VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00462
Package ID: USCOURTS-cofc-1_19-vv-00462
Petitioner: Benjamin Larson
Filed: 2019-03-28
Decided: 2024-02-28
Vaccine: influenza
Vaccination date: 2017-11-13
Condition: Shoulder Injury Related to Vaccine Administration (SIRVA)
Outcome: compensated
Award amount USD: 60000

AI-assisted case summary:
Benjamin Larson, a 53-year-old facility maintenance worker, received an intradermal influenza vaccine on November 13, 2017. He alleged that this vaccination caused a Shoulder Injury Related to Vaccine Administration (SIRVA). Larson experienced immediate pain and stinging at the injection site, which worsened over the following weeks, leading to limited range of motion and difficulty with daily activities. He sought medical treatment approximately a month after the vaccination, initially attempting self-medication. His condition was diagnosed as chronic left shoulder pain, consistent with impingement syndrome and rotator cuff irritation. Larson presented medical records, affidavits from himself and coworkers, and expert testimony from Dr. Uma Srikumaran, who opined that the intradermal vaccine caused an inflammatory response leading to his shoulder injury. The respondent presented expert testimony from Dr. Brian Feeley, who argued that an intradermal injection was unlikely to cause such a deep shoulder injury and suggested Larson's pain was due to pre-existing shoulder pathology. The court found by a preponderance of the evidence that Larson's symptoms began within 48 hours of the vaccination and that the vaccine was the cause-in-fact of his injury, satisfying the Althen prongs for off-Table claims. Following the entitlement ruling, the parties could not agree on damages. The court awarded Benjamin Larson $60,000.00 for pain and suffering, considering the severity and duration of his injury, which affected his dominant arm and physically demanding work.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-00462-0
Date issued/filed: 2023-09-25
Pages: 26
Docket text: PUBLIC ORDER/RULING (Originally filed: 08/28/2023) regarding 44 Ruling on Entitlement. Signed by Special Master Thomas L. Gowen. (hs) Service on parties made.
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Case 1:19-vv-00462-UNJ Document 46 Filed 09/25/23 Page 1 of 26
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 28, 2023
* * * * * * * * * * * * *
BENJAMIN LARSON, *
*
Petitioner, * No. 19-462V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Ruling on Entitlement; Intradermal
AND HUMAN SERVICES, * Influenza (“flu) Vaccine; Shoulder
* Injury.
*
Respondent. *
*
* * * * * * * * * * * * *
Leah VaSahnja Durant, Law Offices of Leah V. Durant, Washington, DC, for petitioner.
Parisa Tabassian, U.S. Department of Justice, Washington, D.C., for respondent.
RULING ON ENTITLEMENT1
On March 28, 2019, Benjamin Larson (“petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program.2 Petitioner alleges that he suffered a
Shoulder Injury Related to Vaccine Administration (“SIRVA”) as a result of receiving an
intradermal Influenza (“flu”) vaccination in his left shoulder on November 13, 2017. Petition
(ECF No. 1). Petitioner filed an amended petition on June 11, 2021, alleging the same injury.
Amended Petition (ECF No. 29).
After a review of the record, including medical records, affidavits, pre-hearing briefing
by the parties, an entitlement hearing, and for the reasons set forth below, I find by preponderant
evidence that the petitioner is entitled to compensation.
1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The Court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion
is posted on the Court’s website, each party has 14 days to file a motion requesting redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). An objecting party must provide the Court with a proposed
redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will
be posted on the Court’s website without any changes. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.

Case 1:19-vv-00462-UNJ Document 46 Filed 09/25/23 Page 2 of 26
I. Procedural History
Petitioner filed his petition on March 28, 2019, alleging that he sustained a left SIRVA
caused by the intradermal flu vaccine administered on November 13, 2017. Amended Petition at
Preamble. Petitioner filed an affidavit on April 12, 2019, a supplemental affidavit on June 4,
2020, and a second supplemental affidavit on August 12, 2022, based on his own personal
knowledge. Petitioner’s Affidavit (“Aff.”) (ECF No. 7); Pet. Supplemental (“Supp.”) Aff (ECF
No. 7); Pet. Second Supp. Aff. (ECF No. 35)
The case was initially referred to the Special Processing Unit (“SPU”). See SPU Initial
Order (ECF No. 5). Petitioner filed medical records and a statement of completion on April 12,
2019. Pet. Exhibit (“Ex.”) 1-3 (ECF No. 7). An initial SPU status conference was held on June 4,
2019, and Chief Special Master Dorsey ordered the case to be transferred because of petitioner’s
claim involves an intradermal flu vaccination. Order (ECF No. 10). The case was reassigned to
my docket on June 19, 2019. See Notice of Reassignment (ECF No. 12).
On October 3, 2019, I held an initial status conference and ordered petitioner to file
additional information regarding the type of delivery system used to administer the flu vaccine to
petitioner, and for respondent to either file a Rule 4(c) report or a status report indicating their
willingness to engage in settlement discussions. Scheduling Order (ECF No. 13). On December
20, 2019, petitioner filed a status report indicating that petitioner was unable to obtain any
further information concerning the route of vaccine administration for the vaccine in question.
Pet. Status Report (ECF No. 16).
On May 4, 2020, respondent filed her Rule 4(c) Report, stating that compensation should
be denied, and the case should be dismissed for failure to demonstrate entitlement to
compensation. Respondent’s (“Resp.”) Report (“Rept.”) at 1 (ECF No. 20). Specifically,
respondent stated that petitioner has not established a Table injury because petitioner received an
intradermal vaccination. Id. at 6. Additionally, respondent stated that petitioner also failed to
establish causation-in-fact. Id.
On June 4, 2020, petitioner filed a supplemental affidavit from petitioner, an affidavit
from Jeff Wuensh, and an affidavit from Mark Hauser. Pet. Supp. Aff; Pet. Ex. 7; Pet. Ex. 8. On
July 6, 2020, petitioner filed an expert report from Uma Srikumaran, MD, MBA, MPH, with
accompanying medical literature.3 Pet. Ex. 9 (ECF No. 23). On August 27, 2020, respondent
3 Dr. Srikumaran serves as an associate professor in the Shoulder Division at the Johns Hopkins School of Medicine
and serves as the Shoulder Fellowship Director and Chair of Orthopaedic Surgery for the Howard County General
Hospital. Pet. Ex. 10 at 1. He also serves as the Medical Director of the Johns Hopkins Musculoskeletal Service
Line in Columbia, Maryland. Id. Each year Dr. Srikumaran sees approximately 2500-3000 patients for shoulder
issues and performs 400-500 shoulder surgeries annually. Id. He has treated approximately ten to twelve patients
with shoulder dysfunction after vaccination in the past five years. (Id.) Dr. Srikumaran received his medical degree
from Johns Hopkins School of Medicine in 2005. Id. He completed his orthopaedic residency at Johns Hopkins
Hospital and completed a shoulder surgery fellowship at Massachusetts General Hospital. Id. Dr. Srikumaran is
board certified in orthopaedic surgery. Id. at 10. He peer-reviews journal articles for several orthopaedic journals
including The Journal of Bone & Joint Surgery, Orthopedics, Clinical Orthopedics and Related Research, and The
Journal of Shoulder and Elbow Surgery. Id. 1-2. Dr. Srikumaran was selected to serve on the Shoulder and Elbow
Content Committee for the American Academy of Orthopaedic Surgery. Id. Petitioner offered Dr. Srikumaran as an
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filed an expert report and accompanying medical literature from Brian Feeley, MD.4 Resp. Ex. A
(ECF No. 24).
On April 9, 2021, I held a Rule 5 status conference and ordered petitioner to file an
amended petition alleging a cause in fact case, instead of a Table Injury, because the vaccination
in question is an intradermal delivery system. Scheduling Order (ECF No. 26). Petitioner filed
the amended petition on June 11, 2021, alleging a SIRVA injury resulting from adverse effects
of a flu vaccination petitioner received on November 13, 2017. Amended Pet.
An entitlement hearing was set for October 11, 2022. See Hearing Order (NON-PDF),
July 8, 2021. On July 28, 2022, petitioner filed a status report requesting a status conference to
discuss whether an evidentiary hearing is necessary at this time, or if an alternative existed that
might speed resolution of this case for all concerned given that the instant case is one of a group
of intradermal cases in the program. (ECF No. 32). A status conference was set on August 4,
2022, and I explained that each intradermal cases is fact specific and having testimony in each
case would be helpful in resolving any factual issues that may be raised. (ECF No. 34).
Petitioner filed a second supplemental affidavit and pre-hearing submissions on August
12, 2022. Pet. Second Supp. Aff; Pet. Pre-Hearing Brief (ECF Nos. 35-36). Respondent filed a
pre-hearing brief on September 9, 2022. Resp. Pre-Hearing Brief (ECF No. 37). A one-day
entitlement hearing was held on October 11, 2022. On October 25, 2022, respondent filed a
status report indicating the respondent was not amenable to negotiation of a settlement at this
time. (ECF No. 41). The parties did not file post-hearing briefs.
This matter is now ripe for adjudication.
II. Evidence Submitted
a. Petitioner’s medical history and affidavits
Petitioner was a 53-year-old facility maintenance worker at the time he received the
intradermal flu vaccination in his left deltoid on November 13, 2017 at the healthcare facility
where he worked. Pet. Ex. 1. Prior to his work in healthcare petitioner “was a civilian Defense
contractor for approximately 22 years,” he worked in “Saudi Arabia, Iraq, Afghanistan, and the
Marshall Islands,” and he “endured to[o] many shots to count over the years in order to fulfill my
expert in orthopedic surgery with expertise in diagnosis, treatment, and surgery of shoulders and was admitted as
such. Tr. 42.
4 Dr. Feeley is a board-certified orthopaedic surgeon. Resp. Ex. B at 1. He received his medical degree from
Stanford University in 2001, completed a research-focused orthopaedic surgery residency at the University of
California, Los Angeles in 2007, and completed a sports medicine and shoulder fellowship at the Hospital for
Special Surgery in New York in 2008. Id. Dr. Feeley has practiced as an orthopaedic surgeon at the University of
California, San Francisco since 2008, where he sees patients with shoulder and knee injuries. Id. He also currently
serves as a professor in residence. Id. Dr. Feeley is a member of the American Academy of Orthopaedic Surgeons,
American Orthopedic Sports, American Shoulder and Elbow Society, and American Orthopaedic Association. Id. at
5. He has published over 150 peer-reviewed manuscripts, several review papers and book chapters, and a book on
rotator cuff tears. Id. at 23-36. Dr. Feeley was offered as an expert in orthopedic surgery and as a shoulder specialist,
and was admitted as such. Tr. 101.
3

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medical deployment requirements to travel overseas. I was never injured due to a needle until
November 13, 2017.” Pet. Supp. Aff. ¶ 8.
Petitioner received the vaccination in his left deltoid and is left hand dominant. Tr. 28.
Petitioner noted in his affidavit that “upon receiving the injection I felt immediate pain and an
overwhelming stinging sensation,” and he “started to have even more severe arm pain over the
next few weeks.” Pet. Aff. ¶ 1. In his supplemental affidavit he noted after receiving the
vaccination at the Employee Health Department he “returned to the shop there were other guys
present who had received their shots earlier that morning. I asked them if they were experiencing
pain like I was. I remember some of my coworkers joking and giving me a hard time about the
shot being painful.” Pet. Supp. Aff. ¶ 2.
He stated that “limited range of motion was something [he] never experienced before,
and full extension of [his] arm caused [him] to have excruciating pain.” Id. at ¶ 2. He “tried to
self-medicate…hoping it would heal.” Pet. Second Supp. Aff. ¶ 4. He stated that he “waited to
seek medical treatment for 2 reasons. Scared of being harassed by my coworkers, and my hopes
like in the past, the belief that self-medicating would work. It got to a point I knew I had to seek
medical treatment.” Id. at ¶ 5.
His first medical encounter following the vaccination was on December 20, 2017, when
he called a nurse at Gunderson Health System stating that he “got the flu shot a couple weeks
ago and [his] arm ha[d] been hurting ever since.” Pet. Ex. 2 at 15. Petitioner arrived “with [a]
complaint of left shoulder pain following the flu shot that he had on 11/13/2017.” Id. at 16. The
reason for disposition noted “moderate pain” that “interferes with normal activities…injection
site reaction to any vaccine.” Id. at 15. Petitioner noted he would see if his shoulder improved
and then see his primary care doctor in a few days. Id.
On January 5, 2018, petitioner presented to Dr. William Scorby with a chief complaint of
“left shoulder pain following the flu shot that he had on 11/13/2017.” Pet. Ex. 2 at 16. Petitioner
stated that he routinely receives flu vaccinations and this time the pain has persisted “for several
weeks.” Id. Upon physical examination, Dr. Scorby assessed petitioner with “chronic left
shoulder pain,” and “persistent pain following a flu shot.” Id. at 17. Dr. Scorby ordered petitioner
to attend physical therapy and follow up in six weeks. Id.
Petitioner presented to physical therapy on January 17, 2018, for his ongoing shoulder
pain. Pet. Ex. 2 at 19. He stated that he was “concerned that part of the needle got stuck in his
arm,” and the mechanism of injury listed “intermuscular flu shot.” Id. at 19. The description of
pain noted “lateral shoulder, tingling into thumb and index finger…pain intensity currently in
sitting 3/10…worst pain in past 25 hours 10/10.” Id. The Kennedy-Hawkins test, Neer’s test, and
cross-over test were positive, he also demonstrated pain and weakness at 0 and 90 degrees of
abduction. Id. at 21. The assessment noted that his signs and symptoms were “most consistent
with impingement syndrome and cuff irritation.” Id. at 23.
Petitioner returned to physical therapy on February 13, 2018 and rated his pain at a “6/10
at rest.” Pet. Ex. 2 at 30. On March 14, 2018, petitioner returned to physical therapy and the
therapist noted that petitioner was “not progressing,” and should be discharged. Id. at 44-45. The
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next day on March 15, 2018, petitioner returned to Dr. Scorby with “continued lateral shoulder
pain with certain movements…[and] intermittent tingling in his thumb, index and middle finger.”
Id. at 49. Dr. Scorby wrote that while petitioner had improved, he “still has pain after four
months,” and that “he has some concern that possibly a portion of the needle broke off and is still
in his shoulder. I think that is not likely, but to investigate further after 4 months of chronic
shoulder pain and to ease his concerns, will get plain films of the left shoulder on his way out.”
Id. at 50. The left shoulder x-ray demonstrated mild degenerative acromioclavicular joint
changes and no foreign body in the shoulder. Id. at 51.
On August 14, 2018, petitioner returned to Dr. Scorby for “questions related to his
chronic left shoulder pain following a flu shot last year in November.” Pet. Ex. 2 at 102. Dr.
Scorby noted that petitioner “has improved,” but continues to have a “low-grade ache in the
lateral shoulder…sometimes it is more intense and that is when he takes an anti-inflammatory or
acetaminophen.” Id. Upon examination, petitioner was noted to have “full active range of motion
to flexion, abduction, crossover adduction, internal and external rotation without pain. He has no
tenderness, no impingement signs…no longer getting any tingling in his left hand.” Id.
Petitioner stated in his affidavit that the “flu shot [he] received has caused [him] severe
discomfort…[he] could not sleep on [his] back for over 6 months.” Pet. Aff. ¶ 6. In his second
supplemental affidavit he stated that in order to sleep he “had to lay in a certain position… or the
pain was overwhelming,” once he fell asleep, he “would wake up with excruciating pain due to
rolling over to a bad sleep position, and pain: sleeping, standing, sitting, laying down, and my
arm extended past a certain distance.” Pet. Second Supp. Aff. ¶ 2. He further explained that he
“was in pain while doing normal tasks…could not participate in my sons’ activities…still have a
dull pain that [he] has learned to live with and control with Tylenol and Advil.” Pet. Aff. ¶ 6.
b. Testimony of Petitioner, Mr. Benjamin Larson
Petitioner testified that on November 13, 2017, he received a flu vaccine as part of his
employment and stated that there was an “option of either an intradermal or the regular flu shot,
and they said that the intradermal is supposed to be pain-free. So I chose the intradermal.” Tr. 5-
6. He recalled that he was sitting and the person administering the vaccination was standing. Id.
Immediately following the vaccination petitioner “had immediate pain and stinging sensation.”
Id. at 6. Petitioner stated that he spoke to his colleagues that day about “the pain and stinging.”
Id. at 7-8. Petitioner testified that the pain was “probably towards the upper side of [his]
shoulder,” towards the “middle” part of his arm. Id. at 28-29. Later that night, petitioner noted
that while the “stinging was starting to go away…the pain was there, and it was tender to the
touch.” Id. at 8. He stated that it impacted his ability to sleep, and at that time could only raise it
to a bit lower than his shoulder.” Id.
The following day, petitioner noted he had pain and range of motion issues “until the
time I…talked to Employee Health.” Id. at 9. During the first week after the shot, it gradually got
worse. Id. at 10. Petitioner indicated that he tried “to self-medicate…[and] when I went to
employee health, it took a considerable amount of time to even see the doctor, because she had to
make the appointment.” Tr. 13. He stated that he mostly used “Tylenol, Advil,
Bayer…icepacks…[and] Aleve.” Id. By December 20, 2017, petitioner set up an appointment
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with a nurse because he “thought the self-medication would work and it got to a point
where…this ain’t working, so I better contact somebody.” Id. at 15-16. On questioning by the
court regarding variations in petitioner’s self-described pain levels, he explained that the pain
“would come and go in spurts where it would get worse and then it would get better…it wasn’t
consistent.” Tr. 29. He stated that he “never didn’t take the medication,” and therefore didn’t
know what the pain in his shoulder was like without medication. Id. Further, he testified that his
shoulder was “tender to the light touch,” and the tenderness was close to the shoulder bone and
“pretty much isolated to where my shot was given, but then the pain had gotten worse…where I
couldn’t even lift my arm.” Id. at 30-31. He classified the pain as “deep pain,” that throbbed at
night, making him sleep on his right side, instead of his dominant left side. Id. at 32.
Petitioner testified that when he visited Dr. Scorby on January 5, 2018, he had a “deep
pain” in his shoulder and his “range of motion…was…pretty messed up.” Tr. 17. Both with Dr.
Scorby and with his subsequent physical therapy (“PT”) sessions, he placed the onset of his pain
“following the flu shot.” Id. at 18. By February 2018, petitioner still had a “dull pain,” and by
May 2018 “the stinging stopped, the tenderness stopped, but it was still the dull pain.” Id. at 19.
During cross-examination, petitioner also noted that the numbness and tingling in his left thumb
and second and third finger first started after the vaccination in question. Id. at 25.
The day of the hearing, petitioner testified that his “pain is gone,” and his range of motion
is “kind of stiff.” Tr. 19-20. The majority of the stiffness petitioner still feels is anytime he fully
lifts his arm over his head. Id. at 20. Petitioner stated on redirect that since the vaccination was
given in his dominant arm he refuses to get other vaccinations in that arm and that “everything
[he does] is with [his] left hand.” Id. at 33.
c. Statements of Mr. Jeff Wuensch and Mr. Mark Hauser
Petitioner additionally filed statements from Mr. Jeff Wuensh and Mr. Mark Hauser, who
are his co-workers and were present on November 13, 2017, after he received the intradermal flu
vaccination. Pet. Ex. 7; Pet. Ex. 8. Mr. Wuensch noted that he was “in the work area on
November 13, 2017…[petitioner] said his arm was hurting and that he didn’t think it was normal
for it to hurt that much.” Pet. Ex. 7. He further noted that petitioner “complained about how
much his shoulder hurt for quite some time.” Id. Mr. Hauser stated that petitioner “said his shot
hurt more than usual and that his arm [is] still sore.” Pet. Ex. 8. He additionally recalled that the
“other guys were kidding around and making fun of [petitioner] because his arm hurt from a flu
shot.” Id.
III. Expert Opinions Regarding Vaccine Causation
a. Petitioner’s Expert Opinion on Causation, Dr. Srikumaran
Dr. Uma Srikumaran submitted on expert report on behalf of petitioner and testified at
the hearing. Pet. Ex. 9 (ECF No. 23). It was Dr. Srikumaran’s opinion that the November 13,
2017 intradermal flu shot was the cause of petitioner’s shoulder pain and dysfunction. Id. at 6;
Tr. 43. Dr. Srikumaran opined that “the vaccination triggered a strong immune mediated
inflammatory reaction in and around the muscles that caused inflammation of the tendons and
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bursa, presenting as shoulder pain.” Id. at 7; Tr. 57. Dr. Srikumaran observed that petitioner did
not have any documented history of shoulder injuries prior to the vaccination. Tr. 44. Further,
Dr. Srikumaran testified that petitioner “consistently and reliably reported the time frame of
immediate pain after the vaccination with increasing intensity over time.” Id.
Regarding petitioner’s delay in seeking care, Dr. Srikumaran stated that “there are many
reasons for when to seek care and there are many barriers to seeking such care.” Tr. 61. He
testified that in his own medical practice, “the vast majority of patients outside of some major
trauma like a car accident are not evaluated within 48 hours.” Tr. 64. He stated that “Most
people are hopeful things will improve with time and basic measures, and they try several over
the counter remedies for many weeks or months before seeking professional evaluation.” Pet.
Ex. 9 at 4. Dr. Srikumaran cited an article by Shi, which examined how people seek pain relief
and the effectiveness of the pain relief methods sought. Pet. Ex. 19.5 Shi explained that “some
people do not seek medical attention, even when moderate or severe pain is
present.…Reluctance to report pain and to use analgesics, considered to be a major barrier to
adequate pain management, is affected by age, education, and socioeconomic status.” Id. at 2.
Dr. Srikumaran stated that “it is quite normal for someone to wait weeks or even longer prior to a
formal evaluation as in[petitioner’s] case.” Pet. Ex. 9 at 4. Even though the petitioner did not
immediately seek care, Dr. Srikumaran opined that the history “provides reliable evidence [that]
his symptoms began the day of vaccination and worsened over time.” Id. at 5.
Dr. Srikumaran stated “while an intradermal vaccination is designed to enter the dermal
layer, technique can lead to a deeper injection location.” Pet. Ex. 9 at 5. He opined that “a needle
can reach a further depth than its length by pressing firmly into the tissue,” and that “it is quite
feasible, and even likely in at least some portion of cases, that some injectors may inadvertently
push harder than is recommended or appropriate.” Id. Dr. Srikumaran testified “if you just
insert the needle through the skin to its depth, it may reach a certain depth, but applying
additional force, because the tissues of the body are compressible, the end of the needle tip can
advance further than its actual length.” Tr. 48.
Dr. Srikumaran testified there is a wide variety of skin thickness and skin thickness is not
uniform across different injection sites, which may affect how the intradermal vaccine is
administered. Tr. 50; see also Pet. Ex. 9 at 5. The Laurent et al. article Dr. Srikumaran
referenced found great variation in skin thickness among men and women and found the mean
skin thickness at the deltoid to be “2.02 millimeters.” Pet. Ex. 17 at 1.6 Further, Laurent found
that skin thickness varied less among people with different BMIs than it did between different
possible injection sites (at the deltoid or waist). Id. at 6. Dr. Srikumaran, consistent with
Laurent, testified that BMI is “not a very good metric to determine skin thickness at the level of
the shoulder or at a specific location.” Tr. 52. When asked whether petitioner’s weight or BMI
has any relation to the use of an intradermal needle, Dr. Srikumaran responded, “It doesn’t tell us
about weight distribution and it can vary….It’s a general indication of size and weight, but I
5 Shi, Q., et a l., People in Pain: How Do They Seek Relief? 8 The Journal of Pain, 624-636 (2007). [Pet Ex. 19].
6 Laurent A., et al., Echographic measurement of skin thickness in adults by high frequency ultrasound to assess the
appropriate microneedle length for intradermal delivery of vaccines, 25 Vaccine 6423-39 (2007). [Pet. Ex. 17].
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don’t think [it’s] particularly relevant to this case.” Tr. 52. During cross-examination, Dr.
Srikumaran testified that “the overall weight [of a patient] may not be as relevant as what you
see locally or what the shape of the shoulder is, the amount of tissue in that specific area where
you intend to inject, which is not completely captured in a metric like weight or BMI.” Tr. 75.
Dr. Srikumaran stated that shoulder injuries related to vaccine administration (“SIRVA”),
are a result of inflammation that is registered after an injection. Tr. 45. He acknowledged that
SIRVA is “traditionally” described for intramuscular injections. Id. However, he argued that the
inflammation that results from a vaccine injection is not limited to an intramuscular vaccine and
could occur because of an intradermal vaccination. Tr. 46. He opined, “….a subdermal or a
dermal injection has the ability to cause a SIRVA type response in the shoulder. Localized pain,
inflammation, can lead to pain in the shoulder, which would affect….how somebody might use
their arm, and that protective behavior can lead to other downstream effects in the shoulder joint
itself. Id.
Dr. Srikumaran stated that both the Bodor and the Atanasoff et al. articles support his
theory that the intradermal vaccine can cause shoulder pain and dysfunction, even though the
two articles discuss shoulder injuries after intramuscular vaccination. Pet. Ex. 9 at 6; Tr. 86. Dr.
Srikumaran acknowledged that there are likely “far more claims related to intramuscular
[vaccines] than intradermal [flu vaccines],” but that the literature shows that a robust local
immune-mediated inflammatory reaction to the flu antigen being delivered somewhere close to
shoulder…[is] leading to some of the common pathologies that [are] commonly interpreted as
subacromial bursitis, tendonitis, bicep tendonitis, capsulitis.” Tr. 59. The Atanasoff article
explains, “…the rapid onset of pain with limited range of motion following vaccination in our
series of patients is consistent with a robust and prolonged immune response within already-
sensitized shoulder structures following injection of antigenic substance into the subacromial
bursa or the area around the rotator cuff tendon.” Pet. Ex. 11; Resp. Ex. A, Tab 3.7 Dr.
Srikumaran opined that even if the intradermal vaccine is administered correctly, the amount of
inflammation can be “quite high,” because of the amount of immune cells in the tissue compared
to the muscle, but that it’s “not just the needle length and volume [of antigen],” but also the
spread of inflammation which is what Atanasoff and Bodor endorse as part of the mechanism
underlying a SIRVA.
Dr. Srikumaran opined that “the inflammational response to the antigen that’s delivered
certainly doesn’t remain localized to a small area of millimeters or centimeters.” Tr. 46. Dr.
Srikumaran testified “that there’s a strong immune-mediated inflammatory reaction to the
antigen that’s delivered locally in the shoulder. And that results in inflammation of various
structures of the shoulder, including the muscles, tendons, bursa, and overlying skin.” Tr. 57; see
also Pet. Ex. 9 at 5.
Drawing a comparison to a bee sting, Dr. Srikumaran opined that a “bee stinger is
approximately 1.5 mm, similar to an intradermal needle length,” and “inflammation is well
known to be capable of growing and spreading to adjacent structures.” Id. at 6; Tr. 46. Dr.
Srikumaran testified that “a subdermal or a dermal injection has the ability to cause a SIRVA
7 S. Atanasoff, et. al., Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049-8052 (2010).
[Pet. Ex. 11; Resp. Ex. A-3].
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type response in the shoulder. Localized pain, inflammation, can lead to pain in the shoulder,
which would affect…how someone might use their arm, and that protective behavior can lead to
other downstream effects in the shoulder joint itself.” Tr. 46.
Dr. Srikumaran stated that the skin is an immune organ that has a lot of immune cells.
Tr. 49. He testified that the idea for intradermal vaccines was to be beneficial because it would
be less painful, and the vaccine would have a smaller dose. Tr. 49. Dr. Srikumaran stated that
the Meijer et al. and Marra et al. articles filed by respondent, demonstrate that “there were either
equivalent or worse reactions from the patient perspectives from an [intradermal] injection
compared to an intramuscular one.” Tr. 49.
The Meijer study, which compared reported side effects between the intramuscularly
administrated flu vaccine to the intradermally administered flu vaccine, found that both local side
effects, such as pain, swelling or redness of skin, and systemic side effects were greater in those
who received the intradermal flu vaccine compared to the intramuscularly administered flu
vaccine. Resp. Ex. A-10 at 5.8 Dr. Srikumaran testified that in this study “a majority of folks
that received the intradermal injection versus the intramuscular one,” demonstrated “actual joint
pain.” Tr. 53-54. Marra was a meta-analysis of immunogenicity and adverse events of the
intradermal vaccine compared to the intramuscular flu vaccine reported in medical literature.
Resp. Ex. A-11 at 1.9 The study found that there was “no significant difference in immunologic
response when comparing the [intradermal] with [intramuscular] administration of the influenza
vaccine,” but that the “intradermal vaccination was associated with a greater incidence of local
adverse events when compared with [intramuscular] administration.” Id. at 1, 9. Dr. Srikumaran
testified that Marra “support[s] the notion that even when we’re talking about a small needle in
the skin, the magnitude of the response can be equivalent or worse than vaccination delivered
with a bigger needle intended for a deeper structure.” Tr. 54.
In response to petitioner’s testimony regarding the nature of his pain going deeper into
his shoulder, Dr. Srikumaran testified that petitioner’s description of the pain beginning closer to
the skin and becoming “deeper over time,” was consistent with an inflammatory response. Tr.
58. He testified that the needle does not need to touch the tendon or bursa “but the inflammatory
response may spread to those areas causing issues, and a patient’s response to that pain even
within superficial layers can affect deeper layers over time…the body’s inflammatory response
to it develops, spreads, and then human beings’ adaptive response is usually to splint that area
that hurts, not use it, that has downstream effects that appear later, not right away.” Tr. 57-58.
Finally, with respect to the onset of petitioner’s pain, Dr. Srikumaran stated that “vast
majority” of patients begin having pain in the two-day period following the vaccination. Tr. 59.
He testified that it is not just coincidence or chronic degenerative disorders “randomly appearing
out of the blue,” but that “there was a demonstrated higher rate…in those that got flu
8 W.J. Meijer, et. al., Influenza vaccination in healthcare workers; comparison of side effects and preferred route of
administration of intradermal versus intramuscular administration, 35 Vaccine 1517-1523 (2017). [Resp. Ex. A-
10].
9 Marra F., et. Al., A Meta-Analysis of intradermal versus intramuscular influenza vaccines: Immunogenicity and
Adverse Events, Influenza Other Respi. Viruses (2012). [Resp. Ex. A-11].
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vaccinations compared to control groups that have subacromial bursitis for other reasons.” Tr.
60. When asked by the Court whether in treating a shoulder injury, is the timing of the
vaccination an “important consideration that helps make a diagnosis or draw a conclusion about
causation,” Dr. Srikumaran responded that “proximal/temporal relationship is very important,”
and that “the 48-hour time frame is the most likely when people report [the pain].” Tr. 61. He
observed that in this specific case, petitioner consistently reported that the pain began within 48-
hours post-vaccination. Tr. 61.
b. Respondent’s Expert Opinion on Causation, Dr. Feeley
Dr. Brian Feeley submitted one expert report on behalf of respondent and testified at the
entitlement hearing. Resp. Ex. A. Dr. Feeley opined that a SIRVA injury to the bursa with an
intradermal injection would be exceedingly unlikely from a mechanical standpoint. Resp. Ex. A
at 4. Dr. Feeley testified that a SIRVA injury “is the result of an acute response to an injection
that inadvertently is placed too deep into the shoulder that results in an inflammatory response
either in the bursa or the area above the rotator cuff in the tendon itself, or if it gets too deep, into
the capsule, resulting in a restricted range of motion and then adhesive capsulitis.” Tr. 102. He
testified that “while there can be a robust immune response in the skin, there is nothing in the
literature to suggest that an intradermal vaccination is going to lead to a shoulder bursitis.” Tr.
103.
He stated that there are three variables that dictate whether an injection could be placed
too deep in the shoulder and affect the structures deep to the deltoid: location of injection, depth
of penetration, and body habitus. Tr. 106; Resp. Ex. A at 4. Dr. Feeley testified that “being too
high or too close to the bone where the deltoid is relatively thinner can lead to a subacromial
injection. Tr. 106. He testified that the depth of penetration is not relevant in this case given that
the vaccine administration included a 1.5 millimeter needle. Tr. 106-107. Dr. Feeley also noted
that there is a small volume of vaccine delivered in an intradermal vaccination and that the
needle length is only 1.5 mm in length, and that petitioner had a higher BMI “with more deltoid
muscle,” making it unlikely that the injection could reach the bursae. Id. Dr. Feeley testified that
“that the intradermal vaccinations have 20 percent of the volume (compared to intramuscular
injections), so the amount of spread within any amount of tissue is going to be considerably
less.” Tr. 108. Dr. Feeley agreed with Dr. Srikumaran that “the dermis or the skin has a high
number of immune cells,” and intradermal injections “were originally thought to be potentially
beneficial…to get the immune response upregulated in that local area and have a more robust
response compared to the relatively low number of immune cells within [the] muscle.” Tr. 108.
Dr. Feeley alternatively testified that he found difficult that a small amount of vaccine material
can “spread through the bursa and create a robust immune response that far away from the
injection…[and] cause a bursitis or capsulitis.” Id.
Dr. Feeley wrote that “the intradermal vaccination has not been associated with a single
case of shoulder pain or SIRVA that has been reported in the literature.” Resp. Ex. A at 5.
During the hearing, he testified that “it would be exceedingly unlikely to get through his deltoid
and into the subacromial bursa, let alone into the shoulder joint itself,” and it would be
exceedingly difficult to get much further past the subcutaneous fat.” Tr. 107-108.
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When asked about the Laurent article, Dr. Feeley stated that even if petitioner’s “skin
thickness is 2 millimeters and the needle is 1.5 millimeters, let’s say…she penetrated 50 percent
more, you’re still only at two and a half to three millimeters…exceedingly unlikely to get the
multiple…35 to 40 millimeters to get into the subacromial space.” Tr. 109. Dr. Feeley stated in
relation to the Laurent article “general thickness of the skin is relative…it changes a little bit.”
Tr. 111. In petitioner, Dr. Feeley opined that his higher BMI indicates a “thicker fat pad, thicker
deltoid muscle.” Tr. 112. He testified that he thought BMI was a small but significant factor. Id.
Dr. Feeley summarized the Bodor article which hypothesized that the “antigen in the
vaccination entered into the subdeltoid bursa, which caused an intense inflammatory response,
and that was based on an injection that came from high down into the deltoid into the subdeltoid
bursa.” Tr. 112. Citing to the medical records in this case, Dr. Feeley noted that “Dr. Scorby
seems to have asked and ascertained that it was given in what he felt was the correct position or a
safe position on the deltoid.” Tr. 113.
Dr. Feeley noted the Arias et al. study reviewed shoulder problems following vaccination
and identified 45 reported cases of shoulder injuries following vaccination and the majority of
reported cases were women with a mean age of 52 years and onset was within four days. Resp.
Ex. A at 4-5; Resp. Ex. A, Tab 2.10 Dr. Feeley wrote, “it is important to note that the intradermal
vaccination has not been associated with a single case of shoulder pain or SIRVA that has been
reported in the literature.” Id. at 5.
Dr. Feeley testified that the SIRVA injuries outlined in Arias “hypothesize[s] that it was
likely due to a poor injection technique, either using too long a needle, or failing to consider the
patient’s overall physical size.” Tr. 110. He stated that the Arias article is not applicable to the
instant case because petitioner was “not excessively thin,” as were the patients in the Arias
article. Tr. 110. During cross-examination, he agreed with the Arias authors that SIRVA can
manifest itself four to seven days post vaccination, and he also agreed with Dr. Srikumaran that
“sometimes patients can have immediate pain, but not report it to a physician because, as with all
of us, we sometimes just assume things are going to go away.” Tr. 121. Dr. Feeley disagreed
with the Arias authors that a SIRVA may present itself as far away as two months after
vaccination. Tr. 122.
During cross-examination about whether petitioner’s age was a factor for the cause of
petitioner’s shoulder pain, Dr. Feeley testified that “his aging happens over a course of
time…[and] the pain that he felt right after the shot would be consistent with having an
intradermal injection, which the literature supports having a more intense local reaction.” Tr.
123. He stated that, “There is going to be, according to the literature, more likely to be redness
and inflammation and itching in that area, and soreness in the area, all of which could be
consistent with a gentleman walking down and reporting that his shoulder hurts after
vaccination.” Tr. 124. However, he stated that petitioner’s report that his pain was “excruciating
as time went on” was not consistent with a reaction to the intradermal vaccination, but instead,
more likely a result of petitioner’s underlying shoulder pathology due to his age. Tr. 123.
10 Arias, L.H. et al., Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations,
Vaccine, http://dx.doi.org/10.1016/j.vaccine.2017.07.055 (2017). [Resp. Ex. A, Tab 2].
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Dr. Feeley testified that the Atanasoff article is likewise not applicable to this case,
because it deals with intramuscular, not intradermal vaccinations. Tr. 110. He noted that the
authors considered “the patient’s gender and BMI,” as important factors “to consider in choosing
the correct length needle for intramuscular injections.” Tr. 111. Dr. Feeley relied on the Arias,
Atanasoff, and Bodor articles, as they “all suggest that these were injections that related to being
too deep and getting into the subacromial or into the subdeltoid space, or into the joint itself.
They don’t discuss intradermal or subcutaneous injections that did not go too deep.” Tr. 113.
During cross-examination, Dr. Feeley testified that he does believe that vaccine administration
can cause shoulder injuries. Tr. 120.
In his expert report, Dr. Feeley outlined an explanation of common shoulder pathologies
such as impingement and rotator cuff tears. Resp. Ex. A at 3. Dr. Feeley testified that “up to 20
percent of people will describe shoulder impingement at some point in their lives. Forty percent
of all shoulder complaints are consistent with impingement.” Tr. 105. Relating to petitioner’s
case, Dr. Feeley stated that “he has a temporally related flu vaccination where he develops
shoulder pain consistent with impingement syndrome (pain with overhead activity, pain at
night).” Id. He opined that petitioner “fits the typical demographic of a patient with
impingement – he is in his mid-50’s, which is the average age for impingement, and his
symptoms that are described both by physical therapy and his occupational health physician are
consistent with diagnosis.” Id; Tr. 103-104. Further, Dr. Feeley testified that “based on the
physical therapy notes and the notes by Dr. Scorby, he got better with anti-inflammatories and
physical therapy, which would be consistent with impingement.” Tr. 104.
Dr. Feeley testified that some of petitioner’s symptoms are also consistent with carpal
tunnel syndrome, which “tends to be numbness and tingling that happens in your thumb, index
and middle finger, [and] tends to be more common in middle-ages, people with repetitive hand
activities.” Tr. 104-105. Dr. Feeley opined that for petitioner “those symptoms seem to be
consistent, especially in the physical therapy notes.” Tr. 105. He further testified that carpal
tunnel is very common and “about 5 to 10 percent of the population,” has it, and risk factors
include “repetitive work, history of prior injury, which [petitioner] does not have.” Id. He also
agreed that even if petitioner has carpal tunnel syndrome that would explain numbness and
tingling in thumb and middle finger, however, carpal tunnel would not explain the pain in his
shoulder. Tr. 125
From a mechanical standpoint, Dr. Feeley opined that intradermal needles are only 1.5
mm in length and that, “Given that the average dermal width is greater than [1.5 mm] and the
deltoid is also 10-40 mm [thick], a SIRVA injury to the bursa with an intradermal needle would
be exceedingly unlikely from a mechanical standpoint.” Resp. Ex. A at 4.
Citing to the Meijer article, which compared the side effect profile between intradermal
and intramuscular vaccination in healthcare workers, Dr. Feeley stated that “while they found the
intradermal vaccination had more local and systemic side effects, 96% reported complete
recovery, and there was no shoulder pain recorded. Id. At 5. Citing to the Marra article, a meta-
analysis of the immunogenicity and safety of intradermal influenza vaccines compared with
intramuscular administration, Dr. Feeley wrote that the authors “found that there was no increase
in the systemic side effects reported of over 13 clinical trials…[and] no reports of shoulder pain
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in these clinical trials with the intradermal vaccinations.” Id. At 5. Dr. Feeley testified in
agreement with Dr. Srikumaran “that the overall number of side effects were higher with the
intradermal vaccinations, but those are mostly local skin side effects…You’re looking for a
robust immune response. So, the local side effects of the intradermal that were more common
were local swelling, redness of the skin, a warm feeling, and itching, and those were all
statistically more likely in the intradermal.” Tr. 113-114. He stated that “even though there’s
more of a short-term local reaction, there doesn’t seem to be any deeper reaction. And there was
no mention of shoulder pain in this article.” Tr. 114.
In his report, Dr. Feeley opined that “petitioner does not report pain following the flu
vaccination…[and] it is difficult to determine how the intradermal injection would extend into
the subacromial space.”. He testified that petitioner’s treating physician, “Dr. Scorby said that he
sees a few patients every year with temporally related pain associated around the time of an
injection that tends to get better with nonoperative management.” Tr. 106. Dr. Feeley testified
that petitioner first sought medical care “about a month and a third after the vaccination,” and it
was not an in-person examination, but instead on the phone. Tr. 114-115. He stated that
petitioner’s delayed treatment goes against “the vast majority of the case reports of bursitis and
adhesive capsulitis…within 24 to 48 hours…[and] that the onset of severe pain is within 48
hours in a vast majority of the cases.” Tr. 115. Dr. Feeley testified that when he wrote his report
he had not seen the affidavits or heard testimony and it was not clear to him at that time when the
pain was reported. Tr. 138. He acknowledged that petitioner’s testimony and the affidavits from
petitioner’s colleagues was consistent with the medical records that the pain occurred around the
time of his vaccination. Tr. 138
During cross-examination, he testified that both intradermal and intramuscular
vaccination are “both equally effective in decreasing the incidence of influenza infections…they
both are equally efficacious or robust.” Tr. 141. He concluded during cross-examination that
“the antigen has something to do with it, but the volume has something to do with it, but I think
proximity is the most important factor.” Tr. 128. Dr. Feeley “would still opine that there needs to
be at least very close proximity of the antigen into the subacromial space for you to have a
SIRVA reaction.” Tr. 129.
I. Legal Standard for Adjudication
a. Finding of Fact
A special master must consider, 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. Section 13(b)(1). “Medical
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.” Curcuras v. Sec’y of
Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
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Accordingly, where medical records are clear, consistent, and complete, they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always
apply. In Lowrie, the special master wrote that “written records which are, themselves,
inconsistent, should be accorded less deference than those which are internally consistent.”
Lowrie, at *19.
The United States Court of Federal Claims has recognized that “medical records may be
incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391
(1998). The Court later outlined four possible explanations for inconsistencies between
contemporaneously created medical records and later testimony: (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 & Human Servs., 110
Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014).
The Court has also said that medical records may be outweighed by testimony that is
given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed. Cl. at 391
(citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed.
Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must
also be determined. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir.
2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110
Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health &
Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s
discretion to determine whether to afford greater weight to medical records or to other evidence,
such as oral testimony surrounding the events in question that was given at a later date, provided
that such determination is rational).
b. Causation
The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a
simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R.
Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, petitioner must prove that the
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vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs.,
165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum. Servs.,
451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner who satisfies this burden is entitled to
compensation unless respondent can prove, by a preponderance of the evidence, that the
vaccinee’s injury is due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B).
To receive compensation through the Program, petitioner must prove either (1) that [he]
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that he suffered an injury that was actually caused by a
vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d
1317, 1319-20 (Fed. Cir. 2006). Because petitioner does not allege that he suffered a Table
Injury, he must prove that a vaccine he received caused his injury. To do so, he must establish,
by preponderant evidence: (1) a medical theory causally connecting the vaccine and his injury
(“Althen Prong One”); (2) a logical sequence of cause and effect showing that the vaccine was
the reason for her injury (“Althen Prong Two”); and (3) a showing of a proximate temporal
relationship between the vaccine and her injury (“Althen Prong Three”). § 13(a)(1); Althen, 418
F.3d at 1278.
The causation theory must relate to the injury alleged. The petitioner must provide a
sound and reliable medical or scientific explanation that pertains specifically to this case,
although the explanation need only be “legally probable, not medically or scientifically certain.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Recently, in
Kottenstette, the Federal Circuit reiterated that proof of causation does not “require identification
and proof of specific biological mechanisms[.]” Kottenstette v. Sec’y of Health & Hum. Servs., --
Fed.Appx.—(Fed. Cir. June 15, 2021) (citing Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 549 (Fed. Cir. 1994). Causation “can be found in vaccine cases….without detailed medical
and scientific exposition of the biological mechanisms.” Knudsen, 35 F.3d 543, 548-49 (Fed.
Cir. 1994). It is not necessary for a petitioner to point to conclusive evidence in the medical
literature linking a vaccine to the petitioner’s injury, as long as the petitioner can show by a
preponderance of evidence that there is a causal relationship between the vaccine and the injury,
whatever the details of the mechanism may be. Moberly v. Sec’y of Health & Hum. Servs., 592
F.3d 1315, 1325 (Fed. Cir. 2010).
Petitioner cannot establish entitlement to compensation based solely on his assertions;
rather, a vaccine claim must be supported either by medical records or by the opinion of a
medical doctor. § 13(a)(1). In determining whether petitioner is entitled to compensation, the
special master shall consider all material in the record, including “any . . . conclusion, [or]
medical judgment . . . which is contained in the record regarding . . . causation.” § 13(b)(1)(A).
The undersigned must weigh the submitted evidence and the testimony of the parties’ proffered
experts and rule in petitioner’s favor when the evidence weighs in his favor. See Moberly, 592
F.3d at 1325-26 (“Finders of fact are entitled—indeed, expected—to make determinations as to
the reliability of the evidence presented to them and, if appropriate, as to the credibility of the
persons presenting that evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are
resolved in petitioner’s favor).
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In Vaccine Act cases, expert testimony may be evaluated according to the factors for
analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579,
594-96 (1993); see also Cedillo, 617 F.3d at 1339 (citing Terran v. Sec’y of Health & Hum.
Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). In Vaccine Program cases, the Daubert analysis
has been used in the weighing of the scientific evidence actually proffered and heard rather than
as a tool for the pre-trial exclusion of expert testimony. Davis v. Sec'y of Health & Hum. Servs.,
94 Fed. Cl. 53, 66–67 (Fed. Cl. 2010) (“uniquely in this Circuit, the Daubert factors have been
employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”), aff'd, 420 F. App'x 923 (Fed. Cir. 2011). The flexible use of
the Daubert factors to determine the persuasiveness and/or reliability of expert testimony in
Vaccine Program cases has routinely been upheld. See, e.g., Snyder v. Sec'y of Health & Hum.
Servs., 88 Fed. Cl. 706, 742–45 (2009). Weighing the relative persuasiveness of competing
expert testimony, based on a particular expert's credibility, is part of the overall reliability
analysis to which special masters must subject expert testimony in Vaccine Program cases.
Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn
on credibility determinations”); see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242,
1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected
to consider the credibility of expert witnesses in evaluating petitions for compensation under the
Vaccine Act”).
Close calls regarding causation must be resolved in favor of the petitioner. Althen, 418
F.3d at 1280 (holding that Congress created a system in which “close calls regarding causation
are resolved in favor of injured claimants”); Knudsen, 35 F.3d at 551 (“If the evidence (on
alternative cause) is seen in equipoise, then the government has failed in its burden of persuasion
and compensation must be awarded.”).
II. Finding of Fact
a. Parties’ arguments regarding onset
In this case, the main issue of fact to be resolved prior to the consideration of causation is
the onset of petitioner’s pain and shoulder dysfunction.
Respondent argued that the onset of petitioner’s shoulder pain was much later than 48-
hours after vaccination and therefore, is not associated with the flu vaccine petitioner received on
November 13, 2017. Resp. Brief at 13. Specifically, respondent argued that petitioner did not
seek medical care for his left shoulder issues until thirty-seven days following the vaccination.
Id. at 13; Pet. Ex. 2 at 15. Further, respondent argued that at the time of that appointment,
petitioner complained of pain since receiving the flu vaccine a couple weeks before, when it was
actually 6 weeks prior. Resp. Brief at 13. Respondent also argued that two months after the
vaccination at a physical therapy appointment, petitioner placed the onset of his symptoms at the
date of vaccination. Id. at 13-14; Pet. Ex. 2 at 19. Respondent’s expert, Dr. Feeley argued that
“petitioner does not report pain following the flu vaccination,” and that petitioner’s delayed
treatment goes against “the vast majority of the case reports of bursitis and adhesive
capsulitis…within 24 to 48 hours…[and] that the onset of severe pain is within 48 hours in a vast
majority of the cases. Resp. Ex. A at 5; Tr. 115.
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Petitioner stated that his shoulder pain began the same day he received the intradermal flu
vaccine, November 13, 2017, and that he consistently reported the immediate pain in his left
shoulder after receiving the vaccination at issue. Pet. Brief at 8; Tr. 6. During his first medical
encounter on December 20, 2017, petitioner argued that he specifically stated that his “arm has
been hurting ever since” the vaccination. Pet. Brief at 8; Pet. Ex. 2 at 15. On petitioner’s January
5, 2018 visit with Dr. Scorby, it noted “left shoulder pain following the flu shot that he had on
11/13/2017.” Id. at 8. Petitioner noted the same onset at his initial physical therapy session, when
it was noted “primary complaint of L shoulder pain following the flu shot on 11/13/2017.” Id.
Further, regarding petitioner’s initial concern that part of the vaccine needle was suck in his arm,
it “would be highly unlikely to have such a suspicion if the onset of pain occurred at some distant
time after the vaccination.” Id. Petitioner also presented corroborating affidavits from co-
workers who recalled him complaining about pain from the shot on the same day as the
vaccination.
Dr. Srikumaran explained that it is very common for individuals to delay treatment and
noted that following his review of the medical records, petitioner consistently referred to the pain
beginning immediately after the vaccination. Pet. Brief at 8-9; Pet. Ex. 9 at 4; Tr. 45. Dr. Feeley
agreed that it is common that patients frequently don’t immediately seek medical care for pain.
Tr. 121.
b. Discussion and conclusion regarding the onset of petitioner’s right shoulder pain
and dysfunction
Petitioner has demonstrated by preponderant evidence that his right shoulder symptoms
began within forty-eight hours of receiving the intradermal flu vaccine on November 13, 2017.
More specifically, petitioner provided preponderant evidence that his left arm pain began within
an hour of the vaccination.
The testimony from petitioner along with his medical records, three affidavits, and two
witness statements demonstrate that he experienced immediate pain the same day he received the
vaccine and that the pain continued, resulting in decreased shoulder mobility. Petitioner testified
credibly that his left arm had an immediate pain and stinging sensation. Tr. 7-8. Petitioner stated
that he returned to work following the vaccination and spoke to his colleagues about “the pain
and stinging” in his left arm. Id. at 28-29. The statements from both Mr. Wuensch and Mr.
Hauser confirm that when petitioner returned to the work area after the vaccination, he
commented about his shoulder pain, and that other co-workers were harassing him because he
was complaining of pain after the flu shot. Pet. Ex 7; Pet. Ex. 8. Mr. Hauser further stated that he
still complained that his arm was still sore as of June 3, 2020, when the statement was dated. Pet.
Ex. 7.
Petitioner filed three affidavits and noted in his affidavit that “upon receiving the
injection I felt immediate pain and an overwhelming stinging sensation,” and he “started to have
even more severe arm pain over the next few weeks.” Pet. Aff. ¶ 1. In his supplemental affidavit
he noted after receiving the vaccination at the Employee Health Department he “returned to the
shop there were other guys present who had received their shots earlier that morning. I asked
them if they were experiencing pain like I was. I remember some of my coworkers joking and
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giving me a hard time about the shot being painful.” Pet. Supp. Aff. ¶ 2.He stated that “limited
range of motion was something [he] never experienced before, and full extension of [his] arm
caused [him] to have excruciating pain.” Id. at ¶ 2. He “tried to self-medicate…hoping it would
heal.” Pet. Second Supp. Aff. ¶ 4.
Upon returning home from work on November 13, 2017, he noted that the “stinging was
starting to go away…the pain was there, and it was tender to the touch.” Id. at 8. He stated that it
“impacted his ability to sleep, and at that time [he] could only raise his arm to a bit lower than
his shoulder.” Id. Petitioner testified that the pain and range of motion issues continued, and the
first week after the shot, it got worse. Id. at 10. During that time, petitioner began to self-
medicate because “it took a considerable amount of time to even see the doctor,” through
employee health, and he began to use “Tylenol, Advil, Bayer…icepacks…[and] Aleve.” Tr. 13.
Petitioner reported to Dr. Scorby and to the physical therapist that he was concerned that
“maybe the needle got stuck in there…nothing else would explain the pain I was having, except
maybe a broken needle.” Tr. 19. Petitioner’s statements to various providers about the possibility
that a vaccine needle was stuck in his arm, further support his contention that the onset of pain
occurred at some time immediately after the vaccination.
His first medical encounter following the vaccination was on December 20, 2017, when
he called a nurse at Gunderson Health System stating that he “got the flu shot a couple weeks
ago and [his] arm ha[d] been hurting ever since.” Pet. Ex. 2 at 15. Petitioner arrived “with [a]
complaint of left shoulder pain following the flu shot that he had on 11/13/2017.” Id. at 16. The
reason for disposition noted “moderate pain” that “interferes with normal activities…injection
site reaction to any vaccine.” Id. at 15. Petitioner noted he would see if his shoulder improved
and then see his primary care doctor in a few days. Id.
Respondent’s argument that petitioner’s shoulder pain began at a later time because he
“did not seek medical care for left shoulder issues until thirty-seven days following the
vaccination,” is unpersuasive. Resp. Brief at 13. A delay in seeking treatment or a failure to
report symptoms to a physician during an appointment for other issues is not necessarily
dispositive of whether a petitioner’s symptoms began within the appropriate timeframe. See
Stephens v. Sec’y of Health & Human Servs., No. 19-1685V, 2021 WL 482355 (Fed. Cl. Spec.
Mstr. Sept. 15, 2021) (finding that petitioner’s onset of pain was within the appropriate
timeframe with a 70-day delay in seeking treatment for a SIRVA); McGee v. Sec’y of Health &
Human Servs., No. 18-1778V, 2021 WL 6059588 (Fed. Cl. Spec. Mstr. Nov. 30, 2021) (finding
onset of shoulder pain within the appropriate timeframe with a five-month delay in treatment);
Desai v. Sec’y of Health & Human Servs., No. 14-811V, 2020 WL 4919777 (Fed. Cl. Spec.
Mstr. July 30, 2020) (finding petitioner had established onset of pain within 48 hours of
vaccination even though she delayed treatment for three months); see also 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. Mar. 19, 2019); Williams v. Sec'y of
Health & Human Servs., 17-830V, 2019 WL 1040410, at *9 (Fed. Cl. Spec. Mstr. Jan. 31, 2019)
(noting a delay in seeking treatment for five-and-a-half months because petitioner
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underestimated the severity of her shoulder injury); Knauss v. Sec'y of Health & Human Servs.,
16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (noting a three-month delay
in seeking treatment); Wyffels v. Sec'y of Health & Hum. Servs., No. 18-1874, 2021 WL 798834,
at *4 (Fed. Cl. Jan. 26, 2021) (noting a three-month delay in seeking treatment). Further, Dr.
Feeley, respondent’s expert initially opined that petitioner did not report pain following the
vaccination, but on questioning by the Court that petitioner exactly described immediate pain 24
to 48 hours, Dr. Feeley agreed. Id. Also, on cross examination, Dr. Feely stated that “I believe
his recollection is that [the pain] occurred around the time of his vaccination.” Tr. 138.
The testimony and affidavits by petitioner additionally explain why he delayed treatment
by noting that he “waited to seek medical treatment for 2 reasons. Scared of being harassed by
my coworkers, and my hopes, like in the past, the belief that self-medicating would work. It got
to a point I knew I had to seek medical treatment.” Pet. Second Supp. Aff at ¶ 5. He testified that
he “was trying to self-medicate,” and “even when I went to Employee Health, it took a
considerable amount of time to even see the doctor, because she had to make the appointment.”
Tr. 13. He further explained that “I thought the self-medication would work and it got to a point
where…this ain’t working, so I better contact somebody.” Tr. 15-16. Petitioner’s reasoning was
consistent with Dr. Srikumaran’s explanation as to why people commonly delay medical
treatment for pain.
Dr. Srikumaran opined that there are many reasons why people delay seeking medical
attention “beyond factors related to the health care system itself, a variety of potential obstacles
may be responsible for the underutilization of medical treatment for pain in the general
population.” Pet. Ex. 9 at 4. He testified that in his own medical practice, “the vast majority of
patients outside of some major trauma like a car accident are not evaluated within 48 hours.” Tr.
64. Dr. Srikumaran stated that “it is quite normal for someone to wait weeks or even longer prior
to a formal evaluation as in [petitioner’s] case.” Pet. Ex. 9 at 4. Following a review of the
medical literature, Dr. Srikumaran opined that the history “provides reliable evidence [that] his
symptoms began the day of vaccination and worsened over time.” Id. At 5.
The evidence submitted in the form of testimony, medical records, affidavits, and witness
statements are consistent with one another that the onset of petitioner’s pain began almost
immediately following the vaccination, well within the 48 hours of receiving the intradermal flu
vaccination on November 13, 2017. Additionally, the medical records also demonstrate that
petitioner consistently related the onset of his pain to the flu vaccination he received in
November. Therefore, I find that petitioner has provided preponderant evidence that the onset of
his left shoulder pain and dysfunction began within 48 hours of receiving the intradermal
influenza vaccine on November 13, 2017.
III. Causation Analysis
a. Althen prong one
Under Althen prong one, the causation theory must relate to the injury alleged. The theory
must be based on a “sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at
548. It must only be “legally probable, not medically or scientifically certain.” Id. At 549.
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However, the theory still must be based on a “sound and reliable medical or scientific
explanation.” Id. At 548. The Federal Circuit explained in Althen that “while [that petitioner’s
claim] involves the possible link between [tetanus toxoid] vaccination and central nervous
system injury, a sequence hitherto unproven in medicine, the purpose of the Vaccine Act’s
preponderance standard is to allow the finding of causation in a field bereft of complete and
direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280 (emphasis added).
For the reasons set forth below, I find that petitioner has provided preponderant evidence
of a sound and reliable theory for how the intradermal influenza vaccine can cause shoulder pain
and dysfunction.
As both experts explained, the intradermal influenza vaccine that petitioner received uses
a 1.5 mm needle and the target is the dermal layer of the skin. Pet. Ex. 9 at 5; Tr. 68. According
to the Marra article submitted by the respondent, “[Intradermal] vaccines are theorized to
improve immune responses because of the abundance of immunostimulatory cells such as
dendritic cells in the dermis.” Resp. Ex. A, Tab 11 at 1. Both experts agreed that the intradermal
vaccine was intended to generate a “robust immune response” because of the higher number of
immune cells in the skin compared to the muscle. Tr. 88, 108.
Petitioner’s expert, Dr. Srikumaran, opined that the intradermal flu vaccine caused an
inflammatory response to the antigen in the vaccine and the inflammatory response spread to the
shoulder structures of petitioner’s shoulder, resulting in pain and dysfunction. Pet. Ex. 9 at 6; Tr.
88. Dr. Srikumaran stated that the intradermal vaccine can cause a strong inflammatory response
in the dermal layer because there are more immune cells in the skin than in muscle and that the
inflammatory response is not predicated upon the length of the needle or the volume of the
antigen but rather to the concentration of immune cells in the skin. He said the amount of
inflammation can be quite high and there is spread of the inflammation to adjacent structures.
Tr.88.
Dr. Feeley argued that the needle used in the intradermal flu vaccine is insufficient in
length to pierce past the dermal layer and inject the antigen into or around the shoulder
structures. Resp. Ex. A at 4. Specifically, he asserted that “it would be exceedingly difficult to
get much further past the subcutaneous fat.” Tr. 108. Dr. Feeley also asserted that the antigen
volume in the intradermal vaccine was smaller compared to the intramuscular flu vaccine and
that it would be difficult for a small amount of vaccine material to “spread throughout the bursa
and create a robust immune response that far away from the injection…[and] cause a bursitis or
capsulitis.” Tr. 108. Instead, Dr. Feeley opined that petitioner’s shoulder pain was from shoulder
impingement, which was due to petitioner’s age and repetitive use. Tr. 106. Finally, Dr. Feeley
argued that the “lack of literature” reporting shoulder pain and dysfunction following
administration of the intradermal flu vaccine makes it less likely that the intradermal flu
vaccination could cause a shoulder injury. Tr. 116. He stated, “This would be one of the only
cases ever.” Id.
Contrary to Dr. Feeley’s assertion that petitioner’s case is “one of the only cases ever,”
involving a shoulder injury following the administration of an intradermal flu vaccination, I have
resolved three other cases involving very similar shoulder injuries following the administration
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of the intradermal flu vaccine. See Lagle v. Sec'y of Health & Hum. Servs., No. 16-1053V, 2022
WL 2299003, at *28 (Fed. Cl. May 25, 2022) (Finding that an intradermal vaccination initiated
an immune-mediated inflammatory response in and around the structures of petitioner’s right
shoulder); Allen v. Sec'y of Health & Hum. Servs., No. 15-1278V, 2022 WL 2255042, at *19
(Fed. Cl. June 2, 2022) (Finding that an intradermal vaccination caused a robust local
inflammatory response, resulting in pain protective behaviors, and ultimately adhesive
capsulitis); Galante v. Sec'y of Health & Hum. Servs., No. 18-1933V, 2022 WL 17852427, at
*24 (Fed. Cl. Nov. 30, 2022) (Finding that an intradermal vaccination initiated an inflammatory
response in and around the structures of his left shoulder, sufficient to induce pain and shoulder
dysfunction). As Dr. Srikumaran rightly explained, the intradermal flu vaccine was only in use
in the United States for a “a very short period of time.” Tr. 89. The Food and Drug
Administration gave approval for the intradermal flu vaccine in May 2011 for use in the 2011-
2012 flu season. However, Sanofi Pasteur suspended the use of the intradermal injector for the
flu vaccine and the last season it was available was the 2017-2018 flu season. Given the limited
time the intradermal vaccine was available, I agree with Dr. Srikumaran’s assessment that
injuries post-intradermal vaccination would be “much more rare than intramuscular ones” and
that accordingly it’s “not surprising that there aren’t studies on it.” Tr. 89.
Regardless of the findings in the other intradermal flu vaccine cases, Dr. Srikumaran’s
theory of vaccine causation in this case is supported by the medical literature. First, two articles
submitted by the respondent, Meijer and Marra, which examined post-immunization effects
found that there were more reported local and systemic side effects after administration of the
intradermal flu vaccine compared to the intramuscular flu vaccine. Specifically, the Meijer
article found that 453 adults who receive the intradermal flu vaccine complained of pain at the
injection site compared to only 79 adults who received the intramuscular flu vaccine. Resp. Ex.
A Tab 10 at 5. Additionally, there were more reports of swelling and redness of the skin in those
who received the intradermal flu vaccine compared to the intramuscular vaccine group.
Importantly, Meijer reported that 62 intradermal vaccine recipients reported joint pain, while
only 14 reported joint pain following the intramuscular flu vaccination. Id. Marra found that the
“intradermal vaccination was associated with a greater incidence of local adverse events when
compared with the intramuscular administration.” Resp. Ex. A, Tab 11 at 9. These articles
demonstrate that the intradermal vaccine can produce local and systemic adverse reactions, like
those after intramuscular vaccination, and more frequently, which are consistent with Dr.
Srikumaran’s theory that the intradermal vaccine can result in a robust inflammatory response.
As explained in Atanasoff, Arias, and Bodor, an inflammatory response to the antigenic
material of the vaccine near or into the structures of the shoulder causes pain and shoulder
dysfunction. Pet. Ex. 9 at 6; Pet. Ex. 11; Pet. Ex. 12; Pet. Ex. 13; Tr. 58-60. Dr. Srikumaran
explained “that there’s a strong immune-mediated inflammatory reaction to the antigen that’s
delivered locally in the shoulder and that results in inflammation of various structures of the
shoulder, including the muscles, tendons, bursa, and overlying skin.” Tr. 46, 57; Pet. Ex. 9 at 7.
Respondent’s expert, Dr. Feeley agreed with the mechanism for a SIRVA from an
intramuscular vaccination. He testified that a “SIRVA is the result of an acute response to an
injection that inadvertently is placed too deep into the shoulder that results in an inflammatory
response either in the bursa or the area above the rotator cuff in the tendon itself, or if it gets too
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deep, into the capsule, resulting in a restricted range of motion and then adhesive capsulitis.” Tr.
102. Dr. Feeley’s primary disagreement as to the potential for a shoulder injury following an
intradermal vaccination focused on the length of the needle used in intradermal injectors. He
asserted that the intradermal needle is too short to penetrate as far as the intramuscular vaccines
and, therefore would be very unlikely to cause shoulder inflammation. Tr. 103, 107; see also
Resp. Ex. A at 4.
In response to Dr. Feeley’s assertion that the intradermal needle is too short for an
inflammatory response to affect the shoulder structures, Dr. Srikumaran credibly explained that
the needle can “reach a further depth than its length by pressing firmly into the tissue.” Pet. Ex.
9 at 5; Tr. 48. He stated that by “applying additional force, because the tissues of the body are
compressible, the end of the needle tip can advance further than its actual length.” Tr. 48. Dr.
Srikumaran testified that “there is quite a bit of variability in skin thickness, both across human
beings in general, but also at the various sites that we could inject, whether it’s the abdomen or
the shoulder, and the actual thickness varies quite a bit across different body types and different
body locations.” Tr. 50-51. The Laurent article explained that that the skin thickness of
individuals between 51-70 years of age, varied from 1.98 mm to 2.28 mm at the deltoid, and Dr.
Srikumaran testified that it makes it “possible for a misplaced injection, even when administered
with a 1.5 mm, to reach structures that can respond with severe inflammation.” Pet. Ex. 9 at 5;
Pet. Ex. 17. Even though Atanasoff was reviewing shoulder issues post-intramuscular
vaccination, the authors wrote that the seated position of a patient and the standing position of
the vaccine administrator may contribute to the inadvertent improper injection of the vaccine
high into the arm. Resp. Ex. A, Tab 3 at 4. In this case, petitioner testified that he was seated,
and the vaccine administrator was standing while she administered the shot, making it more
likely that she was administering the shot closer to petitioner’s bursa.
Dr. Feeley relates petitioner’s pain symptoms following the vaccination to be “consistent
with impingement syndrome.” Tr. 105. He also argued petitioner’s other symptoms of numbness
and tingling in the thumb and index finger are consistent with carpal tunnel syndrome. Tr. 104-
105. During cross-examination, Dr. Feeley acknowledged that “aging happens over a course of
time,” and petitioner’s pain following vaccination is consistent with a “more intense local
reaction.” Tr. 123. Atanasoff explains that many individuals may have chronic shoulder
conditions, including impingement syndrome, that are asymptomatic. Atanasoff states, “In
general, chronic shoulder pain with or without reduced shoulder joint function can be caused by
a number of common conditions, including impingement syndrome, rotator cuff tear, biceps
tendonitis, osteoarthritis and adhesive capsulitis. In many cases, these conditions may cause no
symptoms until provoked by trauma or other events.” Resp. Ex. A, Tab 3 at 3 (emphasis added).
Further, Atanasoff provides that “the rapid onset of pain with limited range of motion following
vaccination in our series of patients is consistent with a robust and prolonged immune response
within already-sensitized shoulder structures following injection of antigenic substance into the
subacromial bursa or the area around the rotator cuff. We believe that this type of phenomenon is
not due to a specific vaccine but results from injection of a vaccine antigen to which a person
has previously been sensitized as a result of previous naturally occurring infection or past
vaccination. This concept is consistent with the vaccines which were given in this case series,
namely influenza….” Id. (emphasis added). Petitioner reported that he had “numerous flu shots
and other shots in the past,” which would increase the likelihood of him having a robust
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inflammatory response to the intradermal flu vaccine he received on November 13, 2017. See
Pet. Ex. 2 at 16. Thus, petitioner may have had an underlying, asymptomatic shoulder condition,
but it became symptomatic after the flu vaccine triggered a robust inflammatory response which
spread to beyond the exact location of the injection point as described by Dr. Srikumaran.
I find Dr. Srikumaran’s opinion as to how the intradermal flu vaccine causes an
inflammatory response and that the inflammation can spread to other structures of the shoulder,
which led to petitioner’s pain and dysfunction, persuasive. In addition to the medical literature
supporting his theory, the analogy between the bee sting and the intradermal vaccine injector was
effective in demonstrating how even a small injection can cause pain beyond the immediate
location of the injection. Therefore, petitioner has presented a reputable scientific theory based
on a sound and reliable medical explanation demonstrating that the intradermal flu vaccine can
cause shoulder pain and dysfunction, thus satisfying Althen prong one.
b. Althen prong two
Under Althen prong two, petitioner must prove “a logical sequence of cause and effect
showing that the vaccination was the reason for [his] injury.” Althen, 418 F.3d at 1278. This
prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the
vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is
relative to the injury, a petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of
causation. See Grant v. Sec’y of Health & Hum. Servs., 9556 F.2d 1144, 1148 (Fed. Cir. 1992).
This sequence of cause and effect is usually supported by facts derived from petitioner’s medical
records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326;
Grant, 956 F.2d at 1148. 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. Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1385 (Fed. Cir. 2015)
(quoting Andreu, 569 F.3d 1375).
Petitioner’s expert, Dr. Srikumaran, opined that the intradermal flu vaccine caused an
immune-mediated inflammatory response that resulted in pain and dysfunction in petitioner’s
left shoulder. Pet. Ex. 9. In petitioner’s case, Dr. Srikumaran noted that the vaccine needle “did
not directly touch the tendon or bursa, rather the inflammatory response likely included these
areas as they are in close proximity.” Pet. Ex. 9 at 7. He testified that petitioner’s “medical
records…reports of his treating physicians, and the description of his pain, function, the physical
exam findings on his shoulder, limited motion, difficulty overhead, weakness and rotation…a
positive Neer and Hawkins sign, the location of the pain being throughout the shoulder,”
demonstrate petitioner’s widespread inflammatory response. Tr. 77. Dr. Srikumaran testified that
there is quite a lot of variability in skin thickness across human beings, and that BMI is not
“particularly relevant…when we’re considering sort of the totality of the facts of the case, his
presentation, the timing of his events.” Tr. 50-52. Dr. Srikumaran stated that it would not take
much excess pressure to inadvertently go through the layers of skin where “both the skin as well
as subcu[taneous] layers have pain fibers, which once irritated can transmit pain deeper. Tr. 73-
74.
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Prior to receiving the vaccine, petitioner did not experience any left shoulder pain or
dysfunction. Petitioner received the intradermal flu vaccination on November 13, 2017. Pet. Ex.
1. Petitioner testified that he was sitting, and the administrator was standing, and the shot was
administered “toward the upper side,” of his left shoulder “an inch, inch and a half,” from the
end of the acromion bone. Tr. 28-29. Petitioner testified that he “had immediate pain and
stinging sensation,” following. Tr. 29. Petitioner stated that after the shot, he returned to the
employee work area and was harassed from his co-workers because he was complaining of pain
following the vaccination. Pet. Supp. Aff. ¶ 2; Tr. 7-8. This is supported by his co-workers’
statements, Mr. Wuensh and Mr. Hauser, who were present when petitioner returned to work and
remarked that “his arm was hurting,” and he “complained about how much his shoulder hurt for
quite some time.” Pet. Ex. 7; Pet. Ex. 8.
Petitioner stated that the first week after the vaccination, the pain worsened and he began
“to self-medicate…[and] when I went to employee health, it took a considerable amount of time
to even see the doctor, because she had to make the appointment.” Tr. 13. He stated that he
mostly used “Tylenol, Advil, Bayer…icepacks…[and] Aleve.” Id. By December 20, 2017,
petitioner set up an appointment with a nurse because he “thought the self-medication would
work and it got to a point where…this ain’t working, so I better contact somebody.” Id. at 15-16.
Petitioner presented to Dr. Scorby on January 5, 2018, with a chief complaint of “left
shoulder pain following the flu shot that he had on 11/13/2017.” Pet. Ex. 2 at 16. Upon
examination, Dr. Scorby assessed petitioner with “chronic left shoulder pain…persistent pain
following a flu shot.” Id. at 17. Dr. Scorby further noted that “every year I will see a few patients
that have had persistent pain in the shoulder following a flu shot.” Id. at 17. Petitioner presented
to his first physical therapy session on January 17, 2018, and the mechanism of injury listed
“intermuscular11 flu shot.” Id. at 19. Petitioner had positive Kennedy-Hawkins, Neer’s, and
Cross-over tests. Id. at 21. Further, petitioner demonstrated reduced flexion and abduction of
the left arm compared to the right, and painful limitation of external rotation at zero degrees and
more so at 90 degrees of abduction. Id. at 20-21. Petitioner expressed concern that part of the
needle was stuck in his arm. Id. at 19. Petitioner continued with physical therapy and was
discharged on March 14, 2018 because he was not progressing. Pet. Ex. 2 at 44-45. Petitioner
returned to Dr. Scorby on March 15, 2018 and was still experiencing pain in his lateral shoulder
and underwent a left shoulder x-ray to rule out a foreign object in his shoulder with showed mild
degenerative acromioclavicular joint changes but no foreign body. Id. at 51.
Petitioner continued to feel pain by August 14, 2018, when he contacted Dr. Scorby in
relation to his “chronic left shoulder pain following a flu shot last year in November.” Pet. Ex. 2
at 102. While petitioner had improved, he continued to use Relafen 750 mg a day and continued
to “have a low-grade ache in the lateral shoulder.” Id.
Petitioner’s onset of pain, shoulder dysfunction and treatment course are consistent with
Dr. Srikumaran theory of how the intradermal flu vaccine can cause shoulder pain and
dysfunction and is supported by the medical literature. The Atanasoff article explained that all
the patients in the cases identified experienced shoulder pain and nearly half expressed concern
11 The reference to an “intramuscular flu shot” is an error and there is no dispute between the parties that petitioner
received an intradermal flu shot on November 13, 2017.
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that the vaccine was administered “too-high.” Pet. Ex. 11 at 2; Resp. Ex. A-3. The petitioner
testified that the vaccine was given high on his arm by the medical assistant. Tr. 28-29.
Additionally, he explained that he was sitting, while the administrator was standing. Id. The
Atanasoff article explained that “while patients are often seated for vaccinations, the standing
position of the provider administering the injection may also contribute to injecting inadvertently
high into the deltoid.” Pet. Ex. 11 at 2; Resp. Ex. A-3.
As discussed above, Marra and Meijer, both found that patients who received the
intradermal flu vaccine compared to the intramuscular vaccine reported higher incidents of
adverse reactions, including swelling, pain at the injection site, joint pain, and erythema. See
Resp. Ex. A, Tabs 10 and 11. Dr. Srikuamran testified that these two articles support his theory
that the inflammatory response from the intradermal vaccine is not dependent on the length or
size of the needle and that “the magnitude of the response [to the intradermal flu vaccine] can be
equivalent or worse than vaccination delivered with a bigger needle intended for deeper
structures. Tr. 54.
Dr. Feeley agreed that the pain petitioner felt right after the intradermal flu vaccine was
consistent with “robust immunological reaction.” Tr. 123. He testified that the skin has “more
nerve endings than muscle,” which would result in more redness, inflammation, itching, and
soreness in the injection area. Tr. 124. However, he contended that petitioner’s ongoing pain,
described as “excruciating,” was not consistent with a local reaction to the intradermal vaccine,
but rather consistent with a chronic degenerative condition in his right shoulder. His opinion is
not persuasive. Importantly, Dr. Feeley acknowledged that impingement syndrome is a chronic
condition. Tr. 123. Furthermore, the x-ray performed on petitioner’s shoulder showed only
“mild acromioclavicular degenerative changes.” See Pet. Ex. 2 at 51. As Dr. Srikumaran
explained, the acromioclavicular joint is recessed “away from the deltoid and the site on the arm
where injections would be,” at the “very end of the collar bone,” and is very small. Tr. 80.
Additionally, nothing in the record suggests that petitioner had shoulder pain prior to receiving
the November 2017 intradermal flu vaccine. The medical records show that petitioner had
tenderness “over the mid muscle belly of the deltoid,” which is more consistent with the location
of a vaccination than the acromioclavicular joint.
While temporal relationship alone is insufficient to find causation, the prompt onset of
pain, with no prior history of shoulder pain and dysfunction, is consistent with an inflammatory
response to the vaccine, as described in the Atanasoff article. Atanasoff explains, “Although
shoulder dysfunction due to mechanical or overuse injury is always a diagnostic consideration,
the rapid onset of pain with limited range of motion following vaccination….is consistent with a
robust and prolonged immune response within already-sensitized shoulder structures following
injection of antigenic substance into the subacromial bursa or the area around the rotator cuff
tendon.” Resp. Ex. A, Tab 3 at 3. Consistent with Dr. Srikumaran’s theory as to how the
intradermal flu causes an inflammatory response, petitioner’s onset and continuity of pain,
followed by shoulder dysfunction and the lack of prior symptoms, establishes a logical sequence
of cause and effect required for Althen prong two.
Accordingly, I find that petitioner has provided preponderant evidence establishing
Althen prong two.
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c. Althen prong three
Under Althen Prong Three, petitioner must establish a “medically acceptable temporal
relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That
term has been equated to the phrase, “medically-acceptable temporal relationship.” Id. A
petitioner must offer “preponderant proof that the onset of symptoms occurred within a
timeframe which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352
(Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also
coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one). Id.
at 1352.
Petitioner testified that the onset of his shoulder pain and dysfunction occurred within 48
hours of receiving the intradermal flu vaccine on November 13, 2017. Pet. Brief at 8.
Petitioner’s testimony, submitted affidavits from his colleagues, and the medical records
establish that petitioner’s shoulder pain began immediately “from a local skin reaction to a
deeper seeded pain,” as Dr. Srikumaran testified, was consistent for a shoulder injury post-
vaccination. Tr 63. Dr. Srikumaran stated that petitioner “consistently and reliably reported
shoulder pain with intensification over time after vaccination to varied medical providers,” and
“that the proximal/temporal relationship is very important…it was consistently reported by
[petitioner] in the medical records, contemporaneous records, his own reports, his own
testimony, and those of the people around him at that time.” Tr. 61. Initially, Dr. Feeley argued
that the onset of petitioner’s pain was “unclear” based on the medical records. Tr. 138.
However, when questioned on cross examination, as to whether petitioner’s testimony and the
supporting affidavits established that petitioner’s pain began within 48-hours of the vaccination,
Dr. Feeley stated that “I believe his recollection is that [the pain] occurred around the time of his
vaccination.” Tr. 138. Thus, petitioner’s immediate onset of pain after the vaccination with
gradual progression to a consistent pain in his shoulder structures is consistent with the theory
proposed by Dr. Srikumaran and establishes a medically acceptable timeframe between the
vaccination and petitioner’s injury.
Consistent with the finding above regarding the onset of petitioner’s left shoulder pain
and dysfunction, petitioner has provided preponderant evidence to satisfy Althen prong three.
V. Conclusion
In accordance with the above, petitioner has established by preponderant evidence that he
is entitled to compensation, demonstrating that the intradermal flu vaccine administered on
November 13, 2017, was the cause-in-fact of his right shoulder pain and dysfunction. A separate
damages order will be issued.
IT IS SO ORDERED.
s/Thomas L. Gowen
Thomas L. Gowen
Special Master
26

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DOCUMENT 2: USCOURTS-cofc-1_19-vv-00462-1
Date issued/filed: 2024-02-28
Pages: 9
Docket text: PUBLIC DECISION (Originally filed: 01/03/2024) regarding 54 DECISION of Special Master Signed by Special Master Thomas L. Gowen. (hs) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-00462-UNJ Document 58 Filed 02/28/24 Page 1 of 9
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: January 3, 2024
* * * * * * * * * * * * *
BENJAMIN LARSON, *
*
Petitioner, * No. 19-462V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
*
Respondent. *
*
* * * * * * * * * * * * *
Leah VaSahnja Durant, Law Offices of Leah V. Durant, Washington, DC, for petitioner.
Parisa Tabassian, U.S. Department of Justice, Washington, D.C., for respondent.
DECISION ON DAMAGES1
On March 28, 2019, Benjamin Larson (“petitioner”) filed a petition for compensation in
the National Vaccine Injury Compensation Program.2 Petition (ECF No. 1). Petitioner alleged
that the intradermal influenza (“flu”) vaccine he received on November 13, 2017, caused him to
suffer a shoulder injury. Id. A ruling on entitlement was issued on August 28, 2023, finding that
petitioner suffered a left shoulder injury which was caused-in-fact by the flu vaccine he received
on November 13, 2017. Ruling on Entitlement (ECF No. 44).
Since the entitlement ruling, the parties have been unable to resolve damages. Both
parties submitted briefs to support their positions. See Petitioner’s (“Pet’r’s”) Memo (ECF No.
52); Respondent’s (“Resp’t’s”) Memo (ECF No. 53).
1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The Court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion
is posted on the Court’s website, each party has 14 days to file a motion requesting redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). An objecting party must provide the Court with a proposed
redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will
be posted on the Court’s website without any changes. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.

Case 1:19-vv-00462-UNJ Document 58 Filed 02/28/24 Page 2 of 9
For the reasons discussed below, I find that petitioner is entitled to an award of
$60,000.00 for actual pain and suffering.
I. Procedural History
The Ruling on Entitlement provides a procedural history of this case since it was filed to
August 28, 2023, and that procedural history is incorporated herewith and shall not be repeated.
Since the filing of the Ruling of Entitlement on August 28, 2023, the parties have been engaged
in unsuccessful damages discussions. Accordingly, the parties were ordered to file briefs in
support of their positions. Petitioner filed a brief on November 27, 2023, requesting that he be
awarded $85,000.00 for pain and suffering. Pet’r Memo at 10. Respondent filed his brief on
December 1, 2023, stating that petitioner should be awarded $47,500.00 for pain and suffering.
Petitioner is not requesting any other forms of damages.
This matter is now ripe for adjudication.
II. Legal standard
The Vaccine Act provides that “[f]or actual and projected pain and suffering and
emotional distress from the vaccine-related injury,” a petitioner may recover “an award not to
exceed $250,000.” 42 U.S.C. § 300aa-15(a)(4). With regard to pain and suffering and all other
elements of damages, the petitioner bears the burden of proof and the medical records are the
most reliable evidence of petitioner’s condition. See, e.g., Brewer v. Sec’y of Health & Human
Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996);
Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 537-38 (2011).
Prior to my appointment as a special master, former Chief Special Master Golkiewicz and
others developed an approach with the goal “to fairly treat all petitioners” by “creat[ing] a
continuum of injury”, in which the statutory cap was reserved for the most severe injuries and
lower awards were made for less severe injuries. Hocraffer v. Sec’y of Health Human Servs.,
No. 99-533V, 2007 WL *914914, at *5 (Fed. Cl. Spec. Mstr. Feb. 28, 2007). In Graves¸ Judge
Merow granted review of a special master’s pain and suffering award, holding that the
“continuum” approach was not “rooted in the statute or precedent”. Graves v. Sec’y of Health
and Human Servs., 109 Fed. Cl. 579, 590 (2013). Judge Merow set forth a different approach in
which the first step is to assess an individual petitioner’s pain and suffering by looking to the
record evidence, without regard to the $250,000 cap. Only then as a second step, if the award
would exceed $250,000, must it be reduced to that maximum. See id. at 589-90.
In the Vaccine Program’s subsequent history, special masters have of course not been
bound by Graves.3 However, they have found it to be persuasive. See, e.g., I.D. v. Sec’y of
3 Decisions of special masters and the U.S. Court of Federal Claims constitute persuasive but not binding authority.
Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). In contrast, the Federal Circuit’s holdings
on legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124
2

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Health & Human Servs., No. 04-1593V, 2013 WL 2448125, at *10 (Fed. Cl. Spec. Mstr. Moran
April 19, 2013) (“Under the interpretation of the statute offered in Graves, cases that used the
spectrum approach, such as Hocraffer and Long, are no longer useful measuring points”); Reed
v. Sec’y of Health & Human Servs., No. 16.1670V, 2019 WL 1222925, at *12 (Fed. Cl. Chief
Spec. Mstr. Dorsey Feb. 1, 2019) (“it must be stressed that pain and suffering is not based on a
continuum”); Selling v. Sec’y of Health & Human Servs., No. 16-588V, 2019 WL 3425224, at *5
(Fed. Cl. Spec. Mstr. Oler May 2, 2019) (“Pain and suffering is not, however, determined based
on a continuum”); Dillenbeck v. Sec’y of Health & Human Servs., No. 17-428V, 2019 WL
4072069, at *13 (Fed. Cl. Spec. Mstr. Corcoran July 29, 2019) (“… special masters appear to
have accepted Graves’s methodology since issuance of that decision… I will apply it herein as
well, although I do so mindful of the need to consider the overall strength of petitioner’s showing
herein”), motion for review granted and remanded on other grounds, 147 Fed. Cl. 131 (2020);
W.B. v. Sec’y of Health & Human Servs., No. 18-1364V, 2020 WL 5509686, at *3 (Fed. Cl.
Chief Spec. Mstr. Corcoran Aug. 7, 2020) (“it must be stressed that pain and suffering is not
based on a continuum”). I agree with this prevailing approach and have followed it in assessing
pain and suffering damages in other SIRVA cases. See Desai v. Sec’y of Health & Human Servs,
No. 14-811V, 2020 WL 8768069 (Fed. Cl. Spec. Mstr. Dec, 21, 2020), recon. denied, 2020 WL
8184767 (Fed. Cl. Spec. Mstr. Dec. 18, 2020).; Yost v. Sec’y of Health & Human Servs., No. 18-
288V, 2022 WL 4593029 (Fed. Cl. Spec. Mstr. Aug. 29, 2022); Youngmark v. Sec’y of Health &
Human Servs., No. 17-1431V, 2022 WL 2306867 (Fed. Cl. Spec. Mstr. May 25, 2022); Galante
v. Sec’y of Health & Human Servs., No. 18-1933V, 2023 WL 1515357 (Fed. Cl. Spec. Mstr. Jan.
13, 2023). I assess the full value of the damages in a particular case before me, then apply the
statutory cap if that becomes necessary.
There is no mathematical formula for assigning a monetary value to a person’s pain and
suffering and emotional distress. I.D., 2013 WL 2448125, at *9 (“[a]wards for emotional distress
are inherently subjective and cannot be determined by using a mathematical formula”). Factors
to be considered when determining an award for pain and suffering include: 1) awareness of the
injury; 2) severity of the injury; and 3) duration of the suffering. Id. at *9 (internal citations
omitted). I find it appropriate to also consider any impairments in function and/or lost ability to
participate in activities which the petitioner previously enjoyed, as a result of the injury.
A special master may also consider prior pain and suffering awards, especially for similar
injuries, from both inside and outside of the Vaccine Program to aid the resolution of the
appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y
of Health & Human Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper
in the chief special master’s decision to refer to damages for pain and suffering awarded in other
cases as an aid in determining the proper amount of damages in this case.”). A special master
may also rely on his or her own experience adjudicating similar claims. Hodges v. Sec’y of
Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated
that special masters would use their accumulated expertise in the field of vaccine injuries to
judge the merits of individual claims).
(2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
3

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III. Parties’ positions
A. Petitioner’s arguments
Petitioner asserts that he should be awarded $85,000.00 in past pain and suffering. Pet’r
Mem. at 2. Petitioner stated that he is “entitled to a significant award for pain and suffering,”
because he was acutely aware of the physical pain and suffering he endured as a result of his
SIRVA and that his pain was “substantial and debilitating.” Id. at 5-6.
Petitioner argues that he was aware of his injury because he immediately felt pain and a
stinging sensation in his shoulder and that his pain intensified over the following weeks. Pet’r
Mem. at 6. He asserts that his pain was so persistent, he was referred to physical therapy. See
Pet’r Ex. 2 at 44-45. When petitioner was discharged in March 2018, petitioner reported that his
pain was a 6 out of 10 and that he continued to have a “deep throbbing pain” in his left shoulder.
Pet’r Mem. at 6; see also Pet’r Ex. 2 at 44. Petitioner also asserts that his left shoulder affected
him physically and emotionally. Pet’r Mem. at 6. He stated that he was unable to participate in
his son’s activities and doing normal everyday tasks caused him pain. Id.
Petitioner argues that the award of $85,000.00 is justified because his pain was
“substantial and debilitating.” Pet’r Mem. at 6. Petitioner states that his medical records
demonstrate that he had decreased range of motion and that his pain was “interfering with
normal activities.” Id. Additionally, the pain petitioner experienced interfered with his sleep and
required medication prior to sleeping. Id. at 7. Furthermore, petitioner asserts that the pain in
his shoulder due to the vaccine injury required multiple appointments with different doctors,
physical therapy appointments, and different medications. Id. He states that his pain eventually
dissipated, he continues to have stiffness in his left shoulder, especially with certain movements.
Id.
In addition to his awareness of his pain, level of pain, and the length of petitioner’s
injury, he argues that a higher award is justified because the injury is to his dominant arm.
Furthermore, his job is physically demanding, and his injury has affected his work-day. Id. at 7.
Petitioner cites the Gentile case as analogous to his, where the petitioner was awarded
$85,000.00 in actual pain and suffering. Pet’r Mem. At 9; Gentile v. Sec’y of Health & Human
Servs., No. 16-980V, 2020 WL 3618909 (Fed. Cl. Spec. Mstr. June 5, 2020). In Gentile,
petitioner had positive Neers and Hawkins signs, like petitioner in this matter, but also had
improvement after the second physical therapy session. Gentile v. Sec’y of Health & Human
Servs., 2020 WL 3618909, at *2. Petitioner acknowledged that the petitioner in Gentile received
three steroid injections, but argues that the second injection resolved her pain, while his pain
level has never reached zero out of ten. Pet’r Mem. At 10. Petitioner in this case states that his
injury is “at least as serious an injury as [petitioner in Gentile] and should be compensated
equally.” Id.
Petitioner also rejected the comparison of his injury to the petitioner in Galante. Pet’r
Mem. at 9. He states that the petitioner in Galante had extensive pre-vaccination conditions
which contributed to the post-vaccination pain and stiffness. Id.: Galante v. Sec’y of Health &
4

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Human Servs., No. 18-1933V, 2022 WL 17852427 (Fed. Cl. Spec. Mstr. Nov. 30, 2022).
Petitioner in this matter asserts that Galante was resolved by a proffer, not a reasoned damage
decision, and proffered cases are not helpful in determining the appropriate amount of
compensation to be awarded in shoulder injury cases. Id. at n.2 (citing Henderson v. Sec’y of
Health & Human Servs., No. 20-1261V, 2023 WL 2728778 (Fed. Cl. Spec. Mstr. Mar. 31,
2023).
Petitioner concluded his brief, stating that he continues to have ongoing stiffness to his
dominant arm and that based on what he has endured, $85,000.00 is an appropriate amount.
B. Respondent’s arguments
Respondent recommends that petitioner be awarded $47,500.00 for all damages available
under Section 15 of the Vaccine Act. Respondent states that petitioner’s injury was mild and
limited. Resp’t Mem. at 6.
Respondent states that petitioner’s symptoms that he alleges are “minimal at best,” as
evidenced by his delay in seeking treatment until thirty-seven days post-vaccination. Resp’t
Mem. at 6. He argues that petitioner’s voluntary delay suggests that the pain was not significant
enough to prompt treatment sooner. Id.; citing Knauss v. Sec’y of Health & Human Servs., No.
16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (finding a three-month delay
in seeking treatment “indicate[d] that [petitioner’s] symptoms did not interfere with his ability to
participate in activities of daily life to a degree that was unmanageable.”).
Respondent also argues that petitioner’s clinical course demonstrates a mild injury.
Resp’t Mem. at 7. He states that petitioner did not receive any steroid injections, was prescribed
a non-steroidal anti-inflammatory medication, presented to three occupational health
appointments, and only participated in four physical therapy sessions related to his shoulder. Id.;
Pet’r Ex. 2 at 55-57, 102. Furthermore, there was no MRI or imaging on petitioner’s shoulder to
corroborate a specific shoulder injury. Resp’t Mem. at 7. Respondent also noted that nine
months after the vaccination, petitioner had normal range of motion in his shoulder, and
petitioner’s resisted motion and strength is “grossly normal and symmetric.” Id.; Pet’r Ex. 2 at
102. However, petitioner also reported at this appointment that he had a “low-grade ache in the
lateral left shoulder” that was noted to be there “most of the time.” Pet’r Ex. 2 at 102.
Respondent asserts that petitioner’s case is more consistent with Galanate than Gentile.
Resp’t Mem. at 8. Respondent states that in Gentile, the petitioner may have had full range of
motion, as asserted in petitioner’s memo, but that she had a painful range of motion. Id.
Additionally, the petitioner in Gentile underwent an MRI which revealed adhesive capsulitis, she
received three steroid injections, and participated in nineteen physical therapy session. Gentile,
at *2-3. This contrasts the petitioner’s treatment course, where he had no imaging of his
shoulder, did not receive any steroid injections, and only attended four physical therapy sessions.
Resp’t Mem. at 8. Additionally, the treating orthopedist in Gentile submitted two letters to the
court stating that petitioner’s pain was likely permanent due to the vaccination. Id.; Gentile,
2020 WL 3618909, at *4. Respondent asserts that the pain and suffering award in Gentile, of
$85,000.00 was appropriate in that matter because the petitioner’s SIRVA “was significantly
5

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more severe than [the petitioner in this case], and any comparison strains credulity.” Resp’t
Mem. at 9.
While respondent acknowledged that Galante was resolved by a proffer for $55,000.00,
the entitlement decision provided facts relevant to the award of pain and suffering. Resp’t Mem.
at 9; Galante v. Sec’y of Health & Human Servs., No. 18-1933V, 2022 WL 17852427 (Fed. Cl.
Spec. Mstr. Nov. 9, 2022). Respondent states that petitioner in Galante delayed treatment for his
shoulder pain for four months and only attended nine physical therapy sessions after diagnosed
with rotator cuff tendinopathy. Id. Furthermore, the petitioner in Galante also endorsed issues
sleeping due to his shoulder pain, felt as if a bee stinger had been stuck in his shoulder, and
testified that his pain impacted both his daily and recreational activities. Id.; Galante, 2022 WL
17852427, at *6. Respondent stated that even though the petitioner in the present case received
an intradermal vaccination, and both petitioner’s delayed seeking treatment, the Galante case
“should serve as the outer limit for damages.” Resp’t Mem. at 9-10. Respondent asserts that the
present case should still be valued less than Galante because petitioner had no MRI imaging to
confirm a shoulder diagnosis, he participated in fewer physical therapy sessions, and he no
longer complained of present pain by the time of the entitlement hearing. Id. Furthermore, the
petitioner in Galante had eleven months of active treatment, while the petitioner in the present
case only had seven. Id. Thus, respondent argues that the appropriate pain and suffering award
should be $47,500.00. Id.
IV. Discussion and conclusion
As noted above, factors to be considered when determining an award for pain and
suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the
suffering. I.D., 2013 WL 2448125, at *9. Impairment of function and loss of activities are also
considered. It does not appear that the parties dispute petitioner’s awareness of his injury. While
the record establishes that petitioner delayed seeking treatment, he also testified that he was
hoping the pain would subside with self-medication and treatment. Pet’r Supp. Aff. at ¶ 5; Tr.
13. He testified that “it got to a point where…. this ain’t working, so I better contact somebody.”
Tr. 15-16. Additionally, at petitioner’s January 5, 2018, medical appointment it was noted that
that petitioner has tried “various over-the-counter medications for only transient relief.” Pet’r
Exhibit (“Ex.”) 2 at 16. He used home medication and remedies for his shoulder pain, indicating
that he was aware of his injury. It is not uncommon that patients with soft tissue injuries try
home remedies for weeks or even months before seeking medial treatment in the hope that the
pain will go away without medical treatment. Thus, his delay in seeking treatment does not have
any bearing on petitioner’s awareness of the injury. Therefore, the focus of the dispute between
the parties is the severity of petitioner’s injury and the duration of his pain and suffering.
The record demonstrates that petitioner overall had a generally moderate-to-mild course
of a left shoulder injury that lasted for less than one year. Initially, when petitioner called the
nurse hotline to report his left shoulder pain, it was recorded that his pain was “moderate,” and it
was “interfering with his normal activities.” Pet’r Exhibit (“Ex.”) 2 at 15. At his January 5,
2018, appointment, petitioner reported that his pain had been “persistent for several weeks,”
since the flu vaccination, but described it as a “dull ache.” Id. at 16. Petitioner also reported that
sleeping on the shoulder was painful. Id. The exam of petitioner’s shoulder showed that he had
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pain in his shoulder at 160 degrees and beyond, and no problem with internal rotation. Id.
Petitioner also demonstrated pain with external rotation and resisted external rotation and
abduction. Id. It appears that his strength was normal. Id. His treating physician recommended
physical therapy along with continuing to ice the shoulder and using 600 mg of Ibuprofen as
necessary. Id. at 17.
At petitioner’s initial physical therapy appointment on January 17, 2018, petitioner
expressed “concern that part of the needle got stuck in his arm.” Pet’r Ex. 2 at 19. Petitioner
reported that his pain intensity when sitting was a 3 out of 10 and at the worst, a 10 out of 10. Id.
He also reported that it was painful to lay on his side while sleeping, he had difficulty reaching
out to the side, and when he rests his arm on the window, it is “achy/painful.” Id. The physical
exam revealed he had reduced range of motion upon flexion and abduction, and had mild pain
upon external rotation, with reduced range of motion. Id. at 21. Petitioner’s shoulders strength
was only mildly reduced upon abduction and external and internal rotation. Id. at 22. He was
positive for Kennedy-Hawkin’s, Neer’s and cross-over tests. Id. The impression was that
petitioner had “signs and symptoms most consistent with impingement syndrome and [rotator]
cuff irritation.” Id. at 23. Petitioner returned to physical therapy on February 13, 2018. Id. at
29. It was recommended that petitioner have physical therapy every other week for 12 weeks.
Id. At this appointment, petitioner reported that his current pain was a 6 out of 10, and that the
shoulder “still bothers him, but not as bad as before.” Id. at 30. Further, he stated that sleeping
was better since he started “more medication” and that while driving his shoulder had a dull
ache. Id. He did show improvement in his shoulder movements, increasing range of motion on
flexion and external rotation. Id. Petitioner also still had positive Kennedy-Hawkins, Neer’s and
cross-over tests. Id. at 31.
On February 20, 2018, petitioner requested that the Flexeril be refilled and reported that
he still had pain in his left shoulder which was approximately at an 8 out of 10. Id. at 34.
During his February 27, 2018, physical therapy appointment, it was recorded that petitioner had
continued improvement in range of motion, but that his pain was a 7 out of 10 at rest. Id. at 40.
He showed improvement on his external rotation from zero degrees abduction and flexion, and
he still had positive Kennedy-Hawkins, Neer’s and cross-over tests. Id. at 41. Petitioner’s fourth
and final physical therapy appointment was on March 14, 2018, where it was recorded that
“patient is not progressing” and he reported a “throbbing deep pain,” with his pain level a 6 out
of 10 at rest. Id. at 45. However, his Kennedy-Hawkins and cross-over tests were negative at
this appointment. Id. at 46.
Petitioner had a follow-up with Dr. Scorby on March 15, 2018, where petitioner reported
that physical therapy had been helpful, but he still had some residual lateral shoulder pain with
certain movements. Id. at 49. Dr. Scorby observed that petitioner had “very mild point
tenderness over the mid-muscle belly of the deltoid,” but that petitioner demonstrated “full active
range of motion to flexion, abduction, internal and external rotation.” Id. Dr. Scorby recorded
that petitioner had “some lateral shoulder pain with resisted external rotation and abduction,” but
that petitioner was “overall improved.” Id. Additionally, petitioner expressed concern that the
needle was still stuck in his arm. Id. Dr. Scorby ordered an x-ray of petitioner’s left shoulder.
Id. at 51. The x-ray showed “mild acromioclavicular degenerative change.” Id. Dr. Scorby
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refilled petitioner’s Nambumetone and cyclobenzaprine one more time on April 19, 2018. Id. at
55. There was no evidence that the needle was stuck in his arm.
From April 2018 until August 2018, petitioner did not seek additional treatment for his
left shoulder. This implies that his shoulder pain had dissipated from the highest pain level of a
seven out of 10 at rest to something less. However, at his August 14, 2018 appointment,
petitioner reported a “low-grade ache” in the lateral shoulder and that it was “there most of the
time.” Pet’r Ex. 2 at 102. Petitioner also reported taking an anti-inflammatory NASID and
occasionally takes Relafen. Id. Petitioner had no impingement signs and he had active range of
motion to flexion, abduction, cross-over abduction, internal and external rotation without pain.
Additionally, his resisted motion was without pain and strength was “grossly normal and
symmetric.” Id. While this appointment shows that petitioner’s pain was significantly reduced
and his range of motion was normal, it also demonstrates that his pain never fully resolved.
Thus, these records support a finding that petitioner initially suffered a moderately painful
shoulder injury for approximately five months, which became mild in May and continued
through petitioner’s last appointment in August 2018.
Neither of the parties’ proposed awards are persuasive. Petitioner’s position is too high,
while respondent’s is too low. Petitioner’s comparison of his treatment course and pain and
suffering to the petitioner in Gentile, is unconvincing. First, the petitioner in Gentile received
three steroid injections and participated in nineteen physical therapy sessions. Gentile, at * 2-3.
Additionally, nearly five years after the vaccine, petitioner in Gentile continued to demonstrate
positive impingement signs. Id., at *3. In this matter, the petitioner did not have any steroid
injections, participated in three physical therapy sessions, and less than one year after
vaccination, demonstrated no positive impingement signs upon examination. See Pet. Ex. 2 at
103. Finally, in Gentile, the petitioner’s treating orthopedist opined that petitioner’s injury was
likely permanent. Id., at *3. There is no such letter in this case or any indication in the limited
medical records that the petitioner’s injury or pain is permanent.
However, respondent’s argument that Galante is an “outlier,” for pain and suffering
awards is also unpersuasive. The facts in the present case and the facts of Galante present many
similarities. Like in the present case, the petitioner in Galante, also expressed trouble sleeping
and using both over-the-counter medication and prescriptions to reduce his pain prior to seeking
treatment. Galante, at *5. Further, the petitioner in Galante also had a rather limited treatment
course, which included only nine physical therapy appointments and no steroid injections. Id. at
*2-3. However, unlike in Galante, the petitioner’s injury in this matter was to his dominant arm
and his work is physically demanding, justifying a slightly increased amount for petitioner’s pain
and suffering. Accordingly, I find that petitioner is entitled to an award of $60,000.00 for pain
and suffering.
V. Conclusion
Consistent with the above, petitioner is awarded a lump sum payment of $60,000.00,
representing pain and suffering. This amount represents all of the damages that are available to
him under 42 U.S.C. § 15(a). The Clerk of the Court shall enter judgment accordingly.
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IT IS SO ORDERED.
s/Thomas L. Gowen
Thomas L. Gowen
Special Master
9