Court Opinion

ID: 6114015
Source: CourtListenerOpinion
Date Created: 2022-01-31 18:01:35.020648+00
Date Added: 2024-06-11T08:13:25.045441
License: Public Domain

In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                         Filed: January 31, 2022

* * *        *    *   *    *   *    *    **  *   *
A.P.,                                     *              PUBLISHED
                                          *
              Petitioner,                 *              No. 17-784V
                                          *
v.                                        *              Special Master Gowen
                                          *
SECRETARY OF HEALTH                       *              Shoulder Injury Related to Vaccine
AND HUMAN SERVICES,                       *              Administration (“SIRVA”); Measles,
                                          *              Mumps, and Rubella (“MMR”);
              Respondent.                 *              Subcutaneous Injection; Causation-in
                                          *              Fact.
* * * * * * * * * * * * *
Anne C. Toale, Maglio Christopher and Toale, Sarasota, FL, for petitioner.
Meghan Murphy, U.S. Department of Justice, Washington, D.C., for respondent.

                                        RULING ON ENTITLEMENT1

       On June 12, 2017, A.P. (“petitioner”) filed a petition for compensation under the National
Vaccine Injury Compensation Program.2 Petitioner alleges that she suffered a Shoulder Injury
Related to Vaccine Administration (“SIRVA”) to her left shoulder as a result of receiving the
measles, mumps and rubella (“MMR”) vaccination on June 8, 2016. Petition at ¶¶ 1,7(ECF No.
1).

       After the filing of multiple expert reports by both parties and several status conferences
with detailed orders, the petitioner filed motions for a Ruling on the Record and for Findings of
Fact and Conclusions of Law. After a review of the record as a whole, including expert reports,
medical records, affidavits and briefing by the parties, and for the reasons set forth below, I

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.
hereby DENY petitioner’s Table Claim, but GRANT her petition for compensation as a cause in
fact claim.

       I.      Procedural History

        Petitioner filed her claim on June 12, 2017, alleging she sustained a left shoulder injury
by the MMR vaccine administered to her on June 8, 2016. Petition; Petitioner Motion for
Findings of Facts and Conclusions of Law (“Pet. Mot.”) (ECF No. 49). This case was initially
referred to the Special Processing Unit (“SPU”). Petitioner filed medical records to support her
claim on June 26, 2017 and a statement of completion the same day. Petitioner’s Exhibits 1-6
(“Pet. Ex.”) (ECF Nos. 7 & 8). Petitioner also filed an affidavit from petitioner on August 28,
2017. Pet. Affidavit (“Aff.”) (ECF No. 10).

        An initial status conference was held on August 28, 2017 by the former Chief Special
Master. Scheduling Order (ECF No. 11). After several extensions of time, respondent stated
that the review of the medical records had been completed and that settlement was not
appropriate for this case. Respondent’s (“Resp”) Status Report (ECF No. 15).

        Respondent filed the Rule 4(c) report, stating that, “The facts of this case, as reflected in
the petition and accompanying documents have been reviewed by medical personnel of the
Division of Injury Compensation Programs at the Department of Health and Human Services
(“DICP”) and their opinion is that this case is not appropriate for compensation under the terms
of the Vaccine Act. Resp. Report (“Rept.”) at 1-2 (ECF. No. 17). Specifically, respondent stated
that petitioner is alleging a Table Injury, SIRVA, for receiving the MMR vaccine
subcutaneously, which does not fit the Table criteria. Resp. Rept. at 6. Respondent argued that
petitioner did not satisfy the Table criteria primarily because she received the MMR vaccination
subcutaneously; that the medical records do not demonstrate that petitioner had an onset of
shoulder pain within forty-eight hours of receiving the vaccination; and that petitioner did not
demonstrate she had suffered the residual effects or complications of her injury for more than six
months after the administration of the vaccine. Id. at 6-7. Further, respondent stated, petitioner
had not provided an expert report setting forth a reliable medical theory or logical sequence of
cause and effect. Id. at 8.

        On February 20, 2018, the case was transferred to my docket. Notice of Reassignment
(ECF No. 19). The undersigned held an initial status conference on March 28, 2018. Scheduling
Order (ECF No. 21). During the status conference, respondent’s counsel confirmed that the
main issue in the case was that petitioner received a subcutaneous injection rather than an
intramuscular injection and that subcutaneous injections were not covered by the Table for
SIRVA. Id. I ordered the petitioner to file a supplemental affidavit explaining why she did not
seek treatment for eight months after the initial period of approximately two months of treatment
and to file an expert report. Id. at 2.

      Petitioner filed a supplemental affidavit on May 9, 2018. Pet. Ex. 9 (ECF No. 23). On
May 24, 2018, petitioner filed an expert report from an orthopedic surgeon, Dr. Domenick J.

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Sisto.3 Pet. Ex. 10 (ECF No. 26). Respondent filed an expert report from Geoffrey B. Abrams,
M.D.4 on December 20, 2018. Resp. Ex. A (ECF No. 28).

        A Rule 5 status conference was held on February 26, 2019. Rule 5 Order (ECF No. 29).
The Rule 5 Order summarized petitioner’s expert, Dr. Sisto’s opinion that the subcutaneous
injection likely hit the posterior branch of the axillary nerve in the left shoulder area, and
respondent’s expert, Dr. Abrams disagreed with that theory. Id. at 3. After review of both
reports and the multiple articles submitted therewith, I indicated that it was plausible that the
subcutaneous injection of the MMR vaccination did cause petitioner’s shoulder injury and that
her symptoms were similar to those reported in multiple other SIRVA cases. Id. I also noted
that the petitioner had had a good recovery and I encouraged the parties to engage in informal
settlement discussions. Id.

       After engaging in unfruitful settlement negotiations, the respondent filed a status report
requesting a status conference and that this case be set for an entitlement hearing. Resp. Status
Rept. (ECF No. 38). On January 9, 2020, petitioner filed a supplemental expert report by
Thomas Wright, M.D.5 Pet. Ex. 12 (ECF No. 39). Respondent filed a responsive supplemental

3
  Dr. Domenick J. Sisto, is a board-certified orthopedic surgeon. Pet. Ex. 11 at 1. Dr. Sisto currently works as an
orthopaedic surgeon at the Los Angeles Orthopaedic Institute, where is specializes in adults with knee and shoulder
injuries. He received his undergraduate degree at the University of Vermont in 1975 and received his medical
degree from George Washington University Medical School in 1979. Id. Dr. Sisto did his residency at the Hospital
for Special Surgery in New York City, then did a fellowship in sports medicine at the Kerlan-Jobe Orthopaedic
Clinic in Inglewood, California. Id. He was a clinical instructor at the Department of Orthopaedic Surgery at
UCLA School of Medicine between 1986-1988. Id. at 2. Dr. Sisto is licensed to practice medicine in New York,
California, and Connecticut. Id. at 2. He serves as an editor for Case Reports in Surgery and is a Principal
Reviewer for the American Journal of Sports Medicine. Id. at 3. Dr. Sisto has been the lead author in multiple
published medical articles on a variety of orthopedic topics, including arthroplasty of the knees, ACL reconstruction
and shoulder stability. Id. at 4-5.
4
  Dr. Geoffrey Abrams is a board-certified orthopedic surgeon. Resp. Ex. A at 1. He currently serves as an
Assistant Professor of Orthopedic Surgery at the Stanford University School of Medicine. Id. Dr. Abrams received
his undergraduate degree in 2000 from Stanford University and received his medical degree from the University of
California, San Diego. Resp. Ex. B at 1. He did a surgical internship at Stanford University Hospital and Clinics
from 2007-08 and completed his residency in 2012 at the same hospital in the Department of Orthopedic Surgery.
Id. He has a subspecialty certificate in Orthopedic Sports Medicine. Id. at 2. Dr. Abrams is licensed to practice
medicine in the states of California and Illinois. Id. Dr. Abrams has authored or co-authored numerous medical
articles on various orthopedic topics. Id. at 2-5. He currently serves as the Director of Sports Medicine for Stanford
University Varsity Athletics, as well as, the Director of the Lacob Family Sports Medicine Center at Stanford
University. Resp. Ex. A at 1.
5
  Dr. Thomas Wright is a board-certified orthopedic surgeon. Pet. Ex. 13 at 2. He received his undergraduate
degree in biology from Emory University in 1979 and his medical degree from the University of Florida in 1983.
Id. Following medical school, he had an internship in General Surgery at the University of Florida and did a
residency in Orthopedic Surgery from 1984-1989. Id. Dr. Wright also had a fellowship at the Mayo Clinic in Hand
and Upper Extremity Surgery. Id. at 2. Dr. Wright currently serves as a professor of orthopedic surgery at the
University of Florida and is the Division Chief of the Hand and Upper Extremity surgery. Id. at 2. He also serves as
an affiliate professor of the University of Florida’s College of Public Health and Health Professions. Id. Dr. Wright
has also authored or co-authored numerous medical articles on the hand and upper extremity orthopedic topics. Id.
at 3-20. Dr. Wright also serves as a journal reviewer for multiple medical journals, including the Journal of Bone
and Joint Surgery, Journal of Hand Surgery, and Journal of Shoulder and Elbow Surgery. Id. at 31.

                                                          3
report by Dr. Abrams on April 3, 2020. Resp. Ex. C (ECF No. 40). On May 14, 2020, petitioner
filed a responsive supplemental report by Dr. Wright. Pet. Ex. 15 (ECF No. 41).

        A second Rule 5 status conference was held on August 11, 2020. Rule 5 Order (ECF No.
43). During this status conference, after reviewing the additional expert reports filed by both
parties and petitioner’s supplemental affidavit, I explained that the record, “[as the record] stands
today, supports petitioner’s claim and [she] has a high likelihood of success.” Id. at 2. The
undersigned again encouraged the parties to resolve the case informally. Id. Respondent was
ordered to file another expert report, responding to Dr. Wright’s responsive report. Id. at 3.

       On October 6, 2020, respondent filed a second supplemental report by Dr. Geoffrey
Abrams and supporting medical literature. Resp. Ex. D (ECF No. 45). Petitioner filed
supporting medica literature on November 23, 2020. Pet. Ex. 18.

        On November 23, 2020, petitioner filed the present motion for a Ruling on the Record
and filed a memorandum in support of her motion the same day. Pet. Mot. (ECF No. 48); Pet.
Memorandum (“Pet. Mem.”) (ECF No. 49).

       Respondent filed a response to petitioner’s motion on January 27, 2021. Resp. Response
(ECF No. 52). On February 3, 2021, petitioner filed a reply to respondent’s response. Pet.
Reply (ECF No. 53).

       This matter is now ripe for adjudication.

       II.     Evidence Submitted

               a. Petitioner’s Medical Records

        On June 2, 2016, petitioner was admitted to Baptist Medical Center in Jacksonville,
Florida for the delivery of her fifth child. Pet. Ex. 2 at 125; Pet. Ex. 9 at ¶ 2. Petitioner gave
birth to a healthy female infant without complications. Pet. Ex. 2 at 125. On June 8, 2016, prior
to being discharged, petitioner received the MMR vaccination in her left upper arm. Id. The
vaccine administration record provides that the vaccine was intended to be administered
subcutaneously. Id.

        On June 9, 2016, petitioner contacted her OB/GYN, inquiring about contraceptives
covered by her insurance. Pet. Ex. 2 at 63. There was also an internal office note indicating that
petitioner’s first post-partum office visit was scheduled for July 18, 2016. Id.

        On June 20, 2016, petitioner called her OB/GYN, this time complaining of left arm pain.
Pet. Ex. 2 at 138. Under Chief Complaint it provided, “Pt calling stating unable to move left
arm. Pt states [illegible] after given shot in arm after delivery. Pt states now 2 weeks later
unable to move arm at all. Pt denies any swelling or pain. Pt states arm is ‘frozen.’” Id.
Petitioner had an appointment the following day on June 21, 2016. Id. at 109. At this
appointment, it was noted that petitioner’s weight was 161.2. Id. The record states, “Pt s/p

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vaginal delivery 6/6/16 c/o unable to move left arm.” Id. An MRI of petitioner’s left shoulder
was ordered. Id. at 58, 62.

        Petitioner had an MRI of her left shoulder performed on June 24, 2016. Pet. Ex. 2 at 6.
The MRI revealed a partial thickness tear of the distal infraspinatus tendon at insertion along the
bursal surface (approximately 50% thickness). Id. On June 27, 2016, Dr. Tiffany Wells
reviewed petitioner’s MRI and observed that it demonstrated a “50% tear in infraspinatus tendon
(part of rotator cuff),” and requested that petitioner be referred to orthopedics. Pet. Ex. 2 at 61.

        On June 28, 2016, petitioner presented to Jacksonville Orthopaedic Institute for an
evaluation of her left shoulder. Pet. Ex. 4 at 43. Petitioner reported that her pain had been
present for approximately three weeks. Id. Petitioner reported she had stiffness in the shoulder
and was no longer able to raise her arm overhead. Id. Additionally, petitioner described her pain
as diffuse in location and sharp in quality. Id. At this appointment, petitioner associated the
onset of her pain to the vaccination she received before being discharge from the hospital after
delivery of her fifth child. Id. The record provides:

       She notes that she gave birth three weeks ago and afterwards was offered the measles,
       mumps and rubella vaccine. She states that after they injected into her lateral left
       shoulder, she began to have increased intense pain and range of motion problems.

Pet. Ex. 4 at 43. Petitioner stated that her pain was a 5/10. Id. A physical exam of the left
shoulder revealed that petitioner’s range of motion was restricted with pain, her flexion and
abduction was restricted to 90 degrees (compared to the right shoulder of 180 degrees), and that
her internal rotation was only to L2 (compared to the right of internal rotation to T12). Id. at 44.
Orthopedist, Dr. Michael Adams, observed that petitioner had strength of 4/5 with external
rotation and abduction, she had generalized tenderness to palpation at “about the deltoid girdle,”
and her bicipital groove was tender to the touch. Id. Dr. Adams reviewed the MRI from June
24, 2016 and observed that it showed, “increased signal along the bursal surface of the
infraspinatus tendon consistent with partial thickness tear,” and that petitioner had “some fluid in
the biceps sheath proximally.” Id. Dr. Adams diagnosed her with left shoulder joint pain and a
left partial acute rotator cuff tear. Id. at 44-5. Dr. Adams recommended a steroid injection. Id.
at 45. Under “Plan,” he noted that petitioner had asked about post injection injuries. Id. He
wrote, “I do not think it is out of the realm of question that she had post-injection stiffness and
pain, but I am unclear at this time that the rotator cuff is a consequence of her vaccination.” Id.

       Dr. Adams gave petitioner a physical therapy prescription. On the prescription it
explains, “36-year-old female with 3 weeks of left shoulder pain post vaccination. Partial
thickness bursal sided rotator cuff tear on MRI.” Id. at 27. The prescription was for six weeks of
physical therapy 2-3 times a week. Id. He also gave her a steroid injection. Id. at 45.

        Petitioner had her first physical therapy appointment on July 4, 2016. Pet. Ex. 5 at 28.
The note provides, “[Petitioner] states that the initial onset occurred on 6/01/2016 when she
reports she had a baby 4 weeks ago and reports insidious onset of [left] shoulder pain.” Id.
Petitioner also reported that she received a shot in the hospital, “which caused a lot of neck pain
and then a few days later her shoulder began getting stiff and she began having pain.” Id.

                                                 5
Additionally, petitioner reported that her cortisone injection had helped “a lot.” Id. At this
appointment, petitioner reported her pain as a 2 to 3 out of 10. Id. She also reported that she had
pain while doing her hair, lifting her shoulder and her shoulder feels stiff. Id. The physical
therapist noted that petitioner had 65% function of her upper left extremity and that petitioner
explained that most of her pain was in the anterior lateral shoulder. Id. Petitioner was tender on
upper trapezoid, supraspinatus tendon, biceps tendon long head, posterior cuff, and parascapular
muscles. Id. Further, her physical examination showed that she had reduced strength upon
shoulder flexion, abduction, and on external and internal rotation. Id. at 29-30. Petitioner’s
assessment was, “Signs and symptoms are characteristic of left partial acute rotator cuff
tear….[Patient] presents with significant loss of shoulder function, strength and active range of
motion.” Id. at 30. The plan was for her to attend physical therapy 2-3 times per week for 8
weeks. Id.

        On August 1, 2016, petitioner had a follow-up appointment with orthopedist, Dr. Adams.
Pet. Ex. 4 at 22. Under “History of Present Illness,” it was noted that petitioner had left shoulder
pain that had been present for 2 months. Id. It explained, “It started after a post-delivery vaccine
and was severe in intensity and diffuse in nature, associated with significantly decreased range of
motion.” Id. Petitioner reported that her pain was “dull and mild in severity,” and that her pain
level was a 1 out of 10, but it had increased in intensity during physical therapy. Id. A physical
exam of petitioner’s left shoulder showed she had full range of motion and her strength was five
out of five. Id. at 23. Despite these findings, he suggested that petitioner finish physical therapy.
Id. Dr. Adams also explained, “We did review some scientific evidence of post vaccine injection
rotator cuff tear when placed in the wrong place. It does appear at this time though, that she is
healing appropriately. No further corticosteroid injection recommended at this time.” Id. at 23.

        On August 5, 2016, petitioner had another physical therapy appointment with therapist,
Kurtis P. Mullaney. Pet. Ex. 5 at 6. While petitioner’s active range of motion for her left
shoulder was documented as “within normal limits,” her strength on flexion, abduction and
external rotation was documented as 4+/5, while her right shoulder had 5/5 strength. Id.
Therapist Mullaney noted that petitioner’s general progression towards the treatment goals was
at 90 percent, but she was still lacking external strength. Id.

         Petitioner was discharged from physical therapy on August 10, 2016. Pet. Ex. 5 at 4.
Therapist Mullaney wrote, “The patient notes functional improvements increased ability to
reach, increased ability to lift, and improved independence with ADL’s. Shoulder feels good.”
Id. at 4. Petitioner’s active range of motion for her left shoulder was documented as “within
normal limits.” Id. However, she again demonstrated decreased strength on flexion, abduction,
and external rotation. Id. Petitioner was assessed as, “General progression towards the patient’s
remaining treatment goals is presently at 80 percent. Knows [Home Exercise Program] well and
had no questions about program.” Id.

        On April 14, 2017, petitioner returned to Dr. Adams for a follow-up of her left shoulder
with persistent pain. Pet. Ex. 6 at 22. He wrote, “Initially she was seen in August 2016 with
post vaccination pain in the shoulder and diagnosed by MRI with partial bursal sided rotator cuff
tear.” Id. Petitioner reported that she had improvement for about one month following her
physical therapy and the corticosteroid injection she received. Id. She described her pain as

                                                  6
located in posterior aspect of her shoulder, which was dull and burning in quality and moderate
in severity. Id. Petitioner reported that her pain was a 5 out of 10 and pain was worse with
lifting and reaching. Id. On physical exam petitioner demonstrated a full range of motion, but
with pain from “80 to 120 degrees of flexion and abduction.” Id. at 23. Her strength was
recorded as a 4 out of 5 and she showed one positive impingement sign. Id. Dr. Adams
recommended petitioner have an additional MRI to evaluate for “persistence of tear or additional
pathology,” given her persistent symptoms and failure to respond to injection and therapy. Id. at
23.

        Petitioner had a second MRI of her left shoulder on April 21, 2017. Pet. Ex. 6 at 12. The
MRI found abnormal bursal surface signal of the distal anterior supraspinatus adjacent to the
footplate. Id. The radiologist, Dr. Brad Talley, opined that the abnormal signal was more related
to tendinosis rather than a low-grade bursal surface partial tear. Id. Additionally, “a tiny sliver
of fluid” was found in the subacromial subdeltoid bursa. Id. at 13.

        Petitioner returned to Dr. Adams on April 26, 2017 following her left shoulder MRI. Pet.
Ex. 6 at 9. At this appointment, petitioner reported that her pain was a 4-5 out of 10. Id. Dr.
Adams wrote that he had reviewed the MRIs and the MRI report from April 21, 2017. Id. at 10.
He noted that petitioner had “mild abnormal signal on the bursal side of the anterior
supraspinatus which may represent a partial tear.” Id. at 10-11. He also wrote, “There is some
persistent tenosynovitis in the proximal biceps tendon which is consistent with review from MRI
from last year.” Id. at 11. He diagnosed petitioner with left shoulder joint pain, left partial
chronic rotator cuff tear, and left shoulder bursitis. Id.

               b. Petitioner’s Affidavit

       On May 8, 2018, petitioner executed a detailed affidavit. Pet. Affidavit (“Aff.”) (ECF
No. 23). Petitioner stated that while getting ready to leave Baptist Medical Center on June 8,
2016 after the birth of her fifth child, the nurse, Christy, recommended she receive an MMR
booster. Pet. Aff. at ¶¶ 2-3. She explained that the nurse, Christy, administered the shot at
approximately 5:30 pm to the back of her upper left arm. Id. at ¶ 3. Petitioner stated, “As I
received the shot, the pain was excruciating,” and she had asked the nurse if it “was going into
the muscle.” Id. Petitioner stated, “the pain was so intense I felt like it was going into my bone.
I almost came up off the bed that I was sitting on!” Id. Even though petitioner had been given
Percocet and ibuprofen for afterbirth pains from labor, she could still feel the pain. Id. at ¶ 4.

         Petitioner also described how the vaccine was administered to her by the nurse on June 8,
2016. Id. at ¶ 6. She explained that the nurse had her sit up on the bed, the nurse stood next to
and over her to give the injection. Id. Petitioner stated that she “felt the shot being given and it
was high on my upper arm towards the back.” Id. The shot was “immediately and unusually
painful.” Id. In addition to the shoulder pain, petitioner began to experience “terrible neck
pain,” which she described as pain on her left side that “radiated down into [her] left shoulder.”
Id. at ¶ 7. Petitioner stated that, “The neck pain started after the shoulder pain.” Id. She
explained that from Wednesday until Monday, June 13th, 2016, her arm and should became stiff.
Id. Petitioner explained that by Wednesday, June 15th, she could not lift her arm. Id. Petitioner
stated that her arm was “weak and shaky,” and she could not lift it up to a 90 degree angle of her

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body. Id. Petitioner stated that she was unable to wash or brush her hair or apply deodorant. Id.
She explained that the pain and range of motion, “…made taking care of my newborn and my
other children extremely difficult. I was trying to nurse my newborn and yet I couldn’t move my
left arm.” Id. Petitioner thought that it was a minor side effect from the MMR shot, but it was
not getting better, but worse. Id.

         Petitioner stated that she told her OB/GYN on June 20, 2016 that she was unable to move
her left arm and she was able to meet with an orthopedist a week later. Id. at ¶ 8. Petitioner
stated that the prescribed physical therapy and injectable cortisone gave her improvement by the
time the therapy sessions ended in August. Id. at ¶ 8. She explained that, “Over the course of
therapy, including my injection, my shoulder pain was reduced and therapy ended on August 5,
2016….After that point, I had motion in my arm but the pain in the back of my upper arm and
shoulder returned after a month or so, and I had not regained strength in my arm.” Id. She stated
that her doctor told her that the rotator cuff should heal completely since “the tear was only
50%.” Id. She stated that, “However…the pain and stiffness, while never completely gone,
started to worsen, so I saw my orthopedist in April 2017.” Id.

        Petitioner stated that between August 2016 and April 2017 her shoulder/arm symptoms
did not completely disappear, but reduced, so that she could get on with her life. Id. at ¶ 9. She
explained that as the wife of a pastor, she is very involved in her husband’s church and “keeping
it running,” as well as, home schooling her children. Id. Petitioner stated that she would, “assist
in physical activities,” that she was “always involved in the kids’ games, including more physical
ones,” and that she even participated in helping build her new home while pregnant, but she was
unable to do these things even after she completed her physical therapy in August 2016. Id. She
concluded, stating, “During the gap in treatment, as I noted above and told my orthopedist, the
left shoulder pain persisted and affected my ability to be [as] physical as I had been.” Id.

               c. Petitioner’s Expert Reports

                   1. Dr. Domenick J. Sisto, MD

        Petitioner submitted an expert report from Dr. Domenick J. Sisto, an orthopedist on
August 24, 2018. Pet. Ex. 10 (ECF No. 26). Dr. Sisto reviewed petitioner’s medical records and
wrote, “Following my review of the medical records it is clear that this patient sustained an
injury to her left shoulder following the injection of the vaccination that she had sometime in the
early aspect of June 2016.” Pet. Ex. 10 at 12. He also stated that, “My review reveals no
previous records of any problems with the shoulder….” Id.

        Dr. Sisto also noted that petitioner associated the onset of her shoulder pain to her MMR
vaccination on June 8, 2016 to her orthopedist, Dr. Michael Adams. He wrote, “Her complains
are clearly outlined in the report dated June 28, 2016 from Dr. Michael Adams at the
Jacksonville Orthopedic Institute, who documented a post-vaccination injection stiffness of the
shoulder.” Id. at 12. Dr. Sisto observed that petitioner’s medical records from Dr. Adams,
“clearly show that her complaints were secondary to the injection.” Id.

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        Dr. Sisto explained that, “It is well diagnosed and recognized that post-injection
syndrome is unfortunately very common following vaccinations where the medication is given
either intramuscularly or subcutaneously….” Pet. Ex. 10 at 12. He opined that injections given
intramuscularly or subcutaneously can irritate the axillary nerve, which runs approximately 1
inch deep to the deltoid musculature. Id. He opined that a 5/8 inch needle used for subcutaneous
injection or a one inch needle used for intramuscular injection can “cause irritation and
disruption of the axillary nerve and deltoid function.” Id. Dr. Sisto stated that, “The deltoid
muscle is the main muscle that moves the shoulder and certainly can be irritated by an injection.”
Id.

        With regards to the onset of petitioner’s shoulder pain and dysfunction, Dr. Sisto wrote,
“The timing of [stiffness and pain] is obviously consistent with post-injection syndrome. She
had immediate pain and sought treatment after injection.” Id. at 13. He opined, “….this is
clearly a case of shoulder stiffness and irritation of the axillary nerve following her injection.”
Id.

        Subsequently, petitioner informed the Court that Dr. Sisto was unable to continue as an
expert in this case due to personal reasons. Pet. Mot. at n.1.

                        2. Dr. Thomas W. Wright

        On January 9, 2020, petitioner filed a supplemental expert report from Dr. Thomas W.
Wright, an orthopedic surgeon. Pet. Ex. 12 (ECF No. 39). In his first report, Dr. Wright stated,
“It is my opinion that [petitioner] sustained an injection site injury to her left shoulder due to the
MMR vaccine injection on 6/8/2016.” Pet. Ex. 12 at 1. He noted that petitioner had no pre-
existing history of pain in her left shoulder. Id. He also stated, “….the pain started immediately
after the injection and persisted [for] at least 10 months.” Id.

        Dr. Wright stated that he did not believe that petitioner’s axillary nerve was directly
injured with the injection, but instead, the injection could have started a local inflammatory
process near the nerve, which can cause pain. Id. He opined that petitioner had “a direct
injection into the subacromial space and possibly into the infraspinatus which might explain the
edema in the infraspinatus on the initial MRI.” Id. He opined that, “An injection into the
subacromial space can be responsible for initiating a major inflammatory event in the
subacromial bursae resulting in persistent, severe pain.” Id.

        Dr. Wright referenced the article Vaccination-related shoulder dysfunction, by Bodor and
Montalvo, to support his opinion. Pet. Ex. 14.6 The Bodor article examined two case reports
where two healthy individuals developed shoulder and arm pain, weakness and loss of range of
motion following vaccination. Id. at 1. The authors hypothesized that the vaccine was injected
into the subdeltoid bursa in the two individuals, which caused a “robust local immune and
inflammatory response.” Id. at 2. Using ultrasound, the authors measured the location of the
subacromial bursa and found that it extended from 3.0 to 6.0 cm beyond the lateral border of the
acromion. Id. at 2. They also measured the depth below the skin of the subacromial bursa and
found that it lay between 0.8 cm to 1.6 cm below the skin. Id. Bodor and Montalvo explain,

6
    Bodor, M. and Montalvo, E., Vaccination-related shoulder dysfunction, 25 Vaccine 585-587 (2007). [Pet. Ex. 14].

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“Given that the subdeltoid bursa is continuous with the subacromial bursa, this led to
subacromial bursitis, bicipital tendonitis, and inflammation of the shoulder capsule.” Id. at 2.
The authors explained that the first individual developed adhesive capsulitis or frozen shoulder
and the second patient had moderate to severe reduction of shoulder range of motion. Id. at 2-3.
Bodor and Montalvo observed that both patients received multiple injections for the pain to
resolve, “consistent with a primary inflammatory etiology rather than a mechanical overuse
problem.” Id. at 3. Further, the authors recommended that “future influenza and pneumococcal
vaccination guidelines [should] specify that injections should not be performed in the upper third
of the deltoid muscle. Id. at 3.

      Petitioner filed a supplemental report from Dr. Wright on May 14, 2020. Pet. Ex. 15
(ECF No. 41). Dr. Wright’s supplemental report was a response to respondent’s expert report
from Dr. Abrams.

        Dr. Wright stated that while the exact location of the injection given petitioner was not
known, “it is most likely that she was injected in the subacromial space, based on her positive
response to the subacromial steroid injection, and possibly in the infraspinatus.” Pet. Ex. 15 at 3
(original emphasis). Dr. Wright, responding to Dr. Abrams, stated that Dr. Abrams was
assuming that the MMR vaccine was administered in the recommended site of administration for
subcutaneous vaccines by the Centers for Disease Control (“CDC”). Id. at 3; see also Resp. Ex.
C at 1. The CDC diagram Dr. Abrams included in his report, showing the recommended site for
a subcutaneous administration for the MMR vaccine, highlighted an area on the posterior triceps
muscle about half-way down the upper arm. Resp. Ex. C at 1. Dr. Wright noted that aside from
petitioner’s chart, which notes that petitioner received the vaccine in her “left upper,” arm, it
does not provide the precise site of administration. Pet. Ex. 15 at 3.

        Dr. Wright also explained that the package insert for the MMR vaccine itself provides
site administration instructions. Pet. Ex. 15 at 3. The package insert provides, “The dose for any
age is 0/5 ml administered subcutaneously, preferably into the outer aspect of the upper arm.”
Id. Dr. Wright asserted that the package insert provides a much broader charge with regard to
site administration compared to the CDC recommendation and the triceps muscle is not
specified. Id.

        Dr. Wright also cited to article by Eileen Shepard, titled, Injection technique 2:
administering drugs via the subcutaneous route, which provides multiple sites available for
subcutaneous injection. Pet. Ex. 17 at 1.7 The article explains that, “Recommended sites for
subcutaneous injection include the lateral aspects of the upper arm and thigh, and the umbilical
region of the abdomen. The back and lower loins can also be used.” Id. at 1. Importantly, the
article observes, “It is important to avoid inadvertently injecting the drug into muscle, as
intramuscular injection can affect drug absorption….” Id. The article describes that “a lifted
skinfold technique (pinching or bunching the skin) can be used to lift the subcutaneous layer
away from the underlying muscle….This method reduces the risk of inadvertent intramuscular
injection when undertaken correctly; however, releasing the skin too quickly before the injection
is completed or lifting it incorrectly can increase that risk.” Id. Dr. Wright asserted that the

7
 Shepard, E., Injection technique 2: administering drugs via the subcutaneous route, 114 Nursing Times [online],
55-57 (2018). [Pet. Ex. 17].

                                                        10
“lateral aspect of the lower part of the upper arm” area identified in the Shepard article could
encroach on the subacromial space. Pet. Ex. 15 at 2.

        Dr. Wright wrote that, “Both Dr. Adams’ clinical examination of [petitioner] and the
MRI findings support a conclusion that the injection was given in her shoulder area and not in
the triceps region. Pet. Ex. 15 at 2. He noted that petitioner exhibited generalized tenderness to
palpation near the deltoid insertion on the acromion, “which is directly over the posterior greater
tuberosity and infraspinatus insertion site.” Id. at 2. He also explained, “The MRI demonstrated
an abnormal signal in the infraspinatus tendon at its insertion along the bursal surface. This is
located directly underneath the deltoid, where [petitioner] felt tenderness.” Id. at 2-3.

       Dr. Wright opined that the injection was most likely given in the green circled area on the
image of the posterior muscles of the upper arm (recreated below), which was “the most likely
explanation for her clinical presentation and her response to treatment. Id. at 3.

        Finally, Dr. Wright responded to Dr. Abrams’ assertion that petitioner was overweight at
the time of receiving the vaccine, which would have lessened the risk of axillary nerve injury.
Pet. Ex. 15 at 2; see also Resp. Ex. A at 7. Dr. Wright stated that at the time of petitioner’s first
orthopedic consultation her BMI should be 25.8, according to the CDC BMI calculator.
Petitioner’s BMI was actually measured at 25.9 and Dr. Wright observed that the petitioner “was
only several weeks post-partum and breastfeeding, any excess weight was likely concentrated in
her abdominal area and breasts. This is not likely to be relevant to her shoulder anatomy.” Pet.
Ex. 15 at 2.

                                                 11
                 d. Respondent’s Expert Reports

       Respondent submitted expert reports from Dr. Geoffrey D. Abrams, an orthopedic
surgeon. Respondent submitted Dr. Abrams first report on December 20, 2018. Resp. Ex. A
(ECF No. 28).

        In responding to Dr. Sisto’s initial report, Dr. Abrams stated that there was no
documented evidence that petitioner experienced sensory or motor pathology of the axillary
nerve. Resp. Ex. A at 2. Dr. Abrams wrote, “In a typical axillary nerve injury, decreased
sensation about the lateral shoulder would be reported,” but petitioner’s treating orthopedist, Dr.
Adams’ “indicates that the left shoulder is neurovascularly intact,” which indicating no apparent
dysfunction in the axillary nerve sensory function. Id. at 2. Dr. Abrams also stated that neither
of petitioner’s MRIs demonstrated findings consistent with axillary neuropathy. Id.

        Dr. Abrams stated that the recommended subcutaneous injection site for the MMR
vaccine “is the posterior triceps aspect of the upper arm.” Id. at 4. He argued that even if the
vaccine injection was not given at the recommended 45-degree angle, the depth of the axillary
nerve in the “more posterior location is even deeper than found on the lateral aspect of the
shoulder.” Id. He concluded his first report that “there is no objective evidence of injury to the
axillary nerve following petitioner’s receipt of the vaccine administration….it is with reasonable
medical certainty that the petitioner’s shoulder dysfunction is not related to injury of the axillary
nerve.” Id.

        Dr. Abrams second report responded to Dr. Wright’s initial report. Resp. Ex. C at 1. He
states that “it is unlikely” that petitioner’s shoulder dysfunction was caused by a direct injection
of the vaccine into the subacromial space. Id.

        Dr. Abrams re-stated that the “location of the injection for an MMR vaccine is in the
posterior triceps aspect of the upper arm. It is not possible to reach the subacromial space with
an injection given in this location.” Id. He also explained, “a subcutaneous injection is given at
a 45-degree angle, specifically to avoid penetration into the intra-muscular tissues. This makes
deep penetration of the needle even less likely.” Id. at 2. Dr. Abrams stated that the standard
needle length for an MMR vaccination is 5/8th” or 15.9 mm and even if the injection was given
improperly, “it would not be long enough to reach the subacromial space (or the more deeper
infraspinatus tendon…).” Id. Dr. Abrams cited to the article by Nakajima et al., which
examined intramuscular injection sites and proposed a new injection site for intramuscular
injections in the deltoid muscle. Resp. Ex. A, Tab 8 at 1 & 5.8 Dr. Abrams asserted that the
Nakajima article found that the subcutaneous thickness of females at the “typical injection site,
as measured by ultrasound ranged from 6-8 mm and that the thickness of the deltoid muscle at
this location ranged from approximately 15-20 mm.” Resp. Ex. C at 2. He argued that a needle
would have to traverse a minimum distance of approximately 21 mm to even reach the
subacromial space. Id.

8
 Nakajima Y. et al., Establishing a new appropriate intramuscular injection site in the deltoid muscle, 13 Human
Vaccines & Immunotherapeutics 2123-2129 (2017). [Resp. Ex. A, Tab 8].

                                                        12
         The Nakajima article examined the subcutaneous tissue thickness to “determine the
appropriate depth of needle insertion for intramuscular injection.” Id. at 2. The authors of the
study looked at the subcutaneous thickness at four different injection sites that have been
“recommended for safe and appropriate” intramuscular injection sites in the deltoid muscle. Id.
at 1. Subcutaneous thickness measured by ultrasound in females at the four different injection
sites ranged from 3.5 mm to 13.5 mm, with the thinnest subcutaneous layer found at the injection
site approximately 3 cm below the mid-acromion lateral border and the thickest subcutaneous
layer found at the injection site approximately 9 cm below the mid-acromion lateral border. Id.
at 4. The article also examined the thickness of the deltoid muscle to identify which injection
site is thick enough to insert the needle for an intramuscular injection. Id. at 3. The authors
found that the deltoid muscle in both male and female were thinnest at the injection site
approximately 3 to 5 cm below the mid-acromion lateral border and the deltoid muscle gradually
increased distally from the mid-acromion lateral border. Id. at 3-4.

        Additionally, Dr. Abrams asserted that petitioner had an increased BMI, which would
“serve to further increase the distance the needle would have to traverse, making the claim of the
subacromial penetration even less likely.” Resp. Ex. C at 2. Dr. Abrams concluded, “the facts of
the case and the evidence within the medical record make it extremely unlikely that the petitioner
suffered a SIRVA related injury to her shoulder.” Id. at 3.

       III.    Petitioner’s Table Injury

               a. Standard for Adjudication for a Table SIRVA

       The QAI for SIRVA provides:

       (10) Shoulder injury related to vaccine administration (“SIRVA”). SIRVA manifests as
       shoulder pain and limited range of motion occurring after the administration of a vaccine
       intended for intramuscular administration in the upper arm. These symptoms are thought
       to occur as a result of unintended injection of vaccine antigen or trauma from the needle
       into and around the underlying bursa of the shoulder resulting in an inflammatory
       reaction. SIRVA is caused by an injury to musculoskeletal structures of the shoulder
       (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury an
       abnormalities on neurological examination or nerve conduction studies (“NCS”) and/or
       electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the
       condition causing the neurological abnormality is not known). A vaccine recipient shall
       be considered to have suffered a SRIVA if such recipient manifests all of the following:

       (i)     No history of pain, inflammation or dysfunction of the affected shoulder prior to
               intramuscular vaccine administration that would explain the alleged signs,
               symptoms, examination findings, and/or diagnostic studies occurring after vaccine
               injection.
       (ii)    Pain occurs within the specified time-frame;
       (iii)   Pain and reduced range of motion are limited to the shoulder in which the
               intramuscular vaccine was administered; and

                                                13
       (iv)    No other condition or abnormality is present that would explain the patient’s
               symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis,
               mononeuropathies, or any other neuropathy.).

   42 C.F.R. § 100.3(c)(10)(i)-(iv).

               b. Petitioner’s contentions

        Petitioner contends that she has met her burden of proof for a Table SIRVA. Pet. Mot. at
7. Petitioner argues that the Vaccine Injury Table includes SIRVA as a Table Injury for the
MMR vaccine. Id. at 8. Specifically, petitioner argues that improper administration of the MMR
vaccine can satisfy the Criteria for a Table SIRVA. Id.

        Petitioner argues that respondent’s position, “that MMR can, under no circumstances,
result in a table injury because it is meant for subcutaneous administration, rather than
intramuscular,” is inconsistent with the actual Vaccine Injury Table, which includes SIRVA as a
table injury for MMR. Id. at 8-9. Further, petitioner contends that the respondent is “advancing
an erroneous interpretation of the Vaccine Injury Table and its QAI for SIRVA.” Id. at 8.

        Petitioner argues that the introductory paragraph of SIRVA does four things: (1)
describes how SIRVA “manifests,” with shoulder pain and limited range of motion; (2) describes
how SIRVA “occur[s],” “from the unintended injection of vaccine antigen or trauma from the
needle into and around the underlying bursa of the shoulder….” (3) describes what SIRVA is
not; and (4) sets forth four criteria for “who shall be considered to have suffered SIRVA.” Id. at
10. Petitioner acknowledges that the introductory paragraph contains the phrase, “vaccines
intended for intramuscular administration,” but argues that it is “legally improper to read this
sentence in isolation and must be considered in context and harmonized with both the Table and
entire QAI. Id. Specifically, petitioner argues that the second sentence of the QAI SIRVA
paragraph, which provides, “unintended injection of vaccine antigen or trauma from the needle
into and around the underlying bursa” is not intended to exclude injuries where a vaccine should
have been administered subcutaneously, “but for whatever reason, were administered
intramuscularly.” Id.

        Petitioner posits that the QAI acknowledges that SIRVA occurs when the vaccine is
inadvertently administered into the “tendons, ligaments, bursae, etc,” as opposed to the intended
muscle. Id. at 11. Petitioner suggests that, “The two sentences read together clearly contemplate
a scenario where the vaccine administrator (not the manufacturer), intends to place the injection
in one location, i.e. in a muscle, but inadvertently places it someplace else.” Id. (original
emphasis). Further, petitioner states, that the QAI does not explicitly exclude vaccines (to be
considered for a SIRVA) which have been designed by the manufacturer to be injected
subcutaneously, but instead are inadvertently injected intramuscularly, causing injury. Id.

         Then petitioner argues that the introductory paragraph for SIRVA in the QAI would add a
fifth criteria to establish a SRIVA by requiring that a vaccine must have been intended for
intramuscular injection by the manufacturer. Id. at 11. Petitioner contends that if respondent had
intended to exclude vaccines intended for subcutaneous administration from SIRVA Table

                                                14
injuries, respondent should have done so explicitly and not included SIRVA as a covered injury
for MMR in the Table itself. Id. at 11. To advance her argument, petitioner observes that the
first criteria in the SIRVA QAI does not actually require that the vaccine in question have been
intended for intramuscular administration, but only that the vaccine was actually administered
intramuscularly. Id. at 13 (emphasis added).

        Petitioner also argues that the respondent’s position would “lead to an absurd result,” that
runs afoul of the principle of statutory interpretation that absurd results should be avoided. Id. at
11-12. Petitioner specifically cites to the Federal Circuit’s decision in Dupuch-Carron, where
the Court reiterated that, “[i]f a literal construction of the words of a statute be absurd, the act
must be so construed as to avoid the absurdity.” Dupuch-Carron v. Sec’y of Health & Hum.
Servs., 969 F.3d 1318, 1330 (Fed. Cir. 2020), cert denied, However, the Federal Circuit also
explained, “When construing a statutory term or phrase to avoid an absurd result, or when the
term or phrase is “ambiguous,” it “must be read in [its] context and with a view to [its] place in
the overall statutory scheme.” 969 F.3d at 1330 (citing Colonial Press Int’l, Inc. v. United
States, 788 F.3d 1350, 1357 (Fed. Cir. 2015); see also Wassenaar v. Office of Pers. Mgmt., 21
F.3d 1090, 1092 (Fed. Cir. 1994) (stating that “[a] reading of [a statute] which would lead to
absurd results is to be avoided when [it] can be given a reasonable application consistent with
[its] words and legislative purpose”).

        Petitioner states that “under respondent’s proposed interpretation of the Table and QAI
for SIRVA, a vaccine petitioner, like the petitioner in the present case, who was injected
incorrectly in two separate ways, i.e. intramuscularly instead of subcutaneously, and, too deeply
into the deltoid muscle entering the bursa,” would have less chance of recovery for her alleged
vaccine injury than a person receiving an intramuscularly injection administered incorrectly. Pet.
Mem. at 12. The respondent’s position provides less protection to [a] more aggrieved petitioner
and respondent’s interpretation is inconsistent with the goals of the Vaccine Act. Id.

       Finally, petitioner argues that she has satisfied the four enumerated SIRVA criteria
outlined in the QAI.9 Petitioner posits that the MMR vaccination she received was administered
incorrectly and it was injected intramuscularly, therefore, she meets the first criterion for a
SIRVA. Id. Petitioner also argues that she has demonstrated by preponderant evidence that the
onset of her pain began within 48 hours of vaccine administration. Id. at 13.

                    c. Respondent’s contentions

        Respondent argues that petitioner has not established a Table injury because petitioner
received the June 8, 2016 MMR vaccine subcutaneously. Resp. Mem. at 5-6. Respondent states
that the language of the QAI defines a SIRVA as “shoulder pain and limited range of motion
occurring after the administration of a vaccine intended for intramuscular administration in the
upper arm. 42 C.F.R. 100.3(c)(10) (original emphasis). Resp. Mem. at 6. Respondent states
that the MMR vaccine “is a vaccination intended for subcutaneous administration,” and as such,
the petitioner’s claim fails to satisfy the language of the QAI. Further, respondent contends that
petitioner’s argument that her legal rights under the Vaccine Act are being deprived is erroneous

9
    Respondent does not dispute that petitioner has met the (iii) and (iv) criterion of a Table SIRVA.

                                                            15
because petitioner is not being precluded from pursuing a causation-in-fact claim under the Act.
Id. at 7.

         Respondent then argues that petitioner does not satisfy the Table SIRVA criteria’s onset
of pain occurring within 48 hours. Resp. Mem. at 7. Respondent contends that petitioner’s
failure to report her shoulder pain to her OB/GYN until June 20, 2016, approximately twelve
days after receiving the vaccination, is inconsistent with her affidavit that her pain began
immediately. Id. at 8. Respondent also argues that petitioner’s failure to mention her shoulder
pain on June 15, 2016 to her OB/GYN office, when they called petitioner to explain her
contraceptive benefits available under her insurance, is again evidence that petitioner’s onset of
left shoulder pain did not occur within forty-eight hours of vaccination. Id.

         Respondent also suggests that some of petitioner’s contemporaneous medical records
contradict her affidavit. Id. at 9. Respondent states that a physical therapy note on June 4, 2016,
which provides, “She reports having a shot in the hospital which caused a lot of neck pain and
then a few days later her shoulder began getting stiff and she began having pain,” as
contradicting her affidavit, which provides that her left shoulder pain began the same evening as
the vaccination. Id. at 9; see Pet. Ex. 9 at ¶ 2. Citing to Reusser v. Sec’y of Health & Hum.
Servs., respondent posits that the written documentation recorded by the physical therapist is
more reliable than petitioner’s recollection of the events two years later. 28 Fed. Cl. 516, 523
(1993) (stating, “[W]ritten documentation recorded by a disinterested person at or soon after the
event at issue is generally more reliable than the recollection of a party to a lawsuit many years
later.”).

       Respondent concludes that petitioner is not eligible for Table SIRVA presumption of
causation because she received a subcutaneous injection and the medical records do not
demonstrate onset of symptoms within the requisite time of forty-eight hours or less following
vaccination. Id. at 9.

               d. Discussion of Petitioner’s Alleged Table Injury

        The core issue between the parties is whether petitioner can claim a Table SIRVA for the
receipt of an MMR vaccine, which is only intended to be administered subcutaneously.
Petitioner argues that the inconsistency between the Table and the QAI creates a genuine
ambiguity, depriving her of her right under the Vaccine Act, to receive the presumption that the
vaccine in question caused her left shoulder injury. Pet. Mot. at 7-9.

        The starting point for analyzing the respondent’s regulations begins if “there is [an]
express delegation of authority [by Congress] to an agency to elucidate a specific provision of
the statute by regulation. Chevron U.S.A., Inc., v. Nat’l Resources Defense Council, Inc., 467
U.S. 837, 843 (1984). When granting rulemaking power to agencies, Congress usually intends to
give them considerable latitude to interpret the ambiguous rules they issue. Kisor v. Wilkie, 139
S.Ct. 2400, 2412 (2019). Before concluding that a rule is genuinely ambiguous, a court must
exhaust all the “traditional tools” of construction. Kisor v. Wilkie, at 2415 (citing Chevron at 843
n.9). If a genuine ambiguity remains, moreover, the agency’s reading must still be reasonable.
139 S.Ct. at 2416; Thomas Jefferson Univ. v. Shalalala, 512 U.S. 504, 515 (1994). However, if

                                                16
uncertainty does not exist, there is no plausible reason for Auer deference and “the regulation just
means what it means.” Kisor at 2415.

        In this case, Congress has delegated authority to the respondent to promulgate regulations
to modify the Vaccine Injury Table. §300aa-14(c)(1). The respondent may add or remove
illnesses, disabilities, injuries and conditions for which compensation may be provided or change
the time period for which the first symptom or manifestation of the illness, disability, injury or
condition occurs. Id. at (c)(3). Additionally, Congress gave the respondent authority to revise
the Vaccine Injury Table to add vaccines to the Vaccine Injury Table for which the Centers for
Disease Control and Prevention (“CDC”) has recommended for the routine administration to
children and pregnant women. Id. at (e)(1)-(3).

        As in any statutory interpretation case, [the Court starts], of course with the statutory text,
and proceeds from the understanding that unless otherwise defined, statutory terms are generally
interpreted in accordance with their ordinary meaning. Sebelius v. Cloer, 569 U.S. 369, 376
(2013). Petitioner does not dispute that the QAI introductory paragraph for a SIRVA includes
the language “vaccines intended for intramuscular administration.” Pet. Mem. at 11; see also 42
C.F.R. § 100.3(c)(10). Nor does petitioner dispute that the MMR vaccine, at the current time she
received the vaccination, is not intended for intramuscular injection. Id. at 10. According to the
CDC’s Advisory Committee on Immunization Practices (“ACIP”), “routes of administration are
recommended by the manufacturer for each immunobiologic.” Court’s Exhibit 1 (“Ct. Ex.”).10
The AICP outlined the type of vaccine, dose and route of administration for each of the vaccines.
Id. at 11. The MMR vaccine’s route of administration is noted as “subcutaneous.” Id. Thus,
under the ordinary meaning of the phrase “vaccines intended for intramuscular administration,”
the MMR vaccine is excluded from QAI’s SIRVA definition at this time.

        However, petitioner argues that the first sentence of the definition of SIRVA as provided
in the QAI cannot be read in isolation and “must be interpreted in context and harmonized with
both the Table and the entire QAI.” Pet. Mem. at 10. I agree with petitioner that looking at the
entire regulation as whole is instructive, as it is also dispositive.

        When construing a statutory term or phrase to avoid an absurd result, or when the term or
phrase is “ambiguous,” it “must be read in [its] context and with a view to [its] place in the
overall statutory scheme. Colonial Press Int’l v. United States, 788 F.3d 1350, 1357 (Fed. Cir.
2015) (quoting Davis v. Mich. Dep’t of Treasury, 489 U.S. 803, 809 S.Ct. 1500 (1989).
Petitioner argues that the inclusion of SIRVA on the Table for the receipt of an MMR vaccine
and the language of the QAI creates an ambiguity that would lead to absurd results. However,
the Vaccine Injury Table is preceded by an introductory paragraph, which provides:

        In accordance with Section 312(b) of the National Childhood Vaccine Injury Act of 1986,
        title III of Public Law 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note and section
        2114(c) of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 300aa-
        14(c)), the following is a table of vaccines, the injuries, disabilities, illnesses, conditions,
        and deaths resulting from the administration of such vaccines and the time period in

10
  Vaccine Recommendations and Guidelines of the ACIP, https://www.cdc.gov/vaccines/hcp/acip-recs/general-
recs/administration html#t6_1

                                                     17
       which the first symptom or manifestation of onset or of the significant aggravation of
       such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine
       administration for purposes of receiving compensation under the program…..Paragraph
       (c) of this section sets forth the qualifications and aids to interpretations for the terms
       used in the Table. Conditions and injuries that do not meet the terms of the qualifications
       and aids to interpretation are not within the Table.

42 C.F.R. § 100.3(a) (emphasis added). This introductory paragraph makes it clear that the terms
defined in the qualifications and aids to interpretation outlined in paragraph (c) applies to the
illnesses, disability, injuries or conditions that are covered by the Table. Thus, the term SIRVA
as defined at 42 C.F.R. § 100.3(c)(10), which imposes a restriction that the vaccine be intended
for intramuscular administration, governs the Vaccine Injury Table section (a)(III)(C).

        Finally, examining the history of the addition of SIRVA to the Vaccine Injury Table is
also instructive to determine whether the subcutaneous MMR vaccine was intended to qualify as
a Table SIRVA under the regulations.

        Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on
the Vaccine Injury Table. See Vaccine Injury Table: Qualifications and aids to interpretation.
42 C.F.R. § 100.3(c)(10). However, the respondent began the rulemaking process to add SIRVA
to the Table two years prior.

        On July 29, 2015, the respondent promulgated a Notice of Proposed Rule Making
(“NPRM”), to amend the Vaccine Injury Table by regulation. 80 F.R. 45132-01, 2015 WL
4538923 (July 29, 2015). Specifically, respondent proposed adding SIRVA to the Table,
describing it as, “an adverse event following vaccination thought to be related to the technique of
intramuscular percutaneous injection (the process where access to a muscle is obtained by using
a needle to puncture the skin) into an arm resulting in trauma from the needle and/or
unintentional injection of a vaccine into tissues and structures lying underneath the deltoid
muscle of the shoulder.” Id. at 45136. In the proposed rule, respondent stated, “As proposed the
proposed definition indicates, SIRVA is an injury related to the intramuscular injection of a
vaccine. Consequently, by definition, a Table injury of SIRVA will not result for those vaccine
that are not administered by intramuscular injection, including….subcutaneous MMR,
MMRV…” Id. (emphasis added).

        Respondent further stated, “While the Secretary propose adding SIRVA to the Table for
MMR and Varicella vaccines, to meet the proposed QAI for SIRVA, the vaccine must be one
intended for intramuscular administration in the upper arm.” Id. (emphasis added). Respondent
acknowledged that there were no MMR or Varicella vaccines that are administered
intramuscularly at the time, but including SIRVA as a Table injury for those two vaccines (MMR
and Varicella) would not require a modification to the Table in the future, if such of those
vaccines became available to be administered intramuscularly. Id. The respondent further
acknowledged that the “disadvantage of this proposal could be confusion about whether a Table
injury for SIRVA may be satisfied for those vaccines, despite the QAI’s requirement that the
associated vaccine be intended for intramuscular administration.” Id. Respondent sought

                                                18
feedback from the public specifically on the proposal to include SIRVA as Table injury for the
MMR and varicella vaccines. Id.

        On January 19, 2017, the Secretary issued the final Rule amending the Vaccine Injury
Table. 82 F.R. 6294-01, 2017 WL 202456 (F.R). National Vaccine Injury Compensation
Program: Revisions to the Vaccine Injury Table (Jan. 19, 2017). In the final rule, respondent
published a summary of the comments regarding the NPRM, which included comments about
respondent’s proposal to include SIRVA as a Table injury for the MMR vaccines. Id. at *6297.
One commenter agreed with respondent’s proposal to add SIRVA as a Table injury for the MMR
and varicella vaccines “that are currently administered only by percutaneous injection in case an
intramuscular injection is available in the future,” but suggested that “the Table make clear that
SIRVA only pertains to intramuscular injection so there is no confusion with respect to vaccines
administered using a different method.” Id. In responding to the comment, respondent agreed
with the commenter that SIRVA should be an injury listed on the Table “for potential
formulations of MRM and varicella vaccines that are administered by intramuscular injection,”
but also declined to further clarify the Table, stating,

               The QAI specifically states that SIRVA is a condition related to “administration
               of a vaccine intended for intramuscular administration in the upper arm.” Thus,
               the Secretary believes it is clear that to meet the definition of SIRVA in the QAI,
               the vaccine administered must be one intended for intramuscular injection in the
               upper arm.

Id. The respondent’s final rule ultimately added SIRVA as Table injury for the MMR and
varicella vaccines. See 42 C.F.R. §100.3(c)(10).

         To some extent, the undersigned agrees with petitioner that having SIRVA listed as a
Table injury for vaccines that are not available for intramuscular injection (MMR and varicella)
at this time can lead to some confusion as to whether the administration of an MMR vaccination
can give rise to a covered Table SIRVA injury. The inclusion and the language in first SIRVA
criterion, “(i) No history of pain….prior to intramuscular vaccine administration,” does give rise
to some confusion and ambiguity, particularly when a claimant allege that the subcutaneous
vaccination was administered incorrectly, giving rise to a shoulder injury. However, as
discussed above, the NPRM and response to a commenter thereto, provides further clarification
that the inclusion of MMR on the table for SIRVA was merely prospective to account for a
possible future MMR vaccine that was intended for intramuscular administration. It was not
clear if in the course of rule making the possibility of improper intramuscular administration of a
vaccine intended for subcutaneous injection could give rise to a SIRVA injury.

       Nevertheless, when all available sources of clarification of the Vaccine Injury Table and
QAI as applied to the MMR vaccine are utilized, it is apparent that the Secretary intended that
only vaccines intended for administration intramuscularly can give rise to a Table SIRVA injury.
Accordingly, the petitioner is not afforded the presumption of vaccine causation as a Table
claim.

                                                19
       IV.      Petitioner’s Cause-in-Fact Claim

        The finding above only forecloses petitioner’s Table SIRVA claim. In the alternative,
petitioner is alleging a cause-in-fact claim that the MMR vaccine, administered subcutaneously,
was the cause of her left shoulder pain. Pet. Mot. at 14.

       A. Legal Standard

             1. 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).

       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).

                                                20
        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).

           2. Causation

        Petitioner is alleging that the MMR vaccine she received on June 8, 2016 was the cause-
in-fact of her left shoulder injury. Petitioner bears the burden of establishing actual causation.
To do so, she must “show by preponderant evidence that the vaccination brought about the injury
by providing 1) a medical theory connecting the vaccination and injury; 2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and 3) a showing of
proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health &
Hum. Servs., 418 F. 3d 1274, 1278 (Fed. Cir. 2005). There must be preponderant evidence for
each Althen prong. Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 132 (2011), aff.
per curiam, 463 Fed. Appx. 932 (Fed. Cir. 2012).

        Under Althen prong one, the causation theory must relate to the injury alleged. Thus, a
petitioner must provide a “reputable” medical or scientific explanation that the vaccine received
can cause the type of injury alleged. Pafford, 451 F.3d at 1355-56. 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. 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).

        Under Althen prong two, petitioner must prove “a logical sequence of cause and effect
showing that the vaccination was the reason for [her] 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 & Hums. 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.

       Althen prong three requires establishing a “proximate temporal relationship” between the
vaccination and the injury alleged. Althen at 1281. That term has equated to the phrase
“medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof

                                                 21
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
medically acceptable timeframe must align with the theory of how the relevant vaccine can cause
an injury (Althen prong one). Id. at 1352.

        The preponderance of the evidence standard requires the petitioner to demonstrate that it
is “more likely than not” that the vaccine 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 & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner
must demonstrate that the vaccine was “not only [a] 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 & Human Servs., 135 F.3d 1344, 1352-53 (Fed. Cir. 1999); Pafford v. Sec’y of
Health and Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). Causation is determined on a
case-by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen v. Sec’y
of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). A fact-finder may rely upon
“circumstantial evidence” which is consistent with the “system created by Congress, in which
close calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F. 3d at
1280.

         The petitioner often presents expert testimony in support of his or her claim. Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Expert testimony in the
Vaccine Program is usually evaluated according to the factors 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 & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). A special
master may use the Daubert framework to evaluate the reliability of expert testimony, but expert
testimony need not meet each Daubert factor to be reliable. Boatmon v. Sec’y of Health &
Human Servs., 941 F.3d 1351 (Fed. Cir. 2019). The Daubert factors are “meant to be helpful,
not definitive,” and all factors “‘do not…necessarily apply even in every instance in which the
reliability of scientific testimony is challenged.’” Boatmon, 941 F. 3d at 1359 (citing Kumho
Tire Co. v. Carmichael, 526 U.S. 137, 151, 119 S. Ct. 1167, 143 L.Ed.2d 238 (1999). Thus, for
Vaccine Act claims, a “special master is entitled to require some indicia of reliability to support
the assertion of the expert witness.” Moberly at 1324. Where both sides offer expert testimony,
a special master’s decision may be “based on the credibility of the experts and the relative
persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs.,
219 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d 1357 at 1362).

        If the petitioner makes a prima facie case supporting vaccine causation-in-fact, the
burden shifts to respondent to show by a preponderance of the evidence that the injury is instead
due to factors unrelated to the administration of the vaccine. Deribeaux v. Sec’y of Health &
Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (citing § 13(a)(1)(B)). Respondent has the
burden of demonstrating that: “[A] factor unrelated to the vaccination is the more likely or
principal cause of injury alleged. Such a showing establishes that the factor unrelated, not the
vaccination, was ‘principally responsible’ for the injury. If the evidence or alternative cause is
seen in equipoise, then the government has failed in its burden of persuasion and compensation
must be awarded.” Knudsen, 35 F.3d at 551.

                                                22
       B. Finding of Fact

        In this case, there are two issues of fact to be resolved. The first is whether petitioner’s
MMR vaccine was inadvertently or erroneously administered intramuscularly in the shoulder
area as opposed to subcutaneously posterior to the triceps muscle. The second issue is the onset
of petitioner’s shoulder pain and dysfunction.

       1. Site of Administration

               a. Petitioner’s Arguments

        Petitioner asserts that the MMR vaccine was inadvertently administered into her deltoid
muscle into her subacromial bursa. Pet. Mot. at 17-31. She argues that her statements in her
affidavit and to her treating physicians, in addition to, Dr. Wright’s statements, support that the
vaccine was mis-administered high into her upper left arm, instead of subcutaneously, as the
vaccine is intended to be administered. Id.

        There is no doubt in the vaccination record that Baptist Medical Center ordered the MMR
vaccine for petitioner. Pet. Ex. 2 at 132. Additionally, the details of the order indicate the
amount of the vaccine to be given (0.5 ml) and that it is to be given subcutaneously. Id. Further,
the medication administration from Baptist Medical Center indicates that petitioner received the
MMR vaccine in her “left upper” arm. Id. at 200. However, this record does not provide any
further detail regarding the exact location of vaccine administration in her left upper arm or if it
was inadvertently administered into her muscle.

        In her supplemental affidavit, petitioner provided additional detail regarding the location
of the vaccination. She stated, “Christy [my nurse], administered the shot at approximately 5:30
pm on June 8. It was given in the back of my upper left arm.” Pet. Ex. 9 at ¶ 3. Petitioner also
provided, “What I do remember physically about the shot was that, as I was waiting for my baby
and me to be discharged, I was lying on the hospital bed in my room….When the nurse came
into give me the shot, she had me sit up on the bed. She stood next to and over me to give the
injection. I felt the shot being given and it was on my upper arm toward the back.” Id. at ¶ 6.
The shot was itself was extremely painful immediately. Id. at ¶ 5.

        Later, when petitioner went to see orthopedist, Dr. Michael Adams, petitioner described
that she received the MMR vaccine in her “lateral left shoulder,” providing a more specific
location to where she was injected. Pet. Ex. 4 at 43. When Dr. Adams examined petitioner’s left
shoulder, he noted, “Generalized tenderness to palpation about the deltoid girdle. Tender to
palpation over the bicipital groove.” Id. at 44. On April 26, 2017, at a follow-up appointment
with Dr. Adams for ongoing left shoulder pain, petitioner indicated that her pain was “posterior
in location.” Pet. Ex. 6 at 9. The physical examination revealed that petitioner had “tenderness
to palpation [on the] posterior rotator cuff.” Id. at 10.

                                                 23
        Petitioner’s expert, Dr. Wright, acknowledged that it would be difficult to identify the
exact location petitioner received the MMR vaccine, he opined that the injection was “most
likely” injected into the subacromial space. Pet. Ex. 15 at 1; Pet. Ex. 12 at 1. Dr. Wright noted
that petitioner exhibited generalized tenderness to palpation near the deltoid insertion on the
acromion which is directly over the posterior greater tuberosity and infraspinatus insertion site.
Pet. Ex. 15 at 2. He explained, “This is located directly underneath the deltoid, where
[petitioner] felt tenderness.” Id. Dr. Wright also noted that on petitioner’s MRI of her left
shoulder “demonstrated an abnormal signal in the infraspinatus tendon at its insertion along the
bursal surface.” Id. Based on what petitioner stated in her affidavit and the medical records, Dr.
Wright opined that it was likely petitioner received the injection in the deltoid muscle near its
insertion at the acromion, passing through the infraspinatus insertion site at the bursa, into the
subacromial bursa. Pet. Ex. 15 at 2-3; Pet. Mot. at 25. Dr. Wright provided a diagram depicting
where he believed petitioner received the MMR vaccine, re-created below:

Pet. Ex. 15 at 3. The green circle represents area in which Dr. Wright opined that petitioner
received the MMR injection.

         Referencing the Bodor and Montalvo article, Dr. Wright stated that “an injection into the
subacromial space can be responsible for initiating a major inflammatory event in the
subacromial bursae resulting in persistent severe pain.” Pet. Ex. 12 at 1; Pet. Ex. 14 at 2. The
article highlights two case reports of shoulder dysfunction and pain following intramuscular
vaccination. Pet. Ex. 14. The authors hypothesized that vaccine was injected into the subdeltoid
bursa. Id. at 2. The authors explained that the subacromial bursa’s depth below the skin was
approximately 0.8 cm (8 mm) to 1.6 cm (16 mm) below the skin. Id. at 2. They wrote, “We
hypothesize that in both of our cases vaccine was injected into the subdeltoid bursa, causing a
robust local immune and inflammatory response. Given that the subdeltoid bursa is contiguous
with the subacromial bursa, this led to subacromial bursitis, bicipital tendonitis, and
inflammation of the shoulder capsule.” Id. at 2.

                                                24
        Petitioner argued that the skin and deltoid muscle at Dr. Wright’s proposed injection site
is thinner than at the proposed injection site by Dr. Abrams. Using the diagram below from the
Nakajima article, petitioner asserted that the Dr. Wright’s proposed injection site is the region
between b’ and 1/3 bb’. Pet. Mot. at 32.

Resp. Ex. A, Tab 8 at 24. Petitioner stated that, “The total thickness at 1/3 bb’ of skin is 5-6
mm…and of deltoid muscle is 9-13 mm thick….for a total range of 14-19 mm at that site.” Pet.
Mot. at 32; Resp. Ex. A, Tab 8 at 3-4. Petitioner asserted that, “Therefore, even if a 15.9 mm
needled intended for subcutaneous administration was used, it could indeed have reached the
bursa in the manner proposed by Dr. Wright.” Pet. Mot. at 32.

               b. Respondent’s Arguments

        Respondent contests that the “medical records reflect that the MMR vaccine was
administered subcutaneously in petitioner’s left arm,” which is consistent with the CDC
recommendation for subcutaneous injection of an MMR vaccine. Resp. Brief at 11.
Specifically, respondent states that petitioner described the vaccination site as “high on [the]
upper arm toward the back,” which is consistent with the proper injection site being in the
posterior triceps aspect of the upper arm. Id.

        Respondent argued that Dr. Wright’s proposed injection site is not supported by the
record because petitioner did not state that the injection was given on her shoulder or
“completely on the back of her arm.” Resp. Brief at 12. Instead, respondent argued that
petitioner only stated that the vaccine was injected “towards” the back of her arm, which is
“consistent with the CDC recommendation for subcutaneous injection of an MMR vaccine in the
posterior triceps aspect of the upper arm.” Id. at 11.

                                                 25
        Using the diagram from the Nakajima article (above), Dr. Abrams put the petitioner’s
injection site between ½ bb’ and 2/3 bb’ and respondent argued that “this region more closely
fits with petitioner’s description in her supplemental affidavit that the injection was high on her
upper arm-not on her shoulder.” Resp. Brief at 13 (original emphasis).

        Dr. Abrams noted that the standard needle length for an MMR vaccination is 5/8” or 15.9
mm, which would make it difficult for the injection to reach the subacromial space. Resp. Ex. C
at 2. He stated that, “The subcutaneous (skin) thickness of females at the typical injection site, as
measured by ultrasound, range from 6-8 mm. In addition, the thickness of the deltoid muscle at
this location would have to traverse a minimum distance of approximately 21 mm to even reach
the subacromial space-and this was in a patient population significantly below the body mass
index of the petitioner.” Id. at 2. Respondent stated that the even if the needle was injected
“high in the upper aspect of the lateral arm, such as near site, 1/3 bb’ it is highly unlikely that the
needle passed into the structures behind the muscle due to the angle of administration.” Resp.
Brief at 14.

        Dr. Abrams also asserted that a subcutaneous injection given at a 45-degree angle to
specifically “avoid penetration into the intra-muscular tissue.” Resp. Brief at 14; Resp. Ex. C at
2. Respondent argued that the way in which petitioner described the administering nurse
“standing over her” while injecting the vaccine supports proper administration angle of the
vaccine. Resp. Brief at 15. Respondent stated, “From a standing position over a patient, it
would be natural for the needle of the syringe to point downward at an angle towards the floor,
because of the way healthcare professionals hold a syringe between their fingers. Depressing the
syringe perfectly perpendicular to the patient’s arm while standing above the patient would
require holding the syringe in a very awkward manner. It is highly unlikely that this nurse
injected petitioner’s upper arm at the 90-degree angle required to reach the subacromial space,
while petitioner was sitting-down and the nurse was standing over her.” Id.

               c. Conclusion regarding site administration

       Petitioner has presented preponderant evidence that the June 8, 2016 MMR vaccine was
administered high on her left lateral shoulder in the deltoid muscle into the subacromial bursa.

        Petitioner explained that she received the vaccination in her left “upper arm, towards the
back,” in her supplemental affidavit. Consistent with her affidavit, when petitioner presented to
orthopedist, Dr. Adams, she reported that her injection was into the “lateral left shoulder.” Pet.
Ex. 4 at 43. These two descriptions given by petitioner do not indicate that the vaccine was
administered in her triceps region as proposed by respondent, which is lower on the back of the
arm, but instead, both descriptions would put the injection site as being high towards the back of
her arm, closer to her shoulder.

        Petitioner’s statement that the vaccine was administered on her “upper arm toward the
back,” is consistent with the physical examinations post-vaccination. For example, Adams noted
petitioner had, “Generalized tenderness to palpation about the deltoid girdle. Tender to palpation
over the bicipital groove.” Pet. Ex. 4 at 44. Petitioner also had “tenderness to palpation [on the]
posterior rotator cuff.” Pet. Ex. 6 at 10. During her first physical therapy evaluation on July 4,

                                                  26
2016, petitioner demonstrated tenderness on her biceps tendon long head, supraspinatus tendon
and the posterior cuff. Pet. Ex. 5 at 29.

         Additionally, petitioner’s MRIs are also consistent with her description of where the
vaccine was injected into her left arm. The MRI taken on June 15, 2016 revealed the following,
“The infraspinatus tendon demonstrates abnormal increased T2 signal at its insertion.” Pet. Ex. 2
at 6. The impression of the radiologist was, “Partial thickness tear distal infraspinatus tendon at
its insertion along the bursal surface.” Id. Her follow-up MRI taken on April 21, 2017 showed
“abnormal bursal surface signal of the distal anterior supraspinatus adjacent to the footplate,”
and, “a tiny sliver of fluid in the subacromial subdeltoid bursa.” Pet. Ex. 6 at 13.

        Petitioner’s description of the vaccination site being high towards the back of her upper
left arm, makes it more likely that the vaccine was administered in a manner that would have
been in or around the subacromial bursa, as suggested by Dr. Wright. The image below shows
the posterior view of the shoulder, recreated from the S. Atanasoff article, demonstrates the
relationship between the deltoid muscle, the subacromial bursa space to the supraspinatus
tendon.

Pet. Ex. 18 at 3.11 The Bodor article explained that the subacromial bursa extends from 3.0 cm to
6.0 cm beyond the lateral border of the acromion and that it lay anywhere from 0.8 cm (8 mm) to
1.6 cm (1.6 mm) below the skin surface. Pet. Ex. 14 at 2. At Dr. Wright’s proposed injection
site, it is conceivable that a 15.9 mm (or 1.59 cm) needle used for the MMR vaccine could
penetrate into the subacromial bursa, given its depth of 0.8 cm to 1.6 cm below the skin surface.

        Finally, respondent’s argument that petitioner was seated during the vaccine
administration and the administering nurse was standing makes it more likely that the vaccine
was administered in a downward angle, thus making it difficult to penetrate into the subacromial
bursa is not credible. The Atanasoff article explains, “…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….Thus, concurrent seating positions
for both the administrator and the receiver may minimize the risk of the injection being too

11
  Atanasoff, S. et al., Shoulder Injury Related to Vaccine Injury (SIRVA), 28 Vaccine 8049-8052 (2010). [Pet. Ex.
18].

                                                        27
high.” Pet. Ex. 18 at 4. In this case, petitioner stated that when she received the MMR
vaccination, she was seated on the bed and the administering nurse was standing above and
behind her. Pet. Ex. 9 at ¶¶ 3 and 9. Additionally, petitioner described the injection site was
“high” on her left arm. Pet. Ex. at ¶ 9. Given the seated position of the petitioner while
receiving the vaccine and that she described the site as being “high” towards the back of her left
arm, it is more likely that the administering nurse injected the vaccine high on the back of
petitioner’s left arm, penetrating into and around the subacromial bursa.

        Consistent with the above, I find that petitioner has established by preponderant evidence
that the MMR vaccine she received was administered in the subacromial space, high on her left
arm. The administration appears to have been more consistent with an unintended intramuscular
administration, such that it penetrated into and around petitioner’s subacromial bursa.

       2. Onset of Petitioner’s Pain

               a. Respondent’s arguments

         Respondent argues that the evidence does not demonstrate that petitioner experienced
shoulder pain or dysfunction within 48-hours of receiving the MMR vaccine. Resp. Brief at 7.
Respondent specifically argues that, “the contemporaneous medical records do not provide
independent evidence of onset within 48 hours of vaccination, and petitioner’s own statements
are insufficient to meet her burden.” Id. at 9. Respondent states that, “the contemporaneous
medical records reflect that she did not complain of shoulder pain until the June 20, 2016 phone
call to the office of her OB/GYN.” Id. at 8. Respondent states that petitioner had contacted her
OB/GYN’s office five days prior, on June 15, 2016 and did not complain of shoulder pain. Id.
Additionally, respondent argues that petitioner’s supplemental affidavit contradicts the medical
records. Resp. Brief at 8. Respondent states that petitioner stated in her supplemental affidavit
that on June 15, 2016 “her condition was so poor that she could not lift her arm or use it at all,”
however, petitioner waited an additional five days to seek medical treatment. Id.

        Respondent also argues that petitioner’s description of onset of left shoulder pain in the
medical records fails to demonstrate that the pain began within 48 hours. Id. at 9. Respondent
notes that at a physical therapy appointment on July 4, 2016, petitioner reported that, “a shot in
the hospital…caused a lot of neck pain then a few days later her shoulder began getting stiff and
she began having pain.” Id. at 9. But later, in her affidavit, petitioner asserted that the neck pain
started after the shoulder pain.” Id. Respondent stated that this contradiction “calls into question
the reliability of petitioner’s supplemental affidavit.” Id. Respondent concluded that the medical
records do not demonstrate that petitioner’s onset of symptoms was within 48 hours or less
following the MMR vaccination. Id. at 10.

               b. Petitioner’s arguments

         Petitioner argues that the medical records and her affidavit support onset of her left
shoulder injury within 48 hours of receiving the MMR vaccination on June 8, 2016. Pet. Mot. at
32. Petitioner states that she called the OB/GYN office on June 20, 2016 and “the notes of the
call reflect that she stated that her arm was sore after the post-delivery vaccination.” Id. at 19;

                                                 28
Pet. Ex. 3 at 138. Petitioner also states that she told the same to her orthopedist, Dr. Adams at
the June 28, 2016 appointment, the record from which reported that “after they injected into her
lateral left shoulder, she began to have increased intense pain and range of motion problems.”
Id. at 20; Pet. Ex. 4 at 43. Additionally, petitioner asserts that at the same appointment, Dr.
Adams and petitioner appeared to have reviewed a website, which may have been the VICP or
the Table, and he wrote, “I do not think it is out of the realm of question that she had post-
injection stiffness and pain…” Id. at 21; Pet. Ex. 4 at 45.

        Petitioner also asserts that her supplemental affidavit supports the onset of pain within 48
hours of receiving the vaccination. Petitioner explains in her affidavit that she felt excruciating
pain during the vaccination, so much that she nearly came off the bed. Pet. Mot. at 19; Pet. Ex. 9
at ¶ 1. Further, when petitioner called the office on June 20, 2016, the note reads, “Pt. calling
stating unable to move left arm. Pt. states sore after given shot in arm after delivery. Pt. states
now 2 weeks later unable to move warm at all.” Pet. Ex. 3 at 138.

        Petitioner concluded that the evidentiary record documents that the onset of her shoulder
injury followed within 48 hours of the vaccination at issue, which is within a medically
appropriate proximate timeframe.

               c. Conclusion regarding onset of petitioner’s should pain and dysfunction

       Petitioner has demonstrated by preponderant evidence that the onset of her shoulder pain
occurred within 48 hours of her MMR vaccination on June 8, 2016.

        The medical records demonstrate that petitioner consistently attributed the pain in her left
shoulder to the MMR vaccination on June 8, 2016. She called her OB/GYN on June 20, 2016
and reported that she was “unable to move her left arm,” and that her arm has been “sore after
given shot in arm after delivery,” and stated that her arm was “frozen.” Pet. Ex. 3 at 138.
Respondent argued that petitioner spoke to her OB/GYN’s office five days earlier, on June 15,
2016, but did not mention that her left arm was sore. Resp. Brief at 8. However, the records
from the call on June 15, 2016 indicate that the call was about petitioner’s health insurance
benefits covering a specific form of contraceptive. Pet. Ex. 3 at 63. Specifically, on June 9,
2016, the day following the vaccination, it was noted that, “Patient is interested in getting the
Mirena IUD inserted at her postpartum visit. Could you please check benefits and let her know
if it would be covered?” Id. On June 14, 2016, the note indicates that the OB/GYN office
checked petitioner’s health benefits and left a message with petitioner to call back. Id. Petitioner
called back on June 15, 2016 and spoke to Ms. Christina Catlett who noted, “Pt called back-
aware of benefits.” Id. It is clear from the OB/GYN’s internal messaging system, that the
purpose of the call was for checking benefits and not for the purposes of medical treatment.

       As the Federal Circuit articulated in Kirby, there is no “presumption that medical records
are accurate and complete as to all the patient’s physical conditions.” Kirby v. Sec’y of Health &
Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). Following Kirby, a special master must
consider the context of a medical encounter before concluding that it constitutes evidence
regarding the absence of a condition. Hanna v. Sec’y of Health & Hum. Servs., No. 18-1455V,
2021 WL 3486248, at *14 (Fed. Cl. Spec. Mstr. July 15, 2021). In this case, the phone call

                                                 29
between the petitioner and the OB/GYN’s office on June 15, 2016 does not appear to constitute a
medical encounter, instead is appears to be focused on an administrative matter, rather than for
medical care. Further, in prior SIRVA cases it has been held that neither a delay in seeking
treatment in itself, nor a failure to report symptoms to a specialist or emergency room provider
prior to later seeking treatment, is necessarily dispositive of whether a petitioner’s shoulder pain
began within 48 hours of vaccination. See 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). As petitioner explained in her supplemental
affidavit, she has five children under the age of 13 and the delay in telling her medical provider
by 12 days is reasonable, given that she was caring for a newborn at the time, in addition to four
other children at home. Indeed, the reporting of her shoulder pain and inability to lift her arm
within 12 days of vaccination is far faster than many of the cases seen in this program.

        Additionally, when petitioner had her first appointment with orthopedist. Dr. Adams, on
June 28, 2016, she once again attributed the onset to her left shoulder pain to the MMR
vaccination. Pet. Ex. 4 at 43. Under “History of Present Illness,” the note states, “[Petitioner]
notes that she gave birth three weeks ago and afterwards was offered the measles, mumps and
rubella vaccine. She states that after they injected into her lateral left shoulder, she began to
have increased intense pain and range of motion problems.” Id.

        On July 4, 2016, petitioner had her first physical therapy evaluation. Pet. Ex. 5 at 28. At
this appointment under the “Subjective” section it states, “[Petitioner] states that the initial onset
occurred on 6/01/2016 when she [] reports she had a baby 4 weeks ago and reports insidious
onset of left shoulder pain. She reports she does not know why the pain started. She reports
having a shot in the hospital which caused a lot of neck pain and then a few days later her
shoulder began getting stiff and she began having pain.” Id. Respondent argued that this record
shows that petitioner had neck pain and then shoulder pain, which indicates that the shoulder
pain began after forty-eight hours after vaccine administration. Resp. Brief at 9. However, there
is no specific timeframe mentioned in this notation, except for a vague timeframe of “a few days
later.” Further, this notation is the only notation in the record that puts neck pain prior to the
onset of her shoulder pain, which she consistently attributed to the MMR vaccination. This
record was sufficiently vague and unclear as to dates of onset, date of delivery of the baby and
date of vaccination to raise questions about the care taken in questioning about and recording the
onset of pain. It is also the only record introducing this confusion, as when interviewed by an
orthopedist on June 28, 2016, six days prior to the physical therapy appointment, petitioner
unequivocally described the delivery of her baby three weeks before and the onset of pain after
they injected into her lateral left shoulder causing intense pain and range of motion problems.
Pet. Ex. 4 at 43.

        Additionally, at her follow-up appointment with Dr. Adams on August 1, 2016, he noted
that petitioner’s left shoulder pain had been present for two months and stated, “It started after a
post-delivery vaccine and was severe in intensity and diffuse in nature associated with significant
decreased range of motion.” Id. at 22.

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         Petitioner’s supplemental affidavit also supports onset of her left shoulder pain being
within 48 hours of receiving the MMR vaccination on June 8, 2016. She stated, “As I received
the shot, the pain was excruciating.” Pet. Ex. 9 at ¶ 4. She described the pain as “intense” and
“as if it was going into my bone.” Id. She also indicated that she could feel the pain even
though she had been given Percocet for after birth pain. Id. In her affidavit, she explained that
she was having terrible shoulder pain and then neck pain that radiated down to her shoulder. She
articulated that the neck pain started after the shoulder pain. Id. at ¶ 7. Petitioner’s statements
regarding the onset of her left shoulder pain in her supplemental affidavit do not contradict her
medical records and are quite consistent with those recorded by her orthopedist, Dr. Adams.

       The evidence in the record as whole, supports petitioner’s position that the onset of her
shoulder pain began within 48 hours of receiving the MMR vaccine on June 8, 2016. The
twelve-day delay in treatment for her shoulder is consistent with the length of time of that many
other people seek care for shoulder pain following vaccination. See e.g. Smallwood v. Sec’y of
Health & Human Servs., No. 18-291V, 2020 WL 2954958, at *10 (Fed. Cl. Spec. Mstr. Apr. 29,
2020) (observing that it is “common for a SIRVA petitioner to delay treatment, thinking his/her
injury will resolve on its own.”); see also Hartman v. Sec’y of Health & Human Servs., No. 19-
1106V, 2021 WL 4823549, at *5 (Fed. Cl. Spec. Mstr. Sept. 14, 2021) (petitioner reported
shoulder pain less than one more after vaccination and repeatedly sought treatment to relieve her
pain and loss of function.).

        Therefore, petitioner’s statements about the onset of her left shoulder pain occurring
within 48 hours of receiving the MMR vaccine on June 8, 2016 are consistent with the medical
records, which repeatedly note that petitioner attributed the onset of her pain to the vaccination at
issue in this case. As such, petitioner has demonstrated that her left shoulder pain occurred
within 48 hours of vaccination.

       C. Causation

       1. 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.
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).

               a. Petitioner’s arguments regarding Althen prong one

       Petitioner’s expert, Dr. Wright opined that petitioner had a “direct injection into the
subacromial space and possibly into the infraspinatus,” which can “be responsible for initiating a
major inflammatory event in the subacromial bursae resulting in persistent severe pain.” Pet. Ex.

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12 at 1. He acknowledged that he did not know the exact location of petitioner’s injection, but
found it likely that she had received the injection in the subacromial space and possibly in the
infraspinatus, based on her positive response to the steroid injection and the edema found on her
MRI. Pet. Ex. 15 at 1.

        Dr. Wright cited to the Bodor and Montalvo article which describes two case reports of
individuals who experienced shoulder pain and weakness following vaccinations. Pet. Ex. 14.12
The authors hypothesized that the vaccines were injected into the subdeltoid bursa causing a
robust local immune and inflammatory response in the structures of the shoulder. Id. at 2. They
explained that the inflammatory response in the subdeltoid bursa led to subacromial bursitis,
bicipital tendonitis, and inflammation of the shoulder capsule. Id.

         Petitioner also cited to the Atanasoff et al. article, which describes the mechanism of a
SIRVA. Pet. Ex. 18. Petitioner argues that the mechanism of injury described in the Atanasoff
article has been accepted by this Court, and respondent, as sound and reliable. Specifically, the
article provides:

           If…a vaccine is inadvertently injected into the synovial space of the shoulder (bursa or
           joint), pre-existing antibody in the synovial tissues, present as a result of earlier naturally
           occurring infection or vaccination, may lead to a more prolonged inflammatory response.

Pet. Ex. 18 at 3. The authors further explained, “….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.” Id. Importantly, the authors of
Atanasoff et al. observed, “Given that 62% of our cases were overweight or obese based upon
BMI and that no case was considered underweight, needle length alone may not have been the
cause of injection into tissues other than the deltoid.” Id. at 4. They also noted that, “the
standing position of the provider administering the injection may also contribute to injecting
inadvertently high into the deltoid….Thus, concurrent seating positions for both the administer
and the receiver may minimize the risk of the injection being “too high.” Id.

        Petitioner summarized Dr. Wright’s theory as, “an injection in the deltoid muscle, near its
insertion at the acromion, passing through infraspinatus insertion site at the bursa, into the
subacromial bursa, can cause a shoulder injury.” Pet. Mot. at 17; Pet. Ex. 15 at 2.

                    b. Respondent’s arguments regarding Althen prong one

       Respondent’s expert, Dr. Abrams, does not disagree with Dr. Wright’s explanation of the
SIRVA mechanism. Instead, he asserts, “The location of the injection for an MMR vaccine is in
the posterior triceps aspect of the upper arm. It is not possible to reach the subacromial space
with an injection given in this location.” Resp. Ex. C at 1.

       He notes that he MMR vaccine is administered subcutaneously, which, with proper
technique is given at a 45-degree angle in order to avoid penetration into the intra-muscular

12
     Bodor, M. & Montalvo, E., Vaccination-related shoulder dysfunction, 25 Vaccine 585-587 (2007). [Pet. Ex. 14].

                                                          32
tissues. Id. He states that the needle length for administering an MMR vaccine is not long
enough to reach the subacromial space or the infraspinatus tendon. Id. Dr. Abrams argues that
the petitioner’s increased BMI would increase the distance the needle has to traverse to penetrate
the subacromial space, decreasing the likelihood of “inadvertent vaccine needle penetration into
the subacromial space.” Id.

         Respondent, in the response brief to petitioner’s motion, does not question Dr. Wright’s
proposed mechanism, but instead argues that Dr. Wright’s “theory is dependent…on an assumed
site of injection and the manner of injection unsupported by the evidence in this case.” Resp.
Brief at 11.

               c. Discussion and conclusion of Althen prong one

        Petitioner has established a sound and reliable theory to explain how the MMR vaccine,
when administered incorrectly, can be inserted into the synovial space of the shoulder, causing a
shoulder injury related to vaccine administration. The mechanism for a SIRVA injury is well
described in medical literature filed in this case. Both the Atanasoff and Bodor articles support a
causal association between vaccination and shoulder dysfunction.

        As discussed above, the authors of the Atanasoff article specifically opined that if a
vaccine “is inadvertently injected into the synovial space of the shoulder (bursa or joint), pre-
existing antibodies in the synovial tissues, present as a result of earlier naturally occurring
infection or vaccination, may lead to a more prolonged inflammatory response.” Pet. Ex. 18 at 3.
Further, the authors of Atanasoff indicated that a person’s body weight or needle length did not
appear to have an effect on whether the vaccine antigen was injected into tissues other than the
deltoid muscle. Id. at 4. While respondent argued that the needle used for MMR vaccination is
only 15.8 mm, the Bodor article demonstrated that the subacromial bursa sits between 6 mm and
13 mm below the skin’s surface, making it accessible with a 15.8 mm needle length.
Additionally, the Nakajima article explained that the subcutaneous thickness at the proposed
injection site 1/3 bb’ (which corresponds with Dr. Wright’s proposed injection site) was between
3.5 mm to 6.3 mm and the thickness of the deltoid muscle range from 9.0 mm to about 12 mm.
Resp. Ex. A, Tab 8 at 2.

         The Atanasoff article also indicates that the standing position of the vaccine administrator
over a seated patient “may also contribute to injecting inadvertently high.” Pet. Ex. 18 at 4. In
this case, petitioner stated that she was sitting on a bed and the nurse who administered the
vaccine “stood next to and over me to give the injection.” Pet. Ex. 9 at ¶ 6. Petitioner described
the location as being “high on my upper arm towards the back.” Id. Petitioner’s statements that
the vaccine administrator was standing while she was seated and it was administered “high” on
her left upper arm, makes it more likely that the MMR vaccine was mis-administered into her
subacromial bursa, leading to an inflammatory event resulting in persistent pain and movement
dysfunction. The description of tenderness in the shoulder girdle and bicipital groove are also
consistent with a high administration point where the deltoid muscle is thinnest.

       Further, petitioner was diagnosed with left shoulder bursitis, a diagnosis consistent with
other SIRVA cases in the program. Kraus v. Sec’y of Health & Human Servs., No. 17-2001V,

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2021 WL 4705177 (Fed. Cl. Spec. Mstr. Sept. 2, 2021) (petitioner diagnosed with right shoulder
bursitis following a flu vaccination); Lang v. Sec’y of Health & Human Servs., No. 17-996V,
2020 WL 7873272, at *3 (Fed. Cl. Spec. Mstr. Dec. 11, 2020) (petitioner was diagnosed with
bursitis following flu vaccination); Schoonover v. Sec’y of Health & Human Servs. No. 16-1324,
2019 WL 1040642, at *5 (Fed. Cl. Spec. Mstr. Jan. 30, 2019).

       Petitioner has presented a reputable scientific theory based on a sound and reliable
medical explanation, demonstrating that the MMR vaccine, when administered improperly, can
cause a shoulder pain and dysfunction, thus satisfying Althen prong one.

       2. 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 [her] 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).

        Prior to the receiving the MMR vaccine, petitioner did not experience any left shoulder
pain or dysfunction. Petitioner received the MMR vaccine on June 8, 2016 and immediately felt
pain, which led to a reduction in shoulder mobility. Consistent with the finding above that the
MMR vaccination was mis-administered into petitioner’s deltoid muscle penetrating into her
bursa, the medical history relating to petitioner’s left shoulder pain and dysfunction following the
vaccination at issue demonstrates a logical sequence of cause and effect showing that the
vaccination was the reason for her injury.

         On June 20, 2016, petitioner reported to her OB/GYN that she received a shot after the
delivery of her child, and she was “unable to move her left arm.” Pet. Ex. 3 at 138. Petitioner
described her arm as “frozen.” Id. The MRI of petitioner’s left shoulder showed a 50% tear of
the infraspinatus tendon at its insertion along the bursal surface. Pet. Ex. 2 at 6. While it is
unclear if petitioner’s partial thickness tear was caused by the MMR vaccination, the rapid onset
of pain and shoulder dysfunction following the vaccination is consistent with the medical
literature describing SIRVAs. The Atanasoff article explains that common conditions such as
“impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis and adhesive
capsulitis….may cause no symptoms until provoked by trauma or other events.” Pet. Ex. 18 at 3.
The authors of Atanasoff noted, “some of the MRI findings in our case series, such as rotator
cuff tears, may have been present prior to vaccination and became symptomatic as a result of
vaccination-associated synovial pain.” Id. at 3.

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        After the MRI, petitioner sought treatment from orthopedist, Dr. Adams. Pet. Ex. 4 at 43.
At her first appointment, petitioner explained that she received the MMR vaccine into her
“lateral left shoulder” and she began to have “intense pain and range of motion problems.” Id.
Her physical exam revealed restricted active range of motion in her left shoulder, generalized
tenderness to palpation near the deltoid girdle and over the bicipital groove. Id. at 44. Petitioner
was diagnosed with left shoulder joint pain and left partial acute rotator cuff tear. Id. at 45.
Dr. Adams opined that her left shoulder pain could have been related to her MMR vaccination,
stating, “I do not think it is out of the realm of question that she had post-injection stiffness and
pain.” Pet. Ex. 4 at 45.

        Petitioner received a steroid injection in her left shoulder and actively participated in
physical therapy. Pet. Ex. 4 at 25; Pet. Ex. 5 at 4-32. When she returned to Dr. Adams on
August 1, 2016 following six weeks of physical therapy, petitioner noted decreased pain in her
shoulder, but the pain began to increase as intensity in physical therapy increased. Pet. Ex. 4 at
22. Dr. Adams did not recommend another steroid injection, but recommended that she finish
out physical therapy and then begin a home exercise regime. Id. at 4. Dr. Adams also wrote in
petitioner’s medical record, “We did review some scientific evidence of post vaccine injection
rotator cuff tear when placed in the wrong place. It does appear at this time though, that she is
healing appropriately.” Id. at 23.

        Petitioner had a repeat MRI on April 21, 2017, which showed abnormal bursal surface
signal of supraspinatus tendon and a “tiny” amount of fluid in the subacromial subdeltoid bursa.
Pet. Ex. 6 at 13.

        When petitioner returned to Dr. Adams in April 2017, petitioner reported that her left
shoulder pain was persistent and described it as, “posterior in location, dull and burning quality
and moderate in severity.” Pet. Ex. 6 at 9. On physical exam, petitioner demonstrated full range
of motion “with painful arc from 80-120 degree of flexion and abduction,” and she demonstrated
one out of two impingement signs. Id. at 10. Dr. Adams reviewed the most recent MRI and
noted that petitioner had “mild abnormal signal on the bursal side of the anterior supraspinatus,”
and opined that it represented a “partial tear,” and that she had persistent tenosynovitis in the
proximal biceps tendon, consistent with the 2016 MRI. Id. at 9-10. Petitioner was diagnosed
with left shoulder joint pain, left partial chronic rotator cuff tear, and left shoulder bursitis. Id. at
11.

        Finally, petitioner’s expert, Dr. Wright opined, “[petitioner] sustained an injection site
injury to her left shoulder due to the MMR vaccine injection on 6/8/2016. There was no pre-
existing history of pain in the left shoulder, the pain started immediately after the injection, and
persisted at least 10 months.” Pet. Ex. 12 at 1.

       Dr. Abrams’ argument rests entirely on the theory that the MMR vaccine was
administered correctly in accord with the directions of the CDC. It is difficult to conceive of a
subcutaneously injected vaccination into the subcutaneous fat above the triceps muscle causing a
SIRVA injury. However, the evidence particular to this case strongly suggests that the
vaccination was not properly administered with the nurse standing next to and above the seated

                                                   35
patient, giving the injection high in the shoulder, where the muscle is thinnest and the
documented new onset pain occurred.

       Therefore, petitioner’s medical records and supporting opinion by Dr. Wright,
demonstrates that the MMR vaccination administered on June 8, 2016 was the cause of her left
shoulder pain and dysfunction. As such, petitioner has provided preponderant evidence to satisfy
Althen prong two.

       3. 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.

         Both respondent and petitioner in this case postulate that the appropriate medically
acceptable timeframe between vaccination and the injury alleged is 48 hours. Resp. Brief at 7;
Pet. Mot. at 32. However, they disagree as to whether the onset of petitioner’s injury occurred
within 48 hours. Respondent argued that petitioner “failed to show by a preponderance of the
evidence that her shoulder pain began within 48 hours of receiving the vaccine.” Resp. Brief at
16. Petitioner argued that the evidentiary records, including petitioner’s medical records and
affidavits, demonstrate that onset of petitioner’s shoulder injury followed within 48 hours of the
vaccination at issue, which “fits the postulated time frame elucidated in the applicable medical
literature (and the Table).” Pet. Mot. at 32.

       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, I dismiss petitioner’s Table SIRVA claim, but find that she
has established by preponderant evidence that she is entitled to compensation, demonstrating that
the MMR vaccination administered on June 8, 2016 was the cause-in-fact of her left shoulder
pain and dysfunction. A separate damages order will be issued.

       IT IS SO ORDERED.

                                                                     s/Thomas L. Gowen
                                                                     Thomas L. Gowen
                                                                     Special Master

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