          In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                          No. 16-0452V
                                     Filed: March 20, 2018
                                         UNPUBLISHED


    LORRAINE SOFIA,
                                                             Special Processing Unit (SPU);
                        Petitioner,                          Entitlement; Ruling on the Record;
    v.                                                       Decision Without a Hearing;
                                                             Causation-In-Fact; Influenza (Flu)
    SECRETARY OF HEALTH                                      Vaccine; Shoulder Injury Related to
    AND HUMAN SERVICES,                                      Vaccine Administration (SIRVA)

                       Respondent.


Ronald Craig Homer and Joseph Pepper, Conway, Homer, P.C., Boston, MA, for
petitioner.
Adriana Ruth Teitel, U.S. Department of Justice, Washington, DC, for respondent.

                                   RULING ON ENTITLEMENT 1

Dorsey, Chief Special Master:

        On April 11, 2016, Lorraine Sofia (“petitioner” or “Ms. Sofia”) filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa–10, et seq.2 (the “Vaccine Act” or “Program”), alleging that as a result of
receiving an influenza (“flu”) vaccination on September 30, 2014, she suffered a
shoulder injury related to vaccine administration (“SIRVA”). See Petition at 1, 6. The
case was assigned to the Special Processing Unit (“SPU”) of the Office of Special
Masters. For the reasons discussed herein, the undersigned finds that petitioner is
entitled to compensation.


1
  Because this unpublished ruling contains a reasoned explanation for the action in this case, the
undersigned intends to post it on the United States Court of Federal Claims' website, in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits
within this definition, the undersigned will redact such material from public access.
2
 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).


                                                      1
   I.      Procedural History

       Ms. Sofia filed her petition for compensation on April 11, 2016. She alleged that
she suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”) as result of
receiving a flu vaccine on September 30, 2014. On April 15, 2016, petitioner filed 27
medical record exhibits and a Statement of Completion. After conducting a review of
the records, respondent filed a status report on June 9, 2016 noting that, “[r]espondent
has completed her review of the filed medical records and is willing to engage in
discussions regarding a litigative risk settlement.” Respondent’s Status Report dated
June 9, 2016, page 1. The parties, therefore, began discussions regarding an informal
resolution of petitioner’s claim.

        Approximately five months later, on November 28, 2016, petitioner filed a status
report asking for guidance from the Court in order to facilitate the parties’ settlement
discussions. In response, the undersigned held a Rule 5 status conference on February
13, 2017, during which the undersigned discussed her preliminary views on the merits
of petitioner’s claim. These preliminary findings were memorialized in an Order dated
February 23, 2017, and which concluded:

        The undersigned makes a preliminary finding that petitioner meets the
        criteria for SIRVA and that her clinical course is consistent with a SIRVA
        injury. Petitioner did not have a history of shoulder pain prior to
        vaccination that would explain her shoulder symptoms after vaccination.
        The undersigned acknowledges that petitioner had cervical radiculitis
        which explains the paresthesia in her hands she experienced, but the
        undersigned finds that the evidence preponderates in favor of this
        symptom being a distinct condition, separate from her shoulder injury.
        Order of February 23, 2017, page 2-3.

        The parties again resumed settlement discussions. However, on June 16, 2017,
petitioner filed a status report informing the Court the parties were at an impasse. A
status conference was held before the undersigned on August 10, 2017, to discuss
further proceedings and several options were discussed as a means to move this case
forward to resolution. On August 18, 2017, the parties filed a joint status report where
petitioner indicated her preference for a ruling on the record, while respondent preferred
the case be transferred from the SPU to a special master for further proceedings. The
parties agreed to defer to the Court’s preference as to how to proceed. Thereafter, the
undersigned issued an Order on September 14, 2017, stating that, “based on the
undersigned’s review of the procedural posture of this case and the options discussed
during the most recent status conference, the undersigned will issue a ruling on
entitlement based on the evidence and briefs submitted by the parties.” Order of
September 14, 2017, page 1.

       On December 20, 2017, the undersigned filed two articles pertaining to causation
of vaccine-related shoulder injuries which were filed as court exhibits. These articles
are: B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28
Vaccine 8049 (2010), filed as Court Exhibit I, and M. Bodor and E Montalvo,

                                             2
Vaccination Related Shoulder Dysfunction, 25 Vaccine 585 (2007), filed as Court
Exhibit II. (ECF No. 56.)3 The parties were given until January 19, 2018, to provide any
additional evidence regarding entitlement or any response to the court exhibits. (Id.)
No further filings were made and the undersigned considers the record as to entitlement
closed as of January 19, 2018. The matter is now ripe for adjudication.

      II.      Medical History

        Ms. Sofia was born in 1947 and is currently retired, although she frequently
spends her time caring for her grandchildren. Petitioner’s Exhibit (“Pet. Ex.”) 2 at 24;
Pet. Ex. 26 at 1. Her medical history is significant for vertigo and disequilibrium in 2012,
mild canal stenosis of her cervical spine, and arthritis and joint pain. Pet. Ex. 4; Pet Ex.
5 at 1; Pet. Ex. 6 at 2, 7; Pet. Ex. 19 at 2; Pet. Ex. 21 at 17. On September 30, 2014,
she received a flu vaccine to her right arm at Rite Aid Pharmacy. Pet. Ex. 1-3.

       In her affidavit, Ms. Sofia states that later the evening of September 30, 2014,
she felt her right arm begin to ache. Pet. Ex. 26 at 1. A few days later, the pain was still
bothering her and she was unable to sleep because of the throbbing pain. Id. at 1-2.
Ms. Sofia states that the achiness in her shoulder and general uncomfortableness
continued for weeks. Id. She took over-the-counter pain relievers, but the medication
did not help. Id.

       On November 17, 2014, Ms. Sofia presented to her primary care physician, Dr.
Ira Kurz with Summit Medical Group, for a routine follow-up on her hypothyroidism. Pet.
Ex. 2. at 7. During this visit, petitioner complained of marked discomfort to her right
shoulder beginning approximately three and one half weeks prior and after her flu
vaccination.4 Pet. Ex. 2 at 10. No treatment was recommended or discussed for her
shoulder. Id.

        On December 10, 2014, Ms. Sofia presented to FirstCare Medical Group –
Lindhurst, an urgent care provider, with a chief complaint of “throbbing pain r[ight]
humerus after getting her flu vaccine back in late September.” Pet. Ex. 17 at 18. The
physical exam, performed by Dr. George Ambrosio, noted “mildly reduced active range
of motion [(“ROM”] with internal rotation,” and mild pain with palpation on upper anterior
lateral arm. Pet. Ex. 17 at 19. The assessment was “arm pain, right.” Id. Petitioner
was prescribed a muscle relaxant, nabumetone, for the pain and swelling and instructed
to follow up with her primary care physician. Pet. Ex. 17 at 18-20.

        On January 29, 2015, Ms. Sofia was again evaluated by Dr. Kurz, who noted
petitioner’s chief complaint as “right arm pain; R[ight] arm pain x 3 months.” Pet. Ex. 2
at 1. The history of present illness indicates that Ms. Sofia reported that she had
experienced right arm pain “since 09/2014 (since flu vac received) … proximal ½ upper
arm/dorsal surface esp. at night … painful to reach & draw covers on herself. No history
3
    These two articles were also filed as petitioner’s exhibits 43-44.
4
 The undersigned noted that the physician referenced an incorrect time frame for the onset of Ms. Sofia’s
symptoms, as petitioner received the flu vaccine almost seven weeks prior to this appointment.

                                                         3
of trauma.” Id. at 1-2. Under ROS (review of systems) “no muscle aches or weakness”
were reported under musculoskeletal, and “history of vague numbness sensation to
fingers, at times … no weakness,” was listed under neurologic. Id. at 2. It was noted
that Ms. Sofia’s past medical history included “arthritis: cervical & lumbar spine.” Id. Dr.
Kurtz’s assessment was “R[ight] upper arm (noted when lying on back) … arthritic
penetrating pain with full ROM. Paraesthesias to finger tips prob. From Cervical spine
degen. Joint dis.” Id. at 5. His plan was to refer Ms. Sofia to an orthopedist for further
evaluation. Id. The specific diagnoses listed for the visit were: 1. Arthralgia of the upper
arm; 2. Retinal defect; 3. Hypothyroidism; 4. Chronic low back pain; 5. Hyperglycemia;
6. Paresthesia of hand; 7. Chronic pain syndrome-right; 8. Cervical syndrome. Id.

        Ms. Sofia next presented to North Jersey Rheumatology Associates (“NJRA”) on
February 26, 2015 with a chief complaint of “shoulder pain.” Pet. Ex. 13 at 7-8.
Petitioner reported that she had right shoulder pain since September that started after
she received a flu vaccine. She reported it was “painful to sleep on and painful
restricted ROM,” and also noted “mild pain to the hands at the end of the day. Some
numbness to the hands upon waking but resolved shortly after waking.” Id. at 8. The
physical exam, performed by physician assistant (“PA”) Hilary Sugar, noted
inflammation, limited ROM (range of motion), and tenderness of the right shoulder. Id.
at 9. The assessment was subacromial bursitis and parasthesias. Id. For the bursitis,
Ms. Sofia received a steroid injection and was instructed to return in two weeks for a
follow-up. Id. Regarding the parasthesias, it was noted that petitioner was a “‘stomach’
sleeper, causing hyperextension at the c-spine resulting in impingement,” and she was
encouraged to try sleeping on her back. Id. at 10.

        Ms. Sofia returned to NJRA on March 12, 2015, and was again seen by Ms.
Sugar. Pet. Ex. 13 at 4. Ms. Sofia reported that her shoulder was “somewhat better”
since the last visit and injection, but she still had some “tightness and cracking” and pain
at night. Id. The physical exam was unchanged from the last visit. Id. at 5. The
assessment was “shoulder pain,” which was noted to be “improved after IAI [intra-
articular injection] but not completely.” Id. at 6. Petitioner was referred to physical
therapy (“PT”). Id. Petitioner also underwent an x-ray of her right shoulder on March
12, 2015. Pet. Ex. 10 at 1. It revealed “mild degenerative changes of the AC joint
characterized by joint space narrowing, subchondral sclerosis and small marginal
spurs.” Id. “Mild degenerative spurring of the inferior glenoid rim,” was also observed.
Id.

        On April 8, 2015, Ms. Sofia had her initial PT evaluation. Pet. Ex. 14 at 1. In the
history of injury, petitioner reported that she had a flu shot on September 30, 2014, and
had experienced shoulder pain since. Id. She rated her a pain at 8/10. Id. She had
reduced ROM, decreased strength of 2+/5 in most planes of motion, and positive
impingement testing. Id. at 2. During her final PT session, it was documented that
petitioner’s strength had improved to 4/5 in most planes while her ROM remained
relatively unchanged. Id. at 31-32. At the time of her discharge from physical therapy
on May 29, 2015, Ms. Sofia was still experiencing some discomfort in her shoulder.



                                             4
She had pain with abduction and adduction, internal and external rotation, with slight
relief from her symptoms post PT session. Id. Her prognosis by the PA was fair. Id.

        On June 10, 2015, Ms. Sofia saw orthopedic surgeon, Dr. Ronald E. Gennace,
with a chief complaint of “pain in the neck.” Pet. Ex. 16 at 1. However, under HPI
(history of present illness), petitioner also described her shoulder pain, which she
reported had been ongoing for four months. Id. She conveyed that after her flu shot
she “immediately developed a superficial reaction,” and “[o]ver the ensuing weeks the
pain became more severe.” Id. Petitioner also noted that she had received a steroid
injection, which “did not give her much relief.” Id. On exam, Dr. Gennace observed full
range of motion of the right shoulder and no weakness against resisted elevation. Id.
Dr. Gennace described petitioner’s cervical spine x-ray as showing “degenerative disc
disease with displaced nonunion C5-C6.” Id. Petitioner received a diagnosis of
“cervical radiculitis.” Id.

        Ms. Sofia returned to Summit on November 2, 2015, and was evaluated by Dr.
Seth Jawetz, who noted that petitioner’s shoulder pain had not yet been adequately
addressed. Pet. Ex. 24 at 1-4. In the ROS, it is noted that petitioner had
arthralgias/joint pain under musculoskeletal and the physical exam revealed pain with
posterior extension and elevation of shoulder. Id. at 4-5. The visit assessment included
“chronic R[ight] shoulder syndrome (prob. Impingement),” and the diagnostic codes
included arthralgia of the upper arm, cervical syndrome, arthritis of shoulder region joint,
and pain in right arm. Id. at 5. Dr. Jawetz did not believe petitioner’s shoulder pain was
related to her prior flu vaccination. Id. at 7 (noting that vaccination was “unrelated event
in this examiner’s opinion”). Petitioner was scheduled to return in January to be
evaluated by Dr. Kurz. Id. at 1.

        Also on November 10, 2015, Ms. Sofia is evaluated by Dr. Oscar Vazquez at
Active Orthopedics & Sports Medicine, an orthopedic physician, who noted that
petitioner’s shoulder pain began after she was administered a flu shot. Pet. Ex. 23 at 5-
6. Ms. Sofia indicated that she had gotten minimal relief from physical therapy, anti-
inflammatories, cortisone injection and topical patches, and continued to have pain and
limitations. Id. Dr. Vazquez assessed her as having impingement of the right shoulder
and rotator cuff tendonitis, for which he administered a corticosteroid injection and gave
a prescription/referral for a MRI. Id. at 6-7.

       Ms. Sofia presented to the Metropolitan Pain Institute (“MPI”) on March 23, 2016.
Pet. Ex. 29 at 1. She reported having “persistent and progressing neck to hand and hip
to back pain that does periodically radiate.” Id. Petitioner indicated it had been ongoing
for more than six months, and that she had tried physical therapy and NSAIDS. Id. The
ROS did not include any specific reports of shoulder pain. Id.at 2. Based on petitioner’s
subjective complaints and physical exam, she was assessed with sacroillitis, spinal
stenosis, and other intervertebral disc degeneration. Id. at 2-3. Additionally, a diagnoses
of cervical disc disorder with radiculopathy was included. Id. at 3.

       On March 30, 2016, Ms. Sofia underwent an MRI of her cervical spine. Pet. Ex.
30 at 2. The clinical history on the report references “left upper extremity

                                             5
radiculopathy.” Id. There was multilevel neuroforaminal narrowing, and a small central
disc herniation was observed at C6-7. Id. at 2-3. Petitioner underwent an MRI of her
lumbar spine on April 4, 2016. Id. at 4. The MRI was read as showing “disc
degeneration at T11-12, disc bulging at L1-2 and L2-3, disc degeneration with broad
disc protrusion more to left at L3-4 and L4-5, and central disc protrusion with facet joint
DJD [degenerative joint disease] and L5 anterolisthesis noted upon evaluation on the
L5-S1 level.”

        On September 16, 2016, Ms. Sofia returned to Dr. Vazquez. Pet. Ex. 35 at 1.
Dr. Vasquez noted that petitioner’s right shoulder pain improved after a cortisone
injection and as a result, petitioner decided not to undergo the MRI on her shoulder as
he prescribed. Id. However, petitioner conveyed that her “shoulder ha[d] begun to
bother her again.” Id. On exam, there was no reduced range of motion, though pain
was reported during impingement testing. Id. at 2. Additionally, tenderness was
observed on petitioner’s left elbow. Id. The assessment included impingement of the
right shoulder, right rotator cuff tendonitis, and disorder of the tendon of the left elbow.
Id. Dr. Vazquez administered another corticosteroid injection and prescribed petitioner
an anti-inflammatory for her impingement. Id. He also prescribed a topical cream for
left elbow tendonitis. Id. at 3.

        Ms. Sofia followed up with Dr. Vazquez on March 7, 2017. Pet. Ex. 39 at 1. She
reported that she continued to experience shoulder pain, and noted that the cortisone
injection gave her about three months of relief. Id. Her exam was unchanged from the
September 16, 2016 visit. Ms. Sofia received another cortisone injection at the visit,
and was instructed to return as needed. Id.

    III.    Applicable Legal Standards

        Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a
preponderance of the evidence, that all requirements for a petition set forth in section
11(c)(1) have been satisfied. A petitioner may prevail on her claim if she has received a
vaccine covered by the Program and “sustained, or had significantly aggravated, any
illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the “Table”).
§ 11(c)(1)(A) and (C)(i). The most recent version of the Table, which can be found at 42
C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding
injuries, and the time period in which the particular injuries must occur after
vaccination.5 § 14(a). If the petitioner establishes that she suffered such a “Table
Injury,” causation is presumed. Grant v. Sec’y of Health & Human Servs., 956 F.2d
1144, 1146–47 (Fed.Cir.1992).

        If, however, the petitioner suffered an injury that either is not listed in the Table
or did not occur within the prescribed time frame, the petitioner must prove that the

5
  The Vaccine Act authorizes the Secretary of the Department of Health and Human Services to
“promulgate regulations” to periodically modify the Vaccine Injury Table. § 14(c). The updates are
contained in the Code of Federal Regulations (C.F.R.), as cited above.


                                                    6
claimed vaccine caused the alleged injury to receive compensation. § 11(c)(1)(C)(ii)
and (iii). In such circumstances, petitioner is said to assert a “non-Table” or “off-Table”
claim, and must prove her claim by preponderant evidence. § 13(a)(1)(A). A special
master is prohibited from making “such a finding “based on the claims of a petitioner
alone, unsubstantiated by medical records or by medical opinion.” § 13(a)(1). This
standard is “one of . . . simple preponderance, or ‘more probable than not’ causation.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005)
(referencing Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1572-73
(Fed. Cir. 1993). The Federal Circuit has held that to establish an off-Table injury,
petitioner must “prove . . . that the vaccine was not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at 1352. The received
vaccine, however, need not be the predominant cause of the injury. Id. at 1351.

        The Federal Circuit has indicated that petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant, 956 F.2d at 1148). Additionally, "[t]here must be a ‘logical sequence of cause
and effect showing that the vaccination was the reason for the injury.’” Id. The Federal
Circuit subsequently restated these requirements in its Althen decision. Althen requires
a petitioner

                 to show by preponderant evidence that the vaccination
                 brought about her injury by providing: (1) a medical theory
                 causally connecting the vaccination and the injury; (2) a
                 logical sequence of cause and effect showing that the
                 vaccination was the reason for the injury; and (3) a showing
                 of a proximate temporal relationship between vaccination and
                 injury.

418 F.3d at 1278. All three prongs of Althen must be satisfied. Id.

        Section 11(c)(1) also contains requirements concerning the type of vaccination
received and the geographic location where it was administered, the duration or
significance of the injury, and the lack of any other award or settlement. See §
11(c)(1)(A),(B),(D) and (E). With regard to duration, whether a Table or non-Table
claim, the petitioner must establish she

                 (i) suffered the residual effects or complications of such
                 illness, disability, injury, or condition for more than 6 months
                 after the administration of the vaccine, or (ii) died from the
                 administration of the vaccine, or (iii) suffered such illness,
                 disability, injury, or condition from the vaccine which resulted
                 in inpatient hospitalization and surgical intervention.

§ 11(c)(1)(D).


                                                7
   IV.    Analysis - Althen Prongs

                  i. A Medical Theory Causally Connecting the Vaccination and
                     Injury

       To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford v. Sec’y of Health & Human Servs.,
2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). The petitioner must offer a medical theory
which is reputable and reliable. See, e.g., Pafford v. Sec’y of Health & Human Servs.,
451 F.3d 1352, 1355 (reputable); Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1324 (Fed. Cir. 2010) (reliable). The petitioner must prove this prong by
preponderant evidence. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d
1339, 1350 (Fed. Cir. 2010).

                        1. SIRVA Injury

        Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and aids
to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner’s claim was filed before
SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury,
the undersigned’s findings were informed by the Qualifications and Aids to Interpretation
for SIRVA criteria used to evaluate such claims. The criteria are as follows:

        A vaccine recipient shall be considered to have suffered SIRVA if such recipient
manifests all of the following: (i) No history of pain, inflammation or dysfunction of the
affected shoulder prior to intramuscular vaccine administration that would explain the
alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after
vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced
range of motion are limited to the shoulder in which the intramuscular vaccine was
administered; and (iv) No other condition or abnormality is present that would explain
the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial
neuritis, mononeuropathies, or any other neuropathy). Id.; see also National Vaccine
Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg.
45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T,
Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine
administration (SIRVA), Vaccine 28(51):8049-8052).




                                             8
                               a. The elements of petitioner’s SIRVA claim

       The undersigned’s findings and conclusions are as follows:

   1. Petitioner did not have a history of pain, inflammation or dysfunction of the
      affected shoulder prior to vaccine intramuscular administration.

        The undersigned reviewed Ms. Sofia’s medical history prior to her influenza
vaccination. The medical records demonstrate that Ms. Sofia did not have a history of
pain, inflammation or dysfunction of the affected (right) shoulder prior to vaccination.
Thus, petitioner has satisfied this criterion.

   2. Onset occurred within the specified time frame.

        Respondent argues in his responsive motion for ruling on the record, for the first
time, that there “is a lack of sufficient evidence to place the onset of her shoulder pain
either within 48 hours of vaccination as required for a SIRVA table claim, or the more
generous timeframe of four days as was reported in one of the case reports in the
Atanasoff et al article.” Respondent’s Response at 10. Respondent further argues that
“[b]ecause petitioner did not visit a medical provider until approximately six weeks after
vaccination and first sought care for shoulder pain ten weeks after vaccination, there is
only petitioner’s subjective reporting of onset to medical providers.” Respondent’s
response at 10-11. Respondent states that petitioner’s affidavit is “silent regarding why,
if the pain had been ongoing for six weeks, she did not overtly complain about the pain
and seek treatment for it at her November 17, 2014 appointment with Dr. Kurz.” Id. at
11. Finally, respondent argues that petitioner’s subsequent description of her injury to
orthopedist surgeon, Dr. Gennace, states it was first a superficial problem, with pain
occurring over the ensuing weeks. Id. at 11. The undersigned finds these arguments to
be unpersuasive.

        First, the undersigned notes that Ms. Sofia did complain to Dr. Kurz of her
shoulder pain during the November 17, 2014 appointment. Pet. Ex. 2. at 7. During this
visit, Dr. Kurz specifically noted that Ms. Sofia complained of “marked discomfort to her
R[ight] arm where influenza vacc[ination] administered 3 w[eeks] ago.” Pet. Ex. 2 at 10.
This statement is directly contrary to respondent’ assertion that Ms. Sofia “did not
overtly complain about the pain.” The undersigned also previously noted, and notes
again, that Dr. Kurz clearly referenced an incorrect time frame for the onset of Ms.
Sofia’s symptoms, as she received the flu vaccine almost seven weeks prior to this
appointment. Although no treatment or further discussion for her shoulder appeared in
the notes from this visit, this omission does not automatically lead to an implication that
Ms. Sofia did not complain of shoulder pain or seek treatment of her pain. Id. Ms.
Sofia’s affidavit does state in her affidavit that she complained of the pain to her
husband and explains that she attempted to treat her shoulder pain with over the
counter pain relievers before she sought formal medical treatment at urgent care. To
the undersigned, Ms. Sofia’s actions and explanations in these specific circumstances
are reasonable and the testimony in her affidavit is credible.


                                             9
        Based upon the evidence set forth in the medical records and affidavits, the
undersigned makes finds that onset was within 48 hours of the September 30, 2014 flu
vaccination, and therefore, is within the Vaccine Table specified time frame of <48
hours. § 13(a)(1)(A) (preponderant standard). See e.g., Pet. Ex. 2 at 1(petitioner
reported that she had experienced right arm pain “since 09/2014 (since flu vac
received)”; Pet. Ex. 2 at 104 (“marked discomfort to [right] arm where influenza
vacc[ination] administered[.]”); Pet. Ex. at 18 (“[Patient] [complains of] throbbing pain
[right] humerus immediately after getting her flu vaccine back in late September. .
..[Right] arm pain that started after she received the flu shot[.]”); Pet. Ex. 26 at 1(“The flu
vaccine was injected into my right arm. Later that evening, my arm started to ache.”).

   3. Pain and reduced range of motion are limited to the shoulder in which the
      intramuscular vaccine was administered.

        As discussed above, Ms. Sofia received the flu vaccination to her right shoulder
and all of her reports of pain, the objective examinations of reduced range of motion,
impingement and bursitis, and all of the treatments she received due to these
complaints have been limited to her right shoulder. See e.g., Pet. Ex. 26 at 1
(petitioner’s affidavit where she describes the pain to the her right shoulder in the days
and weeks following her flu vaccination); Pet. Ex. 2 at 10 ( at a physician visit, petitioner
reports marked discomfort to her right shoulder beginning approximately three and one
half weeks prior and after her flu vaccination); Pet. Ex. 17 at 18 (on December 10, 2014,
petitioner presents to urgent chare with a chief complaint of “throbbing pain r[ight]
humerus after getting her flu vaccine back in late September’; Pet. Ex. 13 at 5-6 (on
March 12, 2015, Physician’s Assistant Hilary Sugar noted that petitioner’s “shoulder
joints are abnormal, inflammation on the right. Limited ROM on the right. Tenderness
on the right . . . . Bursitis of shoulder, right[,] Shoulder impingement[.]”; Pet. Ex. 24 at 3;
(on November 2, 2015, Dr. Ira Kurz, noted, “Chronic [right] Shoulder Syndrome
(prob[ably] impingement)”; Pet. Ex. 35 at 2 (on November 10, 2015, Dr. Oscar Vazquez
noted that petitioner was suffering from, “Impingement of the right shoulder [and] Right
rotator cuff tendonitis…)”.

      For the above reasons, the undersigned finds that Ms. Sofia experienced pain
and reduced range of motion limited to the shoulder in which she received the vaccine.

   4. 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).

        Prior to her September 30, 2014 flu vaccination, and as respondent notes in his
brief, Ms. Sofia did have a medical history which included possible cervical
radiculopathy and general arthritis. Pet. Ex. 6 at 8. Ms. Sofia underwent a cervical
spine MRI on April 26, 2012, which was interpreted as showing “severe left C4-5 facet
degenerative change”, “congenital fusion of the left C2-3 facet”, and “mild canal stenosis
of C2-3, C3-4, C5-6, and C6-7.” Id. at 8. The intake forms completed by Ms. Sofia in
2012-2014 reflect the presence of arthritis and joint pain. See, e.g. Pet. Ex. 5 at 1; Pet.


                                              10
Ex. 19 at 2; Pet. Ex. 21 at 17. However, respondent’s responsive motion does not
discuss how or why petitioner’s cervical spine issues or general arthritis may have
explained petitioner’s right shoulder symptoms following her flu vaccination.

        A review of the records demonstrate that petitioner’s issues with her cervical
spine appear to affect mostly her left arm, elbow and hand. There is not preponderant
evidence in the record to show that it affected or in any way contributed to her right
shoulder symptoms. A diagnosis of cervical spine radiculopathy does not explain the
specific circumstances of this case where Ms. Sofia experienced an abrupt onset of
right shoulder pain within 48 hours of her September 30, 2014 flu vaccination, nor does
it explain the objective decrease in the range of motion of her right shoulder after
vaccination that was not present previously. See e.g. Pet. Ex. 14 at 2 (results of range
of motion testing showing decreased range of motion in right shoulder versus left
shoulder); see also Pet. Ex. 13 at 8 (“Painful to sleep on and painful restricted [range of
motion]”); Pet. Ex. 13, p. 5 (“The shoulder joints are abnormal, inflammation on the right.
Limited [range of motion on the right. Tenderness on the right”).

       Therefore, the undersigned finds that petitioner’s cervical spine issues are a
separate condition from her right shoulder injury associated with the flu vaccination, and
that there are no conditions or abnormalities present that would explain petitioner’s right
shoulder symptoms.

                  i. Logical sequence of cause and effect showing the vaccine was
                     the reason for the injury

        Guided by the criteria for evaluating a Table SIRVA injury, the undersigned finds
that Ms. Sofia has shown, by a preponderance of the evidence, a logical sequence of
cause and effect showing that her September 30, 2014 flu vaccine was the reason for
her shoulder injury. The SIRVA criteria provides a perfectly logical sequence of cause
and effect including (1) no history of pain, inflammation or dysfunction of the affected
shoulder prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring after
vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced
range of motion are limited to the shoulder in which the intramuscular vaccine was
administered; and (iv) No other condition or abnormality is present that would explain
the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial
neuritis, mononeuropathies, or any other neuropathy). The undersigned has found,
infra, that petitioner has satisfied all these requirements and thus has satisfied Althen
prong two.

       Moreover, based on the undersigned’s knowledge and experience reviewing a
large number of SIRVA claims, petitioner’s clinical course is consistent with SIRVA.
The undersigned further bases this finding on the previously filed articles, Court Exhibit I
(B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28
Vaccine 8049 (2010)) and Court Exhibit II (M. Bodor and E Montalvo, Vaccination
Related Shoulder Dysfunction, 25 Vaccine 585 (2007)).


                                             11
                 ii. Proximate temporal relationship between vaccination and
                     injury

       “The proximate temporal relationship prong [under Althen] requires preponderant
proof that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352
(Fed. Cir. 2008). This analysis involves two inquiries: (1) considering the medical basis
of the proffered theory, how long after vaccination would onset or worsening of the
disease occur; and (2) did onset or worsening of the disease actually occur in the
expected timeframe. The first inquiry necessarily intersects with the prong one
analysis. See Langland v. Sec’y of Health & Human Servs., 109 Fed. Cl. 421, 443
(2013); Veryzer v. HHS, 100 Fed. Cl. 344, 356 (2011).

        As discussed above, under the SIRVA criteria, the onset of the symptoms of
petitioner’s shoulder injury must begin within 48 hour or less of the vaccination. The
undersigned has found that the onset of petitioner’s shoulder injury began within 48
hours of the vaccination, and thus, petitioner has satisfied Althen prong two.

   V.     Conclusion

        A cause-in-fact injury is established when petitioner demonstrates by a
preponderance of the evidence: (1) she received a vaccine set forth on the Vaccine
Injury Table; (2) she received the vaccine in the United States; (3) he sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the
vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A).
To satisfy the burden of proving causation in fact, petitioner must establish each of three
factors announced by the Federal Circuit in Althen v. Sec’y of Health & Human Servs.
by preponderant evidence: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a proximate temporal relationship between vaccination
and injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991).

       In light of all of the above, and in view of the submitted evidence, including
the medical records and the parties’ respective motions, the undersigned finds
petitioner entitled to Vaccine Act compensation.

IT IS SO ORDERED.

                                                 s/ Nora Beth Dorsey
                                                 Nora Beth Dorsey
                                                 Chief Special Master




                                            12
