         In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS
                                          No. 17-1028V
                                      Filed: August 9, 2019
                                         UNPUBLISHED


    BARBARA SAKOVITS,

                         Petitioner,                          Special Processing Unit (SPU);
    v.                                                        Findings of Fact; Onset; Influenza
                                                              (Flu) Vaccine; Shoulder Injury
    SECRETARY OF HEALTH AND                                   Related to Vaccine Administration
    HUMAN SERVICES,                                           (SIRVA)

                        Respondent.


Shealene Priscilla Mancuso, Muller Brazil, LLP, Dresher, PA, for petitioner.
Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for respondent.

                                         FINDINGS OF FACT1

Dorsey, Chief Special Master:

       On July 31, 2017, petitioner filed a petition for compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,2 (the “Vaccine
Act”). Petitioner alleges that she suffered left shoulder injuries caused by the influenza
vaccination she received on October 24, 2014. Petition at ¶¶ 2, 13. The case was
assigned to the Special Processing Unit of the Office of Special Masters.




1The undersigned intends to post this ruling on the United States Court of Federal Claims' website. This
means the ruling will be available to anyone with access to the internet. In accordance with Vaccine
Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned
agrees that the identified material fits within this definition, the undersigned will redact such material from
public access. Because this unpublished ruling contains a reasoned explanation for the action in this
case, undersigned is required to post it on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management
and Promotion of Electronic Government Services).

2National 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).
      For the reasons discussed below, the undersigned finds the onset of petitioner’s
shoulder injury related to vaccine administration (“SIRVA”) occurred within 48 hours of
vaccination. Specifically, petitioner suffered pain immediately upon vaccination.

    I.      Relevant Procedural History

       Following the September 26, 2017 initial status conference, the undersigned
ordered petitioner to file a better vaccine record; any outstanding medical records,
particularly those from later visits to her primary care provider (“PCP”); and a detailed
affidavit addressing the onset of her pain, delay in seeking treatment, and lack of later
PCP records. (ECF No. 8). Over the subsequent seven months, petitioner filed these
documents.3

        On June 19, 2018, respondent filed a status report indicating he intended to
defend this case. (ECF No. 20). On July 20, 2018, he filed his Rule 4(c) report setting
forth his objections. (ECF No. 22). Specifically, respondent argues that petitioner has
not met the criteria for the Table injury of shoulder injury related to vaccine
administration (“SIRVA”) because she has failed to establish that her symptoms began
within 48 hours after vaccination (id. at 3) and “has not provided evidence that satisfies
her burden of proof under Althen[4] (id. at 5).” Petitioner was ordered to file additional
evidence and a motion for a finding of fact regarding the issue of onset. (ECF No. 23).

        A few months thereafter, petitioner filed her motion for a finding of fact. Motion
for Fact Ruling in Regard to the Onset of Petitioner’s Symptoms (“Pet. Motion”), Oct. 25,
2018 (ECF No. 27). On November 27, 2018, respondent filed a status report indicating
that he wished to engage in settlement discussions. (ECF No. 29). After engaging in
settlement discussions, on March 28, 2019, the parties informed the undersigned they
had reached an impasse in their settlement discussions. (ECF No. 35). Two months
later, respondent filed his response to petitioner’s motion for a factual ruling.
Respondent’s Response to Petitioner’s Motion for Onset Ruling (“Res. Response”), filed
May 28, 2019 (ECF No. 29). Petitioner filed no reply.

    II.     Issue

      At issue is whether petitioner’s first symptom or manifestation of onset after
vaccine administration was within 48 hours as set forth in the Vaccine Injury Table. 42
C.F.R. § 100.3(a) XIV.B. (2017) (influenza vaccination). Additionally, the Qualifications
and aids to interpretation (“QAI”) for a Table SIRVA requires that a petitioner’s pain
occur within this same time frame, 48 hours. 42 C.F.R. § 100.3(c)(10).

3See Exhibit 7, filed Oct. 3, 2017 (ECF No. 8) (better vaccine record); Exhibit 8, filed Oct. 23, 2017 (ECF
No. 9) (detailed affidavit); Exhibit 9, filed Apr. 20, 2018 (ECF No. 18) (updated PCP records).
4Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (setting forth the three-
pronged test to establish causation in vaccine cases).

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    III.   Authority

       Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
§ 11(c)(1). A special master may find that the first symptom or manifestation of onset of
an injury occurred “within the time period described in the Vaccine Injury Table even
though the occurrence of such symptom or manifestation was not recorded or was
incorrectly recorded as having occurred outside such period.” Vaccine Act § 13(b)(2).
“Such a finding may be made only upon demonstration by a preponderance of the
evidence that the onset [of the injury] . . . did in fact occur within the time period
described in the Vaccine Injury Table.” Id.
       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.
Vaccine Act § 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).

    IV.    Finding of Fact

        The undersigned makes the finding after a complete review of the record to
include all medical records, affidavits, testimony, expert reports, respondent’s Rule 4
report, and additional evidence filed. Specifically, the undersigned bases the finding on
the following evidence:

           •   On October 24, 2014, petitioner received an influenza vaccination in her
               left deltoid. Exhibit 7 at 1.

           •   On February 10, 2015, petitioner visited her PCP, Dr. Edward Prin,
               complaining of pain in her left shoulder since receiving the influenza
               vaccination four months ago. Exhibit 2 at 9. Dr. Prin assessed petitioner
               as suffering from probable impingement and diagnosed rotator cuff
               syndrome (NOS).5 Exhibit 2 at 10.

           •   Petitioner’s medical records from her PCP from three years prior to
               vaccination show that she sought medical care on the following four
               occasions:

                   o October 4, 2011, for a sore throat (id. at 21);

5NOS is a common medical abbreviation for “not otherwise specified.” MEDICAL ABBREVIATIONS: 32,000
CONVENIENCES AT THE EXPENSE OF COMMUNICATION AND SAFETY (15th ed. 2011) at 230.

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                 o November 22, 2013, for an annual physical (id. at 18);
                 o March 11, 2014, for a cat scratch (id. at 15); and
                 o October 9, 2014, for shortness of breath (id. at 12).

              These medical records provide evidence showing petitioner rarely sought
              medical treatment from her PCP.
          •   On February 13, 2015, petitioner was seen, after a referral from Dr. Prin,
              by an orthopedist, Dr. Oscar Vazquez, at Active Orthopedics and Sports
              Medicine, LLC. Exhibit 3 at 21. Indicating that her left shoulder was still
              bothering her after four months, petitioner expressed her concern that her
              pain was due to the influenza vaccination she received in October. Id.

          •   On June 8, 2015, petitioner underwent a left shoulder MRI. Id. at 25. The
              medical record containing the results of that MRI indicate petitioner was
              suffering “[p]rogressive shoulder pain following flu vaccination 11/2014.”
              Id.

          •   It appears that petitioner attended physical therapy (“PT”) from May 11
              through June 11, 2015, without significant progress. Id. at 40. She
              underwent an evaluation for a second period of PT on July 21, 2015. Id.
              at 42. At that visit, she reported an injury date of “10/2014” which was
              caused by the flu shot she received. Id. Although petitioner described her
              onset as gradual, she indicated she had experienced “pain and limited
              mobility,” since that injection. Id.

          •   When petitioner sought a second opinion from another orthopedist, Dr.
              Stephen Silver, on September 8, 2015, she indicated her pain began
              immediately after vaccination. Exhibit 4 at 1. She added “that she never
              had a problem with [her] left shoulder until 10 months ago in 10/2014
              when she got a flu shot.” Id. While stating that she initially had pain but
              good movement, petitioner indicated that her shoulder “progressively got
              stiffer and froze up on her.” Id.

          •   In her two affidavits, petitioner indicates that her pain began the same day,
              immediately upon vaccination. Exhibit 8, filed Oct. 23, 2017, at ¶ 3 (ECF
              No. 10-1); Exhibit 10, Oct. 28, 2018, at ¶ 3 (ECF No. 25-2). In his affidavit,
              her husband indicates petitioner complained of her pain and swelling on
              the evening of vaccination. Exhibit 11, filed Oct. 28, 2018, at ¶ 4 (ECF No.
              25-3).

        The above medical entries show that petitioner consistently connected her left
shoulder injury to the influenza vaccination she had received. Despite one notation
stating petitioner received this vaccination in November 2014, she reported a date of
vaccination in October 2014 on all other occasions. When providing the duration of her
injury and/or pain, petitioner gave a time period which coincides with the correct date of
vaccination. Regarding the onset of her pain, petitioner described it as occurring the
same day as vaccination, often indicating that it was upon vaccination.

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      As such, the undersigned finds preponderant evidence that petitioner’s
manifestation of onset after vaccine administration occurred within 48 hours.

   V.     Scheduling Order

       Given the undersigned’s finding of fact regarding the onset of petitioner’s pain,
the parties should resume their settlement discussions. Moreover, respondent should
evaluate his current position regarding the merits of petitioner’s case.

      The parties shall file a joint status report indicating their preferred next
step(s) in the case by no than Tuesday, September 10, 2019.

IT IS SO ORDERED.

                                  s/Nora Beth Dorsey
                                  Nora Beth Dorsey
                                  Chief Special Master




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