner is unable to prevail on a Table claim without preponderant evidence of a 48-hour
pain onset and that her symptoms were limited to the left shoulder. The last QAI factor prohibits
compensation for a Table SIRVA if any alternative condition is present that could explain
Petitioner’s symptoms. Petitioner is also unable to satisfy this requirement. As I will discuss in
more detail below, Petitioner was diagnosed with fibromyalgia by her PCP after describing her
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symptoms and undergoing an examination.27 Petitioner’s expert disagreed with Petitioner’s
treating physician’s diagnosis and argued that she suffered from SIRVA. After a review of
Petitioner’s medical records and affidavit, expert reports, medical literature, and the parties’
arguments, I find that there is evidence of a condition present that would explain her symptoms.
b. Diagnosis
Petitioner’s treater and PCP, Dr. Cohn, first mentioned fibromyalgia to Petitioner during
an email exchange in January of 2016. He noted that her “symptoms [(including morning hand
stiffness, hip and thigh pain, chest pain, achy knees and sore wrists)] may fit with this diagnosis,
based on [her] prior normal labs and exams.” Pet’r’s Ex. 2 at 55. In February of 2016, Dr. Del Mar,
another treating PCP, assessed Petitioner with adhesive capsulitis, lumbar radiculopathy, and
“joint pain—fibromyalgia.” Id. at 82. Dr. Del Mar noted Petitioner’s belief that her vaccination
and joint pain were related, but there is no indication that Dr. Del Mar shared that belief. See id.
Dr. Del Mar’s diagnosis was based on her physical exam of Petitioner that revealed right hip and
lumbar tenderness with limited overhead reach. In fact, there is no evidence that any of Petitioner’s
treaters believed that Petitioner’s pain or other symptoms were consistent with SIRVA or were
related to a mechanical error during the administration of her vaccine. Alternatively, the medical
record provides strong evidence that both of Petitioner’s PCPs considered all of Petitioner’s
symptoms, including her multiple areas of joint pain, in identifying fibromyalgia as a differential
diagnosis.
Petitioner’s expert, Dr. Natanzi, opined that Petitioner had been misdiagnosed with
fibromyalgia. He instead asserted that Petitioner had SIRVA based on “the lack of any alternative
etiology for the acute development of [her] shoulder pain in the peri-vaccination period.” Pet’r’s
Ex. 7 at 8. Dr. Natanzi then explained why he believed the alternative etiology proposed by
Petitioner’s treaters is inapplicable. He argued against fibromyalgia because the condition is
defined by musculoskeletal achiness, stiffness, and tenderness. See id. In light of his discussion
and dismissal of the fibromyalgia diagnosis, Dr. Natanzi’s assertion that there is no alternative for
consideration is incredulous. Indeed, Petitioner’s initial post-vaccination complaint to a medical
professional was a “[four] week aching in [her] shoulder [more than in] other joints.” Pet’r’s Ex.
2 at 10–11. Dr. Natanzi discounted this original complaint because of the timing discrepancy
between Petitioner’s post-vaccination reports of onset. However, Petitioner also complained of
achy wrists, knees, and in the middle of her chest in January of 2016; she complained of hand
stiffness and hand weakness and displayed tenderness in the right hip and lower lumbar area in
February of 2016; and she complained of left elbow and hand stiffness in March of 2016. Pet’r’s
Ex. 2 at 35, 33, 80, 98–101. This collection of symptoms paints a clear presentation of the
musculoskeletal achiness, stiffness and tenderness that would indicate Petitioner suffered from
fibromyalgia, consistent with Dr. Natanzi’s definition.
Dr. Natanzi also characterized Petitioner’s shoulder pain as isolated and focal, to be
distinguished from her episodic and secondary peripheral pain in other joints. He opined that
Petitioner, who was 55 years old at the time of her vaccination, suffered from “typical wear and
27 Dr. Del Mar also considered radiculopathy as a differential diagnosis. The QAIs list radiculopathy as an
example of a condition or abnormality that, if present, could explain Petitioner’s symptoms and preclude
a Table SIRVA claim. 42 C.F.R. 100.3(10)(iv).
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tear pains that surface in the latter decades of life.” Pet’r’s Ex. 7 at 9. Petitioner described her
active lifestyle in her affidavit, including kayaking, fishing, hiking, and bowling. Pet’r’s Ex. 4 at
2. It is unclear, according to Dr. Natanzi, at what age a person enters the latter decades of life. It is
also unclear why in her mid-fifties, Petitioner would be unable sit or drive for more than thirty
minutes or need a cortisone injection in her hip because of pain due to normal wear and tear.
Without medical literature or additional evidence, I do not find this line of reasoning persuasive.
Rather, I find Dr. Natanzi’s arguments regarding Petitioner’s age to be unnecessary and
unfounded, and therefore, they did not influence my decision.
Alternatively, Dr. Abrams’ opinion that Petitioner indeed suffered from fibromyalgia was
based on the ACR’s criteria with references to Petitioner’s medical record. Post vaccination,
Petitioner complained of pain in ten different locations on her body that kept her from sleeping
and caused fatigue, leading to melancholy. I am persuaded by Dr. Abrams’ opinion that, in sum,
Petitioner’s symptoms produced WPI and SS scores that would meet ACR’s clinical definition of
fibromyalgia. Dr. Abrams also argued that because Petitioner did not undergo an MRI, “[t]here is
no objective evidence of SIRVA.” Resp’t’s Ex. C at 3. Petitioner’s lack of an MRI does not
preclude a SIRVA diagnosis. Furthermore, the QAIs do not state that an MRI is required in SIRVA
cases. That is a moot issue here, however. The breadth of evidence supporting fibromyalgia makes
further discussion unnecessary.
While I agree with Dr. Abrams’ fibromyalgia diagnosis, I am troubled by his assertions
that obese patients are not as susceptible to a SIRVA. Dr. Abrams relied on one article that
specifically noted the study’s limited application to obese individuals. See Resp’t’s Ex. A4; see
also Resp’t’s Ex. A at 9. He did not otherwise consider or discuss Petitioner’s body type and weight
distribution. This argument likewise has not influenced my decision.
Petitioner has not presented preponderant evidence that she suffered from a Table SIRVA,
nor has she presented preponderant evidence that her injury is consistent with an off-Table
shoulder injury caused by her vaccination. However, Petitioner has asserted some evidence that
her shoulder injury was caused-in-fact by her vaccination, and she presented a theory of causation.
Therefore, I will complete an Althen analysis.
c. Causation-in-fact
i. Althen Prong One: General Causation Theory
SIRVA is a well-known phenomenon in the Program. As previously noted, SIRVA is
clearly defined by the Table and includes several exclusionary factors. These factors, if present,
may prohibit a petitioner from bringing a Table claim, but they do not preclude an allegation that
a petitioner suffered an off-Table shoulder injury caused by vaccination. It is true that Petitioner
must present a causation theory in all off-Table cases. Petitioner’s expert clearly explained in his
report how shoulder injuries caused by vaccinations, including SIRVAs, occur by overpenetration
of the needle into the bursa and/or rotator cuff, causing inflammation and resulting in “adhesive
capsulitis and rotator cuff mediated pain.” Pet’r’s Ex. 7 at 9. Respondent argued that Petitioner’s
theory does “not provide preponderant evidence of a mechanism for how vaccinations can cause
shoulder injuries.” Resp’t’s Ex. A at 8. Respondent simultaneously argued that Petitioner’s
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overpenetration theory is merely “plausible,” which is not the standard of proof in the Program.
While Respondent is correct that plausibility is not the standard, I do not find Respondent’s
argument against the medically acceptable theory of SIRVA to be persuasive given the knowledge
and understanding of SIRVA in the Program. I further find that even in the presence of a history
of inflammation and dysfunction, Petitioner has presented preponderant evidence that the flu
vaccine can cause an off-Table shoulder injury. and she has therefore satisfied prong one of Althen.
ii. Althen Prong Three: Temporal Relationship
During the Table claim analysis, I found that Petitioner has not presented preponderant
evidence that her injury manifested within 48 hours of her vaccination. However, she did present
evidence that her shoulder pain developed shortly thereafter, by mid-October, within the following
several days after her October 14, 2015 vaccination. Although onset within 48 hours is required
by the Vaccine Injury Table, onset in a cause-in-fact claim does not need to occur precisely within
48 hours. In Jewell, the chief special master found that although the petitioner was unable to
establish onset within 48 hours of vaccination, the onset of her shoulder injury within 72 hours
was a “medically appropriate temporal relationship.” Jewell v. Sec’y of Health & Hum. Servs., No.
16-0670V, 2017 WL 7259139, at *3 (Fed. Cl. Spec. Mstr. Aug. 4, 2017). Likewise in Murray, the
petitioner did not establish that her shoulder pain occurred within 48 hours of vaccination, but the
special master found that she “preponderantly demonstrated that her musculoskeletal shoulder
symptoms began within a timeframe for which it is medically acceptable to infer causation-in-
fact.” Murray v. Sec’y of Health & Hum. Servs., No. 17-01357V, 2022 WL 17829797, at *16 (Fed.
Cl. Spec. Mstr. Oct. 27, 2022) (finding that while “a precise onset [was] impossible to pin down,
the record [was] clear in placing onset no later than ‘a few days’ post vaccination,” consistent with
the petitioner’s medical theory). Furthermore, the Federal Circuit has counseled that special
masters should not set “hard and fast deadlines” when evaluating the appropriate timeframe for
onset after vaccination. Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1384 (Fed. Cir.
2015). Accordingly, as Petitioner has presented evidence that shows she experienced the onset of
shoulder pain within a few days of her vaccination, Petitioner has preponderately demonstrated
that her shoulder symptoms began within a timeframe consistent with her causation theory.
iii. Althen Prong Two: Specific Causation
In Capizzano, the Federal Circuit explained that in some contexts, satisfaction of Althen
prongs one and three can provide substantial support for evidence of specific causation to satisfy
prong two. 440 F.3d at 1326. The Circuit found that if an appropriate temporal proximity,
combined with a valid causation theory, demonstrates the logical conclusion that the injury was
vaccine caused, then medical opinions of treating physicians to this effect “are quite probative.”
Id. However, the Circuit also cautioned that the second Althen prong “is not without meaning.” Id.
The Court explained that
There may well be a circumstance where it is found that a vaccine can cause the
injury at issue and where the injury was temporally proximate to the vaccination,
but it is illogical to conclude that the injury was actually caused by the vaccine. A
claimant could satisfy the first and third prongs without satisfying the second prong
when medical records and medical opinions do not suggest that the vaccine caused
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the injury, or where the probability of coincidence or another cause prevents the
claimant from proving that the vaccine caused the injury by preponderant evidence.
Id. at 1327. Thus, it is well established that in terms of demonstrating specific causation, temporal
association alone is not enough to satisfy a petitioner’s burden of proof. See, e.g., Veryzer v. Sec’ y
of Health & Hu m. Servs., 100 Fed. Cl. 344, 356 (2011) (explaining that “a temporal relationship
alone will not demonstrate the requisite causal link and that petitioner must posit a medical theory
causally connecting the vaccine and injury”); A.Y. by J.Y. v. Sec'y of Health & Hum. Servs., 152
Fed. Cl. 588, 595 (2021); Forrest v. Sec'y of Health & Hum. Servs., No. 10-032V, 2017 WL
4053241, at *18 (Fed. Cl. Spec. Mstr. Aug. 10, 2017); Cozart v. Sec'y of Health & Hum. Servs., No.
00-590V, 2015 WL 6746616, at *18 (Fed. Cl. Spec. Mstr. Oct. 15, 2015), aff’d, 126 Fed. Cl. 488
(2016); Crosby v. Sec'y of Health & Hum. Servs., No. 08-799V, 2012 WL 13036266, at *37 (Fed.
Cl. Spec. Mstr. June 20, 2012).
In the present case, Petitioner has presented preponderant evidence that the flu vaccination
can cause an off-Table shoulder injury. She has also presented preponderant evidence that her
shoulder pain manifested within an appropriate time frame consistent with her medical theory to
support vaccine causation. Petitioner has failed, however, to present preponderant evidence that
she has an off-Table shoulder injury caused by vaccination. Therefore, her causation theory and
the corresponding temporal relationship are inapplicable to her condition. Petitioner has not
demonstrated how her causation theory, based on the injury that it contemplates, could be
applicable to her symptoms that far exceed the scope of her shoulder. Petitioner’s theory does not
explain, or even consider, the many additional symptoms that she experienced contemporaneously
with her shoulder injury. Indeed, the medical evidence and statements from Petitioner to her
treaters overwhelming support a diagnosis of fibromyalgia,28 but fibromyalgia is the not the
alleged injury here. Furthermore, I am not a physician, and it is not my role to diagnose Petitioner.
My role is to determine whether there is preponderant evidence that she suffered from the injury
alleged. There is not. Therefore, Petitioner has not satisfied her burden under Althen prong two.
VII. Conclusion
Petitioner has undoubtedly suffered for many years as a result of her multiple joint pain
and stiffness. However, when she sought appropriate medical care and reported this history to her
physicians, they ultimately concluded that she was likely suffering from the systemic disorder
fibromyalgia, rather than any shoulder condition. Petitioner has been unable to overcome that
evidence with her expert evidence or otherwise. After considering the entire record, Petitioner has
not established by preponderant evidence either that her October 14, 2015 flu vaccination resulted
in a Table SIRVA or, alternatively, was the cause-in-fact of an off-Table shoulder injury, consistent
with a SIRVA. Accordingly, Petitioner is not entitled to compensation. Therefore, her case is
DISMISSED.29
28 Respondent presented probative evidence in support of an alternative claim rebuttal. However, as
Petitioner was unable to establish a prima facie case, that analysis is unnecessary. Such evidence was also
considered in support of Drs. Cohn and Del Mar’s opinions that Petitioner suffered from fibromyalgia.
29 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
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IT IS SO ORDERED.
s/Herbrina D. Sanders
Herbrina D. Sanders
Special Master
24

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_18-vv-01077-cl-extra-10735640
Date issued/filed: 2024-04-12
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10269050
--------------------------------------------------------------------------------
    In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                        Filed: February 16, 2024

* * * * * * * * * * * * *  *
TERRY PEDRI,               *                               No. 18-1077V
                           *                               Special Master Sanders
         Petitioner,       *
                           *
v.                         *
                           *
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
         Respondent.       *
* * * * * * * * * * * * * *

Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner;
Sarah C. Duncan, United States Dep’t of Justice, Washington, DC, for Respondent.

                  DECISION AWARDING ATTORNEYS’ FEES AND COSTS1

         On July 24, 2018, Terry Pedri (“Petitioner”), filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2018)2 alleging “a left shoulder injury related to
vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered on
October 14, 2015.” Pet. at 1, ECF No. 1. On April 18, 2023, Petitioner filed a motion for a ruling
on the record. (ECF No. 34). On June 27, 2023, the undersigned issued her decision finding
petitioner is not entitled to compensation and dismissed the petition. (ECF No. 38).

      On October 11, 2023, Petitioner filed a motion for attorneys’ fees and costs. (“Fees App.”)
(ECF No. 42). Petitioner requests total attorneys’ fees and costs in the amount of $27,513.20,


1
  The undersigned 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 invasion 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 unpublished ruling contains a reasoned explanation for the action in this case,
the 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
    National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755.
representing $18,325.70 in attorneys’ fees and $9,187.50 in attorneys’ costs. Fees App. at 2.
Pursuant to General Order No. 9, counsel for Petitioner represents that personal costs were not
incurred in pursuit of her claim. Id. at 2. Respondent responded to the motion on October 12, 2023,
stating that Respondent “is satisfied that the statutory requirements for an award of attorneys’ fees
and costs are met in this case.” Resp’t’s Resp. at 2 (ECF No. 43). Petitioners did not file a reply
thereafter.

       This matter is now ripe for consideration.

       I.      Reasonable Attorneys’ Fees and Costs

        The Vaccine Act permits an award of “reasonable attorneys' fees” and “other costs.” §
15(e)(1). If a petitioner succeeds on the merits of his or her claim, the award of attorneys' fees is
automatic. Id.; see Sebelius v. Cloer, 133 S. Ct. 1886, 1891 (2013). However, a petitioner need not
prevail on entitlement to receive a fee award as long as the petition was brought in “good faith”
and there was a “reasonable basis” for the claim to proceed. § 15(e)(1). In this case, although the
petition was eventually dismissed, the undersigned is satisfied that the requirements for good faith
and reasonable basis have been met, and Respondent has also indicated the is satisfied they have
been met. Accordingly, Petitioner is entitled to a final award of reasonable attorneys’ fees and
costs.

          The Federal Circuit has approved the lodestar approach to determine reasonable attorneys’
fees and costs under the Vaccine Act. Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343,
1348 (Fed. Cir. 2008). This is a two-step process. Id. First, a court determines an “initial estimate
. . . by ‘multiplying the number of hours reasonably expended on the litigation times a reasonable
hourly rate.’” Id. at 1347–48 (quoting Blum v. Stenson, 465 U.S. 886, 888 (1984)). Second, the
court may make an upward or downward departure from the initial calculation of the fee award
based on specific findings. Id. at 1348.

        It is “well within the special master’s discretion” to determine the reasonableness of fees.
Saxton v. Sec’y of Health & Human Servs., 3 F.3d 1517, 1521–22 (Fed. Cir. 1993); see also Hines
v. Sec’y of Health & Human Servs., 22 Cl. Ct. 750, 753 (1991). (“[T]he reviewing court must grant
the special master wide latitude in determining the reasonableness of both attorneys’ fees and
costs.”). Applications for attorneys’ fees must include contemporaneous and specific billing
records that indicate the work performed and the number of hours spent on said work. See Savin
v. Sec’y of Health & Human Servs., 85 Fed. Cl. 313, 316–18 (2008). Such applications, however,
should not include hours that are “‘excessive, redundant, or otherwise unnecessary.’” Saxton, 3
F.3d at 1521 (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)).

        Reasonable hourly rates are determined by looking at the “prevailing market rate” in the
relevant community. See Blum, 465 U.S. at 895. The “prevailing market rate” is akin to the rate
“in the community for similar services by lawyers of reasonably comparable skill, experience and
reputation.” Id. at 895, n.11. Petitioners bear the burden of providing adequate evidence to prove
that the requested hourly rate is reasonable. Id.

               a.      Hourly Rate
        The decision in McCulloch provides a framework for consideration of appropriate ranges
for attorneys’ fees based upon the experience of the practicing attorney. McCulloch v. Sec’y of
Health & Human Servs., No. 09-293V, 2015 WL 5634323, at *19 (Fed. Cl. Spec. Mstr. Sept. 1,
2015), motion for recons. denied, 2015 WL 6181910 (Fed. Cl. Spec. Mstr. Sept. 21, 2015). The
Court has since updated the McCulloch rates, and the Attorneys’ Forum Hourly Rate Fee
Schedules can be accessed online.3

       Petitioner requests the following hourly rates for the work of her counsel at Muller Brazil;
for Ms. Leigh Finfer, $185.00 per hour for work performed in 2018, $200.0 per hour for work
performed in 2019, $225.00 per hour for work performed 2020, $250.00 per hour for work
performed in 2021, and $275.00 per hour for work performed in 2022; for Ms. Shealene Mancuso,
$233.00 per hour for work performed in 2018, $250.00 per hour for work performed in 2019, and
$275.00 per hour for work performed in 2020; and for Mr. Paul Brazil the rate of $317.00 per hour
for work performed in 2018. These rates are consistent with what counsel have previously been
awarded for their Vaccine Program work and the undersigned finds them to be reasonable herein.

               b.      Reasonable Number of Hours

         Attorneys’ fees are awarded for the “number of hours reasonably expended on the
litigation.” Avera, 515 F.3d at 1348. Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton, 3 F.3d at 1521 (quoting Hensley v.
Eckerhart, 461 U.S. 424, 434 (1983)).

        Upon review, the undersigned finds the overall hours billed to be reasonable. Counsel has
provided sufficiently detailed descriptions for the tasks performed, and upon review, the
undersigned does not find any of the billing entries to be unreasonable. Accordingly, Petitioners
are entitled to final attorneys’ fees in the amount of $18,325.70.

               c. Attorney Costs

         Like attorneys’ fees, a request for reimbursement of attorneys’ costs must be reasonable.
Perreira v. Sec’y of Health & Human Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioner requests
a total of $9,187.50 in attorneys’ costs, comprised of the Court’s filing fee and work performed by
a medical expert, Dr. Naveed Natanzi. Petitioner has provided adequate documentation of these
expenses and they appear reasonable in the undersigned’s experience. Accordingly, Petitioner is
awarded the full amount of costs sought.

       II.     Conclusion

        In accordance with the Vaccine Act, 42 U.S.C. §15(e) (2012), the undersigned has
reviewed the billing records and costs in this case and finds that Petitioners’ request for fees and
costs is reasonable. Based on the above analysis, the undersigned finds that it is reasonable to
compensate Petitioners and their counsel as follows:


3
 The OSM Fee Schedules are available at: http://www.cofc.uscourts.gov/node/2914. The hourly rates
contained within the schedules are updated from the decision in McCulloch, 2015 WL 5634323.
    Attorneys’ Fees Requested                                             $18,325.70
    (Reduction to Fees)                                                        -
    Total Attorneys’ Fees Awarded                                         $18,325.70

    Attorneys’ Costs Requested                                            $9,187.50
    (Reduction of Costs)                                                      -
    Total Attorneys’ Costs Awarded                                        $9,187.50

    Total Attorneys’ Fees and Costs                                       $27,513.20


       Accordingly, the undersigned awards a lump sum in the amount of $27,513.20,
representing reimbursement for Petitioners’ attorneys’ fees and costs, in the form of a check
payable to Petitioner and her counsel, Ms. Leigh Finfer.

        In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the
court is directed to enter judgment herewith.4

                IT IS SO ORDERED.

                                                         s/Herbrina D. Sanders
                                                         Herbrina D. Sanders
                                                         Special Master




4
  Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.