Court Opinion

ID: 4678891
Source: CourtListenerOpinion
Date Created: 2021-04-20 17:01:58.760878+00
Date Added: 2024-06-11T09:12:17.531857
License: Public Domain

In the United States Court of Federal Claims
                          OFFICE OF SPECIAL MASTERS

*********************
DANIELLE JENNINGS,       *                          No. 16-779V
                         *                          Special Master Christian J. Moran
             Petitioner, *
                         *                          Filed: July 8, 2020
v.                       *                          Reissued: April 20, 2021
                         *                          entitlement; human papillomavirus
SECRETARY OF HEALTH      *                          (“HPV”) vaccine; asthma/breathing
AND HUMAN SERVICES,      *                          problems; chronic fatigue syndrome;
                         *                          gastrointestinal dysfunction
             Respondent. *
*********************

Scott W. Rooney, Nemes, Rooney P.C., Farmington Hills, MI, for petitioner;
Darryl Wishard, U.S. Dep’t of Justice, Washington, DC, for respondent.

           UNPUBLISHED DECISION DENYING COMPENSATION*

       Danielle Jennings filed a petition for compensation under the National
Childhood Vaccine Injury Compensation Program (the “Vaccine Act” or
“Program”), 42 U.S.C. § 300aa—10 to 34 (2012), alleging that a human
papillomavirus (“HPV”) vaccine she received caused her to develop various
conditions, including asthma/breathing problems. Pet., filed June 30, 2016.
Because Ms. Jennings has not established that she suffered from many of the
conditions for which she seeks compensation and that the record supports a finding
that her asthma/breathing problems existed before the vaccination, she is not
entitled to compensation.

                                    Procedural History

       *  The parties were informed that this decision would be made available to the public. Ms.
Jennings sought redaction of this decision, but her motions were denied. Orders, issued Oct. 19,
2020 and Sep. 15, 2020. After Ms. Jennings requested that the Court of Federal Claims review
the orders denying redaction, the Court denied the motion for review. Order, issued Feb. 8,
2021. Accordingly, this decision is being posted as originally submitted, except for modification
to this footnote.
       Ms. Jennings began this case by filing a petition on June 30, 2016. 1 She
filed a collection of medical records. The petitioner filed the first of six affidavits
from Denise Jennings as exhibit 7 on October 3, 2016. In this October 3, 2016
affidavit, Ms. Jennings set forth a series of allegations about her daughter’s health
and school attendance. Exhibit 7. Some of the affidavit reproduces a chronology
that appears in a medical record from January 2014. Exhibit 14 at 23-27. While
the author of the chronology is not identified, the context suggests that Denise
Jennings prepared this chronology.
      Petitioner periodically filed medical records and other documents over the
next six months. As discussed in the summary of events, the collection of medical
records was not ideal as petitioner did not produce records from every office of
every doctor who treated her. On April 5, 2017, petitioner represented that she was
waiting for only one more set of medical records. Otherwise, the record was
essentially completed. Pet’r’s Status Rep., filed Apr. 5, 2017.
        This status report allowed the Secretary to review the submitted material.
The Secretary summarized the medical records. Resp’t’s Rep., filed May 1, 2017,
at 2-8. After reviewing the standards for entitlement, the Secretary argued that
petitioner had not established that Ms. Jennings was entitled to compensation. The
Secretary “disputes that petitioner has demonstrated that vaccine-related injury.”
Id. at 9. The Secretary indicated that neither a treating doctor nor a retained expert
offered any theory to explain how a vaccine caused Ms. Jennings’s injury. Id. The
Secretary also disputed the temporality in that some symptoms occurred before the
vaccination and some diagnoses occurred months after the vaccination. Id. at 11.
       After the Secretary recommended against compensation, to facilitate the
drafting of reports from experts, the undersigned proposed a set of instructions for
the expert. Order, issued May 23, 2017. The draft instructions later became final.
Order, issued Aug. 2, 2017.
     In a June 12, 2017 status conference, petitioner disputed the accuracy of
some of the medical records, which the Secretary had summarized. Thus, Ms.

       1 Initially, Denise Jennings, the mother of Danielle Jennings, acted as petitioner because
Danielle had not reached the age of majority. However, Danielle eventually became the
petitioner. Order, issued Aug. 23, 2018. Whether Denise Jennings or Danielle Jennings was the
petitioner does not affect the outcome.

                                                2
Jennings was given an opportunity to file an affidavit. She also requested an
opportunity to file an amended petition. Order, issued June 14, 2017.
      Petitioner first filed her amended petition. The amended petition alleges that
Danielle Jennings “continues to suffer from a toxic reaction to the vaccinations as
identified above.” Am. Pet., filed June 21, 2017, ¶ 11. The amended petition does
not specify a particular disease or condition that the vaccinations allegedly caused.
However, the amended petition does assert that after the vaccinations, Ms.
Jennings experienced “hand numbness, headaches, handwriting difficulties, visual
comprehension difficulties” as well as “memory impairments and neurologic
impairments.” Id. ¶¶ 9-10.
       Petitioner submitted affidavits from Denise Jennings on July 14, 2017
(exhibit 19) and September 1, 2017 (exhibit 20). The former discussed potential
sources of information about Danielle’s health in the relevant time. The latter
contested some of the material found in the medical records from Dr. Baptist.
Petitioner also filed more medical records and school records.
       Petitioner announced an intention to retain an expert. Pet’r’s Status Rep.,
filed Oct. 12, 2017. After multiple enlargements of time, petitioner filed the first
report from Dr. Santoro on May 29, 2018. Exhibit 26. This report did not comply
with the August 2, 2017 Expert Instructions. For example, Dr. Santoro did not
define the condition that was affecting Danielle. Consequently, petitioner was
ordered to obtain a supplemental report. Order, issued June 25, 2018.
       This supplemental report from Dr. Santoro was filed on August 23, 2018.
Exhibit 27. Dr. Santoro, again, did not reach a conclusion about Danielle’s
diagnosis. Order, issued Sept. 17, 2018. The Secretary intended to file an expert
report in response.
        After similarly receiving multiple enlargements of time, the Secretary filed a
report from Dr. MacGinnitie on February 14, 2019. Exhibit A. Dr. MacGinnitie
challenged many aspects of Dr. Santoro’s opinion, including the lack of diagnosis.
Id. at 4-5, 9.
      Petitioner’s response to Dr. MacGinnitie’s report took place in two forms.
Denise Jennings challenged some of Dr. MacGinnitie’s factual assertions in an
affidavit. Exhibit 39. Dr. Santoro disputed some of Dr. MacGinnitie’s medical
opinions in two more reports. Exhibits 40-41.

                                          3
        The Secretary filed another report from Dr. MacGinnitie on September 10,
2019. Exhibit P. 2 In the ensuing status conference, the parties stated that the stage
for developing expert reports was finished. Accordingly, the parties were directed
to file briefs regarding entitlement. Order, issued Sept. 25, 2019. This order
allowed the parties to file a limited amount of additional information, including
updated medical records for Danielle.
      The parties complied. Petitioner filed her brief with additional evidence on
March 4, 2020. Exhibits 42-53. The Secretary filed his brief on March 27, 2020.
The Secretary, too, filed additional evidence. Exhibits U-Z. Although permitted
additional time, petitioner did not file a reply. The case is ready for adjudication.
                              Standards for Finding Facts
      Petitioners are required to establish their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted).

      The process for finding facts in the Vaccine Program begins with analyzing
the medical records, which are required to be filed with the petition. 42 U.S.C.
§ 300aa–11(c)(2). Medical records that are created contemporaneously with the
events they describe are presumed to be accurate. Cucuras v. Sec’y of Health &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

       Not only are medical records presumed to be accurate, they are also
presumed to be complete, in the sense that the medical records present all the
patient’s medical issues. Completeness is presumed due to a series of propositions.
First, when people are ill, they see a medical professional. Second, when ill people
see a doctor, they report all their problems to the doctor. Third, having heard about
the symptoms, the doctor records what he or she was told.

      Appellate authorities have accepted the reasoning supporting a presumption
that medical records created contemporaneously with the events being described

       2 The Secretary also designated another document as exhibit P, a disciplinary action
against Dr. Neuenschwander, that was filed on July 15, 2019.

                                               4
are accurate and complete. A notable example is Cucuras in which petitioners
asserted that their daughter, Nicole, began having seizures within one day of
receiving a vaccination, although medical records created around that time
suggested that the seizures began at least one week after the vaccination. Cucuras,
993 F.3d at 1527. A judge reviewing the special master’s decision stated that “[i]n
light of [the parents’] concern for Nicole’s treatment . . . it strains reason to
conclude that petitioners would fail to accurately report the onset of their
daughter’s symptoms. It is equally unlikely that pediatric neurologists, who are
trained in taking medical histories concerning the onset of neurologically
significant symptoms, would consistently but erroneously report the onset of
seizures a week after they in fact occurred.” Cucuras v. Sec’y of Health & Human
Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993).

       Judges of the Court of Federal Claims have followed Cucuras in affirming
findings by special masters that the lack of contemporaneously created medical
records can contradict a testimonial assertion that symptoms appeared on a certain
date. See, e.g., Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608
(Fed. Cl. 2010) (stating “[g]iven the inconsistencies between petitioner’s testimony
and his contemporaneous medical records, the special master’s decision to rely on
petitioner’s medical records was rational and consistent with applicable law”),
aff’d sub nom. Rickett v. Sec’y of Health & Human Servs., 468 Fed. Appx. 952
(Fed. Cir. 2011) (non-precedential opinion); Doe/17 v. Sec’y of Health & Human
Servs., 84 Fed. Cl. 691, 711 (2008); Ryman v. Sec’y of Health & Human Servs.,
65 Fed. Cl. 35, 41-42 (2005); Snyder v. Sec’y of Health & Human Servs., 36 Fed.
Cl. 461, 465 (1996) (stating “The special master apparently reasoned that, if Frank
suffered such [developmental] losses immediately following the vaccination, it was
more likely than not that this traumatic event, or his parents’ mention of it, would
have been noted by at least one of the medical record professionals who evaluated
Frank during his life to date. Finding Frank’s medical history silent on his loss of
developmental milestones, the special master questioned petitioner’s memory of
the events, not her sincerity.”), aff’d, 117 F.3d 545, 547-48 (Fed. Cir. 1997).

       The presumption that contemporaneously created medical records are
accurate and complete is rebuttable, however. For cases alleging a condition found
in the Vaccine Injury Table, special masters may find when a first symptom
appeared, despite the lack of a notation in a contemporaneous medical record. 42
U.S.C. § 300aa-13(b)(2). By extension, special masters may engage in similar
fact-finding for cases alleging an off-Table injury. In such cases, special masters
are expected to consider whether medical records are accurate and complete. To
overcome the presumption that written records are accurate, testimony is required
                                         5
to be “consistent, clear, cogent, and compelling.” Blutstein v. Sec’y of Health &
Human Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June
30, 1998).

      In determining the accuracy and completeness of medical records, special
masters will consider various explanations for inconsistencies between
contemporaneously created medical records and later given testimony. The Court
of Federal Claims has identified four such explanations for explaining
inconsistencies: (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 Health &
Human Servs., 110 Fed. Cl. 184, 203 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014).

      When weighing divergent pieces of evidence, special masters usually find
contemporaneously written medical records to be more significant than oral
testimony. Cucuras, 993 F.2d at 1528. Testimony offered after the events in
question is less reliable than contemporaneous reports when the motivation for
accurate explication of symptoms is more immediate. Reusser v. Sec’y of Health
& Human Servs., 28 Fed. Cl. 516, 523 (1993). However, compelling oral
testimony may be more persuasive than written records. Campbell, 69 Fed. Cl. at
779 (“[L]ike any norm based upon common sense and experience, this rule should
not be treated as an absolute and must yield where the factual predicates for its
application are weak or lacking.”); Camery v. Sec’y of Health & Human Servs., 42
Fed. Cl. 381, 391 (1998) (this rule “should not be applied inflexibly, because
medical records may be incomplete or inaccurate”); Murphy v. Sec’y of Health &
Human Servs., 23 Cl. Ct. 726, 733 (1991) (“[T]he absence of a reference to a
condition or circumstance is much less significant than a reference which negates
the existence of the condition or circumstance.”) (citation omitted), aff’d, 968 F.2d
1226 (Fed. Cir. 1992).

                                 Finding of Facts
       Ms. Jennings was born in 2000 at 32 weeks gestation. Her early birth may
have contributed to some respiratory issues. See exhibit 8 at 10, exhibit 25 at 48-
49, 63. Otherwise, events in her first 12 years seem not to affect the outcome of
this case. For example, her pediatrician, Marcia Newcombe, assessed her as a well

                                         6
child in an August 20, 2011 examination. Exhibit 25 at 6.3 Ms. Jennings’s general
good health had allowed her to play soccer since kindergarten. Id. at 29.
      On March 9, 2013, the family brought home a golden Labrador Retriever.
Exhibit 14 at 24 (chronology Denise Jennings apparently created in conjunction
with an appointment on January 30, 2014).4 As discussed briefly below, the
Secretary’s expert suggested that an allergy to this dog could have been
responsible for Ms. Jennings’s breathing problems. Exhibit A at 5-6.
       Following the August 20, 2011 well-child appointment, Ms. Jennings’s next
appointment with her pediatrician was on March 23, 2013. The chief complaint
was “pain in abdomen / chest / back after running for a few minutes x 1 month.”
Dr. Newcombe assessed her as having “exercise induced asthma” with “no vocal
cord paralysis.” Dr. Newcombe demonstrated how to use an inhaler and stated that
if Ms. Jennings were not better with an inhaler, then she should seek testing with a
pulmonologist. Exhibit 25 at 5. Dr. Newcombe recommended the first dose of the
HPV vaccine. Id.; see also exhibit 1. Ms. Jennings asserts she had a mild reaction
to the first dose of the HPV vaccine, given on March 23, 2013. However, she does
not claim compensation for any injury related to the first dose. See Pet’r’s Br. at
23, 38.5
      In later medical records, doctors recorded histories from Ms. Jennings and
her mother that Ms. Jennings developed asthma and/or breathing difficulties after
the HPV vaccination. E.g., exhibit 6 at 10-13, 29-33. These histories are not
correct. The March 23, 2013 record establishes that Ms. Jennings came to Dr.
Newcombe because she was having breathing problems when she ran, resulting in

       3 In June 2013, Ms. Jennings and her mother told a doctor that in January or February,
Ms. Jennings was ill and tested for strep. She recovered from it completely. Exhibit 25 at 29. In
August 2013, another doctor recorded a history that Ms. Jennings possibly had an influenza
infection in January 2013. Exhibit 25 at 57. Similarly, in January 2014, two doctors were
informed that in February 2013, Ms. Jennings experienced a febrile illness, either influenza or
mononucleosis. Exhibit 6 at 42-44, exhibit 14 at 22-28. However, the set of records from the
pediatrician contain no notes from January or February 2013, corroborating the accounts of
illness.
       4 While much of the chronology is repeated in the initial affidavit of Denise Jennings
(exhibit 7), the information about the family getting a new dog is not in the affidavit.
       5  The statute of limitations precludes compensation for an injury that developed shortly
after the first HPV vaccination.

                                                7
a diagnosis of “exercise induced asthma,” and a recommendation to consult a
pulmonologist. Exhibit 25 at 5.
      The pulmonologist whom Ms. Jennings saw was Martin Hurwitz from the
West Bloomfield Asthma, Allergy, and Pediatric Pulmonology Center on May 14,
2013. Ms. Jennings and her mother told Dr. Hurwitz that “Since the beginning of
the indoor soccer season last fall [2012], Danielle has experienced pressure
sensation on the chest and lightheadedness and almost near syncope after 10
minutes of hard running.” Exhibit 25 at 61. 6 While Ms. Jennings reported that her
symptoms were better during the outdoor soccer season, a bronchodilator inhaler
was not effective. Dr. Hurwitz recorded that Ms. Jennings “is not allergic to any
foods or medications” and that the family has two pet dogs. Id. at 62. Dr. Hurwitz
tested Ms. Jennings’s pulmonary function with a spirometry. The results were
below predicted rates. Dr. Hurwitz wanted an echocardiogram to see if Ms.
Jennings might have any structural abnormalities.
       To obtain the echocardiogram, Ms. Jennings saw a pediatric cardiologist,
Elliott Weinhouse, on May 17, 2013. Dr. Weinhouse recounts that Ms. Jennings
was a “very precious, 12-year-old young lady,” who has a “recent onset of chest
pain with sports.” Exhibit 2 at 2; exhibit 25 at 34 (duplicate). Dr. Weinhouse
administered an echocardiogram, which detected a small antero-inferior pericardial
effusion. A “pericardial effusion” is the “accumulation of more than 50 mL of
pericardial fluid in the pericardium.” Dorland’s Illustrated Medical Dictionary 589
(32nd ed. 2012). After a follow-up examination a few days later, Dr. Weinhouse
opined that the pericardial infusion was a residual from a previous viral-like
illness. Exhibit 2 at 4. He recommended no vigorous sports or gym class until Ms.
Jennings was re-examined in a month.
      Less than a month later, the family sought a second opinion regarding the
pericardial effusion with a different pediatric cardiologist, Daniel R. Turner.
Exhibit 3 at pdf 3-7. Dr. Turner’s report provides information about her
cardiopulmonary function as well as information directly relevant to Ms.
Jennings’s claim that the vaccination harmed her by causing her to develop
headaches. Ms. Jennings wanted a second opinion because she had upcoming

       6 Dr. Hurwitz’s record is an example of the disorganization of medical records. His May
14, 2013 report appears in the set of records of Dr. Newcombe. However, the report of the
spirometry, a test to measure breathing, that Dr. Hurwitz administered is found in the high school
records. Exhibit 12 at 12. It appears that petitioner did not produce a set of records directly from
the West Bloomfield Asthma, Allergy, and Pediatric Pulmonology Center.

                                                 8
tryouts for a travel-league soccer team and wanted to know if exercise restrictions
were necessary. Id. at pdf 4.
       With respect to Ms. Jennings’s breathing, Dr. Turner wrote that “Recently,
Danielle started a new indoor soccer league and both Danielle and her mother
noticed a marked difference in her exercise tolerance. . . . She sought medical
attention for this and was recommended an albuterol inhaler, but according to
Danielle it was tried and did not help.” Exhibit 3 at pdf 3-4. Dr. Turner
administered an electrocardiogram, echocardiogram, and exercise stress test. Id. at
pdf 5-6. Based upon these studies, Dr. Turner reached an impression that Ms.
Jennings had “Exercise-induced chest pain, noncardiac in nature, and likely related
to asthma with response to albuterol.” Id. at pdf 6. Dr. Turner referred Ms.
Jennings back to her pediatrician for management of her asthma.
      In addition to this detailed assessment of Ms. Jennings’s cardiopulmonary
function, Dr. Turner conducted a review of systems. In this context, Dr. Turner
stated that Ms. Jennings “complains of headaches that occur every other day. They
occur in the frontal areas and occasionally will spread back to the parietal and
occipital areas in a band-like arrangement. . . . [S]he takes aspirin to treat the
problem.” Exhibit 3 at pdf 5. Dr. Turner’s report appears to be the first time a
doctor noted that Ms. Jennings was suffering headaches after the vaccination. Dr.
Turner did not record how long Ms. Jennings was having headaches.
       Ms. Denise Jennings averred that her daughter collapsed during a soccer
game on or about June 8, 2013. Exhibit 7 at 1 (affidavit, sworn Oct. 3, 2016).
However, medical records do not corroborate this account. On October 29, 2013, a
pediatric neurologist, Iqbal Allarakhia, recorded a history that “About a year ago,
while playing soccer, [Ms. Jennings] collapsed on the field although she did not
lose responsiveness or awareness. She did not feel lightheaded or dizzy.” Exhibit
22 at 36. Dr. Allarakhia’s history is slightly supported by Dr. Turner’s June 5,
2013 report before the alleged collapse in which Dr. Turner stated “There was one
episode of near syncope when she [was] playing where she felt very dizzy. On that
day, she was not sure if she had hydrated appropriately.” Exhibit 3 at pdf 4. The
context of Dr. Turner’s report places this incident before 2013, possibly meaning
the fall 2012. Ms. Jennings’s expert, Dr. Santoro, does not cite this alleged
collapse in his medical history nor does he assert syncope as one of the symptoms
or injuries that Ms. Jennings suffered. Consequently, although Ms. Jennings may
have collapsed sometime during 2012, the assertion about collapsing during a
soccer game on or about June 8, 2013 is not credited.

                                         9
      Another reason for not accepting the assertion about a collapse on June 8,
2013, is that this incident is not memorialized in the well-child visit with Dr.
Newcombe on July 5, 2013, approximately one month later. See exhibit 25 at 4.
While the handwriting makes this report difficult to read, the doctor assessed Ms.
Jennings as a “well teen.” She also has “exercise induced asthma.” Id. Dr.
Newcombe recommended another dose of varicella and HPV. Id.; see also exhibit
1. This second dose, given on July 5, 2013, allegedly caused Ms. Jennings’s health
problems. See Pet’r’s Br. at 1, 38; footnote 5, above.
       Once more, there are allegations that Ms. Jennings’s health declined after the
July 5, 2013 vaccination. E.g., exhibit 7 (Denise Jennings’s first affidavit) at 2;
exhibit 39 (Denise Jennings’s sixth affidavit). Some medical records provide this
history. Of this group, the earliest medical record was created by a holistic
practitioner on January 30, 2014. Exhibit 14 at 21. However, Ms. Jennings has
not submitted any medical records from later July or early August 2013, describing
any health problems.
       Instead, the next medical record after the July 5, 2013 well-child visit is an
appointment with a pediatric pulmonologist, Lokesh Guglani, on August 27, 2013.
Exhibit 25 at 56. Dr. Guglani states that he is seeing Ms. Jennings and her older
sister, who provided a letter from their mother with a history, upon referral from
Dr. Turner, the cardiologist. Ms. Jennings reported having breathing difficulty
after 5-10 minutes of running during soccer games and requiring frequent
substitutions when she had been playing recently. After obtaining a history, which
is more-or-less consistent with the chronology above, and performing various tests,
Dr. Guglani opined that Ms. Jennings might be suffering from vocal cord
dysfunction, rather than exercise induced asthma. Id. at 59. He, accordingly,
recommended breathing exercises and a possible referral to a speech therapist. Id.
      It appears that in January 2014, Denise Jennings created a chronology
stating that in early September 2013, her daughter’s “right hand was weak and she
had difficulty writing or grabbing anything with power.” Exhibit 14 at 26; accord
exhibit 7 (affidavit) at 4. However, in an October 29, 2013 medical record, a
doctor stated, “This patient and her mother have not noticed [a] change in
handwriting or clumsiness or any kind of subtle disequilibrium.” Exhibit 25 at 26.
The October 29, 2013 record is more reliable because it was created closer in time.
      Ms. Jennings returned to her pediatrician on September 23, 2013. The chief
complaint was “chest pain x 1 night, pounding feeling, worse when walking,
headaches.” Additional details are provided in different handwriting: “HA
[headaches] 2-3x occurs while resting after CP [presumably chest pain] . . .
                                         10
[positive] dizzy w/ HA, [no] abd. pain, pounding band-like HA; . . . ill 7 months
ago when CP began; . . . HA starts in occipital region.” Exhibit 25 at 3. Due to the
illegible handwriting, how Dr. Newcombe responded to the report of headaches is
not entirely clear. 7 She seems to have described Ms. Jennings as a “well looking
child.” Id.
      An episode of chest pain while playing soccer prompted Ms. Jennings and
her family to seek treatment at the emergency department of the Detroit Medical
Center for the Children’s Hospital of Michigan on October 16, 2013. Exhibit 15 at
19-34. In one history, Ms. Jennings reported “‘shaking’ and ‘numbness’ of her
hands occasionally, when she has episodes of chest pain.” Id. at 27. None of the
reports from this emergency room visit suggest Ms. Jennings was having
headaches. Ms. Denise Jennings reported that her daughter had a URI in January
2013, and after which developed chest pain and difficulty breathing with exercise.
Id. One consulting physician–who might be a pulmonologist–stated, “I do think
some of her symptoms are related to vocal cord dysfunction and I encouraged her
to continue the relaxation exercises that were reviewed by Dr. Guglani and the
speech therapists.” Id. at 31. Tests, such as chest X-rays, electrocardiogram, and
pulmonology tests, were negative. See exhibit 14 at 26; exhibit 25 at 24.
      After the visit to Children’s Hospital of Michigan, Ms. Jennings returned to
see Dr. Hurwitz, the pediatric pulmonologist. Ms. Jennings and her mother
informed Dr. Hurwitz that a doctor at the Children’s Hospital of Michigan
suggested that she might have vocal cord dysfunction. Thus, Dr. Hurwitz
requested records from the hospital so that he could evaluate the basis for that
suggestion. Dr. Hurwitz recorded that Ms. Jennings’s chief complaint was chest
pain with shortness of breath. Ms. Jennings also complained of “arm numbness
and [having] trouble opening jars with her right hand. This began several weeks
ago.” Exhibit 25 at 26. In addition to obtaining a release to acquire the records
from the hospital, Dr. Hurwitz prescribed a medication and anticipated seeing Ms.
Jennings about in one month.

       7  Ms. Jennings’s retained expert, Dr. Santoro, stated that “The first manifestation of the
headaches post-vaccination was the report of September [2013]. Exhibit 25, p. 3.” Exhibit 27 at
4. However, Dr. Santoro appears to overlook Dr. Turner’s June 5, 2013 report that Ms. Jennings
was having headaches every other day. Exhibit 3 at pdf 5. Similarly, in an affidavit, Denise
Jennings averred that her daughter “began complaining of headaches within the first two weeks
after the vaccinations in July 2013.” Exhibit 39 ¶ 10. Ms. Jennings, too, seems to have missed
the report of headaches to Dr. Turner in June 2013.

                                               11
      Ms. Jennings went to her pediatrician on October 25, 2013. The chief
complaint was “R hand feels numb, headache.” Exhibit 25 at 2. Dr. Newcombe’s
notes, which remain difficult to read, indicate that Ms. Jennings is “lt [light]
sensitive” and has a “bad HA almost every day.” In reference to Ms. Jennings’s
recent trip to the Children’s Hospital of Michigan, Dr. Newcombe recorded that a
pulmonologist proposed vocal cord dysfunction, but the exercises were not
helping. Ms. Jennings also recounted that her “R hand feels numb from HA” and
she “can’t read handwriting.” It appears that Ms. Jennings was referred to a
neurologist and ordered an MRI. See exhibit 22 at 22 (results of MRI).
       Before the appointment with the neurologist, Ms. Jennings saw a specialist
in allergies and immunology, Harvey Leo, on October 28, 2013. Exhibit 25 at 50. 8
Dr. Leo’s report begins with a statement that Ms. Jennings “has had a fairly
complex past medical history.” Exhibit 25 at 48. His report elaborates on this
topic in two respects. Dr. Leo recounts that Ms. Jennings “has been seen on
several occasions because of recurrent shortness of breath issues with exercise.
She has had a full cardiac workup and pulmonary workup by our pulmonology and
cardiology colleagues.” Id. Dr. Leo stated that “They [apparently Ms. Jennings
and her parents] also feel that symptoms worsened when the new dog . . . was
brought into the home in the past year.” Id.9 In addition, Dr. Leo noted that Ms.
Jennings “has currently been evaluated for migraine headaches” and that she plays
competitive soccer. Id.
       Dr. Leo administered a skin prick test. The results showed “positive
reactivity to grasses predominantly.” Exhibit 25 at 49. Dr. Leo concluded that Ms.
Jennings “has evidence of allergic rhinitis, which is probably playing an overall
role in the possibility of asthma-like issues. We suspect she does have some true
asthma given her early birth history . . . . However, this may be confused with both
vocal cord dysfunction.” Id. Dr. Leo recommended different medications to help
when she had breathing difficulties.

       8  Information about the date of this appointment is not consistent. While the last page
states that Dr. Leo digitally signed his report on September 17, 201 3, the appointment was on
October 28, 2013. Exhibit 25 at 50; see also exhibit 14 at 26.
         Like the records from Dr. Hurwitz, reports from Dr. Leo appear in only the records of Dr.
Newcombe. It appears that petitioner did not file any records obtained directly from Dr. Leo’s
practice, Allergy & Immunology Associates of Ann Arbor, P.C.
       9While Dr. Leo’s report does not specify when the Jennings took in a new dog, Denise
Jennings’s chronology states that this happened on March 9, 2013. Exhibit 14 at 24.

                                               12
      A pediatric neurologist, Iqbal Allarakhia, saw her on October 29, 2013. Dr.
Allarakhia’s record begins by stating that Ms. Jennings “two weeks ago had a
severe headache during which she developed numbness of the right hand and also
mild weakness of both hands, which lasted the whole day.” Exhibit 22 at 36. Dr.
Allarakhia provides details about Ms. Jennings’s headaches. The frequency of
severe headaches was “about once a month, usually in the morning.” Id. “The
headache starts in the occipital region, then develops like a band and involves the
frontal region, squeezing in nature, not pulsatile without nausea, vomiting.” Id.
“The headache intensity averages at about 8/10.” Id.
      Dr. Allarakhia conducted an examination and reviewed the MRI, which Dr.
Newcombe had ordered. He assessed her as having “Complicated migraine with
numbness of the right hand.” Id. at 37. He recommended that she avoid migraine
triggers, such as insufficient fluid intake, skipping meals, stress, and insufficient
sleep. Because her headaches were not very frequent, Dr. Allarakhia did not
prescribe a prophylactic medication, but did prescribe Fioricet for when headaches
started. Id.
      When Ms. Jennings, with her mother and father, returned to Dr.
Newcombe’s pediatric group on November 16, 2013, they saw Dr. Ada Kendall.
Exhibit 25 at 1. 10 Ms. Jennings or her parents were “very frustrated” by her lack of
progress. Her headaches were worse and causing concentration problems at
school.
     Ms. Denise Jennings’s chronology and affidavit mentions one doctor for
which no records have been filed, Dr. Pittaway. Exhibit 14 at 26; exhibit 7 at 6.
On November 19, 2013, Dr. Pittaway tested Ms. Jennings’s digestive system and
recommended various supplements, which Ms. Jennings had not started to take.11

       10  While Dr. Kendall’s full name does not appear in the medical records, Dr. Ada Kendall
is listed as one of the pediatricians in the same medical group as Dr. Newcombe, Providence
Park Pediatrics (https://healthcare.ascension.org/Locations/Michigan/MIDET/Novi-Ascension-
Medical-Group-Providence-Park-Pediatrics). Dr. Kendall also appears to have signed the
medical record for this visit. Exhibit 25 at 1.
       11 Ms. Jennings appears to be referencing Dr. Kenneth Pittaway of the Institute of Natural
Health Sciences (http://www.institutenhs.com/). Dr. Pittaway is listed as having a N.D. (natural
doctor) degree and a Ph.D. (specialty not identified) but does not appear to have a M.D. (medical
doctor) degree. Ms. Jennings has not filed any records from the Institute of Natural Health
Sciences.

                                               13
      According to Denise Jennings’s chronology, Dr. Newcombe said “‘her brain
[was] misfiring and incorrectly signaling pain where none exists’” at a November
21, 2013 appointment. Exhibit 14 at 26. 12 Dr. Newcombe recommended seeing a
psychologist for consultation and treatment.
       Around November or December, Ms. Jennings had “daydreams, tune outs,
and staring spells” that resolved by January 14, 2014. Exhibit 8 at 9. Around this
time, according to Denise Jennings’s chronology, her daughter’s teachers and
classmates noticed a change in her behavior and short-term memory loss. Exhibit
14 at 26. Ms. Denise Jennings wrote to her daughter’s teachers on December 17,
2013, that Danielle was making slow progress. Exhibit 24 at 7.
      Ms. Jennings started hyperbaric oxygen therapy on December 13, 2013.
According to a patient information form, Ms. Denise Jennings learned about the
Oxford Hyperbaric Therapy Center from a “friend/relative” and the reason for
seeking treatment was “Gardasil Vaccination Poisoning.” Exhibit 9 at 6. This
notation appears to be the first instance Ms. Jennings, or a parent, linked Ms.
Jennings’s health problems with the vaccination. Ms. Jennings had 26 sessions of
hyperbaric oxygen, lasting until January 20, 2014. Id. at 5.
       The connection to the vaccination is also mentioned in the next report from
the immunologist, Dr. Leo, on December 16, 2013. Ms. Jennings’s family “has
been very concerned about increasing episodes of memory loss, muscle weakness
and chest pain. . . . These symptoms have escalated and they are now concerned
about the amnesia and confusion as well as significant amount of sleep.” Exhibit
25 at 43. “The family was concerned if the Gardasil was the triggering factor for
these reactions. They would like to discuss the possibility of heavy metal testing
and other testing components of the Gardasil. We informed the parents that there
are no specific testing modalities at this time for the components of Gardasil aside
from limited skin prick testing, which would not answer the particular issues they
have.” Id.
       Dr. Leo appears to have taken these complaints, “particularly the memory
loss issues and concerns about the vaccine” seriously. He suggested “several other
explanations that should be pursued first before we identify the vaccine as a major
cause.” One possibility was autoimmune disease and vasculitis. Therefore, Dr.
Leo ordered ANA profiles. Second, Dr. Leo wanted a sleep study to see whether
sleep issues could be contributing to fatigue and memory loss. Third, Dr. Leo
       12The medical records for Dr. Newcombe’s medical group (exhibit 25) do not contain a
corresponding record for this appointment.

                                             14
noted hypothyroidism was possible, although he doubted that problem because Ms.
Jennings’s weight had not changed. Fourth, Dr. Leo ordered tests to rule out
mononucleosis. Finally, Dr. Leo recommended formal neuropsychological testing
to document objectively any amnesia or memory loss. Exhibit 25 at 44.
       A set of laboratory results from a blood draw on December 19, 2013, appear
as exhibit 6, pages 20-24. The ordering doctor was Cheryl A. Johnstone of the
Medical Clinic of Northville. In this context, there is no discussion of the
significance of any results.
      The first appointment for Ms. Jennings in 2014 was at the Michigan Institute
for Neurological Disorders, where she saw John Manica, on January 14, 2014. Dr.
Manica addressed his letter to Dr. Johnstone.13 Dr. Manica obtained a history that
is generally consistent with the history recounted above. Ms. Jennings was
experiencing headaches daily that lasted all day. 14 Ms. Jennings further described
her headaches as “pressure-like” and sufficiently painful to “bring tears” and to
miss school one or two times per week. 15 Dr. Manica assessed her as
“experiencing adolescent migraine headaches. . . . Her neurological examination is
normal.” Exhibit 8 at 10. Dr. Manica instructed Ms. Jennings to keep a headache
journal and prescribed medication. He anticipated seeing Ms. Jennings again in
about one month.
     Dr. Manica also ordered an MRI of Ms. Jennings’s brain and a routine
awake EEG with hyperventilation and photic stimulation. Both these tests were
normal. Exhibit 8 at 8, 13.
     Ms. Jennings saw James Neuenschwander from the Bio Energy Medical
Center on January 30, 2014. Denise Jennings explained that they saw Dr.

       13   Petitioner has not filed any records obtained directly from Dr. Johnstone’s office.
       14Although Dr. Manica’s history states Ms. Jennings developed headaches since March
2013, the first report of headaches was Dr. Turner’s June 5, 2013 report.
       15 The middle-school records for the 2013-2014 academic year show that Ms. Jennings
was absent from classes between 27 and 43 times per class. Denise Jennings’s affidavit provides
additional details about school absences. Exhibit 7 at 7-8. Nonetheless, all her grades were
either A’s or A minuses. Exhibit 24 at 3.

                                                  15
Neuenschwander because the family was having “difficulty getting a clear
diagnosis from providers.” Exhibit 39 ¶ 15.16
       It appears that in advance of this appointment Ms. Jennings prepared a
detailed chronology to which this decision has cited. See exhibit 14 at 24-27.
Based upon this history and information communicated orally, Dr.
Neuenschwander assessed Ms. Jennings as suffering from reactive airway disease,
toxic encephalitis, allergies, and fatigue syndrome. Id. at 22. He recommended
various supplements. Id. at 23.
       Following the January 30, 2014 appointment with Dr. Neuenschwander, it
appears that Ms. Jennings saw doctors much less frequently. For example, it
appears that Ms. Jennings did not have any appointments with her pediatrician, Dr.
Newcombe, after November 21, 2013. See exhibit 14 at 26.17 Similarly, Ms.
Jennings did not file any records showing treatment in 2014 with the immunologist
(Dr. Leo) or the pediatric pulmonologist (Dr. Hurwitz). A pediatric neurologist
was expecting to see Ms. Jennings, but was, on February 18, 2014, waiting for Ms.
Jennings to submit a headache questionnaire before scheduling an appointment.
Exhibit 6 at 18. Whether Ms. Jennings did not see doctors, or she did not file
records from doctors, such as Dr. Johnstone, whom she did see in this time, is
difficult to determine. In any event, the record shows that Ms. Jennings saw Dr.
Neuenschwander on March 31, 2014, and May 21, 2014. Exhibit 14 at 15, 18.
       Around this time, Ms. Jennings also consulted with Mark Flannery, who is a
chiropractor in California. Dr. Flannery describes himself as having experience in
nutrition. On April 3, 2014, and May 8, 2013, Dr. Flannery ordered blood tests.
See exhibit 11 at 5-15. While Ms. Jennings filed these test results as part of Dr.
Flannery’s records, this exhibit contains no reports of office visits or evaluations.
However, on October 27, 2014, Dr. Flannery wrote a two-paragraph letter “To
Whom it May Concern,” which appears in Ms. Jennings’s high school records. Dr.

       16  The Secretary filed a disciplinary complaint from the Michigan Department of
Licensing and Regulatory Affairs, Board of Medicine, alleging that Dr. Neuenschwander
improperly advised a patient regarding medical treatment. CM/ECF No. 133, attachment #1.
Dr. Neuenschwander later entered into a consent order admitting to one count of negligence or
failure to exercise due care and paid a punitive fine on May 20, 2015. (https://aca3.accela.com/
MILARA/GeneralProperty/LicenseeDetail.aspx?LicenseeNumber=4301050438&LicenseeType=
Medical%20Doctor).

       17As noted above, the medical records for Dr. Newcombe’s pediatric group (exhibit 25)
do not contain a corresponding record for this appointment.

                                              16
Flannery stated that Ms. Jennings “has been diagnosed with a reaction to the
Gardasil vaccine.” Exhibit 12 at 15.
       Ms. Jennings saw a neurologist, Gireesh Velugubanti, on July 14, 2014.
Exhibit 6 at 28. 18 Dr. Velugubanti note begins that Ms. Jennings was well until the
first Gardasil vaccination on March 23, 2013 “when she developed difficulty in
breathing that again began shortly after the vaccination.” Exhibit 6 at 28. 19 Dr.
Velugubanti conducted a neurologic examination. His assessment included four
parts. First, to rule out a partial seizure disorder, he ordered long-term video
monitoring. Second, with respect to episodic memory loss, Dr. Velugubanti did
not detect any memory impairments in the working or declarative domain of
testing. Third, for headaches, Dr. Velugubanti recommended physical therapy.
Fourth, he wanted to rule out conversion disorder. He stated: “I have reviewed
side effects of Gardasil and did not identify any associations in the side effect
profile. Vaccine associated damage is being worked up through Bioenergy Dr.
Wine.” Id. at 32. 20
      Ms. Jennings underwent a three-day EEG, beginning on August 1, 2014. Dr.
Velugubanti interpreted the EEG as “abnormal.” While the background was
normal, there were “occasional interictal diffuse spike and polyspike and wave
discharges throughout the recording.” Dr. Velugubanti suggested that Ms.
Jennings might suffer from “juvenile myoclonic epilepsy / primary generalized
primary epilepsy.” Exhibit 4 at 2. The next document from Dr. Velugubanti is a
“To Whom it May Concern” letter, dated January 28, 2015, which is nearly six
months later. While he states Ms. Jennings “has also been seen for multiple
medical appointments” regarding headaches and migraines, there are no reports
from any other appointment.
      The neuropsychological evaluation recommended by Dr. Velugubanti was
performed on August 27, 2014, by Allison Myers, a psychologist, and Annette
Richard, an intern. Ms. Myers determined that Ms. Jennings’s performance on
memory was “variable and suspected to be impacted by suboptimal

       18  Exhibit 6 is the set of records from the University of Michigan Health System. Dr.
Velugubanti’s July 14, 2014 report is a scanned or faxed copy. Records from the office of Dr.
Velugubanti, Michigan Neurology Associates PC, do not contain the July 14, 2014 report. See
exhibit 4.
       19This report is not accurate. Dr. Newcombe recorded breathing problems on the day of
vaccination. Exhibit 25 at 5.
       20   Dr. Neuenschwander’s organization is known as “Bio Energy.”

                                              17
effort/disengagement.” Exhibit 5 at 5. Ms. Myers tied this performance to “a
discrepancy between self-reported symptoms and known patterns of brain function
as the patient reported frequent amnesia for recent events and sudden inability to
read, cognitive symptoms which are not consistent with epilepsy or other
neurological disorders.” Id. at 6. The diagnostic impressions were “unspecified
neurocognitive disorder” and “[rule out] conversion disorder.” Id. at 11.
      Before Ms. Jennings had the neuropsychological evaluation, Ms. Jennings
saw another pediatric pulmonologist, Wan Chong Tsai, upon referral from Dr.
Newcombe. Exhibit 22 at 4-10.21 Dr. Tsai’s impressions included asthma, vocal
cord dysfunction, allergic rhinitis, and “possible Gardasil vaccine-related
neurologic adverse effect with report of new seizure onset under active evaluation
currently.” Id. at 9.
      On two days in December 2014, Ms. Jennings underwent a second
neuropsychological evaluation at Dr. Velugubanti’s referral. Exhibit 12 at 16-25.
The evaluator was Angela K. DeBastos, a pediatric neuropsychologist. Id. at 25.22
Ms. DeBastos did not comment on Ms. Jennings’s effort or consistency of
responses. Ms. DeBastos found that the results of her testing are “consistent with a
cognitive disorder secondary to a history of non-convulsive seizure activity,
chronic headaches and fatigue, and possible mild traumatic brain injury.” Id. at 20.
       At the end of 2014, Ms. Jennings was involved in a car accident, but this
accident does not affect her claim that a vaccine injured her. In 2015, Ms.
Jennings periodically saw Dr. Neuenschwander, but these appointments also are
not relevant. She may have seen Dr. Johnstone (see exhibit 6 at 48), but she did
not file any records from Dr. Johnstone.
       In 2016, Ms. Jennings saw two doctors, whose reports have some relevance
to her claim. On April 29, 2016, she saw a doctor with a specialty in allergy and
immunology at the University of Michigan Health System, Alan P. Baptist. The
reason for the visit was “adverse reaction to HPV vaccine 3 years ago, this caused
immunology and allergy issues. She has seen many other doctor[s], allergists, and

        The filed records from Dr. Newcombe do not contain any reports from visits shortly
       21

before Ms. Jennings saw the pediatric pulmonologist.
       22 Ms. DeBastos’s report is found in the school records and was a basis for aspects of the
section 504 plan. The school records do not contain the earlier neuropsychologic report from
Ms. Myers. Likewise, Ms. DeBastos does not mention the previous report from Ms. Myers.

                                               18
Mom would like to try to find out how to fix the issues this has caused.” Exhibit 6
at 9.
       Dr. Baptist’s history begins inaccurately. His report states: “Mother states
[Ms. Jennings] was doing well until the age of about 13. States that had no asthma,
and got HPV vaccine in 2013. Notes that in soccer about 2 months later was
having some breathing difficulties and was diagnosed w/ asthma. Also seemed to
develop headaches.” Id. at 10. This sequence of events is wrong because Dr.
Newcombe reported breathing problems on the day of the vaccination. See exhibit
25 at 6. Dr. Baptist also recounted that tests for allergies on multiple foods came
back positive. Exhibit 6 at 10. 23
       Dr. Baptist’s history also states that Ms. Jennings “[h]as been diagnosed w/
chronic fatigue syndrome.” Id. at 10. This piece of information also appears
mistaken as the doctor who diagnosed Ms. Jennings with chronic fatigue syndrome
is not readily apparent. At best, Dr. Neuenschwander included a diagnostic code
for “other fatigue.” Exhibit 14 at 14.
      For current problems, Dr. Baptist recorded that “all foods give problems –
fatigue, headache, abdominal pain.” Id. Ms. Jennings also has difficulty with
breathing, including shortness of breath. For the food allergies, Dr. Baptist
recommended a limited diet and then a food diary. Id. at 12. Dr. Baptist was
concerned that Ms. Jennings might suffer from chronic fatigue syndrome and he
recommended a pediatric rheumatologist.
       For the family’s concern about the HPV vaccination, Dr. Baptist stated that
“he spent considerable time . . . going over the literature regarding the HPV
vaccine and autoimmune disease or neurologic disease. There are some studies
that do not seem to support any increased incidence of autoimmune disease nor of
neurologic disease after the vaccine.” Id.24 “It is difficult for me to assess whether
it truly was the vaccination or a coincidence that the symptoms occurred. There
unfortunately is no clear way to determine this other than giving the vaccine
[again] which of course the family is understandably reluctant to do.” Id. Dr.
Baptist concluded his letter to Dr. Johnstone by saying that he would see Ms.

        23   Dr. Neuenschwander ran a comprehensive food panel on January 5, 2016. Exhibit 14
at 2.
        24 Denise Jennings has challenged the accuracy of Dr. Baptist’s assertion that he reviewed
literature about adverse effects of the HPV vaccine. Exhibit 20.

                                               19
Jennings again on as-needed basis. Dr. Baptist also referred Ms. Jennings to a
pediatric rheumatologist for treatment of possible chronic fatigue syndrome.
      The second relevant record from 2016 was the record from a pediatric
rheumatologist, Mark Hoeltzel. Dr. Hoeltzel came to the impression that Ms.
Jennings suffers “numerous symptomatic complaints that do not fit well into a
recognized pattern of rheumatologic disease. However, given the fact that no
alternate etiology has been discovered, I think it is reasonable to perform [a]
preliminary screen for underlying autoimmune disease.” Exhibit 18 at 10.
Although Dr. Hoeltzel ordered laboratory testing, he planned not to see Ms.
Jennings again because she did not have an underlying autoimmune disease.
      The foregoing records were available to the doctors the parties retained, Drs.
Santoro and MacGinnitie, when they wrote their reports. When the parties were
instructed to file briefs regarding entitlement, Ms. Jennings was also ordered to file
updated medical records. Order, issued Nov. 12, 2019.
       In response, Ms. Jennings filed a single set of medical records, which were
from Edward Conley of the Fatigue and Fibromyalgia Clinic. The records contain
results of blood tests and Dr. Conley’s report of a visit on August 29, 2019.
Exhibit 53. 25 Dr. Conley’s assessment was: “Chronic Fatigue [rule out] CFIDS.
History of positive CMV? HHV6? Migraines. Asthma under treatment.
Cognitive dysfunction. History of Seizures. Multiple other diagnoses.” Id. at 9.
In Dr. Conley’s view, Ms. Jennings “had a neurological reaction to the Gardasil
vaccine causing weakness/seizures.” Dr. Conley recommended a series of
supplements. He also noted that Ms. Jennings was leaving for an unspecified
college in New York in 48 hours. Id.
                           Standards for Finding Entitlement

      A petitioner is required to establish her case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

      25   Ms. Jennings did not file any records for 2017 or 2018.

                                                20
       Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master's decision that petitioners were not
entitled to compensation); see also Lampe v. Sec'y of Health & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the
special master confused preponderance of the evidence with medical certainty).
       An element of a petitioner’s case is to establish that the vaccinee suffered “at
least one defined and recognized injury” and “not merely a symptom of
manifestation of an unknown injury.” Lombardi v. Sec’y of Health & Human
Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). An allegation that the vaccinee had
“dysethesia” or an “idiosyncratic severe reaction” does not satisfy this requirement.
Lasnetski v. Sec’y of Health & Human Servs., 128 Fed. Cl. 242, 263 (2016)
(denying motion for review), aff’d, 696 F. App’x 497 (Fed. Cir. 2017).
                                      Analysis
      Here, Ms. Jennings has put forward multiple problems that the HPV vaccine
allegedly caused. These problems can be grouped into two categories. For most
conditions, Ms. Jennings has not satisfied the requirement to demonstrate that she
suffers from a defined injury as explained in section A below. Thus, she cannot
receive compensation for any of them. The remaining category consists of the one
condition, breathing trouble, that she did suffer. While sufficient evidence
establishes she suffered from some respiratory ailment, her breathing problems
existed before the vaccination. See section B below. Finally, section C explains
why a ruling on the papers is appropriate and a hearing is not necessary.
      A. Conditions Not Established
      The issue of diagnosis has run throughout this case. The Instructions to
Experts particularly directed any expert to discuss the appropriate diagnosis by
including, among other points, the diagnostic criteria for any disease that the expert
proposes. Order, issued Aug. 2, 2017, ¶ 4. Dr. Santoro was required to prepare a
supplemental report because his first report did not present a diagnosis. Order,
issued June 25, 2018; see also exhibit 26 (Dr. Santoro’s first report). Once the
experts presented their opinions, the order for briefs in advance of adjudication
again raised this issue. Order, issued Nov. 12, 2019, at 5. Ms. Jennings’s brief did
not address the topic of diagnosis in a separate section of her brief, making

                                          21
identification of the injury that she alleges a vaccination caused more difficult. See
Vaccine Rule 8(f) (waiver of arguments not specifically raised)
       In one respect, the simplest point came from Dr. Santoro. He stated Ms.
Jennings’s “constellation of symptoms cannot be given a definitive disease
diagnosis.” Exhibit 41 at 1. This statement reflects the struggles of Ms. Jennings’s
treating doctors to identify the problem or problem from which she suffers. Ms.
Jennings alleged numerous symptoms in the amended petition: exercise
intolerance, asthma, hand numbness, headaches, handwriting difficulties, visual
comprehension difficulties, reading difficulties, memory impairments, neurological
impairments. Of those conditions, Dr. Santoro found support for headaches,
reactive airway disease, fatigue/chronic fatigue syndrome, non-convulsive
epilepsy, digestive disease, and cognitive/memory issues. Exhibit 27 at 2-8. On
the other hand, Dr. Santoro took no position on toxic encephalitis and did not posit
that petitioner suffered systemic inflammatory response syndrome. Id. at 5. Ms.
Jennings brief seemingly narrows the list of relevant diseases to (1) asthma /
allergic reaction, (2) chronic fatigue syndrome, and (3) gastrointestinal disease.
Pet’r’s Br. at 25-37 (discussing these conditions in the context of prong 2 of
Althen). These conditions are considered in turn.
      Asthma / allergic reaction. Ms. Jennings suffered problems with breathing.26
Thus, resolution of this condition is deferred to section B below.
       While Ms. Jennings links asthma to an allergic reaction, the claim that she
suffered an allergic reaction stands on much shakier ground. She argues that she is
allergic to a yeast component in the HPV vaccine and developed food allergies,
particularly to gluten. Pet’r’s Br. at 23-24. The brief cites no medical records to
support these arguments. Dr. Santoro’s August 21, 2018 report does not mention
“yeast,” and bases an opinion about food allergies on the affidavit from Denise
Jennings. See exhibit 27 at 6. Dr. Santoro’s June 4, 2019 report asserts that Ms.
Jennings “developed an adverse reaction to yeast proteins after the July 2013
vaccination,” exhibit 40 at 3, but provides no citation for this assertion. This report

       26 Even for her breathing problems, the treating doctors appear not to have settled on a
specific diagnosis for Ms. Jennings. Her pediatrician, Dr. Newcombe, diagnosed her as having
“exercise induced asthma” on March 23, 2013. Exhibit 25 at 5. But after some attempts to treat
asthma did not succeed, a pediatric pulmonologist, Dr. Guglani, suggested that Ms. Jennings
might suffer from vocal cord dysfunction. Id. at 59. Dr. Leo noted that these conditions are
often confused. Id. at 49. Dr. Neuenschwander assessed Ms. Jennings as suffering from reactive
airway disease. Exhibit 14 at 22.

                                              22
does not mention allergies. Finally, Dr. Santoro’s August 3, 2019 report discusses
neither yeast nor allergies. See exhibit 41.
       In contrast, Dr. MacGinnitie has opined that Ms. Jennings has not
demonstrated that she suffered from food allergies. Exhibit A at 9. Dr.
MacGinnitie, who has specific expertise in allergy (see, exhibit B (curriculum
vitae)), discounted any findings made by Dr. Neuenschwander. Although the
testing from Dr. Neuenschwander could offer some superficial support that Ms.
Jennings is allergic to certain foods, any such minimal support is so tenuous that
neither Dr. Santoro nor Ms. Jennings has relied upon it.
       Consequently, Ms. Jennings has not established, by preponderant evidence,
that she suffers from food allergies.
      Chronic fatigue syndrome. In her brief, Ms. Jennings maintains that she was
diagnosed with chronic fatigue syndrome. However, these arguments are
erroneous.
        Ms. Jennings presents arguments about chronic fatigue syndrome in two
places. First, she asserts she “has been diagnosed with Chronic Fatigue Syndrome
after the 2013 vaccination. Exh. 22, p. 5. The onset was shortly after the second
dosage.” Pet’r’s Br. at 24. This record does not support the proposition for which
it is cited.
      Page 5 of exhibit 22 is part of a seven-page report from Wan Chong Tsai, a
pediatric pulmonologist, written on August 14, 2014. Page 5 contains no
discussion of fatigue. However, on page 6, Dr. Tsai recounts that Ms. Jennings
“denies any cough, wheezing, fatigue . . .” Exhibit 22 at 6. Consistent with Ms.
Jennings’s denial of fatigue, Dr. Tsai did not list chronic fatigue or anything like
chronic fatigue among his impressions. See id. at 9. Thus, the first basis for the
diagnosis of chronic fatigue syndrome does not sustain the argument.
      Second, Ms. Jennings states she “did receive a diagnosis of chronic fatigue
syndrome at the University of Michigan.” Pet’r’s Br. at 30, citing exhibit 6 at 11;
accord exhibit 40 (Dr. Santoro’s report) at 3; Pet’r’s Br. at 9. This citation has
some basis as Dr. Baptist was informed in 2016 as part of Ms. Jennings’s history
that Ms. Jennings “[h]as been diagnosed w/ chronic fatigue syndrome” and
concluded that her “symptoms seem most consistent with chronic fatigue
syndrome.” Exhibit 6 at 10, 12.
      However, crediting Dr. Baptist’s conclusion is not possible. Preliminarily,
the doctor who originally diagnosed Ms. Jennings as suffering from chronic fatigue
                                         23
syndrome is not clear from Dr. Baptist’s record or Ms. Jennings’s brief. It seems
that Dr. Baptist may have carried forward a diagnosis without much analysis.
More significantly, Ms. Jennings did not complain about fatigue in many
appointments after the vaccination. See exhibit 27 (Dr. Santoro’s report) at 5
(describing instances in which Ms. Jennings did not complain of fatigue). Instead,
she complained that her breathing problems were interfering with her attempts to
compete in travel-level soccer. E.g., exhibit 25 at 61 (Dr. Hurwitz on May 14,
2013: Ms. Jennings “has experienced pressure sensation on the chest and
lightheadedness and almost near syncope after 10 minutes of hard running”);
exhibit 25 at 26 (reporting, at August 27, 2013 appointment, chest symptoms in
soccer practices and games after running); exhibit 15 at 19-34 (emergency room
visit on October 16, 2013 for collapsing while playing soccer); id. at 48 (Ms.
Jennings reporting at October 28, 2013 appointment that she plays competitive
soccer). Playing soccer is inconsistent with the fatigue associated with chronic
fatigue syndrome. See McCabe v. Sec’y of Health & Human Servs., No. 13-570V,
2018 WL 3029175, at *37-42 (Fed. Cl. Spec. Mstr. May 17, 2018) (discussing
diagnostic criteria for chronic fatigue syndrome).
      Accordingly, Ms. Jennings has not demonstrated, by a preponderance of
evidence, that she suffers from chronic fatigue syndrome.
        Gastrointestinal Disease. Compared with the allegations that Ms. Jennings
suffered allergies or chronic fatigue syndrome, her claim that she suffered from
gastrointestinal disease is even less developed. In the context of her Althen prong
1 argument concerning molecular mimicry, Ms. Jennings argues she “continues to
suffer gastric problems that developed after the second dosage.” Pet’r’s Br. at 25.
However, Ms. Jennings provided no citation to this assertion. Later, in the section
on Althen prong 2, Ms. Jennings adds more argument about molecular mimicry.
Id. at 33-37. Within this extended section, the only portion even loosely
suggesting Ms. Jennings suffered from gastrointestinal problems is on page 35.
There, Ms. Jennings asserts that she “also has developed gastrointestinal problems
post-July 2013 vaccination. These problems first developed within four weeks after
vaccination of July 2013.” Again, the absence of any citation to a medical record
is noticeable.
       Dr. Santoro provides minimal support. In his August 21, 2018 report, Dr.
Santoro states that Ms. Jennings has gastrointestinal problems based upon food
allergies. Exhibit 27 at 6. The basis for this statement is Denise Jennings’s
affidavit, exhibit 7. Dr. Santoro’s June 4, 2019 report asserts that Ms. Jennings
“further developed gastrointestinal problems post-July 2013 vaccination. These
problems first developed within four weeks after vaccination of July 2013,” exhibit
                                        24
40 at 3, but provides no citation for this assertion. Finally, Dr. Santoro’s August 3,
2019 report provides no information that Ms. Jennings suffered from
gastrointestinal problems. See exhibit 41.
      Ms. Jennings has not identified any treating doctors who diagnosed her with
any gastrointestinal disease. It appears that none of the doctors who treated Ms.
Jennings referred her to a gastroenterologist and there are no records from a
gastroenterologist who treated her. To the extent that Dr. Santoro has reached this
diagnosis independently, Dr. Santoro seems to rely solely upon the affidavit of
Denise Jennings, which is not a reliable basis for a diagnosis. Thus, Ms. Jennings
has not established by preponderant evidence that she suffers from a
gastrointestinal disease.
      In sum, Ms. Jennings has not established that she suffered from allergies,
chronic fatigue syndrome, or gastrointestinal disease. Absent this predicate, a full
Althen analysis is not required. Hibbard v. Sec’y of Health and Human Servs., 698
F.3d 1355, 1365 (Fed. Cir. 2012).
       B. Breathing Difficulties
       Ms. Jennings argues that she developed asthma and breathing problems after
the first HPV vaccination in March 2013. She bases this argument upon her
mother’s affidavit, exhibit 7. Pet’r’s Br. at 24, 26. As noted several times
throughout the section summarizing Ms. Jennings’s medical records, this
chronology is not factually correct. Ms. Jennings had breathing problems when
she came to Dr. Newcombe’s office for the appointment in which she was given
the first HPV vaccination. Exhibit 25 at 5. Thus, Ms. Jennings cannot prevail on a
theory that the HPV vaccination caused her breathing difficulties. See Locane v.
Sec'y of Health & Human Servs., 685 F.3d 1375, 1380-81 (Fed. Cir. 2012). 27
       Ms. Jennings claim regarding breathing difficulties is being resolved based
upon the pre-existing nature of those problems as Ms. Jennings has not claimed
significant aggravation. In doing so, the undersigned is not determining how the
evidence preponderates for other elements, including the role of any factors other
       27  Conceivably, Ms. Jennings could have argued that the second HPV vaccination
aggravated a pre-existing condition. However, although Denise Jennings states that her
daughter’s breathing problems were worse after the July 2013 HPV vaccination, Dr. Santoro has
failed to present a minimally persuasive opinion regarding significant aggravation. See Wittner
v. Sec’y of Health & Human Servs., 43 Fed. Cl. 199, 209 (1999) (“general statements that new
symptoms appeared or became more severe ‘following’ each immunization are too vague to
show on-Table onset or significant aggravation”).

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than a vaccine in causing her breathing difficulties. However, a preliminary view
is that a factor other than a vaccine could explain Ms. Jennings’s respiratory
problems. Ms. Jennings first sought treatment for breathing problems from Dr.
Newcombe approximately two weeks after the family brought a new dog into their
home. See exhibit 25 at 48 (Dr. Leo’s October 28, 2013 report). Dr. MacGinnitie
suggested an allergy to dogs was a better explanation for Ms. Jennings’s breathing
problems. Exhibit A at 5-6. If this opinion were credited, then a factor unrelated
to the vaccination would have caused her breathing problems.
       C. Resolution on the Papers is Appropriate
       The undersigned has reviewed the entire record.28 Ms. Jennings retained Dr.
Santoro, who presented opinions that Ms. Jennings suffered from various
conditions for which there was little, if any, support in the contemporaneously
created medical records. Instead, Dr. Santoro seems to have accepted the accuracy
of an affidavit created years later. When there is a disparity between information
in contemporaneously created medical records and affidavits, a special master is
not required to hold a hearing to receive testimony from an expert. Burns v. Sec’y
of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993).
                                         Conclusion
      Ms. Jennings has not established that she is entitled to compensation. The
Clerk’s Office is directed to enter judgment in accord with this decision unless a
motion for review is filed.
       IT IS SO ORDERED.

                                                     s/Christian J. Moran
                                                     Christian J. Moran
                                                     Special Master

       28While the collection of medical records appears to contain gaps in that Ms. Jennings
seems to not have filed records from the offices of all doctors who treated her, such as Dr.
Hurwitz, Dr. Leo, Dr. Pittaway, and Dr. Johnstone, the record is sufficient to evaluate her claim
for compensation.

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