Court Opinion

ID: 4586579
Source: CourtListenerOpinion
Date Created: 2020-11-16 17:01:35.992778+00
Date Added: 2024-06-11T13:48:35.375282
License: Public Domain

In the United States Court of Federal Claims
                              OFFICE OF SPECIAL MASTERS
                                   Filed: October 20, 2020

*************************
SCOTT TAYLOR,              *                          PUBLISHED
                           *
               Petitioner, *                          No. 16-1403V
                           *
v.                         *                          Special Master Nora Beth Dorsey
                           *
SECRETARY OF HEALTH        *                          Ruling on Entitlement; Causation-in-Fact;
AND HUMAN SERVICES,        *                          Tetanus-Diphtheria-Acellular Pertussis
                           *                          (“Tdap”) Vaccine; Shoulder Injury Related
               Respondent. *                          to Vaccine Administration (“SIRVA”).
                           *
*************************

Shealene P. Mancuso, Muller Brazil, LLP, Dresher, PA, for petitioner.
Ronalda E. Kosh, U.S. Department of Justice, Washington, DC, for respondent.

                                RULING ON ENTITLEMENT1

        On October 26, 2016, Scott Taylor (“petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleges that he suffered left shoulder injuries as the
result of a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccination administered on July 13,
2015. Petition at Preamble (ECF No. 1).

1
  Because this Ruling contains a reasoned explanation for the action in this case, the undersigned
is required to post it on the United States Court of Federal Claims’ website in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services). This means the Ruling will be available to
anyone with access to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14
days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
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). All citations in this Ruling to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
       After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that petitioner provided preponderant
evidence that the Tdap vaccine caused petitioner’s left shoulder injuries, which satisfies his
burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1280
(Fed. Cir. 2005). Accordingly, petitioner is entitled to compensation.

I.     PROCEDURAL HISTORY

        Petitioner filed his petition on October 26, 2016, alleging that he sustained left shoulder
injuries caused by a Tdap vaccine administered on July 13, 2015. Petition at Preamble.
Petitioner filed medical records with his petition. Petitioner’s Exhibits (“Pet. Exs.”) 1-3.
Petitioner filed additional medical records and affidavits from November 2016 to March 2018.
Pet. Exs. 4-14. The parties engaged in settlement discussions beginning in January 2017, until
they reached an impasse in April 2018. Order dated Jan. 19, 2017 (ECF No. 15); Joint Status
Report (“Rept.”), filed Apr. 4, 2018 (ECF No. 45).

       On June 7, 2018, respondent filed his Rule 4(c) Report, stating that the records had been
reviewed by medical personnel of the Department of Health and Human Services, Division of
Injury Compensation Programs, and concluded that the case was not appropriate for
compensation. Respondent’s (“Resp.”) Rept. at 1 (ECF No. 47). In the Rule 4(c) Report,
respondent acknowledged that Shoulder Injury Related to Vaccine Administration (“SIRVA”)
was added as a Table claim for the Tdap vaccine effective for petitions filed on or after March
21, 2017, and thus,

       the previous Table is in effect for this petition, and it does not include SIRVA
       injuries. Nevertheless, even if the amended Table did apply to this petition, . . . it
       would not meet the Table criteria[] because the contemporaneous medical records
       do not establish the threshold requirement of onset of pain within forty-eight
       hours of vaccination. See 42 C.F.R § 100.3(c)(10)(i)-(iv).
Id. at 6 n.4. Thereafter, petitioner filed updated medical records on July 6, 2018. Pet. Exs. 20-
21.

        On August 20, 2018, petitioner filed an expert report by Dr. Naveed Natanzi. Pet. Ex. 25.
Petitioner also filed a number of medical journal articles and Dr. Natanzi’s CV. Pet. Exs. 25.1-
25.13, 30. On November 8, 2018, respondent filed an expert report by Dr. Geoffrey D. Abrams,
along with his CV. Resp. Exs. A-B. Respondent later filed medical literature from Dr. Abrams.
Resp. Ex. A, Tabs 1-20.

       In December 2018, the parties resumed settlement discussions. Joint Status Rept., filed
Dec. 28, 2018 (ECF No. 61). On October 16, 2019, the parties reported that they reached an
impasse during settlement discussions and agreed to move forward with further litigation. Pet.
Status Rept., filed Oct. 16, 2019 (ECF No. 82). The parties explained that their “attempt to settle
this matter on a litigative risk basis was unsuccessful, [and] until petitioner is found entitled to an
award of compensation, the parties agree the issue of damages is not ripe for consideration at this
juncture.” Pet. Status Rept., filed Nov. 12, 2019 (ECF No. 84).

                                                  2
       This case was reassigned to the undersigned on February 5, 2020. Notice of
Reassignment dated Feb. 5, 2020 (ECF No. 86). The undersigned held a status conference on
March 18, 2020, at which time the undersigned and parties agreed that this case could be
resolved through a ruling on the record and a briefing schedule was set. Order dated Mar. 18,
2020 (ECF No. 88).

       On May 18, 2020, petitioner filed a motion for a ruling on the record. Motion for Ruling
on the Record (“Pet. Mot.”), filed May 18, 2020 (ECF No. 89). Respondent filed his response on
July 31, 2020. Respondent’s Response to Pet. Mot. (“Resp. Response”), filed July 31, 2020
(ECF No. 96). Petitioner filed a supplemental expert report and medical literature from Dr.
Natanzi on September 17, 2020. Pet. Exs. 31-34.

       This matter is now ripe for adjudication.

II.    FACTUAL HISTORY

       A.      Medical Records

        Petitioner’s past medical history was significant for bilateral meniscus tears, sleep apnea,
and rosacea. Pet. Ex. 2 at 29. On July 13, 2015, at fifty-two years old, petitioner saw his
primary care physician (“PCP”), Dr. Sean McElhaney, who assessed petitioner with peripheral
neuropathy. Id. at 29, 32. At this visit, petitioner received a Tdap booster vaccine in his left
deltoid. Pet. Ex. 2 at 32; Pet. Ex. 5 at 4.

       On July 28, 2015, petitioner was seen by his PCP and assessed with “[n]ewly diagnosed
diabetes” and hypertriglyceridemia. Pet. Ex. 2 at 32-33. There is no indication that petitioner
complained of left shoulder pain. See id. at 32-34.

        On August 9, 2015, petitioner e-mailed his PCP stating, “[l]eft shoulder still quite sore
from [Tdap] shot. Muscle burns a bit. Looks fine, not swollen. Is this normal?” Pet. Ex. 4 at 2.
In a follow-up e-mail the following day, petitioner added there is “[n]o redness or discoloration,”
the shoulder joint and muscle are “sore all of the time but more when in use,” and his pain
“limit[s] some types of movement like lifting over [his] shoulder.” Id. at 1. In response, Dr.
McElhaney stated,

       The muscle ache people get in the deltoid region where shot is given wouldn’t
       hurt this long. Usually starts 1-2 days after vaccine, lasts a few days (maybe up to
       a week in rare cases), but shouldn’t last 2+ weeks. Given description of pains and
       what movements bother it, it sounds possibly like tendonitis or bursitis to the
       shoulder itself.
Id. Dr. McElhaney recommended petitioner ice his shoulder, take anti-inflammatories,
and return if the pain does not improve. Id.

                                                   3
      From August to October 2015, petitioner had three doctor’s appointments for other
medical issues. Pet. Ex. 2 at 35-47. There are no complaints or concerns of left shoulder pain
documented at these visits. See id.

         On November 9, 2015, petitioner presented to Dr. Arti Rajvanshi, complaining of left
arm pain that “has been present for 3 months after getting Tdap” vaccine. Pet. Ex. 2 at 47-48.
Petitioner described the pain as “constant” and “achy and burning” from his “shoulder to elbow.”
Id. at 48. The pain was noted to get worse with lifting, carrying, and moving or extending his
neck. Id. On exam, petitioner exhibited a full range of motion (“ROM”). Id. at 50. On exam of
his left shoulder, Dr. Rajvanshi noted “Neer’s mildly positive. Jobe’s positive. Provocative test
for infraspinatus mildly positive.” Id. The assessment was tendinopathy of left rotator cuff, and
petitioner was referred to physical therapy (“PT”). Id.

        On November 18, 2015, petitioner began PT with Jaime M. McCann, PT, DPT. Pet. Ex.
2 at 51. The physical therapist documented petitioner’s history that “[h]e got a tetanus in the left
shoulder and a few days after the shot, the pain in the shoulder started. It got better as time went
on, but it hasn’t gone away.” Id. Petitioner’s pain was also noted to be “achy and burning” and
“moving down his arm to the lateral epicondyle on the left arm.” Id. He rated his pain as a 5/10
and indicated that his pain decreases with rest but affects his ability to sleep. Id. The physical
therapist noted petitioner’s Neer test was markedly positive. Id. at 53. Petitioner had decreased
ROM with shoulder abduction and internal and external rotation. Id. The assessment was “left
tendinopathy of rotator cuff.” Id. at 54.

        Petitioner had seven additional PT sessions from November 2015 to January 2016, at
which time he was discharged from PT. Pet. Ex. 2 at 56-87. During a session on December 1,
2015, petitioner continued to have decreased ROM with external rotation. Id. at 62. By
December 9, 2015, petitioner had full ROM. Id. at 66. Upon discharge, petitioner still had some
issues lifting and moving heavy objects. Id. at 86. He was prescribed a home exercise program.
Id. at 87.

         On February 17, 2016, petitioner saw orthopedic surgeon, Dr. Jefferson Cartwright, who
noted that petitioner presented for a left shoulder injury caused by a Tdap vaccine seven months
prior. Pet. Ex. 3 at 6. Petitioner described his pain at rest as 5/10 and pain with activity as 7/10.
Id. Dr. Cartwright obtained X-rays of petitioner’s left shoulder, which revealed “[m]ild to
moderate arthritis of the left GHJ [Glenohumeral Joint]. No fractures are noted. The ACJ
[Acromioclavicular Joint] demonstrates arthrosis. There is significant radiographic subacromial
impingement.” Id. at 7. On exam, petitioner tested moderately positive under the Neer and
Hawkins tests. Id. at 7-8. Dr. Cartwright diagnosed petitioner with pain, impingement
syndrome, bursitis, bicipital tendinitis, partial thickness rotator cuff tearing, and superior glenoid
labrum lesion (“SLAP Lesion”) of his left shoulder. Id. at 7. He also diagnosed petitioner with
lateral epicondylitis and pain over lateral epicondyle in his left elbow. Id. Dr. Cartwright added
that petitioner “clearly has impingement, rotator cuff symptomatology, and biceps and SLAP
pathology and it is exceedingly unlikely that a vaccine of [any kind] produced all of [petitioner’s
injuries].” Id. at 8. He recommended an MRI of petitioner’s shoulder. Id.

                                                  4
        On March 3, 2016, petitioner was seen by his PCP for left shoulder pain in the left lateral
deltoid, top of shoulder, and up to the neck. Pet. Ex. 2 at 92. The pain was noted to be dull and
constant “since July 2015,” exacerbated with certain movements, and made better with rest. Id.
His PCP’s assessment was probable tendinopathy and “tear of tendon vs labrum based on history
and failed PT.” Id. at 94-95.

        Petitioner saw Dr. Cartwright for a follow up on his left shoulder on March 10, 2016.
Pet. Ex. 3 at 15. Dr. Cartwright noted that petitioner’s left shoulder MRI with contrast,
completed on March 7, showed “1. Anteroinferior glenoid labral tearing, with adjacent glenoid
labral articular cartilage defect. 2. Low-grade partial-thickness intrasubstance tear of the mid
supraspinatus tendon. No full-thickness rotator cuff tear. 3. Mild chronic biceps tendon tearing.
4. Moderate acromioclavicular joint osteoarthritis.” Id. at 16.

       On March 24, 2016, petitioner returned to Dr. Cartwright for a left shoulder evaluation
and a cortisone injection in his left shoulder. Pet. Ex. 3 at 20. After injection, petitioner’s pain
was noted to be 0/10. Id. at 21. On March 31, 2016, petitioner returned for a left shoulder
follow-up evaluation and another cortisone injection. Id. at 25. Petitioner’s pain level after his
second cortisone injection was 0/10. Id. Dr. Cartwright noted “ROM shows flexion 160 degrees
and abduction 156 degrees.” Id. at 27.

       Petitioner next saw Dr. Cartwright on April 14, 2016, for a left shoulder follow-up
evaluation. Pet. Ex. 3 at 29. Petitioner rated his pain at rest as 0/10 and pain with activity as
1/10. Id. Petitioner described his pain as a “slight pinch with overhead use” and sometimes a
“mild burning in the deltoid.” Id. Although petitioner reported no pain while sleeping and no
neck pain, he continued to have pain when carrying or picking up objects with his arms
extended. Id. Shoulder flexion remained at 160 degrees and abduction increased to 162 degrees.
Id. Dr. Cartwright recommended PT, but noted it was not necessary at this point, and petitioner
declined. Id. at 31. Dr. Cartwright also recommended petitioner follow-up as needed and obtain
an MRI if his symptoms return in less than two months. Id.

        On October 17, 2016, petitioner saw orthopedist, Dr. Kenneth Oates, complaining of left
shoulder pain. Pet. Ex. 7 at 8. Dr. Oates noted petitioner’s “symptoms began last February
following a TDAP vaccination.” Id. Dr. Oates noted petitioner was “tender over subacromial
space,” and “[i]mpingement signs are positive for the Neer, Hawkins[,] and painful arc
maneuvers.” Id. at 9. A left shoulder X-ray showed “type II acromion. Moderately severe AC
joint degenerative changes. Glenohumeral joint is normal.” Id. Dr. Oates’ impression was
subacromial impingement/bursitis of left shoulder, osteoarthritis of left acromioclavicular joint,
and left biceps tendonitis. Id. Dr. Oates stated that he discussed with petitioner “the possibility
of his attempted intramuscular [Tdap] vaccination being injected into his subacromial bursa,
causing subsequent subacromial bursitis. This in conjunction with underlying degenerative
change could be the causation of his discomfort.” Id.

        From October 20 to November 23, 2016, petitioner attended eleven PT sessions. Pet. Ex.
6 at 4-18. The PT initial evaluation note states onset is “unknown” but describes his pain as

                                                 5
“developing in February 2016 after a flu shot in the left shoulder.”3 Id. at 4. On initial exam,
petitioner had decreased ROM but after treatment, he had no change in internal rotation but some
improvement in external rotation and flexion. Id. at 16, 18.

       On November 30, 2016, petitioner returned to Dr. Oates and reported that PT was
“aggravating his symptoms” and he saw “no significant improvement.” Pet. Ex. 8 at 5. Dr.
Oates recommended “left shoulder arthroscopic with subacromial decompression, major
debridement and possible biceps tenodesis,” to which petitioner agreed. Id. at 6-7.

        Petitioner underwent arthroscopic surgery of the left shoulder on January 5, 2017. Pet.
Ex. 8 at 8. Postoperatively, petitioner again attended PT sessions.4 Pet. Ex. 9 at 9-31. On March
21, 2017, petitioner was noted to still be experiencing limitations in ROM, specifically flexion
and abduction. Id. at 26.

         At a post-operative visit with Dr. Oates on May 12, 2017, petitioner reported that he
“feels like he has plateaued in [PT]” and “is feeling more achy pain in his shoulder with motion.”
Pet. Ex. 8 at 16. On exam, Dr. Oates noted “good strength and motion,” as well as “[n]on tender
over AC joint and subacromial area. Mildly positive Hawkins. Negative Neer and painful arc.”
Id. at 17.

       Petitioner received an MRI arthrogram of the left shoulder on June 6, 2017. Pet. Ex. 8 at
19. Dr. Oates noted the MRI showed,

          AC joint resection that looks appropriate. There is a partial thickness rotator cuff
          tear of the supraspinatus. There is some tendinitis of the biceps. There is a sub
          labral hole anteriorly that does not appear to be a SLAP lesion. Sub acromial
          decompression appears to have been appropriately performed. There is no muscle
          atrophy. There are other post op changes that appear appropriate.
Id.

         Petitioner next saw Dr. Oates on February 23, 2018, complaining of “‘grinding[,’] pain
with [ROM] (especially reaching out), limited [ROM], and weakness of the left shoulder.” Pet.
Ex. 14 at 1. On exam, Dr. Oates noted that petitioner had a “[m]ildly positive Hawkins. Positive
Neer and negative painful arc. Negative cross-body. Negative Yergason’s and Speed’s tests.”
Id. at 2. Petitioner elected to continue with a home exercise plan. Id. at 3.

       On July 3, 2018, Dr. Oates wrote petitioner “will have permanent restrictions as of July 1,
2018” and that petitioner had to “[l]imit overhead lifting to occasional and no greater than [15
pounds].” Pet. Ex. 21 at 1.

3
    The undersigned finds this reference to administration of a flu shot instead of Tdap erroneous.
4
  Petitioner’s avers he attended 29 PT sessions from January 2017 to March 21, 2017. Pet. Ex.
11 at ¶ 10. A review of petitioner’s PT records, however, shows that he attended 18 PT sessions
from January 19, 2017 to March 21, 2017. See Pet. Ex. 9 at 9-31.

                                                   6
        From May 23, 2018 to March 4, 2019, petitioner presented to Dr. Jimmy Y. Cui for neck
and back pain. Pet. Ex. 20 at 3-5; Pet. Ex. 28 at 7-27. Left shoulder pain was documented in
petitioner’s past medical history. See id.

       B.      Affidavits

        Petitioner, Mrs. Gina Taylor, and Mr. Eric Hilton executed affidavits in support of
petitioner’s case. Pet. Exs. 11-13.

               1.      Petitioner

        In his affidavit, petitioner stated that he received a Tdap vaccine on July 13, 2015 and
immediately after, he “felt pain in [his] left shoulder, but didn’t think much of it because [he]
thought some discomfort was normal after receipt of a vaccination.” Pet. Ex. 11 at ¶¶ 2-3. Two
days later, the pain “was getting worse” Id. at ¶ 3. He “experienced pain with a vaccination in
the past, which lasted longer than usual, but eventually it went away on its own,” and “[he]
hoped this pain would resolve on its own as well.” Id.

        He averred the pain “was specifically in [his] left shoulder and was worse with
movement.” Pet. Ex. 11 at ¶ 3. Petitioner described the pain as a “constant . . . burning
sensation in the shoulder muscle and joint.” Id. at ¶ 5. He also found it difficult to lift his left
arm over his shoulder. Id. He disclosed his pain to his wife, son, and employees. Id. at ¶ 4.

       After three weeks without improvement, he contacted his PCP on August 9, 2015,
informing him of his “ongoing burning shoulder pain and limited left shoulder movement.” Pet.
Ex. 11 at ¶ 5. His PCP recommended ice and anti-inflammatories, which petitioner used over the
next few months. Id. This provided him with “some relief,” decreasing his pain “from very
intense” to “moderate and improving.” Id. at ¶ 6. However, “[a]ctivity continued to make the
pain worse and it was notably more severe at night.” Id. He still “hoped the pain would
continue to decrease and eventually resolve on its own.” Id.

        Petitioner explained that he waited to see a doctor because he is “the kind of person that
doesn’t usually go to a doctor unless something is bleeding real[ly] bad.” Pet. Ex. 11 at ¶ 7. He
also stated that if he were to go to a doctor, he felt he would need to take time off work for PT.
Id. Because he owns a small business and “taking time off during the work week is quite
disruptive to production,” he waited to see a doctor until work was slow. Id.

        In November 2015, four months after vaccination, petitioner was still experiencing pain,
which he described “was more intense when [he] moved [his] left arm, and had begun to slowly
radiate through [his] left upper arm, down to [his] elbow.” Pet. Ex. 11 at ¶ 8. On November 9,
2015, he was examined by Dr. Arti Rajvanshi, who referred petitioner to PT and prescribed
Ibuprofen. Id. On November 18, 2015, petitioner began PT until January 27, 2016. Id. at ¶ 9.
During this time, he was also doing a home exercise program and “continued working light duty,
since [he] could not work at full-capacity in [his] business.” Id.

                                                   7
        After PT, he was still experiencing pain and sought treatment from an orthopedic
specialist. Pet. Ex. 11 at ¶ 10. From February to November 2016, he “had a left shoulder x-ray
and MRI, two steroid injections into [his] left shoulder, and eleven (11) additional [PT] sessions,
before being scheduled for left shoulder surgery on January 5, 2017.” Id. After his surgery, he
“had an additional twenty-nine (29) physical therapy sessions through March 21, 2017.” Id.

        In May 2017, he tried going back to work full-time, but was unable to do any of the
required shoulder or chest-high activities. Pet. Ex. 11 at ¶ 15. He also “could not pull or push
with [his] left arm,” which is “frequently required for [him] to function in this environment and
work at [his] full capacity in [his] business.” Id. In June 2017, he was able to return to work
full-time at a reduced capacity. Id. He averred that he “cannot perform at [his] full capacity as
[he] could prior to vaccination.” Id.

        As of December 7, 2017, the date on which petitioner executed his affidavit, he was still
experiencing pain, stiffness, and soreness in the mornings for several hours. Id. at ¶ 17. He
states he hit a plateau in his recovery. Id.

               2.      Mrs. Gina Taylor

         Mrs. Gina Taylor is petitioner’s wife. Pet. Ex. 12 at ¶ 2. She averred that before
petitioner’s July 13, 2015 vaccination, petitioner “never complained of pain or difficulty using
his left arm or shoulder.” Id. at ¶ 3.

       On the day after petitioner’s Tdap vaccination, she noticed his left shoulder was hurting.
Pet. Ex. 12 at ¶ 4. Mrs. Taylor explained that “[h]e was getting dressed and could barely lift his
arm to put on his shirt.” Id. She “continued to notice [petitioner] struggling to do things like get
dressed or reach up to get a plate or cup from the kitchen cabinet.” Id. at ¶ 5. One day, she was
re-decorating and needed petitioner’s help moving furniture, “but [he] was unable to help
because his shoulder hurt too much.” Id. The yard work and home repairs that petitioner used to
do became her responsibility. Id. Mrs. Taylor averred that petitioner “is not a guy that
complains much about his ailments but after several weeks of watching him wince in pain, [she]
eventually convinced him to call his doctor about it.” Id.

       Petitioner completed PT but it did not seem to help, and he got very discouraged. Pet.
Ex. 12 at ¶ 6. “[Mrs. Taylor] noticed [petitioner’s] pain more at home than at work.” Id. at ¶ 7.
She manages the business office, so she did not often see him working in the welding or machine
shop. Id.

        She averred that “[t]his injury has had a tremendous impact on [petitioner].” Pet. Ex. 12
at ¶ 9. “Before the vaccination, he was his normal self—very physical and active and never
having to hesitate to move any part of his body in order to do something, be it work, play[,] or
otherwise.” Id. Mrs. Taylor asserted that he “is not his normal ‘pre-vaccination self’ to date and
[she] [does not] know if he ever will be.” Id.

                                                 8
               3.      Mr. Eric Hilton

        For the past eleven years, Mr. Eric Hilton has worked at Arlington Machine and Welding,
which is owned and operated by petitioner. Pet. Ex. 13 at ¶ 2. Mr. Hilton “was mostly in control
of the fabrication side of the company with [petitioner’s] help and [petitioner] was in charge of
the machining aspects.” Id. at ¶ 5. He averred that before petitioner’s July 13, 2015 vaccination,
petitioner “never complained of pain or difficulty using his left arm or shoulder.” Id. at ¶ 3.

         Mr. Hilton stated that the day after petitioner received his Tdap vaccine, petitioner
complained about a sore shoulder during their lunch break. Pet. Ex. 13 at ¶ 4. He thought
petitioner’s pain was normal. Id. Mr. Hilton noted petitioner’s “work was effected immediately
after his vaccination.” Id. “[H]e started to rely on others to do things he would normally be able
to do himself.” Id. As Mr. Hilton and petitioner continued to work together, Mr. Hilton “could
tell that [petitioner] was in pain and could not work as he used to.” Id.

         In the following months, petitioner would ask Mr. Hilton to help “unload or load stuff as
[their] job requires some heavy lifting.” Pet. Ex. 13 at ¶ 5. In the beginning of 2017, petitioner
explained to Mr. Hilton that because he was going to have surgery on his shoulder, Mr. Hilton
would not have much assistance at work. Id. at ¶ 7.

      Mr. Hilton averred that petitioner “is still not back to his usual self.” Pet. Ex. 13 at ¶ 8.
On an October 23, 2017 installation, Mr. Hilton “was still required to most of the hard work
when before [petitioner] was always working with [him] side by side.” Id.

III.   EXPERT REPORTS

       A.      Petitioner’s Expert, Dr. Naveed Natanzi

               1.      Background and Qualifications

        Dr. Natanzi is a board certified specialist in physical medicine and rehabilitation. Pet.
Ex. 25 at 1. He received his B.A. from University of California, Santa Barbara in 2007 and his
D.O. from Western University of Health Sciences in 2012. Pet. Ex. 30 at 2. From 2012 to 2016,
Dr. Natanzi completed a rotating internship at Downey Regional Medical Center and a residency
and fellowship in physical medicine and rehabilitation at University of California, Irvine. Id. at
1. Thereafter, he worked as a fellow and an attending physician in interventional regenerative
sports and spine medicine at the Bodor Clinic. Id. Currently, Dr. Natanzi is an attending
physician in interventional pain management at the Pasadena Rehab Institute and is the founder
of the Regenerative Sports and Spine Institute. Id. Dr. Natanzi has served on various
committees and authored or co-authored numerous publications. Id. at 3.

               2.      Opinion

       Dr. Natanzi opines that the records show that petitioner sustained a SIRVA injury due to
his Tdap vaccination on July 13, 2015. Pet. Ex. 25 at 10. Before reaching his opinions, Dr.

                                                  9
Natanzi reviewed petitioner’s medical records, affidavits, MRI, and respondent’s Rule 4(c)
Report. Id. at 1-5. He also reviewed and cited supporting medical literature. Id. at 6-7, 11-12.

        Dr. Natanzi opines that in petitioner’s case, an “inadvertent over penetration of the
vaccination needle” resulted in “tendinous and or bursal penetration,” causing petitioner’s
radiating pain to his elbow, “typical of rotator cuff and bursal referred pain.” Pet. Ex. 25 at 9.
He further explained that the “vaccine interacts with naturally occurring antibodies from a prior
vaccination[5] resulting in [] months of a robust and prolonged inflammatory response” and the
“development of bursitis, impingement, tendinopathy, and mild capsulitis.” Id.

        Dr. Natanzi believes that over penetration by the vaccination needle is “increasingly
likely” based on medical literature and logistics of vaccine administration—“the standing
position of the injector and resting (non-abducted) left arm position while the injection [is]
performed.” Pet. Ex. 25 at 9. As support, Dr. Natanzi cites Atanasoff et al.6 In Atanasoff, the
authors identified thirteen cases filed from 2006 to 2010 in the database of claims submitted to
the Vaccine Program where “vaccine administration led to significant shoulder pain and
dysfunction.” Pet. Ex. 25.5 at 1-2. Based on their investigation, the authors’ proposed
mechanism “is the unintentional injection of antigenic material into synovial tissues resulting in
an immune-mediated inflammatory reaction.” Id. at 1. “[T]he rapid onset of pain with limited
range of motion following vaccination . . . is consistent with a robust and prolonged immune
response.” Id. at 3. The authors noted that some of their MRI findings “may have been present
prior to vaccination and became symptomatic as a result of vaccination-associated synovial
inflammation. Other findings such as fluid collections, localized tendon inflammation, and
bursitis are more consistent with the vaccine needle over-penetration mechanism.” Id. at 3-4.

        Dr. Natanzi also cites Bodor and Montalvo,7 where the authors examined two patients
with shoulder pain and weakness following vaccination and hypothesized that the “vaccine was
injected into the subdeltoid bursa, causing a robust local immune and inflammatory response.”
Pet. Ex. 25.2 at 1-2. They explained, “[g]iven that the subdeltoid bursa is contiguous with the
subacromial bursa, this led to subacromial bursitis, bicipital tendonitis, and inflammation of the
shoulder capsule,” as well as “adhesive capsulitis.” Id. at 2. Because multiple structures within
the shoulder were involved in both patients, Bodor and Montalvo found this suggested “a
primary inflammatory etiology rather than a mechanical overuse problem.” Id. at 3. The authors
concluded that “the diagnosis of vaccination-related shoulder dysfunction . . . [should] be
considered in patients presenting with shoulder pain and weakness following a vaccine
injection.” Id.

5
 A vaccine administration record showing petitioner’s prior Tdap vaccination was not filed.
However, the fact that he received a “Tdap booster” on July 13, 2015, implies that he had
previously received the Tdap vaccine. See Pet. Ex. 2 at 32.
6
 S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28 Vaccine
8049 (2010).
7
  Marko Bodor & Enoch Montalvo, Vaccination-Related Shoulder Dysfunction, 25 Vaccine 585
(2007).

                                                10
       Dr. Natanzi notes that prior to the vaccination at issue, petitioner had no history of left
shoulder pain or dysfunction. Pet. Ex. 25 at 8. An MRI from March 7, 2016 revealed
“glenolabral tearing with a labral articular cartilage defect, a partial thickness supraspinatus
tendon tear, chronic biceps tendon tear, and moderate acromioclavicular degenerative joint
disease.” Id. Additionally, orthopedic evaluations conducted by Drs. Cartwright and Oates
“revealed signs of impingement syndrome and bursitis of the left shoulder.” Id.

        Dr. Cartwright found petitioner “clinically demonstrated signs of rotator cuff, biceps, and
SLAP pathology” and concluded it was “exceedingly unlikely” that petitioner’s symptoms are
due to a vaccine. Pet. Ex. 25 at 8. Dr. Natanzi opines that “it is more likely than not that chronic
degenerative changes in the labrum and acromioclavicular joint are age related and were present
and asymptomatic before and after the injury.” Id. He further opines that findings of mild
rotator cuff tearing and impingement are typical “in cases of SIRVA needle over-penetration or
become symptomatic as a result of vaccine-associated synovial inflammation.” Id. at 8-9. He
concludes that “either clinically indistinguishable scenario demonstrates a clear causal associated
relationship.” Id. at 9.

     Dr. Natanzi, quoting the Qualifications and Aids to Interpretation (“QAI”) relative to
SIRVA in the Vaccine Injury Table, explains

       [a] vaccine recipient shall be considered to have suffered SIRVA if such recipient
       manifests all of the following:
          i.   No history of pain, inflammation or dysfunction of the affected shoulder
               prior to intra-muscular vaccine administration that would explain the
               alleged signs, symptoms, examination findings, and/or diagnostic studies
               occurring after vaccine injection.
         ii.   Pain occurs within the specified time-frame;
        iii. Pain and reduced range of motion are limited to the shoulder in which the
               intra-muscular vaccine was administered; and
        iv.    No other condition or abnormality is present that would explain the
               patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
               brachial neuritis, mononeuropathies, or any other neuropathy).

Pet. Ex. 25 at 9 (emphasis omitted). Dr. Natanzi opines that petitioner meets all of the criteria.
Id.

        Given the temporal association between vaccination and petitioner’s symptoms and the
absence of any pre-vaccination dysfunction, Dr. Natanzi concludes “with a high degree of
likelihood,” the July 13, 2015 Tdap vaccination caused petitioner’s left shoulder dysfunction.
Pet. Ex. 25 at 10.

        In a supplemental expert report, Dr. Natanzi notes that both he and Dr. Abrams agree that
(1) petitioner suffers from a shoulder condition, (2) petitioner had no history of shoulder pain
prior to vaccination, and (3) petitioner has a history of uncontrolled diabetes. Pet. Ex. 31 at 1.

                                                 11
        With regard to the effect of petitioner’s diabetes, Dr. Natanzi concedes that petitioner’s
“underlying hyperglycemic state may have predisposed him more to an injury,” but opines that
“the injury to the rotator cuff or subacromial bursa would only happen if the needle penetrated
those structures.” Pet. Ex. 31 at 2. He further explains that “had the vaccine been correctly
administered,” petitioner’s vaccine-related bursitis or tendinitis could not have developed and
thus, the over-penetration of the vaccination needle led to an injury that was exacerbated by
petitioner’s diabetes. Id.

        Dr. Natanzi opines that “although it is possible that the bursitis, tendinitis, and possible
capsulitis spontaneously and coincidentally surfaced in the days post-vaccination, it is extremely
improbable,” especially given the fact that petitioner had no prior shoulder pain and petitioner’s
symptoms are characteristic of a SIRVA injury. Pet. Ex. 31 at 3. Additionally, petitioner’s
underlying diabetes “may have contributed to the severity of his shoulder pain[,] but had no role
in the initiation of pain.” Id. Therefore, he maintains that “to a reasonable degree of certainty
that a SIRVA injury caused [petitioner’s] shoulder pain.” Id.

       B.      Respondent’s Expert, Dr. Geoffrey D. Abrams

               1.      Background and Qualifications

       Dr. Abrams is a board certified orthopedic surgeon with a subspecialty certification in
sports medicine. Resp. Ex. A at 2. He received his B.A. from Stanford University in 2000 and
his M.D. from the University of California, San Diego in 2007. Resp. Ex. B at 2. Thereafter, he
completed a surgical internship in general surgery and residency in orthopedic surgery at
Stanford University Hospitals and Clinics, as well as a fellowship in orthopedic sports medicine
at Rush University Medical Center. Id. Dr. Abrams currently works as an Attending Physician
at Veterans Administration Hospital, Palo Alto, Assistant Professor at Stanford University
School of Medicine, and Director of Lacob Sports Medicine Clinic at Stanford University. Id.
He also serves as team physician for numerous professional and collegiate sports teams. Resp.
Ex. A at 2; Resp. Ex. B at 24-25. Dr. Abrams has authored or co-authored over 180 publications
and serves on various committees and journals. Resp. Ex. B at 3-9, 11-24.

               2.      Opinion

         Dr. Abrams agrees with Dr. Natanzi’s statement that “it is more likely than not that
chronic degenerative changes in the labrum and acromioclavicular joint are age related and were
present and asymptomatic before and after the injury.” Resp. Ex. A at 4 (quoting Pet. Ex. 25 at
8). However, he argues Dr. Natanzi failed to consider the effect of petitioner’s diabetes
diagnosis on the “pain, function, and structure of his shoulder nor the high incidence of rotator
cuff pathology in the adult population.” Id. at 5. Dr. Abrams opines that petitioner’s “history of
extremely high glucose levels at the time in question may have [led] to, or been a major factor[]
in[,] the development of his shoulder pain and dysfunction.” Id. at 8.

       Based on the medical records, Dr. Abrams finds “it is nearly certain that [petitioner] was
experiencing hyperglycemia,” which is “known to have significant negative effects on the
shoulder and makes patients more susceptible to inflammatory conditions,” for years prior to

                                                 12
vaccination. Resp. Ex. A at 5. He explains that “hyperglycemia permanently alters tissue
macromolecules through accelerated advanced glycation end-products (AGEs) formation,” and
the “AGEs cause qualitative and quantitative changes in extracellular matrix components which
can affect cell adhesion, growth, and matrix accumulation.” Id. In particular, Dr. Abrams points
out that “AGEs are known to affect collagen, a major component of the rotator cuff.” Id.

         According to Dr. Abrams, hyperglycemia not only damages tendon tissues, but is also
linked to inflammation. Resp. Ex. A at 5. Although Dr. Natanzi opines that petitioner’s
impingement and bursitis were caused by the Tdap vaccine, Dr. Abrams notes “AGEs are
involved in a cycle of inflammation,” leading to “a self-renewing process of inflammation.” Id.
Therefore, “due to [petitioner’s] underlying extreme hyperglycemia, his body was primed to
initiate an exaggerated inflammatory response to what otherwise was likely to be an innocuous
event.” Id. at 5-6.

        In response to Dr. Natanzi’s opinion that rotator cuff tearing and impingement are often
found in needle over-penetration cases, Dr. Abrams argues injection “is unlikely to be [] causal []
as rotator cuff pathology is extremely common in the adult population, even in those without
shoulder pain.” Resp. Ex. A at 6. As support, Dr. Abrams cites Yamaguchi et al.,8 which
examined over 500 patients presenting with unilateral shoulder pain and found a majority had
rotator cuff tearing on their contralateral, or asymptomatic, shoulder. Resp. Ex. A, Tab 18 at 2-3.
The Yamaguchi study also found “a high correlation between the onset of rotator cuff tears
(either partial or full thickness) and increasing age,” observing “the average age was 48.7 years
for patients with no rotator cuff tear, 58.7 years for those with a unilateral tear, and 67.8 years for
those with a bilateral tear.” Id. at 1, 3. The authors further noted their “finding of a strong (50%)
likelihood of a bilateral tear after the age of sixty-six years is consistent with an intrinsic etiology
for rotator cuff tears associated with natural aging.” Id. at 5. Similarly, Reilly et al.9 conducted a
systematic review and found “[r]otator cuff tears are frequently asymptomatic.” Resp. Ex. A,
Tab 13 at 1. However, Reilly noted age was not frequently recorded and determined it was
inappropriate to reach a conclusion regarding age. Id. at 5.

         Additionally, Dr. Abrams opines that “imaging-proven rotator cuff pathology in
asymptomatic patients is more common in those with diabetes.” Resp. Ex. A at 6. In Abate et
al.,10 the authors examined 80 subjects, 48 with diabetes and 32 controls, who did not complain
of shoulder pain or dysfunction and concluded that “age-related rotator cuff tendon changes are
more common in diabetics.” Resp. Ex. A, Tab 1 at 2, 5.

8
  Ken Yamaguchi et al., The Demographic and Morphological Features of Rotator Cuff Disease:
A Comparison of Asymptomatic and Symptomatic Shoulders, 88 J. Bone & Joint Surgery 1699
(2006).
9
  P. Reilly et al., Dead Men and Radiologists Don’t Lie: A Review of Cadaveric and
Radiological Studies of Rotator Cuff Tear Prevalence, 88 Annals Royal Coll. Surgeons Eng. 116
(2006).
10
  Michele Abate et al., Sonographic Evaluation of the Shoulder in Asymptomatic Elderly
Subjects with Diabetes, 11 BMC Musculoskeletal Disorders 278 (2010).

                                                  13
        Dr. Abrams maintains that shoulder impairments are very common in those with diabetes
and cites Shah et al.,11 which found 63% of patients with diabetes reported shoulder pain or
disability. Resp. Ex. A at 6 (citing Resp. Ex. A, Tab 15 at 5). Dr. Abrams argues many of these
shoulder impairments were due to tendinopathy of which diabetes is a well-known risk factor.
Id. Petitioner exhibited “evidence of ‘lateral epicondyle tenderness, pain with resisted wrist
extension,’” which Dr. Abrams opines is “consistent with lateral epicondylitis (tennis elbow), a
type of tendinopathy more frequently found in those with diabetes and indicative of a state of
overall compromised tendon health.” Id.

        Dr. Abrams opines that Dr. Natanzi inaccurately asserted that “pain radiating to the level
of the elbow (is) typical of rotator cuff and bursal referred pain.” Resp. Ex. A at 6. Instead, Dr.
Natanzi believes that petitioner’s elbow exam was “consistent with lateral epicondylitis” due to
“tenderness at the lateral epicondyle and pain with resisted wrist extension” and thus, it was not
caused by shoulder pathology. Id. Dr. Abrams further opines that petitioner’s underlying
diabetes was “more of a contributing factor to the visualized rotator cuff pathology rather than
the vaccine injection.” Id.

        Additionally, Dr. Abrams asserts that petitioner’s PT notes state that petitioner’s loss of
motion was primarily in external rotation, which is associated with adhesive capsulitis, or frozen
shoulder. Resp. Ex. A at 6. Dr. Abrams opines that “those with poor blood sugar control over a
longer period are at an increased risk of the development of adhesive capsulitis.” Id. at 7. Here,
“petitioner’s blood sugar level was extremely elevated at initial diagnosis and remained in the
uncontrolled range for at least six months following his diagnosis,” which “raises the possibility
that the petitioner’s shoulder pain and dysfunction may have, in part, been related to adhesive
capsulitis.” Id. Dr. Abrams opines that petitioner’s condition is “more than likely” related to
petitioner’s diabetes than the Tdap vaccine because “there is no evidence that the vaccine
administration was given in the glenohumeral joint, the most common location of pathology in
adhesive capsulitis.” Id.

        Because the records do not indicate the location of the injection in petitioner’s deltoid,
whether petitioner was standing or sitting during injection, or the length of the needle, Dr.
Abrams states he is unable to determine “whether the petitioner was at increased risk for SIRVA
based on the injection technique nor whether the injection was administered into the subacromial
space, as hypothesized by Dr. Natanzi.” Resp. Ex. A at 7. Dr. Abrams believed petitioner’s
“underlying medical condition (diabetes/hyperglycemia) was a significant factor in the
development and persistence of his shoulder dysfunction.” Id.

        Even if petitioner suffered a SIRVA injury, Dr. Abrams argues that most SIRVA
patients’ shoulders return to full and/or pain-free function within a few months to one year after
vaccination, which has not happened in petitioner’s case. Resp. Ex. A at 7-8. Dr. Abrams
opines this “was likely due to [petitioner’s] underlying diabetes and subsequent overall
inflammatory state.” Id. at 8.

11
 K.M. Shah et al., Upper Extremity Impairments, Pain and Disability in Patients with Diabetes
Mellitus, 101 Physiotherapy 147 (2015).

                                                14
       Dr. Abrams concludes that “[w]ith reasonable medical certainty, the petitioner’s
underlying medical condition was a significant factor in the development of his shoulder pain,”
and thus, he does not meet the fourth QAI requirement—no other condition or abnormality is
present that would explain the patient’s symptoms. Resp. Ex. A at 8.

IV.    DISCUSSION

       A.      Standards for Adjudication

       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
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). The received vaccine, however, need not be the
predominant cause of the injury. Shyface, 165 F.3d at 1351. 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).

       B.      Factual Issues

        A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records are presumed to be
accurate. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
To overcome the presumptive accuracy of medical records, a petitioner may present testimony
which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Hum. Servs.,
No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v.
Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr.
June 30, 1998)).

                                                15
        There are situations in which compelling testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the
factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum.
Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)
(“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent.” (quoting Murphy v. Sec’y of Health & Hum. Servs., 23
Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992))). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir.
1993).

        Despite the weight afforded medical records, special masters are not bound rigidly by
those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &
Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see
also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.
Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to §
13(b)(1) which directs the special master or court to consider the medical records (reports,
diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special
master or court to be bound by them”).

       C.      Causation

        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 he 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’s claim predates the inclusion of
SIRVA on the Table, he must prove his claim by showing that his injury was caused-in-fact by
the vaccination in question. § 11(c)(1)(C)(ii). To do so, petitioner must establish, by
preponderant evidence: “(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.”
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). Petitioner
cannot establish entitlement to compensation based solely on her 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

                                                16
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).

V.     CAUSATION ANALYSIS

       A.      Althen Prong One

         Under Althen Prong One, petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon v.
Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Knudsen, 35
F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 214, 223 (2011) (noting that
special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence
that is both “relevant” and “reliable”). If petitioner relies upon a medical opinion to support her
theory, the basis for the opinion and the reliability of that basis must be considered in the
determination of how much weight to afford the offered opinion. See Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (“The special master’s decision
often times is based on the credibility of the experts and the relative persuasiveness of their
competing theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed.
Cir. 1994) (stating that an “expert opinion is no better than the soundness of the reasons
supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))).

         The mechanism for a SIRVA injury is well described in the medical literature filed in this
case. In Atanasoff, the authors propose that the causal mechanism “is the unintentional injection
of antigenic material into synovial tissues resulting in an immune-mediated inflammatory
reaction.” Pet. Ex. 25.5 at 1. They found “rapid onset of pain with limited range of motion
following vaccination . . . is consistent with a robust and prolonged immune response.” Id. at 3.
MRI findings supported the conclusion that shoulder impairments, such as rotator cuff tears,
“may have been present prior to vaccination and became symptomatic as a result of vaccination-
associated synovial inflammation.” Id. Similarly, Bodor and Montalvo proposed that a “vaccine
was injected into the subdeltoid bursa, causing a robust local immune and inflammatory
response.” Pet. Ex. 25.2 at 1-2. They found multiple structures within the shoulder involved,
which suggested “a primary inflammatory etiology rather than a mechanical overuse problem.”
Id. at 3.

       Further, when proposing the addition of SIRVA to the Vaccine Table, respondent
discussed the mechanism by which this injury is caused. See National Vaccine Injury
Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, 45137 (July
29, 2015).

                                                17
        The undersigned takes judicial notice of the fact that respondent added SIRVA after
receipt of an intramuscularly administered Tdap vaccine to the Table. Such recognition of the
causal association between vaccine and injury has been held to support the establishment of the
theory required by the first Althen prong. See Doe 21 v. Sec’y of Health & Hum. Servs., 88 F.
Cl. 178, 193 (2009), rev’d on other grounds, 527 F. App’x 875 (Fed. Cir. 2013).

        Additionally, the undersigned notes that, prior to the adoption of the revised Table, which
is effective for petitions filed on March 21, 2017 and later, respondent conceded entitlement in
numerous SIRVA cases alleging causation by an intramuscularly administered Tdap vaccine.
See, e.g., Larson v. Sec’y of Health & Hum. Servs., No. 16-219V, 2016 WL 3006349 (Fed. Cl.
Spec. Mstr. Mar. 23, 2016). Even after the revised Table became effective, respondent continued
to concede cases which may not have met the Table criteria, but in which respondent,
nevertheless, believed causation had been established. See, e.g., Muller-Carillo v. Sec’y of
Health & Hum. Servs., No. 19-183V, 2020 WL 1079508 (Fed. Cl. Spec. Mstr. Feb. 4, 2020).

        Moreover, petitioner submitted the expert opinion of Dr. Natanzi who provided a sound
and reliable medical and scientific theory of causation supported by medical literature. Dr.
Natanzi explained that the injection resulted in tendinous and/or bursal penetration, leading to a
“robust and prolonged inflammatory response” and the “development of bursitis, impingement,
tendinopathy, and mild capsulitis.” Pet. Ex. 25 at 9.

        The undersigned finds petitioner has provided by preponderant evidence a sound and
reliable theory that the Tdap vaccine administered intramuscularly can cause SIRVA, and
therefore, petitioner has satisfied the first Althen prong.

       B.      Althen Prong Two

        Under Althen Prong Two, petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must
show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).

        In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d
at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as
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.’” (quoting Althen,
418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are
created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528. The
petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,
rechallenge, the presence of pathological markers or genetic predisposition, or general
acceptance in the scientific or medical communities to establish a logical sequence of cause and
effect.” Capizzano, 440 F.3d at 1325. Instead, petitioner may satisfy his burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.

                                                18
       With regard to the second Althen prong, the undersigned finds there is a preponderance
of evidence in the record to support a logical sequence of cause and effect showing the July 13,
2015 Tdap vaccination to be the cause of petitioner’s left shoulder pain. See Althen, 418 F.3d at
1278. First, Dr. Natanzi’s report and the medical literature provide a framework for evaluating
whether petitioner’s claim is consistent with SIRVA. The criteria are as follows:

        [a] vaccine recipient shall be considered to have suffered SIRVA if such recipient
        manifests all of the following:
           i.   No history of pain, inflammation or dysfunction of the affected shoulder
                prior to intra-muscular vaccine administration that would explain the
                alleged signs, symptoms, examination findings, and/or diagnostic studies
                occurring after vaccine injection.
          ii.   Pain occurs within the specified time-frame;
         iii. Pain and reduced range of motion are limited to the shoulder in which the
                intra-muscular vaccine was administered; and
         iv.    No other condition or abnormality is present that would explain the
                patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
                brachial neuritis, mononeuropathies, or any other neuropathy).

Pet. Ex. 25 at 9.

                1.     Prior Condition

        Based upon a review of the record as a whole, including the medical records, affidavits,
and expert reports, the undersigned finds there is no evidence that petitioner experienced any
issues with his left shoulder prior to vaccination.

                2.     Pain Onset

        Respondent argues that petitioner has not established that his left shoulder pain began
within a temporally appropriate time frame. Resp. Response at 26. Respondent acknowledges
that “the affidavits . . . support petitioner’s claim . . . that his pain started immediately after the
Tdap vaccine,” but contends “these statements should be afforded minimal weight as they were
prepared in preparation of litigation over two years after the date of the vaccination in question.”
Id. at 28. Respondent also argues the medical records do not support petitioner’s assertion that
his pain began immediately after vaccination, and cites to various records that describe onset. Id.
at 27-28.

        Relying on the affidavits and contemporaneous medical records, petitioner argues he
experienced left shoulder pain and increased pain in his left shoulder with movement within 48
hours of the Tdap vaccination. Pet. Mot. at 10-14. Additionally, petitioner’s expert, Dr. Natanzi,
opined that petitioner’s left shoulder pain began “immediately after vaccination” and “is a direct
result of the Tdap vaccine.” Pet. Ex. 25 at 1, 9; see also Pet. Ex. 31 at 2.

      The earliest in time document regarding onset is the e-mail that petitioner sent to his PCP
on August 9, 2015. Petitioner wrote, “[l]eft shoulder still quite sore from [Tdap] shot.” Pet. Ex.

                                                  19
4 at 2. The next day, August 10, petitioner sent a follow-up e-mail explaining that his shoulder
was “sore all of the time but more when in use” and his pain was limiting his movement. Id. at
1. In response, Dr. McElhaney stated that “muscle ache . . . where shot is given wouldn’t hurt
this long . . . shouldn’t last 2+ weeks. Given description of pains and what movements bother it,
it sounds possibility like tendonitis or bursitis to the shoulder itself.” Id.

       In this e-mail exchange, petitioner used the phrase, “still quite sore.” A plain reading of
the e-mail exchange is that petitioner had pain at the time of his vaccination or immediately after,
and the pain was still present on August 9 and had never gone away. Petitioner did not describe
pain onset that began at some time later but related it back to vaccination.

       On November 9, 2015, petitioner was seen by Dr. Rajvanshi, who noted “[p]ain has been
present for 3 months after getting Tdap” vaccination. Pet. Ex. 2 at 48. Dr. Rajvanshi does not
describe any gap of time between vaccination and pain onset.

         Dr. Cartwright, on February 17, 2016, wrote petitioner’s “symptoms caused by a vaccine
- Tdap 7 months ago.” Pet. Ex. 3 at 6 (emphasis omitted). On March 3, 2016, petitioner was
seen by Dr. McElhaney who documented, “[p]ain has been present for since July 2015.” Pet. Ex.
2 at 92.

        The most specific record, documented November 18, 2015 by petitioner’s physical
therapist, places onset of pain “a few days after the [Tdap] shot.”12 Id. at 51. The undersigned
considers “few” to mean two or three days.13

        The affidavits support a finding that petitioner’s pain began within 48 hours of
vaccination. Petitioner claims he immediately began to have pain in his left shoulder after
receipt of the Tdap vaccination. Pet. Ex. 11 at ¶ 3. He described the pain as a “constant . . .

12
  Later records from 2016 reference onset in February 2016. Dr. Oates, on October 17, 2016,
noted petitioner’s “symptoms began last February following a [Tdap] vaccination.” Pet. Ex. 7 at
8. Petitioner’s initial PT evaluation on October 20, 2016 documents onset as “unknown” but
describes petitioner’s pain as “developing in February 2016 after a [] shot in the left shoulder.”
Pet. Ex. 6 at 4. The reference to administration of a flu shot instead of Tdap is erroneous.
Descriptions of onset in February are inconsistent with the earlier in time and most
contemporaneous records, and thus, the undersigned finds them to be less reliable.
13
   If “few” means two days, then onset would be within 48 hours, meeting the causation-in-fact
requirement. If “few” instead means three days, or 72 hours, then petitioner still meets the
causation-in-fact requirement. See Jewell v. Sec’y of Health & Hum. Servs., No. 16-0670V,
2017 WL 7259139 (Fed. Cl. Spec. Mstr. Aug. 4, 2017). Like petitioner’s PT notes, the PT notes
in Jewell place onset “a few days” after vaccination. Id. at *3. Relying heavily on the PT
records, the undersigned in Jewell found the onset of the petitioner’s shoulder injury to be within
72 hours and thus, was medically appropriate. Id. In making this determination, the undersigned
also relied on Atanasoff, who found that while most patients experienced pain within 48 hours,
8% of patients experienced shoulder pain at four days. Id.; Pet. Ex. 25.5 at 2 tbl.1.

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burning sensation in the shoulder muscle and joint” that was worse with movement. Id. at ¶¶ 3,
5. He also found it difficult to lift his left arm over his shoulder. Id. at ¶ 5. Petitioner’s wife,
Gina Taylor, confirms that she began to notice petitioner’s left arm pain the day after
vaccination. Pet. Ex. 12 ¶ at 4. Petitioner’s longtime employee, Mr. Hilton, recalls petitioner
complaining of a sore shoulder the day after vaccination and noted petitioner’s “work was
effected immediately after his vaccination.” Pet. Ex. 13 at ¶ 4.

       The difficulty in ruling on onset in some SIRVA cases is exemplified by the facts here.
Tdap vaccinations can cause soreness. As explained by petitioner’s PCP in his email, post Tdap
vaccine site soreness usually lasts a few days. If the soreness does not go away, then there is
concern for tendonitis or bursitis, the hallmarks of SIRVA. It may be difficult for a petitioner to
determine whether their soreness is a normal reaction to vaccination, or something more.
Regardless of this difficulty, here, based on the petitioner’s email exchange with his physician,
the medical records, and affidavits, the undersigned finds the onset of petitioner’s shoulder pain
began immediately after vaccination, and well within two days, or 48 hours of his July 13, 2015
Tdap vaccination.

               3.      Pain and Limited Range of Motion

        Based on the petitioner’s affidavit and medical records, petitioner’s vaccine-related
symptoms were limited to his left shoulder. Records from petitioner’s August 9, 2015 email to
his PCP and November 9, 2015 visit to Dr. Rajvanshi documented complaints of left shoulder
pain. Pet. Ex. 2 at 47-48. On November 18, 2015, petitioner’s physical therapist, Jaime
McCann, noted petitioner’s pain in his left shoulder, that was moving down to his elbow, and
assessed petitioner with “left tendinopathy of rotator cuff.” Id. at 54. At that visit, petitioner
exhibited decreased ROM with shoulder abduction and internal and external rotation. Id. at 53.

         Petitioner saw orthopedic surgeon, Dr. Cartwright, on February 17, 2016, complaining of
a left shoulder injury for seven months, and he found petitioner “clearly has impingement, rotator
cuff symptomatology, and biceps and SLAP pathology.” Pet. Ex. 3 at 6-8. In March 2016, Dr.
Cartwright noted “ROM shows flexion 160 degrees and abduction 156 degrees.” Id. at 27.

        On October 17, 2016, petitioner saw orthopedist, Dr. Oates, complaining of left shoulder
pain and Dr. Oates’ impression was subacromial impingement/bursitis of left shoulder,
osteoarthritis of left acromioclavicular joint, and left biceps tendonitis. Pet. Ex. 7 at 8-9. From
October to November 2016, petitioner attended PT. Pet. Ex. 6 at 4-18. On initial exam,
petitioner had decreased ROM. Id. at 4. By discharge, petitioner had improved ROM, but it was
not normal. Id. at 16, 18.

        After his January 4, 2017 left shoulder surgery, petitioner attended additional PT
sessions. Pet. Ex. 9 at 9-31. Upon discharge, petitioner was still experiencing limitations in
flexion and abduction. Id. at 26.

       Petitioner’s expert, Dr. Natanzi, opined that petitioner’s pain and decreased range of
motion were isolated to his left shoulder. Pet. Ex. 25 at 9.

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               4.      Other Condition or Abnormality

        Dr. Natanzi identifies no other condition or abnormality that explains petitioner’s
symptoms. Pet. Ex. 25 at 9. In contrast, Dr. Abrams opines that petitioner’s “underlying
medical condition (diabetes/hyperglycemia) was a significant factor in the development and
persistence of his shoulder dysfunction,” and thus, this criteria was not met. Resp. Ex. A at 7-8.
In response, Dr. Natanzi concedes that petitioner’s underlying hyperglycemic state and diabetes
may have predisposed him to an injury, but the injury occurred due to the injection needle
penetrating the structures. Pet. Ex. 31 at 2. Thus, Dr. Natanzi opines petitioner’s diabetes “had
no role in the initiation of [petitioner’s shoulder] pain.” Id. at 3.

        Based upon the medical literature filed by respondent, it appears that it is not uncommon
for people with diabetes to have shoulder impairments. However, the Atanasoff authors stated
that in many cases, conditions including “impingement syndrome, rotator cuff tear, biceps
tendonitis, osteoarthritis[,] and adhesive capsulitis[,] . . . may cause no symptoms until provoked
by trauma or other events.” Pet. Ex. 25.5 at 3. The authors concluded that “some of the MRI
findings . . . may have been present prior to vaccination and became symptomatic as a result of
vaccination-associated synovial inflammation.” Id. Here, petitioner may have had pre-existing
pathology, but he was not symptomatic until after vaccination.

       While petitioner’s diabetes may have made it more likely for him to have suffered a
shoulder injury, and may have affected his clinical course, the undersigned finds that his diabetes
was not an alternative cause, or factor unrelated to vaccination, which caused petitioner’s
symptoms. As Dr. Natanzi explained, petitioner’s shoulder symptoms began only after
vaccination, which is further supported by Atanasoff. Thus, the undersigned finds petitioner’s
vaccination 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, 165 F.3d at 1352-53).

        In conclusion, petitioner’s injury meets the criteria for a SIRVA injury and the clinical
course of petitioner’s injury mirrors a typical SIRVA injury. Therefore, the undersigned finds
petitioner has proven by preponderant evidence a logical sequence of cause and effect and has
satisfied the second Althen prong.

       C.      Althen Prong Three

       Althen Prong Three requires petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
equated to mean a “medically acceptable temporal relationship.” Id. The petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disease’s etiology, it is medically acceptable to infer causation-in-
fact.” De Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The
explanation for what is a medically acceptable time frame must also coincide with the theory of
how the relevant vaccine can cause the injury alleged (under Althen Prong One). Id.; Koehn v.
Sec’y of Health & Hum. Servs., 773 F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro v. Sec’y of
Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013).

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        As stated above, the undersigned finds the onset of petitioner’s left shoulder pain
occurred within 48 hours of vaccination. The timing of onset shows a proximate temporal
relationship between vaccination and injury. See Althen, 418 F.3d at 1278. The temporal
association is appropriate given the mechanism of injury. Thus, petitioner has satisfied the third
Althen prong.

       D.      Alternative Causation

        Because the undersigned concludes that petitioner has established a prima facie case,
petitioner is entitled to compensation unless respondent can put forth preponderant evidence
“that [petitioner’s] injury was in fact caused by factors unrelated to the vaccine.” Whitecotton v.
Sec’y of Health & Hum. Servs., 17 F.3d 374, 376 (Fed. Cir. 1994), rev’d on other grounds sub
nom., Shalala v. Whitecotton, 514 U.S. 268 (1995); see also Walther v. Sec’y of Health & Hum.
Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007). As discussed above in the analysis related to
Althen Prong Two, the undersigned found the respondent failed to establish evidence to show
that petitioner’s SIRVA injury was caused by a source other than his vaccination. Thus,
respondent did not prove by a preponderance of evidence that petitioner’s injury is “due to
factors unrelated to the administration of the vaccine.” § 13(a)(1)(B).

VI.    CONCLUSION

        Based on the record as a whole and for the reasons discussed above, the undersigned
finds there is preponderant evidence to satisfy all three Althen prongs and to establish
petitioner’s July 13, 2015 Tdap vaccination caused his left shoulder pain and limited range of
motion, resulting in the need for surgery. Thus, the undersigned finds that petitioner has
established by preponderant evidence that he is entitled to compensation. A separate damages
order will issue.

       IT IS SO ORDERED.

                                                     s/Nora Beth Dorsey
                                                     Nora Beth Dorsey
                                                     Special Master

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