Rissler v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: October 25, 2021
* * * * * * * * * * * * * * *
NANCY RISSLER, * No. 18-1208V
*
Petitioner, * Special Master Sanders
*
v. *
*
SECRETARY OF HEALTH * Fact Hearing; Onset of Injury;
AND HUMAN SERVICES, * Prevnar-13 Vaccine; Shoulder Injury
* Related to Vaccine Administration
Respondent. * (“SIRVA”)
* * * * * * * * * * * * * * *
Glen H. Sturtevant, Jr., Rawls Law Group, Richmond, VA, for Petitioner.
Kyle E. Pozza, U.S. Department of Justice, Washington, DC, for Respondent.
FACT RULING 1
On August 14, 2018, Nancy Rissler (“Petitioner”) filed a petition pursuant to the National
Vaccine Injury Compensation Program. 2 Petitioner alleged that she developed a left shoulder
injury related to vaccine administration (“SIRVA”), 3 which was caused-in-fact by the Prevnar-13
vaccine (“pneumococcal conjugate vaccine” or “PCV 13”) she received on May 1, 2017. Pet. at 1,
ECF No. 1. At this time, I find it is necessary to make a factual determination as to the date of
onset of Petitioner’s left-sided shoulder pain. After carefully analyzing the information in the
record and the testimony provided during the fact hearing, I find that Petitioner has established by
a preponderance of the evidence that she experienced left shoulder pain within forty-eight hours
of her vaccination. However, as a Table claim is not before me, this factual determination does not
reach the issue of whether Petitioner’s shoulder injury was caused-in-fact by her PCV 13
vaccination.
1
This fact ruling shall be posted 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). In accordance with Vaccine Rule 18(b), a party has 14 days to identify
and move to delete medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further,
consistent with the rule requirement, a motion for redaction must include a proposed redacted fact ruling.
If, upon review, I agree that the identified material fits within the requirements of that provision, such
material will be deleted from public access.
2
The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10 et seq. (hereinafter “Vaccine Act,” “the Act,” or “the Program”). Hereafter, individual section references
will be to 42 U.S.C. § 300aa of the Act.
3
At the time of filing of Petitioner’s petition, she alleged that she suffered from “left shoulder impingement,
adhesive capsulitis, tendinopathy, tendinitis, superior labral tearing, and [] debilitating pain, weakness, and
restricted range of motion[.]” Pet. at 1.
I. Procedural History
On August 14, 2018, Petitioner filed her petition alleging that she suffered a left-sided
SIRVA as a result of the Prevnar-13 vaccine she received on May 1, 2017. Pet. at 1. Three days
later, Petitioner filed ten exhibits consisting of her affidavit, medical records, affidavits from Mr.
Brett Rissler and Ms. Cami Wilson, and vaccination records. Pet’r’s Exs. 1–10, ECF Nos. 5-1–5-
10. The same day, Petitioner filed a statement of completion. ECF No. 6.
During a status conference on October 17, 2018, the parties discussed “the obvious issue
of the second non-covered vaccination ([s]hingles) 4 administered on June 7, 2017, in the same arm
as the vaccination alleged as causal, (Prevnar[-]13, administered May 1, 2017)[.]” Order at 1, ECF
No. 8. Petitioner also acknowledged that “the records from [P]etitioner’s primary care provider
indicated she suffered from neck pain in May 2015[,] and back pain in May 2016[.]” Id. at 2. At
the conclusion of the status conference, the presiding special master ordered Petitioner to file
outstanding medical records, “particularly those from treatment received in May through October
2017[,] which would help identify the onset of [P]etitioner’s pain and those from any treatment of
[P]etitioner’s arthralgia during the three years prior to vaccination[.]” Id. at 3.
On January 4, 2019, Petitioner filed four additional medical records exhibits consisting of
a pharmacy record and those of treating specialists, including dermatology and gastroenterology.
Pet’r’s Exs. 11–14, ECF Nos. 9-1–9-4. The same day, Petitioner submitted an amended statement
of completion. ECF No. 11. On April 1, 2019, Respondent filed a status report indicating that
Petitioner failed to file medical records related to her treatment of bursitis or tendonitis or from
“an orthopedist or other specialty [] related to the treatment in May 2015 through May 2017 for
neck and back pain and arthralgia.” ECF No. 13 at 2. The presiding special master ordered
Petitioner to submit the requested outstanding records or an affidavit, if needed. ECF No. 14. In
response, Petitioner filed a supplemental affidavit followed by a statement of completion on May
21, 2019. Pet’r’s Ex. 15, ECF Nos. 17–18.
Respondent filed his Rule 4(c) report on September 20, 2019. Resp’t’s Rule 4(c) report,
ECF No. 20. In his report, Respondent argued that this case should be dismissed because Petitioner
has not shown by a preponderance of the evidence that she suffered a shoulder injury within forty-
eight hours of the injection, nor that the injury was limited to the left shoulder as required by the
Table. Id. at 10–11. Respondent also argued Petitioner could not show her alleged left shoulder
injury was unrelated to her prior tendonitis, bursitis, or prior injury, or, alternatively, that her injury
was caused-in-fact by the Prevnar-13 vaccine. Id. at 11–12.
On October 9, 2019, this case was reassigned to me. ECF Nos. 21–22. On December 4,
2019, I held a status conference with the parties and discussed the evidence filed to date. See Min.
Entry, docketed Dec. 4, 2019. During the status conference, “Petitioner acknowledged that there
is evidence in the medical records that is inconsistent with [Petitioner’s] affidavits.” Order at 1,
ECF No. 23. At the conclusion of the conference, I ordered Petitioner to submit additional evidence
corroborating the onset of her symptoms. Id.
4
Zostavax is not a covered vaccine on the Vaccine Injury Table. See 42 C.F.R. § 100.3(a)(XIV).
2
On February 3, 2020, Petitioner filed two additional affidavits from Ms. Cami Wilson and
Mr. Brett Rissler. Pet’r’s Exs. 16–17, ECF Nos. 24-1–24-2. The same day, Petitioner submitted a
status report highlighting the citations in Petitioner’s medical records and supplemental affidavits,
which corroborate her argument in favor of onset. ECF No. 25.
I held a status conference with the parties on February 11, 2020. See Min. Entry, docketed
Feb. 12, 2020. Following the status conference, at the parties’ request, I scheduled this matter for
a fact hearing on May 28, 2020, to determine the date of onset of Petitioner’s left shoulder
symptoms. Order at 1, ECF No. 26. Due to the COVID-19 pandemic, the fact hearing was not held
as scheduled on that date. Non-PDF Order, docketed May 26, 2020. I rescheduled the fact hearing
for July 1, 2021, and it was held as scheduled. ECF No. 29. This matter is now ripe for
consideration.
II. Summary of Relevant Evidence
a. Medical Records
Petitioner received the Prevnar-13 vaccine at issue on May 1, 2017. Pet’r’s Ex. 1 at 1, ECF
No. 5-1. Petitioner’s immunization record indicates that she received the vaccine in her left deltoid.
Pet’r’s Ex. 4 at 1, ECF No. 5-4. At the time of vaccination, Petitioner was fifty-two years old, and
her prior medical history was significant for neck pain, Crohn’s disease, 5 anxiety, insomnia,
sinusitis, 6 gastroesophageal reflux disease (“GERD”), 7 eczema, 8 and sciatica. 9 See Pet. at 1; Pet’r’s
Ex. 5 at 1–16, ECF No. 5-5; Pet’r’s Ex. 7 at 1, 4–6, ECF No. 5-7. According to her petition,
Petitioner had a “past medical history significant for bursitis 10 of her right shoulder (approximately
5
Crohn’s disease is “one of the principal forms of inflammatory bowel disease, a chronic granulomatous
disease of the gastrointestinal tract of unknown etiology; it can involve any part of the tract, but most often
is found in the terminal ileum. Characteristics include scarring and thickening of the bowel wall that
frequently leads to intestinal obstruction, abscesses, and fistula formation. There is a high rate of recurrence
after treatment.” Dorland’s Illustrated Medical Dictionary 1263, 531 (32nd ed. 2012) [hereinafter
“Dorland’s”].
6
Sinusitis is “inflammation of a sinus, usually a paranasal sinus; it may be purulent or non[-]purulent, acute
or chronic. Types are named for the sinus involved.” Dorland’s at 1722.
7
Gastroesophageal reflux disease (“GERD”) is “any condition noted clinically or histopathologically that
results from gastroesophageal reflux, ranging in seriousness from mild to life-threatening; principal
characteristics are heartburn and regurgitation.” Dorland’s at 533.
8
Eczema is “any of various pruritic, papulovesicular types of dermatitis occurring as reactions to
endogenous or exogenous agents. In acute types there may be erythema, edema, inflammatory infiltrates in
the dermis, vesiculation, crusting, and scaling. In chronic types there may be lichenification, skin
thickening, signs of excoriation; and areas of hyperpigmentation or hypopigmentation.” Dorland’s at 592.
9
Sciatica is “a syndrome characterized by pain radiating from the back into the buttock and along the
posterior or lateral aspect of the lower limb; it is most often caused by protrusion of a low lumbar
intervertebral disk. The term is also used to refer to pain anywhere along the course of the sciatic nerve.”
Dorland’s at 1678.
10
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.
3
[twenty-eight] years ago and resolved), [and] tendinitis 11 in both shoulders (approximately
[twenty-two] years ago and resolved).” Pet. at 1. Petitioner also reported to medical providers that
she suffered a “previous shoulder injury [about twenty] years ago.” See Pet’r’s Ex. 8 at 22, ECF
No. 5-8.
On May 3, 2017, two days after receipt of the Prevnar-13 vaccination, Petitioner presented
to her gastroenterologist, Dr. Van Dinter, for an “evaluation and second opinion of a new diagnosis
of Crohn’s disease[.]” Pet’r’s Ex. 14 at 329, ECF No. 9-4. During this visit, Dr. Van Dinter noted
that Petitioner was taking “daily NSAIDs 12 due to fluctuating oligoasymetric arthritis 13 –
shoulders/hips are the most problematic.” Id. at 330. Dr. Van Dinter opined that Petitioner “likely
has [inflammatory bowel disease] (“IBD”) 14 associated with arthritis.” Id. at 332. On May 8 and
10, 2017, Petitioner communicated with Dr. Van Dinter’s office via email regarding an MRI to
confirm the status of her Crohn’s disease. Id. at 314. Petitioner did not complain of left shoulder
pain during her office visit or email communications with Dr. Van Dinter on these dates. See id.
On May 17, 2017, sixteen days after receipt of the Prevnar-13 vaccination, Petitioner
presented to her primary care physician (“PCP”), Dr. Bolin, for a two-week history of anxiety.
Pet’r’s Ex. 5 at 18. Dr. Bolin noted Petitioner’s history of GERD and diffuse arthralgia. Id. His
assessment of Petitioner included “anxiety panic[,] diarrhea[,] GERD[,] allergies[, and]
arthralgias[.]” Id. Petitioner did not report shoulder pain during this visit. See id.
Petitioner communicated with Dr. Van Dinter’s office via email on May 23 and June 3,
2017, regarding her MRI testing to confirm the status of her Crohn’s disease. Pet’r’s Ex. 14 at 293,
308. Dr. Van Dinter indicated that Petitioner’s Crohn’s disease was “mild.” Id. at 293. In return,
Petitioner wrote that “[s]ymptom wise [she wa]s frustrated.” Id. Petitioner reported that she was
experiencing diarrhea four- to- five- times daily. Id. She also reported that “in an effort to reduce
stress[,]” she was exercising “more than normal and c[ould not] do any sit ups or ab work without
triggering lingering right[-]side pain/twinges.” Id. Petitioner did not report any complaints of left-
sided pain. See id.
On June 6, 2017, Petitioner returned to Dr. Van Dinter for a follow-up of her Crohn’s
disease. Id. at 271. Dr. Van Dinter noted that Petitioner had not taken NSAIDs since March 2017,
as her arthritis was “better.” Id. at 275. He also noted that Petitioner had recently received the
Prevnar-13 vaccine and she inquired about receiving the Zostavax (shingles) vaccine. Id. at 272.
Petitioner did not report left shoulder pain during this visit. See id. The next day, on June 7, 2017,
Petitioner received the Zostavax vaccine in her left arm. Pet’r’s Ex. 6 at 1, ECF No. 5-6; Pet. at 2.
11
Tendonitis or tendinitis is “inflammation of tendons and of tendon-muscle attachments[.]” Dorland’s at
1881.
12
NSAIDs are “nonsteroidal anti-inflammatory drugs. They are any of a large, chemically heterogeneous
group of drugs that inhibit cyclooxygenase activity, resulting in decreased synthesis of prostaglandin and
thromboxane precursors from arachidonic acid. All NSAIDs have analgesic, antipyretic, and anti[-
]inflammatory actions.” NSAIDs include ibuprofen, aspirin, and naproxen. Dorland’s at 1293.
13
Oligoarthritis or oligoasymetric arthritis is “arthritis of a small number of joints.” Dorland’s at 150.
14
Inflammatory bowel disease is “a general term for those inflammatory diseases of the intestines that have
an unknown etiology[.]” Dorland’s at 536.
4
Two days later, on June 9, 2017, Petitioner contacted Dr. Van Dinter via email. Pet’r’s Ex.
14 at 256. Petitioner reported that she received a shingles vaccine on June 7, 2017, but did not
report any arm pain in the left shoulder or otherwise. Id. Petitioner returned to Dr. Van Dinter for
a follow-up regarding her Crohn’s disease on July 20, 2017. Id. at 229. She reported that she was
exercising more, and Dr. Van Dinter noted she had “greater exercise capacity/tolerance with less
post [] exercise arthralgias.” Id. at 230. Dr. Van Dinter indicated that Petitioner’s Crohn’s disease
was “improved[.]” Id. at 234.
Five months after receiving the Prevnar-13 vaccination, on October 11, 2017, Petitioner
presented to her PCP with complaints of “left shoulder discomfort, [and] decrease in mobility[.]”
Pet’r’s Ex. 5 at 19. Dr. Bolin noted that Petitioner reported the onset of her discomfort after
“receiving [the P]revnar vaccine . . . and then shingles vaccine [a] few weeks later[,] uncertain if
related[.]” Id. Upon examination, Petitioner exhibited full range of motion (“ROM”) in her left
shoulder. Id. Dr. Bolin noted Petitioner had “tenderness to palpation” in the anterior/RC deltoid.
Id. He assessed Petitioner with left-sided tendonitis. Id.
Petitioner presented to orthopedist Dr. Michael Howard on October 17, 2017. Pet’r’s Ex.
7 at 1–3. During this visit, Petitioner reported a “history of bursitis ([twenty-five] years ago) and
tendonitis ([twenty] years ago), and she previously had injections for both conditions.” Id. at 1.
Petitioner reported that she “started to have pain in her [left] arm after having [two] immunity
shots (DOI 06/01/2017). After the shots, her arm became achy, and it has not improved since.” Id.
Dr. Howard noted that “[s]he now has an almost constant achy pain in her volar shoulder around
the [acromioclavicular (“AC”)] joint, 15 but the pain was originally in her lateral upper arm.” Id.
Upon examination of the left shoulder, Dr. Howard noted that Petitioner exhibited tenderness to
palpation, decreased ROM, and positive impingement tests. Id. at 2. Dr. Howard diagnosed
Petitioner with a “rotator cuff tendinopathy, 16 biceps tendinopathy[,] and [AC] joint tendinitis.”
Id. at 3. He also noted his impression of impingement syndrome, 17 an incomplete rotator cuff tear
or rupture, and primary osteoarthritis of the left shoulder. Id. at 2. Dr. Howard administered a
steroid injection to Petitioner’s subacromial joint of the left shoulder and referred her to physical
therapy (“PT”). Id. at 3.
Petitioner reported to PT at Plano Therapy Center on October 18, 2017. Pet’r’s Ex. 8 at
20–25. During this visit, Petitioner reported that her left shoulder pain began on May 1, 2017, with
a “gradual onset.” Id. at 21. She “denied any specific traumatic onset of symptoms.” Id. at 22. She
reported pain when reaching behind, overhead, or in “weird positions.” Id. Upon examination,
Petitioner had “mild ROM deficits, especially extension . . . local weakness, and decreased
posterior and inferior glenohumeral joint mobility contributing to aberrant movement patterns and
pain.” Id. at 23. The reporting physical therapist recommended treatment with PT two- to- three
15
The acromioclavicular (“AC”) joint is “the synovial joint between the acromion of the scapula and the
acromial extremity of the clavicle[.]” Dorland’s at 971.
16
Tendinopathy is “any pathologic condition of a tendon; also called tendinitis.” Dorland’s at 1881.
17
Impingement syndrome is “a type of overuse injury with progressive pathologic changes resulting from
mechanical impingement by the acromion, coracoacromial ligament, coracoid process, or
acromioclavicular joint against the rotator cuff; changes may include reversible edema and hemorrhage,
fibrosis, tendinitis, pain, bone spur formation, and tendon rupture.” Dorland’s at 1834.
5
times per week for eight weeks. Id. at 24. Petitioner attended only one additional PT appointment
at Plano Therapy Center on October 25, 2017. Id. at 30–31.
On October 19, 2017, Petitioner followed up with Dr. Van Dinter regarding her Crohn’s
disease. Pet’r’s Ex. 14 at 192. During this visit, Dr. Van Dinter noted that Petitioner had a history
of “[l]eft shoulder pain[.]” Id. at 193. Dr. Van Dinter indicated that Petitioner’s “[a]rthritis [wa]s
better and [she] continue[d] to note improved exercise tolerance – running 2–3 times per week and
doing hot yoga[.]” Id. He also noted that her Crohn’s disease was “[i]mproved.” Id. at 196.
Petitioner followed up with Dr. Howard on January 16, 2018. Pet’r’s Ex. 7 at 4–6.
Petitioner reported that following her left subacromial injection, she experienced “a few weeks of
relief, but her pain ha[d] returned and [wa]s progressively getting worse.” Id. at 4. Dr. Howard
noted that Petitioner was “unable to reach behind her back or reach over her head.” Id. Upon
examination, Dr. Howard noted Petitioner had a decreased ROM, mild AC tenderness, and positive
impingement signs. Id. at 5. Dr. Howard’s impression was “[a]dhesive capsulitis[,] 18
impingement/rotator cuff tendinopathy[, b]iceps tendinitis and superior labral tear[, and AC]
arthritis[.]” Id. He opined that “[h]er symptoms represent a constellation of mild aggravation and
likely adhesive capsulitis.” Id. Dr. Howard administered another steroid injection and referred
Petitioner back to PT. Id. at 6.
Petitioner presented to PT at Clair Physical Therapy on January 17, 2018. Pet’r’s Ex. 9 at
7. Petitioner reported that she “started having difficulty at her [left] shoulder [with] pain and
flexibility in May 2017 after receiving a pneumonia injection in her shoulder.” Id. Petitioner
continued that “her pain got gradually worse over the next few months, [especially] in October
[2017.]” Id. Petitioner described her pain as a “constant dull, aching pain at her [left]
ant[erior]/lat[eral shoulder] that can become sharp/shooting at times.” Id. at 8. Petitioner also
reported intermittent numbness and tingling, that radiated from her left forearm into her left first
through third digits. Id. The reporting physical therapist recommended continued PT. Id. at 9.
Petitioner had an MRI of her left shoulder on January 22, 2018. Pet’r’s Ex. 7 at 12–13.
Petitioner’s clinical history taken during this visit noted that she had been experiencing “left
shoulder pain for [six] months.” Id. at 12. Dr. Ramandeep Singh noted that the findings of the MRI
showed Petitioner had “small glenohumeral joint effusion, mild supraspinatus and infraspinatus
tendinopathy, mild tendinopathy of the biceps tendon[,] and no tears of the rotator cuff.” Id. at 13.
On February 13, 2018, Petitioner followed up with Dr. Howard. Id. at 7. During this visit,
Petitioner reported her “shoulder has improved since the last visit[]” in January 2018. Id. She also
reported an increased active ROM and strength. Id. Upon examination, Dr. Howard noted “mild
[AC] tenderness [and n]egative impingement signs.” Id. at 8. Dr. Howard reviewed Petitioner’s
January 22, 2018 MRI with her and noted it revealed “mild inflammation in the inferior capsule,
thickening of the superior and middle glenohumeral ligaments[,] which can be seen with adhesive
18
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.
6
capsulitis[.]” Id. He assessed Petitioner with “improving” adhesive capsulitis, biceps tendinitis,
impingement, and AC arthritis and recommended additional PT. Id.
Petitioner reported to physical therapist Mark McBride on February 15, 2018. Pet’r’s Ex.
9 at 29. Petitioner indicated that she had attended ten PT appointments so far. Id. She reported that
her left shoulder “ha[d] been doing much better overall . . . but [she] still ha[d] tightness [with
external and internal rotation].” Id. at 30. However, Petitioner reported that she felt her ROM was
improving. Id.
Petitioner followed up with Dr. Howard on March 22, 2018. Pet’r’s Ex. 7 at 10. Petitioner
reported that she had been attending PT once per week to work on her ROM. Id. However, she
indicated that she had “pain during and after [PT.]” Id. Petitioner acknowledged that her ROM had
improved, but not in the last couple of weeks. Id. She also reported difficulties getting dressed. Id.
Petitioner returned to PT on April 2, 2018. Pet’r’s Ex. 9 at 49. Petitioner indicated she had
attended nineteen appointments since evaluation. Id. During this visit, Petitioner reported her
“[left] shoulder [wa]s getting better . . . [and] she only ha[d] pain [with] reaching in certain
directions, such as behind her back to clasp her bra, but it [wa]s getting better[,] as was performing
her regular daily activities.” Id. at 50. However, Petitioner exhibited “deficits in strength and
ROM[.]” Id. at 51. Petitioner did not return to PT after this visit, and she was discharged from PT
on May 8, 2018. Id. at 5.
On July 16, 2018, Petitioner followed up with gastroenterologist Dr. Van Dinter. Pet’r’s
Ex. 14 at 5. Dr. Van Dinter noted that Petitioner was taking Celebrex for her left shoulder pain
starting in December 2017, but stopped in February 2018. Id. He noted that Petitioner felt her use
of Celebrex could have affected her Crohn’s disease. Id. Petitioner has not filed any additional
medical records after this date.
b. Affidavits
i. Petitioner’s Affidavits
Petitioner has filed two affidavits in support of her claim and testified at the fact hearing.
Pet’r’s Exs. 1, 15, ECF Nos. 5-1, 17-1; Tr. 9–147. Petitioner attested that she did not have arm or
shoulder pain prior to the Prevnar-13 vaccine she received on May 1, 2017. Pet’r’s Ex. 1 at 1, 3.
In her supplemental affidavit, Petitioner clarified that in May 2015, she reported to her PCP, Dr.
Bolin, for neck pain which resolved with medications. Pet’r’s Ex. 15 at 1. She noted that in May
2016, she returned to Dr. Bolin for low back pain, which was again resolved with medications,
including a Toradol 19 injection. Id.
Petitioner wrote that she received the Prevnar-13 vaccine during her annual physical
examination on May 1, 2017. Pet’r’s Ex. 1 at 1. Petitioner attested that she received the vaccine in
19
Toradol is “the trademark for preparations of ketorolac tromethamine.” Dorland’s at 1940. Ketorolac
tromethamine is “a nonsteroidal anti[-]inflammatory drug [NSAID] administered intramuscularly,
intravenously, or orally for short-term management of pain; also applied topically to the conjunctiva in the
treatment of allergic conjunctivitis and of ocular inflammation following cataract surgery.” Id. at 984.
7
her upper left arm and that “[i]t seemed to be injected with an unusual amount of force and it hurt
more than prior vaccinations [she] had received.” Id. Petitioner wrote that, following the vaccine,
her left upper arm was then “sore” and that she “developed a large red welt that was warm to the
touch[.]” Id. She noted that during the same appointment, she inquired about also receiving the
shingles vaccination but was told that her PCP’s office “no longer offered it[.]” Id.
Petitioner posited that “[a] month later,” her “left upper arm/shoulder was still sore to the
touch and sometimes it hurt when [she] moved it.” Id. She explained that she “thought about going
to the doctor at this time,” but due to her recent Crohn’s disease diagnosis, she refrained. Id. She
wrote, instead, she used “heat and ice on [her] left arm and shoulder and [was] taking Tylenol for
the pain[.]” Id.
Notably, Petitioner acknowledged that she had an appointment with Dr. Bolin on May 17,
2017, sixteen days following her Prevnar-13 vaccine, for the purpose of discussing her increased
anxiety associated with her recent Crohn’s disease diagnosis. Pet’r’s Ex. 15 at 1. Petitioner agreed
that during this visit, Dr. Bolin wrote that she had arthralgias, but she opined “he was referring to
[her] hip pain . . . because that is what [she] told the GI doctor as part of [her] Crohn’s disease
treatment.” Id. Petitioner wrote that she was experiencing “left arm pain from the vaccination
during this time but [] didn’t mention it because . . . [she] assumed that it still was the temporary
pain associated with vaccinations and that it would resolve itself and [that] it wasn’t related to the
Crohn’s or the anxiety [she] was having.” Id.
Petitioner wrote that she received the shingles vaccine on June 7, 2017, in her lower left
arm, the same arm in which she received her PCV 13 vaccination. Pet’r’s Ex. 1 at 1. She attested
that she did not receive the injection in her right arm out of concern that she “might end up with
two painful arms.” Id. Petitioner wrote that she experienced “mild soreness in the area of the
injection” but that this soreness “was gone in a few days.” Id.
Petitioner further wrote that throughout the summer of 2017, she noticed “stiffness in [her]
left shoulder in the mornings on waking, and [she] had difficulty with certain movements with
[her] left arm.” Id. at 2. She explained that the pain and stiffness in her left shoulder increased in
frequency and was “fairly constant” by October 2017. Id. She also noted her difficulties with “tasks
such as putting on or taking off a jacket[]” and sleeping during this time. Id.
Petitioner wrote that she first sought treatment on October 11, 2017, for her left-sided
shoulder pain that she “had been having [] since the Prevnar-13 vaccination.” Id. She indicated
that Dr. Bolin prescribed her a Medrol Dosepak, 20 but that it did not relieve her symptoms. Id.
Petitioner wrote that she then made an appointment with orthopedic surgeon, Dr. Howard, on
October 17, 2017. Id. Petitioner further wrote that when asked how she injured her shoulder, she
reported that “the problems had started with the Prevnar-13 vaccination on May 1, 2017.” Id. She
also noted that she received the shingles vaccine a month later, “but that it was given in a different
location in [her] arm and had not hurt like the Prevnar-13 vaccination.” Id.
20
A Medrol Dosepak is a prescription of Medrol. Medrol is the “trademark for preparation of
methylprednisolone.” Dorland’s at 1120. Methylprednisolone is “a synthetic glucocorticoid [steroid]
derived from progesterone, used in replacement therapy for adrenocortical insufficiency and as an anti[-
]inflammatory and immunosuppressant in a wide variety of disorders[.]” Id. at 1154.
8
Petitioner continued that, by Thanksgiving 2017, she could not take her coat off, reach
behind her to hook her bra, or do certain yoga poses that required her to lift her left arm or extend
her left shoulder without “severe pain.” Id. Petitioner wrote that for insurance purposes, she chose
to forego having an MRI until January 2018. Id. She noted that Dr. Howard diagnosed her with
impingement syndrome, bicipital tendinitis, and adhesive capsulitis of the left shoulder on January
16, 2018. Id. Petitioner explained that Dr. Howard recommended treatment with PT, but “[t]he
sessions were very painful and each time [she] dreaded having to go.” Id. at 2–3. Despite this pain,
Petitioner admitted her ROM was improving by February 13, 2018, and she “no longer ha[d]
pain[]” as of April 2, 2018. Id. at 3.
ii. Mr. Brett Rissler’s Affidavits
Mr. Brett Rissler submitted two affidavits in support of Petitioner’s claim and testified at
the fact hearing. Pet’r’s Exs. 2, 17, ECF Nos. 5-2, 24-2; Tr. 147–170. Mr. Rissler is married to
Petitioner. Pet’r’s Ex. 2 at 1. He wrote that Petitioner “came home from work the day of the
[Prevnar-13] vaccination [on May 1, 2017,] complaining of pain in her left arm[, and s]he had a
large red welt where the shot had been given.” Id. Mr. Rissler further wrote that Petitioner had pain
and discomfort and “was clearly having a hard time sleeping on her left side[]” over the next couple
of weeks following the Prevnar-13 vaccine. Id.
He continued that “[a]bout a month later,” Petitioner received the shingles vaccine in the
same arm as the Prevnar-13 vaccine, which “was still bothering her [] from the month before[.]”
Pet’r’s Ex. 17 at 1. Mr. Rissler attested that Petitioner told him that she received the shingles
vaccine “down lower and toward the back of her [left] arm.” Id. He wrote that Petitioner “didn’t
complain about pain from the shingles shot like she did with the Prevnar-13 vaccine . . . [and] she
didn’t form a red welt[.]” Id.
Mr. Rissler corroborated Petitioner’s difficulties with “certain movements causing her pain
and discomfort,” including getting dressed, hooking her bra or swimsuit top, or reaching behind
her back in the course of her usual activities throughout the summer of 2017. Pet’r’s Ex. 2 at 1. He
wrote that Petitioner dealt with the pain in her left arm “[f]or months” prior to receiving treatment
with Dr. Bolin in October 2017. Id.
iii. Ms. Cami Wilson’s Affidavits
Ms. Cami Wilson submitted two affidavits in support of Petitioner’s claim and testified at
the fact hearing. Pet’r’s Exs. 3, 16, ECF Nos. 5-3, 24-1; Tr. 172–191. Ms. Wilson is Petitioner’s
colleague as a clinical dietician. Pet’r’s Ex. 3 at 1. Ms. Wilson attested that Petitioner first reported
pain and decreased mobility in her upper left arm and shoulder following her receipt of the Prevnar-
13 vaccine on May 1, 2017. Id. Specifically, Ms. Wilson wrote that she “remembere[d] the day
[Petitioner] got the Prevnar shot because she was complaining to [her], saying it was the worst
shot [Petitioner had] ever had due to the pain and soreness associated with it.” Pet’r’s Ex. 16 at 1.
Ms. Wilson wrote that Petitioner’s “mobility complaints progressed over the course of
about a year . . . [and b]y the summer time, . . . [Petitioner] found it difficult to put her jacket on[.]”
Pet’r’s Ex. 3 at 1. She also noted that Petitioner’s arm and shoulder “started out as sore/tender, and
9
[she] would often see [Petitioner] rubbing/massaging her left shoulder.” Id. Ms. Wilson
corroborated that Petitioner had increased pain in the fall of 2017. Id.; see also Pet’r’s Ex. 16 at 1.
Regarding Petitioner’s shingles vaccination she received on June 7, 2017, Ms. Wilson
noted that Petitioner explained that she received the shingles vaccine also “in the left arm[]”
because “the [left] arm already hurt[,] and she didn’t want both arms hurting[]” during that time.
Pet’r’s Ex. 16 at 1. Ms. Wilson wrote that Petitioner received a flu vaccine in October 2017, but
chose to get it in her right arm because the pain associated with her Prevnar-13 vaccine had not
subsided on her left side. Id.
c. Testimony
i. Petitioner
Petitioner began her testimony by explaining her prior history of shoulder, back and neck
pain. She described pain decades prior from working as a waitress and carrying her daughter when
she was a small child. Tr. 15–16. That pain, she testified, resolved years prior to the start of her
post-vaccination pain. Tr. 17:11–19. Petitioner then discussed her treatment for neck pain and back
pain in May of 2015 and 2016, respectively. Tr. 18:17–25, 19:1–12, 18–23. She testified that “it
wasn’t to do with my shoulders at all.” Tr. 19:20–21. The pain was “on [her] back, like on either
side of [her] neck, that muscle that sits there right on the top.” Tr. 19:18–19. The doctor “called it
the trapezius muscle that was spasming.” Tr. 19:22–23.
At the time that Petitioner got her PCV 13 vaccine, she was dealing with her recent Crohn’s
disease diagnosis. She testified that the diagnosis “caused me anxiety. It made me question, you
know, my health in general.” Tr. 23:14–15. Petitioner remembered very specific details about her
vaccination. Petitioner testified that through the course of her care at her PCP’s office, she
recognized the nurse that administered the vaccine and described her as “a little hyper nurse” that
is always “high energy.” Tr. 27:24. Petitioner noted that for this vaccination she was sitting on the
examination table, but with “all the immunizations [she’s] gotten, [she] rarely ever g[o]t on
immunization in the doctor’s office.” Tr. 26:24–25, 27:1. She described the color of the needle and
said that she thought that it was “big shot.” Tr. 28:6–15. Petitioner said she tried to relax and didn’t
“want to tense up when the needle [wa]s coming close.” Tr. 29:5. Petitioner explained that she
looked away, but she remembered grabbing the table with her right hand because she “felt the
force.” Tr. 29:7–8. Petitioner stated that the needle went into her skin at an angle pointing up. Tr.
29:13–14. She testified that “[i]t hurt like a shot has never hurt.” Tr. 29:15–16. Petitioner did not
have a specific recollection of discussing her pain the day of vaccination, but testified that “I can’t
believe I wouldn’t have mentioned to [Ms.Wilson] how bad that shot hurt. And then I definitely
remember talking to her when I got the shingles shot because I was just kind of relieved how easy
that shot went” when compared to the Prevnar-13 shot. Tr. 10–14.
Petitioner testified that she “couldn’t sleep on that arm,” the night of her Prevnar-13
vaccine. Tr. 31:15. The next day, she noticed a welt and “definitely a lot of pain, more pain than
normal.” Tr. 31:24–25. In the following days, Petitioner stated that she noticed that her left arm
hurt, but she decided to minimize use of it because she is right-hand dominant. Tr. 33:20–24. She
did not go to the hospital and considered,“[w]as [the pain] a seven or eight? No, because I was
10
able to isolate it and not really use that arm.” Tr. 34:18–19. The pain was not hindering Petitioner’s
ability to do her everyday things, and she self-medicated. Tr. 49–50.
When asked why she did not bring up her shoulder pain at her doctor’s visit two days post
vaccination on May 3, 2017, Petitioner noted that Dr. Van Dinter is a gastroenterologist that was
treating her Crohn’s disease. Tr. 36:7–8. According to Petitioner, it did not make sense to her to
talk to Dr. Van Dinter about her shoulder pain, because it was unrelated to her Crohn’s and outside
of his area of expertise. Tr. 36:8–10. Petitioner also explained that she “didn’t even entertain going
to a doctor [for her shoulder pain] because it’s not like they can take the shot away,” and due to
her autoimmune disease, she is unable to take commonly prescribed pain medications. Tr. 38:12–
14. She did not want to be perceived as a “pain seeker.” Tr. 38:15–16. Despite this assertion, Dr.
Van Dinter noted in the visit notes that Petitioner was taking NSAIDs for shoulder/hip pain due to
her fluctuating oligoasymetric arthritis during this time. Pet’r’s Ex. 14 at 330. Petitioner described
talking to Dr. Van Dinter and clarified that if she felt aches and pain in her hips, she “would
mindlessly pop a Motrin and just chalk it up to getting older.” Tr. 40:13–24. She did not “recall at
this visit talking about [her] shoulders because that pain was more like — you know, it was kind
of achy hip kind of pain.” Tr. 40:15–18. She testified that she “ha[d] no idea why he put [a note
about her shoulder] in there.” Tr. 42:16–17. Petitioner said although she was experiencing shoulder
pain at this time, it was not related to the arthritis pain she was experiencing in her hips, which Dr.
Van Dinter proposed could also be an inflammatory result of her Crohn’s disease. Tr. 39:25–42:17.
She noted that prior to her Prevnar 13 vaccination, and even leading up to this appointment with
Dr. Van Dinter, she was not “having any shoulder achiness or [symptoms that she] would consider
arthritic . . . just [] achiness in [her] hips[.]” Tr. 42:18–24.
Petitioner described her appointment with PCP, Dr. Bolin, and discussed the anxiety she
felt about upcoming testing related to another possible autoimmune disease, rheumatoid arthritis
(“RA”). 21 Tr. 46:12–14. She did not discuss the shoulder pain during that appointment because
she was wholly focused on the anxiety related to her Crohn’s and test results for RA. Tr. 47:1–16.
Petitioner “wouldn’t say [the shoulder pain] was resolved, but it wasn’t to the point of pain like
after the first couple weeks of the shot either.” Tr. 11–13. During the month of May and into June,
Petitioner testified that she self-medicated with Tylenol, heat, and ice. Tr. 49:16–20. Specifically,
Petitioner remembered using Tylenol “four or five times out of the week.” Tr. 51:1–2.
Leading up to her shingles vaccination, Petitioner stated that she did not want to risk having
arm pain in both arms. Tr. 52:4–6. She testified that she decided to get the shingles vaccine in the
left arm because it was already hurting, and unlike the inter-muscular PCV 13 vaccination, the
shingles vaccination was subcutaneous. 22 Tr. 52:9–13; see also Pet’r’s Ex. 6 at 1 (noting that
21
Rheumatoid arthritis is “a chronic systemic disease primarily of the joints, usually polyarticular, marked
by inflammatory changes in the synovial membranes and articular structures and by muscle atrophy and
rarefaction of the bones. In late stages, deformity and ankylosis develop. The cause is unknown, but
autoimmune mechanisms and virus infection have been postulated.” Dorland’s at 157.
22
It is well-established in the Program that a SIRVA is limited to injuries following intramuscular injections
only, not subcutaneous injections. See 42 C.F.R. § 100.3(c)(10) (indicating that “SIRVA manifests as
shoulder pain and limited [ROM] occurring after the administration of a vaccine intended for intramuscular
administration in the upper arm.”); see also Small v. Sec’y of Health & Hum. Servs., No. 15-478V, 2019
WL 6463985, at *11 (Fed. Cl. Spec. Mstr. Nov. 1, 2019) (finding that the petitioner’s “influenza vaccination
11
Petitioner’s shingles vaccine was subcutaneous). Petitioner explained that she understood the
difference between an inter-muscular injection, such as the PCV 13 shot or her Humira shots, and
subcutaneous injections. Tr. 51:11–17. She noted that “[t]he shingle [sic] shot was a sub-Q. So[,]
it means it just goes underneath the skin; it doesn’t need to go into a muscle.” Tr. 51:16–18.
Petitioner clarified that she didn’t know that the shingles vaccination was different than the PCV
13 vaccine before her appointment, but the person who administered the vaccine, told her that she
could get the shingles injection on the lower, fatty part of her arm. Tr. 53:9–15. Unlike her PCV
13 vaccine, Petitioner testified that there was no pain following the shingles vaccination, and she
did not develop any redness or swelling in the area. Tr. 55:23–25.
Throughout June and July 2017, Petitioner continued to experience shoulder pain, but she
did not have any regularly scheduled appointments with her PCP and did not feel it necessary to
schedule an appointment for her shoulder pain alone. Petitioner testified, “it was achy, and it — I
want to say, the pain at this point had kind of evolved.” Tr. 61:8–9. She continued that her “arm
didn’t hurt that bad anymore to touch where the area of the shot went into, but the achiness, it kind
of just — it kind of just drifted up into the shoulder and it was just kind of a — like a dull ache.”
Tr. 61:10–13. Petitioner was unable to say why she did not approach her doctor about a cortisone
shot similar to the one she received for her pain in previous decades. She stated, “I didn’t even
think along those lines.” Tr. 63:14–15.
Petitioner described “a lightbulb moment” in September 2017, that finally convinced her
to go see her PCP. Tr. 66:16–19. She explained that she was in the car with her husband, and she
tried to reach behind the front seat to grab a water from the cooler in the back. Tr. 9–12. Petitioner
stated that “[i]t was just too painful” for her to reach, and she had to unbuckle her seatbelt to get
the water for him while he was driving. Tr. 66:20–21. Petitioner explained that when she did go
see Dr. Bolin in October, she related her pain back to the PCV 13 shot “because the shot was so
painful” at the time of vaccination and thereafter. Tr. 68:23–25.
Petitioner testified that she told Dr. Howard her pain began in May 2017 because that was
the month of the PCV 13 vaccination. She testified that she “[doesn’t] know why he put 6/1/2017,
because that’s not the date of either one of those shots.” Tr. 71:3–5. Petitioner noted that at that
time of vaccination, she “didn’t even know about the shot court.” Tr. 71:12. She said, “okay, [the
pain is caused by] one of these shots, you know, like something’s — you know, of course, the first
one, this was the one that made sense because it hurt so bad and it was hurting for a full month
before I got the second shot, the shingles shot. So yeah, I just kind of jointly talked about the two
shots together.” Tr. 71:14–19.
Petitioner testified that the cortisone shot that she received in October 2017 helped her with
the pain, “but not as dramatic as it had in the past.” Tr. 74:20. She explained that the shot lessened
the pain but did not alleviate it completely. Tr. 74:5–19. She described the pain “like [] a headache
in my shoulder.” Tr. 75:15. That pain turned into a “sharp, shooting pain” towards Christmas time
was intramuscularly administered[,] and her shingles vaccine subcutaneously administered. Therefore, to
the extent petitioner suffered any vaccine-related [shoulder] injury, her flu vaccine would have been more
likely than her shingles vaccine to have caused her injury.”). I find the same is true here. To the extent that
Petitioner suffered a SIRVA, her intermuscular flu vaccine is more likely than her subcutaneous shingles
vaccine to have caused her shoulder injury.
12
and “it felt like somebody was pulling [her] arm out of [her] socket like the pain that just takes
your breath away.” Tr. 75:16, 19–21. Specifically, Petitioner discussed “making Christmas
cookies” and stated, “I reached up . . . just without even thinking.” Tr. 82:15–17. She said the pain
“knock[ed] the wind out of me,” and she then believed she needed to schedule the MRI that her
doctor previously referred her for. Tr. 82:21–24.
Petitioner was asked about her experience with physical therapy. She testified that she
described the pain at the beginning of her physical therapy as stabbing, burning, and achy. Tr.
86:14–15. She explained that the experience was “degrading and it hurt like hell.” Tr. 90:22.
Petitioner felt like she could do the exercises at home. Tr. 90:25. Now, Petitioner says it “feel[s]
like I have really good range of motion” and no pain. Tr. 93:4–6.
On cross-examination, Petitioner was asked why she did not bring up her injury from the
Prevnar-13 vaccination during her receipt of the shingles vaccination. She said she was “not going
to complain about a shot to a doctor. I just didn’t want to seem whiney.” Tr. 118:16–17. Petitioner
also clarified the tingling and numbness that she felt following the PCV 13 vaccine. She described
it as a tingling sensation she would feel occasionally at night. Tr. 130:23–24. Petitioner also
described tingling when “reaching up above” accompanied by “a quick, sharp pain.” Tr. 131:13–
14. This type of pain first began, according to Petitioner, in the summer of 2017. Tr. 132:3–4.
During the summer, the tingling occurred at night, but “as October, November’s rolling around,
December, that’s when [she was] like going, okay, when [she] made a movement with that arm,
[she would] feel some tingling.” Tr. 133:6–8.
I asked Petitioner to help me establish a chronology for her NSAID use leading up to and
around the time of her Prevnar-13 vaccination. She testified that she was “one of these people if
[she] had an ache, [she] would pop a pill. Pop an NSAID.” Tr. 125:25, 126:1. Petitioner asserted
that she stopped taking NSAIDs in March 2017, pre vaccination, because her doctor told her they
“were causing [her gastrointestinal] issues[]” related to her Crohn’s disease. Tr. 126:7.
ii. Mr. Brett Rissler
Testifying on behalf of his wife, Mr. Rissler reiterated the account he provided in his
affidavits. He explained that on May 1, 2017, Petitioner’s left shoulder was “definitely sore to the
touch [and s]he [] had some stiffness[.]” Tr. 151:8–9. He specifically focused on his wife’s
inability to sleep due to the pain. Tr. 153:8–14. Mr. Rissler said, “she definitely had pain,
discomfort, limitations. It was affecting her sleep as well. She wouldn’t be able to lay on her side
and she was typically a side sleeper.” Tr. 153:13–14. He added that in the weeks immediately
following her vaccination, he would see Petitioner “sitting watching TV and [he] would look over
and [he] would see her rubbing [her arm] and working it too, as well.” Tr. 153:21–23. Mr. Rissler
said his wife is “not a complainer” and noted “we didn’t really talk about it much that way and her
focus was really kind of dealing with the Crohn’s diagnosis and everything around that.” Tr.
153:24–25, 154:1.
Generally, Mr. Rissler testified that his wife’s pain “was intermittent so it wasn’t, you
know, a constant daily complaint or anything.” Tr. 157:12–13. He continued, that “it seemed to
13
oddly progress[,] and it would be — it would wax and wane a little bit where some days or weeks
it would be less noticeable but always there.” Tr. 157:14–17.
Mr. Rissler also remembered when Petitioner received the shingles vaccination. He
described their conversation about her getting that vaccine in the same arm as the PCV 13 vaccine.
He explained that Petitioner wanted the shot in the “[s]ame shoulder, so if there was [sic] problems
and discomfort, it would be just one shoulder. She’s very dominant right-handed so she didn’t
want to risk anything going on that way for work or anything else.” Tr. 155:8–12. Mr. Rissler
testified that eventually, he told his wife that she needed to make an appointment with her doctor,
and in “late September, early October” she went to see Dr. Bolin. Tr. 158:23. Mr. Rissler described
Petitioner’s response to the physical therapy prescribed by Dr. Bolin and noted that the physical
therapy “was very difficult for her, not only the pain, but just the emotional side of it, the frustration
with even having to deal with it as well.” Tr. 159:23–25.
After her Prevnar-13 vaccine, Mr. Rissler and his wife shifted from “an equal partnership
when it came to taking care of the house,” to Mr. Rissler taking on more responsibilities,
particularly when it came to yardwork and other things outside. Tr. 161:13–17. Mr. Rissler
corroborated that in the summer of 2017, he began needing to help his wife “with her shirt or a
couple times just even getting her bra on [because s]he couldn’t reach back to her back very
consistently that way.” Tr. 162:4–6.
iii. Ms. Cami Wilson
Ms. Wilson testified consistent with her affidavits. She provided a timeline for Petitioner’s
pain progression. She stated that she noticed “initially, [Petitioner complained to her about] just
soreness . . . [which she thought Petitioner] kind of babied [] a little bit.” Tr. 176:1–4. Ms. Wilson
explained that the day after Petitioner’s Prevnar-13 vaccine, Petitioner told her that “there was this
sharp pain. Any time [Petitioner] touched it, it was very, very painful to touch.” Tr. 175:15–17.
Ms. Wilson was not sure if this conversation took place on the day Petitioner received the vaccine,
or the next day. Tr. 175:4–6. She stated that she did not see the red welt on Petitioner’s arm because
they “often wear[] long sleeves at work[,]” but that Petitioner “just talked [to her] about it.” Tr.
175:20–23. But then by summer, Ms. Wilson observed that Petitioner “started losing some
mobility,” and she could not reach behind her back to put on a coat when it was cold in their office.
Tr. 176:7–14.
Ms. Wilson noted that, at one point, Petitioner “was losing sleep with her coming in late.”
Tr. 182:23–24. Petitioner told Ms. Wilson that she would “wake up [with] this sharp pain and it
would kind of take her a while to like fall back asleep.” Tr. 183:2. Ms. Wilson said Petitioner was
running on low sleep and she was taking Ambien, but it did not help. Tr. 182:24–25. Ms. Wilson
testified that “towards the fall, definitely into the winter, she was having a hard time — she was
like ‘I had to go and buy new bras’ because she was having a hard time reaching back behind her.”
Tr. 183:9–12. Ms. Wilson explained that Petitioner “was just altering her work schedule, coming
in later, staying later in the day and then also just kind of changing her habits of — due to mobility
problems towards the fall.” Tr. 183:14–17.
14
I asked Ms. Wilson to tell me how she remembered the year of Petitioner’s vaccination.
She testified that “the affidavit helped, but I would have said it was — we— I can remember the
time frame of where we were in the office.” Tr. 189:22–24. She continued that “[s]he and I have
moved into four different offices in the seven years that I have been there, so we — I’m able to
remember around what time frame that happened based on the office that we were in.” Tr. 189:24–
15, 190:1–2.
Ms. Wilson was also asked if she spoke to Petitioner about her testimony and she
responded, “at the end of the day, I would always tell her, like, it’s — what happened to you[.] I
don’t know what happened to you because I’m not her. I can only speak on the things that I saw
and that I — I saw her [do] or she told me.” Tr. 186:3–7.
III. Applicable Legal Standard
To receive compensation under the Vaccine Act, Petitioner must demonstrate either that:
(1) she suffered a “Table injury” by receiving a covered vaccine and subsequently developing a
listed injury within the time frame prescribed by the Vaccine Injury Table set forth at 42 U.S.C. §
300aa-14, as amended by 42 C.F.R. § 100.3; or (2) that she suffered an “off-Table injury,” one not
listed on the Table as a result of her receipt of a covered vaccine. See 42 U.S.C. §§ 300aa-
11(c)(1)(C); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010);
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir. 2006).
The Vaccine Injury Table considers a SIRVA a presumptive injury for the Prevnar-13
vaccine if the first symptom or manifestation of onset of the illness occurs within forty-eight hours
of an intramuscular vaccine administration. See 42 C.F.R. § 100.3(a)(XIV). The Qualifications
and Aids to Interpretation (“QAI”) further specify:
A vaccine recipient shall be considered to have suffered a SIRVA if such recipient
manifests all of the following:
i) No history of pain, inflammation or dysfunction of the affected
shoulder prior to intramuscular vaccine administration that would
explain the alleged signs, symptoms, examination findings, and/or
diagnostic studies occurring after vaccine injection;
ii) Pain occurs within the specified time-frame;
iii) Pain and reduced range of motion are limited to the shoulder in which
the intramuscular vaccine was administered; and
iv) No other condition or abnormality is present that would explain the
patient’s symptoms (e.g. NCS/EMG or clinical evidence of
radiculopathy, brachial neuritis, mononeuropathies, or any other
neuropathy).
42 C.F.R. § 100.3(c)(10). If, Petitioner is unable to succeed on a Table claim, Petitioner may,
alternatively, prove that her injury was caused-in-fact by a Table vaccine. In order to succeed on
a theory of causation-in-fact, Petitioner would have to show:
15
by preponderant evidence that the vaccination brought about [the] injury by
providing: (1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of a proximate temporal relationship between
vaccination and injury.
See Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. § 11(c)(2). The special master is required to
consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury,
condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” § 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). Pursuant
to Vaccine Act § 13(a)(1)(A), a petitioner must prove their claim by a preponderance of the
evidence. A special master must consider the record as a whole, but is not bound by any diagnosis,
conclusion, judgment, test result, report, or summary concerning the nature, causation, and
aggravation of petitioner’s injury or illness that is contained in a medical record. § 13(b)(1).
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). 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.” Cucuras
v. Sec’y of Health & Hum. Servs., 933 F.2d 1525, 1528 (Fed. Cir. 1993). Indeed, contemporaneous
medical records are ordinarily to be given significant weight due to the fact that “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.” Id. However, there is
no “presumption that medical records are accurate and complete as to all of the patient’s physical
conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021) (finding
that a special master must consider the context of a medical encounter before concluding that it
constitutes evidence regarding the absence of a condition.). 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.
Judges of the Court of Federal Claims have reaffirmed the finding in Cucuras that the lack
of contemporaneously created medical records can contradict a testimonial assertion that
symptoms appeared on a certain date. See, e.g., Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.
Cl. 598, 608 (Fed. Cl. 2010) (stating “[g]iven the inconsistencies between petitioner’s testimony
and his contemporaneous medical records, the special master’s decision to rely on petitioner’s
medical records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y
16
of Health & Hum. Servs., 468 Fed. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion); Doe/17
v. Sec’y of Health & Hum. Servs., 84 Fed. Cl. 691, 711 (2008); Ryman v. Sec’y of Health & Hum.
Servs., 65 Fed. Cl. 35, 41-42 (2005); Snyder v. Sec’y of Health & Hum. Servs., 36 Fed. Cl. 461,
465 (1996) (stating “[t]he special master apparently reasoned that, if Petitioner suffered such
[developmental] losses immediately following the vaccination, it was more likely than not that this
traumatic event, or his parents’ mention of it, would have been noted by at least one of the medical
record professionals who evaluated Petitioner during his life to date. Finding Petitioner’s medical
history silent on his loss of developmental milestones, the special master questioned Petitioner’s
memory of the events, not her sincerity.”), aff’d, 117 F.3d 545, 547–48 (Fed. Cir. 1997).
For cases alleging a condition found in the Vaccine Injury Table, special masters may find
when a first symptom appeared, despite the lack of a notation in a contemporaneous medical
record. 42 U.S.C. § 300aa-13(b)(2). By extension, special masters may engage in similar fact-
finding for cases alleging an off-Table injury. In such cases, special masters are expected to
consider whether medical records are accurate and complete. To overcome the weight of medical
records, testimony is required to be “consistent, clear, cogent, and compelling.” Blutstein v. Sec’y
of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30,
1998).
In determining the accuracy and completeness of medical records, special masters will
consider various explanations for inconsistencies between contemporaneously created medical
records and later given testimony. The Court of Federal Claims has identified four such
explanations for explaining inconsistencies: (1) a person’s failure to recount to the medical
professional everything that happened during the relevant time period; (2) the medical
professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of
symptoms that did not exist. La Londe v. Sec’y of Health & Hum. Servs., 110 Fed. Cl.
184, 203 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014).
When weighing divergent pieces of evidence, special masters usually find
contemporaneously written medical records to be more significant than oral testimony. Cucuras,
993 F.2d at 1528. Testimony offered after the events in question is less reliable than
contemporaneous reports when the motivation for accurate explication of symptoms is more
immediate. Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523 (1993). However,
compelling oral testimony may be more persuasive than written records. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common sense
and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking.”); Camery v. Sec’y of Health & Hum. Servs., 42
Fed. Cl. 381, 391 (1998) (this rule “should not be applied inflexibly, because medical records may
be incomplete or inaccurate”); Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733
(1991) (“[T]he absence of a reference to a condition or circumstance is much less significant than
a reference which negates the existence of the condition or circumstance.”) (citation
omitted), aff’d, 968 F.2d 1226 (Fed. Cir. 1992).
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IV. Discussion
a. Date of Initial Complaint of Injury
Although Petitioner has not alleged a Table claim, the accompanying QAIs for a SIRVA
Table claim are nonetheless informative and help frame the analysis of the facts currently in
dispute, namely the onset of pain. Despite the lack of contemporaneously created medical records
immediately following Petitioner’s PCV 13 vaccine, I find she has provided preponderant evidence
that she experienced pain consistent with SIRVA within forty-eight hours of injection. It is true
that Petitioner does not have medical records that document a complaint of shoulder pain
consistent with SIRVA to a medical provider for more than five months post vaccination.
However, when Petitioner did initially complain about the relevant shoulder pain in October 2017
and thereafter, she consistently related it back to her PCV 13 vaccination. Petitioner credibly
explained that she did not seek treatment immediately because she has received vaccines in the
past and expected some degree of soreness and pain. She also testified that she was more concerned
about her recently diagnosed autoimmune disease and did not want to seem as though she was
complaining about a routine vaccine to a specialist. Although contemporaneous medical records
often contain evidence that is contradictory to a petitioner’s claim, the lack of medical records or
treatment is not per se evidence that a petitioner was not suffering from an injury. See 42 U.S.C.
§ 300aa-13(b)(2); see also Kirby, 997 F.3d at 1383. Indeed, it is not uncommon in the Program for
individuals not to seek treatment immediately for shoulder pain post vaccination. See, e.g., Lang
v. Sec'y of Health & Hum. Servs., No. 17-995V, 2020 WL 7873272, at *11 (Fed. Cl. Spec. Mstr.
Dec. 11, 2020) (citing Forman-Franco v. Sec’y of Health & Hum. Servs., No. 15-1479V, 2018
WL 1835203 (Fed. Cl. Spec. Mstr. Feb. 21, 2018); Tenneson v. Sec’y of Health & Hum. Servs.,
No. 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018), mot. rev. denied 142 Fed.
Cl. 329 (2019); Gurney v. Sec’y of Health & Hum. Servs., No. 17-481V, 2019 WL 2298790 (Fed.
Cl. Spec. Mstr. Mar. 19, 2019)). In fact, it is not at all unusual for people not to seek immediate
medical care for an injury consistent with SIRVA. See, e.g., Hanna v. Sec’y of Health & Hum.
Servs., No. 18-1455V, 2021 WL 3486248 (Fed. Cl. Spec. Mstr. July 15, 2021) (citing Lang, 2020
WL 7873272, at *10 (noting that “[R]espondent’s expert has conceded that there is no such thing
as an ‘appropriate’ time to seek treatment” for SIRVA); Smallwood v. Sec’y of Health & Hum.
Servs., No. 18-291V, 2020 WL 2954958, at *10 (Fed. Cl. Spec. Mstr. Apr. 29, 2020) (finding that
it is “common for a SIRVA petitioner to delay treatment, thinking his/her injury will resolve on its
own.”)). It is also reasonable that an individual seeing a gastroenterologist for treatment of Crohn’s
disease may decide not to discuss a recent joint injury. Petitioner has therefore presented a logical
explanation for her delay in seeking medical treatment.
Petitioner gave a very detailed, credible account of her vaccination, which trumps the lack
of contemporaneous medical records post vaccination. See Blutstein, 1998 WL 408611, at *5. She
described the nurse who administered the shot, her location in the room, and the color and size of
the syringe and needle. She described her behavior in the moments leading up to the vaccination
and the way the needle felt as it entered her arm. Petitioner also described the subsequent lingering
pain in her arm and the red welt that formed at the injection site. Petitioner provided contextual
details throughout her testimony, including during her discussions of her Crohn’s disease and
interactions with family and coworkers, that bolstered her credibility.
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Her fact witnesses also presented credible evidence to support Petitioner’s assertion that
she complained of pain within a day of her vaccination. See id. Mr. Rissler corroborated
Petitioner’s account in a filed affidavit and during his consistent and credible hearing testimony,
as did Petitioner’s co-worker, Ms. Wilson. Ms. Wilson’s testimony was also credible in its context.
Ms. Wilson testified that while she did not see the welt, she remembered Petitioner describing the
pain and redness she experienced immediately after her vaccination. Ms. Wilson testified that she
could not remember if the conversation she had with Petitioner was the same day as the vaccine,
or the day after, but was confident that it was one of those days. She did remember the year and
the time of year however, because she and Petitioner had changed offices several times during that
period. Ms. Wilson explained that she could remember when the conversation occurred based on
the location of her office space. Ms. Wilson’s ability to relate her conversation with Petitioner back
to a specific time of year and place, even though it occurred several years ago, is reasonable and
persuasive. Therefore, I find that Petitioner has established it more likely than not that she
experienced shoulder pain within forty-eight hours of vaccination.
b. Table Claim
The majority of SIRVA injuries seen in the Program are presented as Table claims.
However, in this case, a Table claim is not before me, because Petitioner does not state a claim
based on a Table injury. Instead, she asserts in her petition that her “left shoulder impingement,
adhesive capsulitis, tendinopathy, tendinitis, superior labral tearing, and the debilitating pain,
weakness, and restricted range of motion associated with these conditions [] were caused-in-fact
by the vaccination.” Pet. at 1. Although Petitioner has presented preponderant evidence of shoulder
pain within forty-eight hours of vaccination, this Ruling does not reach whether Petitioner’s pain
was caused-in-fact by her Prevnar-13 vaccination.
For her claim to be successful, Petitioner must still establish by preponderant evidence that
her shoulder pain resulted from her vaccination rather than from any of her pre-vaccination
conditions. Petitioner’s medical records include several related conditions and ailments that
preceded her vaccination, including a history of neck and low back pain, and arthralgias associated
with Crohn’s disease. Furthermore, Dr. Van Dinter noted two days post vaccination that Petitioner
had fluctuating arthritis in her shoulders and hips. Pet’r’s Ex. 14 at 330. This record was
contradicted by later evidence 23 that showed she stopped self-medicating with NSAIDs for
arthritis-related pain in March 2017, and any arthritis pain at that time was limited to her hips.
However, the inconsistencies in the record with regard to Petitioner’s pre-vaccination history of
23
Petitioner’s medical records indicate that she had been diagnosed with, and was self-medicating with
NSAIDs for, asymmetric oligoarthritis in her shoulders and hips prior to vaccination. Petitioner testified
that the arthritis pain she was experiencing at the time of her May 3, 2017 appointment with Dr. Van Dinter
was only in her hips. Tr. 40:15–18. She was unsure why Dr. Van Dinter noted she was taking NSAIDs for
arthritic shoulder pain at that time. Tr. 42:16–17. Petitioner also clarified that she took Motrin as needed
for general aches and pain, but discontinued her NSAID use in March of 2017, two months prior to her
PCV 13 vaccination due to concerns related to her Crohn’s disease. Petitioner’s medical records are less
helpful on this point because a record from her evaluation with Dr. Van Dinter two days post vaccination
documents continued daily NSAID use, Pet’r’s Ex. 14 at 330, while a subsequent record from the same
provider from a June 2017 visit, notes that Petitioner ceased all NSAID use in March 2017. Id. at 275.
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shoulder problems must be fleshed out and reconciled in order for her vaccine-caused shoulder
injury claim to be successful.
V. Conclusion
Based on the above reasoning, I find that the evidence submitted by Petitioner establishes
by a preponderant standard that she experienced an onset of left-sided shoulder pain within forty-
eight hours following her PCV 13 vaccination. Without expert testimony, I am unable to reach a
decision regarding the cause of said injury. Accordingly, Petitioner has fourteen (14) days from
the filing of this Ruling to file a status report indicating how she wishes to proceed.
IT IS SO ORDERED.
s/Herbrina D. Sanders
Herbrina D. Sanders
Special Master
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