Court Opinion

ID: 6330980
Source: CourtListenerOpinion
Date Created: 2022-04-13 17:03:16.718369+00
Date Added: 2024-06-11T09:22:54.815682
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                            No. 18-1017V
                                        Filed: March 10, 2022
                                             PUBLISHED

    STACY RATZLAFF,                                             Special Master Horner

                         Petitioner,
    v.                                                          Findings of Fact; Onset; Tetanus
                                                                Diphtheria acellular Pertussis (Tdap)
    SECRETARY OF HEALTH AND                                     Vaccine; Shoulder Injury Related to
    HUMAN SERVICES,                                             Vaccine Administration (SIRVA)

                         Respondent.

Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
Petitioner.
Rachelle Bishop, U.S. Department of Justice, Washington, DC, for Respondent.

                                            FINDING OF FACT 1

      On July 16, 2018, Stacy Ratzlaff 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 a Shoulder Injury Related to Vaccine
Administration (“SIRVA”), resulting from adverse effects of a Tetanus-Diphtheria-
Pertussis (“Tdap”) vaccination she received on November 15, 2016. Petition at 1. On
June 7, 2021, petitioner moved for a finding of fact that onset of her shoulder pain
occurred within 48 hours of her vaccination as required by the Vaccine Injury Table.
(ECF No. 52.) Respondent requests a finding that petitioner has not established that
onset of her condition occurred within 48 hours of vaccination. (ECF No. 54.) For the
1
  Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the Fact 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, I agree that the identified material fits within this definition, I 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
reasons discussed below, I find that there is preponderant evidence that petitioner’s left
shoulder pain began within 48 hours of the administration of her November 15, 2016
Tdap vaccination.

    I.      Procedural History

        As noted above this case was initially filed on July 16, 2018. It was assigned to
the Special Processing Unit. (ECF Nos. 1, 5.) Petitioner filed her Statement of
Completion on October 1, 2018. (ECF No. 14.) Respondent filed a Rule 4(c) Report
recommending against compensation on August 21, 2019. (ECF No. 24.) Respondent
raised, inter alia, the question of whether onset of petitioner’s shoulder pain occurred
within 48 hours of her vaccination as alleged. (Id.) The case was subsequently
reassigned to me on May 1, 2020. (ECF No. 36.) On April 28, 2021, the parties
confirmed that this case is ripe for a finding of fact as to the onset of petitioner’s
shoulder pain. (Scheduling Order (Non-PDF), 4/28/2021.) Petitioner filed the instant
motion on June 7, 2021, respondent filed his response on July 16, 2021, and petitioner
filed a reply on August 2, 2021. (ECF Nos.53-55.) This motion is now ripe for
resolution. 3

    II.     Factual History

            a. Medical Records

        Petitioner received her Tdap vaccination in her left shoulder on November 15,
2016, during a well woman exam with her gynecologist, Emily Webb, M.D. (Ex. 1, p. 1;
Ex. 13, p. 4.) Prior to the vaccination at issue in this case, petitioner had remote history
of prior left shoulder pain; however, by the time of her most recent pre-vaccination
primary care appointment she reported no left shoulder complaints. (E.g. Ex. 14, p. 29;
Ex. 4, pp. 16-19.)

     On November 23, 2016, eight days post-vaccination, petitioner presented to
Advanced Physical Therapy for an evaluation of pain in her left shoulder. (Ex. 2, pp. 48-

3
  In her motion, petitioner went beyond the prompting of my April 28, 2021 order by arguing not only in
favor of specific a finding of fact regarding onset, but also asserting that she should be found entitled to
compensation for her alleged Table injury. (ECF No. 52, pp. 5-6, 9.) However, she also noted that she
was declining to substantively address aspects of her required Table showing that do not deal with the
issue of onset. (Id. at 9.) Respondent’s response argued that petitioner is not entitled to compensation,
but substantive discussion was limited to the question of onset. (ECF No. 54.) Prior to the filing of
petitioner’s motion, I had confirmed with the parties only that this case was ripe for a finding of fact as to
onset. Special masters “must determine that the record is comprehensive and fully developed before
ruling on the record.” Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020) (citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012); Jay v.
Sec’y of Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir. 1993.)); see also Vaccine Rule 8(d);
Vaccine Rule 3(b)(2). Moreover, the parties must have a full and fair opportunity to present their case
and develop a record sufficient for review. Id. Accordingly, I decline to reach the question of petitioner’s
ultimate entitlement to compensation at this time even though the onset of petitioner’s condition appears
to be the primary, if not sole, issue being litigated by the parties.

                                                       2
49.) Petitioner’s history was recorded as “shot to arm 3 days ago has become severe.
Now pain continues to increase each day and is spreading all around.” (Id. at 48.) The
physical therapist also confirmed reduced range of motion in flexion and internal and
external rotation. (Id.) Under assessment, the physical therapist indicated that petitioner
“appears to have irratation [sic] to soft tissue from injection[.] Appears to have irratation
[sic] in [joint] due to limited movement[,] popping[,] and high level of pain all the time.” 4
(Id. at 49.)

       Petitioner first sought care for her shoulder pain from her primary care physician,
Robert Roeser, D.O., on December 14, 2016. (Ex. 4, pp. 11-14.) Dr. Roeser recorded
that petitioner “presents for left shoulder pain. She received a TDaP shot on 11/15/2016
at Dr. Webb’s office, and it was injected into her joint. She has been to physical therapy
3 times a week for the last 3 weeks. She is here for a shoulder injection to help with the
inflammation.” (Id. at 11.) Dr. Roeser observed on physical exam “normal except left
shoulder(s) tender glenohumeral joint decreased range of motion.” (Id. at 13.) His
assessment was “pain in the left shoulder” and “bursitis of the left shoulder.” (Id.) He
offered a shoulder joint injection of Marcaine/kenalog.” (Id. at 14.)

         Petitioner was discharged from physical therapy on December 20, 2016. (Ex. 2,
pp. 53-54.) After that, she did not return for further treatment of her shoulder injury until
November 17, 2017. (Ex. 3, pp. 5-8.) In the interim, she had follow up appointments for
her Crohn’s disease and migraines on March 2, 2017, and June 15, 2017, at which her
shoulder pain was not mentioned. (Ex. 4, pp. 3-10.) She established care with a new
primary care physician, Dr. Brooke Dunlavy, on June 26, 2017. (Ex. 3, pp. 9-12.)
Shoulder pain was not discussed and physical examination indicated normal movement
in all joints. (Id. at 11.) Petitioner also had appointments with specialists,
gastroenterology on August 8, 2017, and endocrinology on August 24, 2017. (Ex. 3, pp.
16-19, 24-28.)

       When petitioner returned to Dr. Dunlavy on November 17, 2017, for her annual
well woman exam, she raised the issue of her left shoulder pain. (Ex. 3, pp. 5-8.)
Petitioner’s history was recorded in relevant part as “[patient] is concerned about L[eft]
shoulder pain that has been present for a year. [Patient] states that she had a Tdap shot
in her L[eft] shoulder that was given too high, ever since she has had pain in her L[eft]
shoulder.” (Id. at 5.) Physical examination showed “[d]ecreased abduction/adduction
both with active and passive motion in [left upper extremity” as well as “drop arm” and
“pain with opposed internal rotation.” (Id. at 8.) X-rays were negative for any
abnormality. (Id. at 33.) However, Dr. Dunlavy suspected a rotator cuff etiology and
referred petitioner to an orthopedist. (Id. at 8.)

4
  The physical therapist recommended physical therapy two to three times per week for six weeks. (Ex. 2,
p. 49.) Petitioner returned to physical therapy on November 28, November 30, December 2, December 5,
December 9, December 12, and December 20, 2016. (Id. at 51-72.) However, the initial onset of
petitioner’s shoulder pain was not revisited with the physical therapist.

                                                   3
        Petitioner saw orthopedist Ryan Livermore, M.D., on December 5, 2017. (Ex. 5,
pp. 105-09.) Dr. Livermore recorded a “13 month history of left shoulder pain following
a Tdap booster injection.” (Id. at 105.) He explained that petitioner “noted typical
injection soreness the first day, but this worsened and continued.” (Id.) Dr. Livermore
recorded the date of injury as November 15, 2016, and concluded that the “[h]istory and
exam are certainly concerning for iatrogenic 5 subacromial bursitis secondary to a
wayward injection . . .” (Id. at 105, 109.)

         Petitioner subsequently underwent shoulder surgery on December 29, 2017. (Ex.
6, pp. 1-2.) Petitioner then returned to physical therapy beginning January 2, 2018. (Ex.
2, p. 73.) The history provided at that time indicated petitioner “had onset of pain in left
shoulder approx. 1 year ago after receiving a Tdap booster shot into the left shoulder . .
.” (Id.)

       This is not a complete summary of petitioner’s medical history relative to her left
shoulder injury; however, upon my review of the entire record the remaining medical
records are far less probative regarding the onset of her condition and need not be
specifically addressed.

            b. Witness Statements

                     i. Petitioner

       Petitioner filed an affidavit signed July 31, 2018, declaring in relevant part under
penalty of perjury:

        On November 15, 2016, I went in for my yearly checkup at my gynecologist,
        Dr. Webb. At the end of my visit, she suggested I receive my TDAP booster.
        The nurse came in and gave it to me. I noticed she was injecting it really
        high up on my shoulder compared to other shots I had received, but I figured
        she knew what she was doing. The shot was painful, but I thought pain
        from an injection was probably normal and would likely go away on its own.
        By the next day, my shoulder was extremely painful and difficult to move.
        The pain continued so I saw a physical therapist on November 23, 2016.
        He was able to see where I had been given the shot and commented that it
        had been given way too high.

(Ex. 11, p. 1.)

                     ii. Trevor Ratzlaff

        Petitioner submitted a “To Whom it May Concern” letter by her husband, Trevor
Ratzlaff, discussing her shoulder pain. (Ex. 23.) Mr. Ratzlaff indicates that he recalls
petitioner’s shoulder pain beginning “the night of the injection” and that she still has pain

5
  Iatrogenic “[d]enot[es] [a] response to medical or surgical treatment, usually denot[ing] unfavorable
responses.” Stedman’s Medical Dictionary, 28th Ed. (2006), p. 942

                                                     4
more than three years later. (Id. at 1.) He indicates that petitioner was frustrated when
she returned from her appointment because she had initially been reluctant to receive
the Tdap vaccination. (Id.) Mr. Ratzlaff recalls that petitioner initially believed that the
pain she was experiencing was normal post-vaccination arm soreness, but that she
began calling friends and family that night to ask whether they felt her pain was normal.
(Ex. 23, p. 1.)

                 iii. Chloe Johnson

      Petitioner submitted an undated handwritten letter by her 14-year-old daughter,
Chloe Johnson. (Ex. 24.) Ms. Johnson recalls in relevant part that petitioner
complained of “bad” shoulder pain within hours of returning from the medical
appointment at which she received the subject vaccination. (Id.) The remainder of Ms.
Johnson’s affidavit addresses petitioner’s subsequent course.

                 iv. Jacie Benson

        Petitioner submitted a “To Whom it May Concern” letter by her oldest daughter,
Jacie Benson, dated May 5, 2020. (Ex. 25.) Ms. Benson’s letter focuses in significant
part on expressing anger and frustration regarding the circumstances of petitioner’s
injury as well as describing reasons why petitioner may have neglected self-care. (Id.)
In relevant part, Ms. Benson states that she speaks with her mother daily and that “I
remember my mom calling me the evening she got her tdap shot, which was in
November 2016, stating her arm was hurting more than normal after getting a shot, and
she thought the nurse gave her the shot too close to her shoulder.” (Id. at 1.)

                 v. Kelsey Nelson

       Petitioner submitted a “To Whom it May Concern” letter by her daughter, Kelsey
Nelson, dated May 4, 2020. (Ex. 26.) Ms. Nelson echoes several points similar to those
expressed by Ms. Benson regarding reasons petitioner’s pursuit of healthcare may have
been delayed or incomplete. (Id.) With regard to onset she states that “I recall speaking
with my mother, Stacy Ratzlaff, the day that she received her shot. The shot was
painful, but she did not think too much of it. Shortly after she left the doctor[’]s office
she realized the pain she was feeling was not a normal reaction to the shot. The next
morning when I spoke to my mother again, she was in much more pain and was unable
to even move her arm.” (Id.)

                 vi. Gary Simon

       Petitioner submitted a “To Whom it May Concern” letter by her father, Gary
Simon, dated May 3, 2020. (Ex. 27.) In relevant part he recalls “talking to Stacy the day
after she received an injection and her remarking how badly her shoulder hurt and how
she thought something might be wrong. At the time neither of us realized just how
badly she was hurt or how much pain lie ahead for her.” (Id.)

                                              5
                    vii. Laura Bownds

        Petitioner submitted an undated “To Whom it May Concern” letter by her friend
and former neighbor, Laura Bownds. (Ex. 28.) With regard to onset of petitioner’s
shoulder pain, Ms. Bownds recalls that “I noticed a huge change in Stacy beginning in
Nov 2016, and during this particular phone call, she was crying and worried on the
phone. She discussed being in excruciating pain due to an injection given that day, and
she thought it was given in the wrong area. Being a nurse myself, I explained where
injections in the arm should be given. Stacy discussed that the injection was given
close to her shoulder and she was experiencing awful pain.” (Id.)

    III.      Party Contentions

       In her motion, petitioner argues that both the medical records and “affidavits”
support a finding that petitioner experienced shoulder pain within 48 hours of her
vaccination. (ECF No. 52, pp. 6-7.) Petitioner further stresses the importance of
affidavits as evidence regarding factual issues and contends that the affidavits in this
case alone could support a fact finding in petitioner’s favor. (Id. at 7-9.)

        In his response, respondent counters that neither the medical records nor
petitioner’s affidavit and accompanying witness statements preponderantly establish
onset within 48 hours of vaccination. (ECF No. 54.) Respondent stresses that
petitioner’s November 23, 2016 medical record places onset three days earlier, which
would be about five days post-vaccination. (Id. at 2-3 (citing Ex. 2, p. 48).) He further
stresses that the later December 5, 2017 medical record indicates petitioner
experienced only typical post-vaccination soreness before later experiencing worsened
pain. (Id. at 3 (citing Ex. 5, p. 105).) Respondent also contends that the witness
statements contradict petitioner’s affidavit. Whereas petitioner indicated she initially
thought her pain was normal and would subside, the witness statements indicate the
pain was severe immediately and was immediately suspicious of an injury. (Id. at 3-4.)

           Respondent summarizes his argument as follows:

           Judging the record as a whole, a clear pattern emerges. As we move farther
           in time away from the vaccination, petitioner recalls a closer temporal
           relationship between the vaccination and the onset of her symptoms. This
           type of misinformation effect is a common and understandable cognitive
           bias, but also underscores the importance of relying on contemporaneous
           records in making factual determinations.

(Id. at 4.)

        In reply, petitioner stresses that her treating physicians repeatedly attributed her
condition to her vaccination and none raised any alternative cause of the injury or date
of onset. (ECF No. 55, p. 2.) Petitioner contends that it is respondent rather than
petitioner that gives too little weight to the contemporaneous medical records. (Id.)

                                               6
Petitioner contends that the medical records alone also favor a finding of onset of
shoulder pain occurring within 48 hours of vaccination. (Id. at 3.)

        Petitioner also contends that the witness statements in this case constitute
“relevant and reliable” evidence regardless of whether they are sworn statements. (ECF
No. 55, p. 3.) Citing Vaccine Rule 8(b)(1), petitioner stresses that special masters are
not bound by common law or statutory rules of evidence. (Id.) Petitioner argues the
inconsistency among witness statements urged by respondent is not persuasive
because all the statements place onset of shoulder pain within 48 hours of vaccination.
(Id. at 3-4.)

   IV.    Legal Standard

       Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove the facts
underlying their claim by a preponderance of the evidence. A special master must
consider the record as a whole, 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. §
13(b)(1).
        The Federal Circuit has held that contemporaneous medical records are
ordinarily to be given significant weight due to the fact that “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.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993). Thus, 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 *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this
rule is not absolute. In Lowrie, the special master wrote that “written records which are,
themselves, inconsistent, should be accorded less deference than those which are
internally consistent.” Id. (quoting Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct.
726, 733 (1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992)).
        When witness testimony is offered to overcome the presumption of accuracy
afforded to contemporaneous medical records, such testimony must be “consistent,
clear, cogent, and compelling.” Camery v. Sec'y of Health & Human Servs., 42 Fed. Cl.
381, 391 (1998) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V,
1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). Further, the Special
Master must consider the credibility of the individual offering the testimony. 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). In determining
whether to afford greater weight to contemporaneous medical records or other
evidence, such as testimony, there must be evidence that this decision was the result of
a rational determination. Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 416-17
(Fed. Cir. 1993). The special master is obligated to consider and compare the medical
records, testimony, and all other “relevant and reliable evidence contained in the

                                             7
record.” La Londe v. Sec'y Health & Human Servs., 110 Fed. Cl. 184, 204 (2013) (citing
§ 12(d)(3); Vaccine Rule 8), aff'd, 746 F.3d 1334 (Fed. Cir. 2014); see also Burns, 3
F.3d at 417.
    V.      Analysis

       In this case, both parties raise arguments in their motion papers that miss the mark.
Nonetheless, when considering the record as a whole, there is preponderant evidence
that the onset of petitioner’s shoulder pain occurred within 48 hours of her vaccination.

        Petitioner is correct that special masters are not bound by traditional rules of
evidence. Accordingly, I have considered the witness statements in this case as
relevant evidence even though they are unsworn. However, petitioner’s further
suggestion that they are therefore necessarily also reliable is not persuasive. Even
before reaching the substance of the unsworn statements, several factors reduce the
weight that can be afforded them. First, the great majority are by witnesses with close
familial connections to petitioner. These relationships are not disqualifying, but suggest
a need for caution due to the potential for bias. Second, and relatedly, these witnesses
have not been sworn and have also not been subjected to cross-examination.
Accordingly, these statements are not on equal footing with either sworn statements or
contemporaneous medical records. Contrary to petitioner’s suggestion that the witness
statements alone could support a finding in petitioner’s favor, I conclude that if it were
the case that this fact finding turned on these unsworn witness statements alone, then a
fact hearing would likely have been necessary.

        However, respondent’s interpretation of the medical records is also lacking.
Petitioner’s contemporaneous medical records indicate that a mere eight days post-
vaccination, she presented to a physical therapist for medical care for shoulder pain that
she specifically attributed to the vaccination at issue. (Ex. 2, p. 48.) Respondent
stresses first and foremost that this record erroneously states that petitioner’s
vaccination occurred three days prior (Id.) Respondent acknowledges this may be a
clerical error, but nonetheless urges that it suggests an onset of pain beginning
November 20, 2016. (Id.) While this error leaves the record somewhat ambiguous, I
disagree with respondent’s interpretation. The record misstates the date of vaccination,
but still places onset within the specific context of the vaccination. Accordingly, it
strongly suggests onset that was understood by the physical therapist to be temporally
proximate to vaccination and does not offer any suggestion that onset was anything
other than associated with that vaccination. 6

6
  The specific notation at issue reads in full: “Shot to arm 3 days ago has become severe. Now pain
continues to increase each day and is spreading all around.” (Ex. 2, p. 48.) Because this record clearly
contains an error on its face (i.e. petitioner was not vaccinated three days prior), it is not possible to
accept it without some form of reinterpretation. There are actually multiple plausible readings that would
be consistent with onset within 48 hours of vaccination with only the most modest of corrections. First,
there could be a plain numeric error: “Shot to arm [8] days ago has become severe.” Second, the lack of
punctuation could be the issue: “Shot to arm[,] 3 days ago has become severe.” Respondent’s
interpretation is less modest and less satisfying in that it compounds the error(s) at issue. In respondent’s
interpretation, this record still misstates the date of vaccination (3 days prior instead of 8 days prior) but

                                                      8
        Moreover, respondent’s preferred interpretation of this initial encounter is less
persuasive when considering the medical records as a whole. Similar to the November
23, 2016 physical therapy encounter, when petitioner sought follow up care from Dr.
Roeser about three weeks later, she similarly reported shoulder pain related to her
November 15, 2016 Tdap vaccination and specifically associated the pain with the
injection itself penetrating the joint. (Ex. 4, p. 11.) This detracts from respondent’s
interpretation of the November 23 record.

        Additionally, when petitioner later sought orthopedic care for her shoulder pain,
the orthopedist concluded that the “[h]istory and exam are certainly concerning for
iatrogenic subacromial bursitis secondary to a wayward injection . . .” (Ex. 5, pp. 105,
109.) Respondent contends that this record should be interpreted as reporting only
typical injection site soreness on the day of vaccination (ECF No. 54, p.3); however, this
is directly refuted by the orthopedist’s explicit notation that injury onset was November
15, 2016 (Ex. 5, p. 105). While it is certainly true that considerable time elapsed before
petitioner sought orthopedic care, there is nothing in the interim medical records that
contradicts these medical records by suggesting any other period of initial onset.
Accordingly, when considering the medical records as a whole, the evidence
preponderates in favor of a finding that onset of petitioner’s shoulder pain occurred
within 48 hours of her vaccination.

         Respondent is correct that there are inconsistencies among the witness
statements in this case that are challenging to reconcile. In her own sworn statement,
petitioner states that “[t]he shot was painful, but I thought pain from an injection was
probably normal and would likely go away on its own. By the next day, my shoulder
was extremely painful and difficult to move.” (Ex. 11, p. 1.) One of her daughters (Ms.
Nelson) similarly stated that petitioner complained of pain the day of the vaccination, but
initially “did not think too much of it” and was in much more pain the next day. (Ex. 26.)
In contrast, another daughter (Ms. Benson) specifically recalls petitioner reporting on
the date of vaccination that her shoulder was “hurting more than normal” after getting
the shot. (Ex. 25, p. 1.) Her father similarly stated that petitioner suspected something
was wrong the day of the vaccination. (Ex. 27.) Her friend indicated she was in
“excruciating pain” and “crying” on the day of the vaccination. (Ex. 28.) Petitioner
stresses that none of the statements place onset outside of a 48-hour timeframe;
however, these statements reflect very different assessments of petitioner’s symptoms
and her state of mind on the day of her vaccination. Without further examination, it
would be difficult to credit all of the witness statements as reliable. Importantly,
however, the medical records in themselves preponderantly establish onset within 48
hours of vaccination. Moreover, petitioner’s own sworn affidavit is consistent with the
medical records. (Compare Ex. 11, p. 1 and Ex. 5, p. 105.) Accordingly, there is no
conflict between the contemporaneous medical record and the sworn testimony.

also cryptically places onset of pain on November 20 based on the happening of an event (vaccination)
that didn’t actually occur on that date.

                                                   9
        Nor is the fact that petitioner initially thought her shoulder pain was “typical
injection soreness the first day” necessarily significant. Although petitioner’s subjective
complaints are probative as to the severity and timing of her symptoms, she is not
herself competent to speak to the medical significance of her complaints. Accord
James-Cornelius on Behalf of E. J. v. Sec'y of Health & Human Servs., 984 F.3d 1374,
1380 (Fed. Cir. 2021) (“While lay opinions as to causation or medical diagnosis may be
properly characterized as mere ‘subjective belief’ when the witness is not competent to
testify on those subjects, the same is not true for sworn testimony as to facts within the
witness's personal knowledge. . . .”) As noted above, her orthopedist assessed an
injury secondary to vaccination occurring on the date of vaccination. (Ex. 5, pp. 105,
109.)

   VI.    Conclusion

        In light of all of the above, I find that there is preponderant evidence that
petitioner’s alleged shoulder pain began within 48 hours of her November 15, 2016
Tdap vaccination.

IT IS SO ORDERED.

                                                  s/Daniel T. Horner
                                                  Daniel T. Horner
                                                  Special Master

                                             10