# Valdez v. Secretary of Health and Human Services

> United States Court of Federal Claims · August 8, 2024

URL: https://www.frixlaw.com/law-library/cases/10734573

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** August 8, 2024
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Daniel T. Horner
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10734573

## How later opinions describe it (automated extraction)

- holding the special master did not err in resolving the case pursuant to Althen prong two when respondent conceded that petitioner met Althen prong three
- stating that “there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be accepted in its entirety and cannot be rebutted”
- applying the six-part Loving test.

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1550V
Filed: July 8, 2024

Special Master Horner
ELIZABETH VALDEZ,

Petitioner,
v.

SECRETARY OF HEALTH AND
HUMAN SERVICES,

Respondent.

Michael Avrim Firestone, Marvin Firestone, MD, JD, and Associates, San Mateo, CA,
for petitioner.
Nina Ren, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On October 9, 2018, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2012), 2 alleging that she suffered
small fiber neuropathy, neuropathy, paresthesia, weakness, and related complications,
and/or a significant aggravation of chronic fatigue syndrome and fibromyalgia, following
an influenza (“flu”) vaccination that she received on October 10, 2015. (ECF No. 1.)
However, petitioner subsequently amended her petition to instead allege that her
symptoms constituted a significant aggravation of a pre-existing somatic symptom

1 Because this document contains a reasoned explanation for the action taken in this case, it must be

made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic
Government Services). This means the document 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 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.

§ 300aa-10, et seq.

1
disorder. 3 (ECF No. 74.) For the reasons set forth below, I conclude that petitioner is
not entitled to compensation and the petition is dismissed.
I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).

In many cases, however, the vaccine recipient may have suffered an injury not of
the type covered in the Vaccine Injury Table. In such instances, an alternative means
exists to demonstrate entitlement to a Program award. That is, the petitioner may gain
an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination
in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation the
presumptions available under the Vaccine Injury Table are inoperative. The burden is
on the petitioner to introduce evidence demonstrating that the vaccination actually
caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005); Hines ex rel. Sevier v. Sec’y of Health & Human Servs.,

3 The term “somatic” means “pertaining to or characteristic of the soma or body,” with “soma” referring to

“the body as distinguished from the mind.” Somatic, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=46193 (last visited June 26, 2024); Soma,
DORLAND’S MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=46186
(last visited June 26, 2024). The term “somatoform” refers to “physical symptoms that cannot be
attributed to organic disease and appear to be of psychic origin.” Somatoform, DORLAND’S MEDICAL
DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=46201 (last visited June 26,
2024). “Somatoform disorders” are a category of mental disorders characterized by somatoform
symptoms that are not voluntary and not explained by any general medical condition, the effects of a
psychoactive drug, or any other mental disorder. Somatoform disorders, DORLAND’S MEDICAL DICTIONARY
ONLINE, https://www.dorlandsonline.com/dorland/definition?id=71228 (last visited June 26, 2024). Under
the Fifth Edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental
Disorders (“DSM-5”), “somatic symptom disorder” is the currently preferred diagnostic term for these
types of disorders which are categorized as “somatic symptom disorder and related disorders.” (Ex. 17,
p. 32; Ex. A, pp. 29-30.) Somewhat confusingly, “somatic symptom disorder” also refers to a specific
condition from which the broader category of conditions takes its name. This case involves that specific
condition.

2
940 F.2d 1518, 1525 (Fed. Cir. 1991). Because petitioner’s injury is not listed on the
Vaccine Injury Table, petitioner must satisfy this burden of proof.

The showing of “causation-in-fact” must satisfy the “preponderance of the
evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-
13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that
standard, the petitioner must show that it is “more probable than not” that the
vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need
not show that the vaccination was the sole cause of the injury or condition, but must
demonstrate that the vaccination was at least a “substantial factor” in causing the
condition, and was a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165
F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical
sequence of cause and effect showing that the vaccination was the reason for the
injury;” the logical sequence must be supported by “reputable medical or scientific
explanation, i.e., evidence in the form of scientific studies or expert medical testimony.”
Althen, 418 F.3d at 1278; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
1148 (Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based
solely on his or her assertions; rather, the petition must be supported by either medical
records or by the opinion of a competent physician. § 300aa-13(a)(1).

In what has become the predominant framing of this burden of proof, the Althen
court described the “causation-in-fact” standard, as follows:

Concisely stated, Althen’s burden is to show by preponderant evidence that
the vaccination brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a logical sequence
of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of proximate temporal relationship between
vaccination and injury. If Althen satisfies this burden, she is entitled to
recover unless the [government] shows, also by a preponderance of the
evidence, that the injury was in fact caused by factors unrelated to the
vaccine.

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. However, that expert’s opinion must be based upon “sound and
reliable” scientific explanation. Boatmon v. Sec’y of Health & Human Servs., 941 F.3d
1351, 1359 (Fed. Cir. 2019) (quoting Knudsen ex rel. Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)). The Althen court also indicated
that, in finding causation, a Program factfinder may rely upon “circumstantial evidence,”
which the court found to be consistent with the “system created by Congress, in which
close calls regarding causation are resolved in favor of injured claimants.” 418 F.3d at
1280.

3
A petitioner may also allege that a vaccine caused a “significant aggravation” of a
pre-existing condition. The Vaccine Act defines a significant aggravation as any change
for the worse in a pre-existing condition which results in markedly greater disability,
pain, or illness accompanied by substantial deterioration of health. § 300aa-33(4).
Where a petitioner in an off-Table case is seeking to prove that a vaccination
aggravated a pre-existing injury, petitioners must also address three additional factors.
See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)
(combining the first three Whitecotton factors for claims regarding aggravation of a
Table injury with the three Althen factors for off table injury claims to create a six-part
test for off-Table aggravation claims); see also W.C. v. Sec’y of Health & Human Servs.,
704 F.3d 1352, 1357 (Fed. Cir. 2013) (applying the six-part Loving test.). The additional
Loving factors require petitioners to demonstrate aggravation by showing: (1) the
vaccinee’s condition prior to the administration of the vaccine, (2) the vaccinee’s current
condition, and (3) that the vaccinee’s current condition constitutes a “significant
aggravation” of the condition prior to the vaccination. W.C., 704 F.3d at 1357.

II. Procedural History

This case was initially assigned to another special master. (ECF No. 4.) In
December of 2018, petitioner filed an affidavit marked Exhibit 1 and medical records
marked as Exhibits 2-8. She also filed a self-completed VAERS submission at Exhibits
9 and 11, an affidavit by her husband as Exhibit 10, and additional medical records at
Exhibit 12. (ECF Nos. 7-8.) She filed her Statement of Completion on December 10,
2018. (ECF No. 9.) Respondent’s medical review of the case began in August of 2019,
and based on that review, respondent requested that petitioner file additional medical
records. (ECF No. 16.) Petitioner filed the requested medical records and an amended
Statement of Completion in September of 2019. (ECF Nos. 19-20.) The case was
reassigned to the undersigned in the interim. (ECF Nos. 17-18.)

Respondent filed his Rule 4 Report, recommending against compensation, on
March 23, 2020. (ECF No. 27.) Respondent disputed that petitioner’s medical records
supported her allegation that she suffered either any form of neuropathy following her
vaccination or any significant aggravation of fibromyalgia and/or chronic fatigue
syndrome. (Id. at 22-23.) Respondent also disputed that she had demonstrated
vaccine causation of any of her alleged conditions. (Id. at 23-27.)

Following the filing of respondent’s report, I held a follow up status conference.
(ECF No. 28.) I advised that, based on my preliminary review of the medical records, it
appeared that petitioner was an unreliable historian, that there was no objective
evidence to support the alleged small fiber neuropathy or fibromyalgia, and that the
medical records appeared to preponderantly establish the presence of a somatoform
disorder. (Id. at 1-2.) Accordingly, before I would conclude petitioner had a reasonable
basis to proceed based on either fibromyalgia or small fiber neuropathy, I required
petitioner as a threshold matter to have a qualified expert establish either (a) that
petitioner does not have a somatoform disorder or (b) that her somatoform disorder
cannot explain her allegedly vaccine caused symptoms. (Id. at 2.) In response,

4
petitioner’s counsel requested the opportunity to explore whether petitioner could
establish that her somatoform disorder itself was significantly aggravated by her
vaccination. (Id.)

Petitioner then filed additional medical records (Exhibits 15-16, 27-33) and an
expert report with supporting materials by neurologist and psychiatrist W. Curt
LaFrance, Jr., M.D., M.P.H. (Exhibit 17-26). 4 (ECF Nos. 30, 37, 42-43, 45, 47, 53.) Dr.
LaFrance opined that petitioner had suffered symptoms of a somatic symptom disorder
that were worsened by her flu vaccination. (Ex. 17, pp. 32-33.) He indicated that her
medical work up “does not reveal a medical or neurological etiology for her symptoms.”
(Id. at 32.) Petitioner filed a further Statement of Completion on June 3, 2021. (ECF
No. 48.) In September of 2021, respondent filed responsive expert reports by
psychiatrist Joel Dimsdale, M.D. (Exhibit A) and neurologist Mark Bromberg, M.D.,
Ph.D. (Exhibit C). (ECF Nos. 51-52.) Respondent’s experts agreed that petitioner likely
suffered a somatic symptom disorder, rather than any neurologic condition, but
disagreed that petitioner’s flu vaccine played a causal role in her subsequent medical
course.

On December 9, 2021, I held a follow up status conference to discuss the
experts’ reports. (ECF No. 54.) I observed that “it appears that the crux of the
competing opinions – between Dr. LaFrance and Dr. Dimsdale – concerns the
distinction between a preceding versus precipitating event in the context of a somatic
symptom disorder.” (Id. at 1.) I requested that, in addition to any other issues the
parties intended to address, Drs. LaFrance and Dimsdale address in greater depth what
factors contribute to whether an event constitutes a precipitating event. (Id.) I also
advised that I was not aware of any prior precedent establishing that a strictly
psychological injury could be a cognizable injury under the Vaccine Act and prompted
the parties to consider that legal issue. 5 (Id. at 1-2.)

Thereafter, the parties exchanged further reports by Drs. LaFrance and
Dimsdale, but not Dr. Bromberg. (ECF Nos. 35, 59, 61-62; Exs. 34-55, E.) After review
of these reports, I held a further status conference on August 26, 2022. (ECF No. 63.)
During the conference, I confirmed that petitioner intended to continue pursuing her
claim as a significant aggravation of a somatoform disorder and that she did not wish to
raise any additional arguments in response to Dr. Bromberg’s report. 6 (Id. at 1.) The
parties agreed to proceed with a ruling on the written record. (Id.)
4 Dr. LaFrance’s report and supporting materials were misfiled and struck multiple times.

5 Although the parties did subsequently include some discussion of this issue in their briefs, because I

have otherwise concluded for the reasons discussed below that there is not preponderant evidence that
petitioner’s vaccination actually caused a significant aggravation of her psychological condition, it is not
ultimately necessary to reach that question.

6 I have reviewed Dr. Bromberg’s report. However, it is not necessary to discuss Dr. Bromberg’s report

because the parties have ultimately agreed that petitioner has not suffered any neurologic condition
resulting from her vaccination. As discussed below, in his second report, Dr. LaFrance specifically
agreed on petitioner’s behalf that Dr. Bromberg was correct to conclude that petitioner’s flu vaccine had
not resulted in any “physical damage.” (Ex. 34, p. 4.)

5
In January of 2023, petitioner subsequently filed additional medical records (ECF
No. 66; Exs. 56-57) and a motion for a ruling on the written record (ECF No. 69).
Respondent initially filed his response in April of 2023. (ECF No. 71.) However,
petitioner then filed an amended petition conforming the allegations of her petition to the
injury and theory she had pursued through Dr. LaFrance’s opinion. (ECF No. 74.)
Respondent filed an amended response to petitioner’s motion on June 22, 2023. (ECF
No. 75.) Petitioner filed her reply on July 28, 2023. (ECF No. 77.)

In light of the above, I have determined that the parties have had a full and fair
opportunity to present their cases and that it is appropriate to resolve entitlement on the
existing record. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck v.
Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that
“special masters must determine that the record is comprehensive and fully developed
before ruling on the record”). Accordingly, this matter is now ripe for resolution.

III. Factual History

Petitioner has an extensive medical history wherein many efforts were made to
hopefully discover the etiology of her various symptoms. In litigating this claim,
however, petitioner has acknowledged through her expert that she suffered a somatic
symptom disorder, that her symptoms had no organic basis, and that her vaccination
caused no physical harm. (Ex. 34, pp. 3-4.) Moreover, the nature of her somatic
symptom disorder is such that she has persistently initiated contact with her treating
physicians regarding her various symptoms, generating a large quantity of medical
records. Thus, in the interest of brevity and consistent with the expert opinions offered
in the case, this summary presents petitioner’s history with the full benefit of hindsight
as the course of a somatic symptom disorder. Nonetheless, although the resulting
summary will not necessarily capture every symptom report or the efforts undertaken to
determine their cause, I have reviewed the entirety of the medical records.

a. Pre-vaccination medical records

In April of 2006, petitioner saw neurologist Dr. John Bissell for a hospital follow
up visit for what was assessed as late effects of a stroke. (Ex. 14, p. 14.) Petitioner
reported that she continued to feel dizzy, dysphagic, and numb on the left side. She
presented in a wheelchair but was able to ambulate with a cane or walker, despite a
left-sided limp. She also reported experiencing double vision. Dr. Bissel assessed
dysphagia and late effect of stroke, but he noted that risk factors for stroke were
controlled. (Id.)

Petitioner returned to Dr. Bissel on May 15, 2006, with complaints of blurry
vision, headaches, and insomnia. (Ex. 14, p. 28.) It was noted that petitioner’s eye
exam was normal, and a repeat MRI of her brain was unremarkable. Petitioner’s
neurologic examination revealed difficulty with finger to nose testing and continued

6
difficulty ambulating. Dr. Bissel suspected vertiginous disorder due to labyrinthine
dysfunction with functional overlay, but his primary diagnosis was dizziness.
Notes for a telephone encounter on June 16, 2006, include reports of difficulty
swallowing and speaking. (Id. at 37.)

Petitioner’s next appointment with Dr. Bissel was on August 7, 2006. (Ex. 14, p.
45.) It is noted that petitioner had recently gone to the emergency department for
paroxysmal supraventricular tachycardia (“PSVT”) and had felt weak ever since. It was
further noted that, by that point, petitioner had been on disability for ten years with a
highly sedentary lifestyle. Petitioner’s neurologic examination was normal, despite initial
limping and apparent gait instability. Dr. Bissel’s diagnosed petitioner with somatoform
disorder. He noted that there was no evidence of neurologic disease and that he did
not believe petitioner’s prior episodes were caused by a stroke. (Id.)

In January of 2011, petitioner presented to Kaiser Permanente for a regular
appointment with her primary care physician, Dr. Serene Tran. (Ex. 2, p. 37.)
Petitioner’s medical history was notable for somatoform disorder with stroke-like
symptoms, chest pain, and palpitations. Petitioner reported improvement in her
strength and ability to walk without support; however, she continued to complain of
chest pain and palpitation when she is upset. It is noted that petitioner could not
tolerate many medications “due to nonspecific symptoms.” A review of symptoms
revealed achiness and stiffness in her fingers, especial in the morning and at night, as
well as anxiety. Petitioner’s neurologic exam was normal. (Id.) Later that month, on
January 31, 2011, petitioner returned to Dr. Tran with no new complaints, and her
somatoform disorder was noted to be stable. (Id. at 39.)

During a pre-operative examination on November 19, 2012, in preparation for a
cervical loop electrosurgical excision procedure (“LEEP”), it was noted that petitioner
had a history of reaction to multiple anesthetic agents. (Ex. 2, p. 364.) Petitioner was
referred to Dr. Christopher Jakle on November 27, 2012, for an evaluation of her
alleged reaction to several medications. (Id. at 341.) Petitioner reported adverse
reactions, including dyspnea, dizziness, vomiting, and weakness, following receipt of
carpal tunnel injections, containing lidocaine 7 and dexamethasone, 8 and an epidural.
Dr. Jakle described petitioner as a “[v]ery suggestive individual who anticipates
reactions to many medicines and procedures” and suggested that her past reactions
were most likely vasovagal. (Id.)

7 Lidocaine is a drug that is typically applied topically for its anesthetic, sedative, analgesic,

anticonvulsant, and cardiac depressant properties. Lidocaine, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=28237 (last visited June 27, 2024).

8 Dexamethasone is synthetic glucocorticoid that is also applied topically as an anti-inflammatory or used

orally in replacement therapy for adrenocortical insufficiency, as an anti-inflammatory and
immunosuppressant, and as an antiemetic in chemotherapy. Dexamethasone, DORLAND’S MEDICAL
DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=13599 (last visited June 27,
2024).

7
On December 14, 2012, petitioner saw Dr. Train with complaints of fainting. (Ex.
2, pp. 442-43.) Petitioner described an episode of lightheadedness and blurry vision
while walking, which was mostly resolved after lying down. (Id. at 441.) She reported
feeling tightness in the chest and numbness on the face for a few minutes following the
episode. Additionally, petitioner reported stress and low back pain with no radiation or
neurologic symptoms. (Id.) Petitioner’s neurologic examination was normal, but her
physical examination revealed back pain with motion and tenderness along the
paraspinal muscle in the low back. (Id. at 442.) Dr. Tran assessed lumbosacral strain
and dizziness of unknown etiology; however, she questioned whether the condition
could have been a side effect of petitioner’s hypertension medication, dehydration, or
anxiety. (Id. at 443.)

On March 21, 2013, petitioner presented to the emergency department with
multiple complaints. (Ex. 2, p. 531.) She reported a gradual onset of palpitations,
lightheadedness, chest discomfort, nausea, and generalized weakness. She described
the chest discomfort as substernal non-radiating pressure without jaw pain and reported
that the lightheadedness was worse when standing up. She denied associated
headache, fever, chills, abdominal pain, urinary complaints, or focal weakness. (Id.)
Petitioner’s physical and neurologic examinations were normal. (Id. at 533-34.)
Petitioner’s symptoms improved after receiving IVF fluids, and all diagnostic testing was
normal. (Id. at 535-36.) The attending physician diagnosed petitioner with “symptoms
likely secondary to palpitations from mild dehydration” and explained, “I do not suspect
that this patient has a life-threatening etiology to the presentation today requiring further
diagnostic testing or evaluation.” (Id.)

Petitioner complained of intermittent palpitations in December of 2013. (Ex. 2, p.
908.) She reported that her heart rate remained elevated for 20 minutes or so and that
she felt as if she could pass out due to the palpitations; however, she reported more
recently feeling tired without palpitation or chest pain. (Id.) She admitted that she may
have been stressed due to the holidays. (Id. at 909.) Dr. Tran assessed PSVT, ordered
labs, and advised petitioner to rest, hydrate, and reduce her stress. (Id. at 910.)

On April 9, 2014, petitioner was seen by Dr. Dorothy Hong for upper back pain
that radiated to her chest. (Ex. 2, pp. 988-89.) Petitioner reported palpitations, chest
pain with movement, a burning sensation in the epigastrium, and tiredness. (Id.) She
further detailed her history of palpitations, noting that she usually experiences one-to-
two episodes per year, which include palpitations, tachycardia, lightheadedness, chest
discomfort, and fatigue with no clear trigger. (Id. at 989.) She explained that the
episodes generally last for a few minutes with the longest episode lasting two hours.
(Id.) Dr. Hong assessed petitioner’s chest pain as multifactorial and provided a different
diagnosis of gastroesophageal reflux disease (“GERD”), myofascial pain, or PSVT. (Id.
at 992-93.) She noted that petitioner’s labs were normal, and EKG performed that day
revealed no evidence of acute coronary syndrome. Dr. Hong directed petitioner to
follow up regarding an ablation procedure and reduce her stress. (Id.) Two days later,
on April 11, 2014, petitioner presented for an urgent visit with gynecologist Dr. Sarah
Fletcher. (Id. at 1011.) Petitioner reported a two-week history of intermittent abdominal

8
pain and cramping; however, Dr. Fletcher doubted that petitioner’s pain had a
gynecologic origin. (Id. at 1012.)

Petitioner presented for a dermatology appointment on April 17, 2014. (Ex. 2,
pp. 1029-30.) During this encounter, petitioner received an injection of Kenalog. 9 (Id. at
1030.) Immediately thereafter, petitioner experienced weakness and dizziness. She
reported a history of allergic reaction to dexamethasone with similar symptoms of
weakness and dizziness. Her dermatologist questioned whether petitioner experienced
an allergic reaction to Kenalog, given that her symptoms were not consistent with an
acute allergic reaction. He also questioned her previous allergic reaction to
Dexamethasone. Somatoform disorder or vasovagal symptoms were on her differential.
(Id.)

On April 28, 2014, petitioner presented to the emergency department with
complaints of weakness following an episode of tachycardia. (Ex. 2, p. 1043.) She
reported an uptick in the frequency of episodes of palpitations and suggested that this
could be why she felt more tired than normal. (Id.) Petitioner’s examination and workup
were normal. (Id. at 1044-45.) The attending physician determined that petitioner’s
symptoms were consistent with benign palpitations, and she was discharged home in
an improved condition. (Id. at 1045.)

Petitioner underwent an ablation for typical atrioventricular nodal re-entry
tachycardia without complications on May 5, 2014. (Ex. 2, p. 1096.) In a telephone
encounter that took place two days after the procedure, on May 7, 2014, petitioner
complained of lightheadedness, dizziness when standing, nausea, coldness in her feet,
and intermittent chest pain since the ablation. (Id. at 1146-47, 1151.) She reported a
blood pressure of 111/64 and a heart rate of 67 bpm. (Id. at 1146-47.) Given her
recent procedure and the nature and severity of her reported symptoms, petitioner was
directed to go to the emergency room. (Id. at 1147, 1151.)

The following day, on May 8, 2014, petitioner reported continued but improved
lightheadedness; however, she also reported new symptoms of shortness of breath with
activity, chest soreness when breathing deeply, “heaviness” in the left arm, and
numbness in the left foot and left side of the face. (Id. at 1155, 1164.) She further
reported a history of “mild stroke.” (Id.) That same day, she presented to the
emergency department with complaints of left arm weakness and left-sided facial
numbness and swelling. (Id. at 1166-69.) It was also noted that petitioner “has multiple
comatic complaints that are chronic.” (Id.) Petitioner underwent a brain MRI and MRA
without contrast, which showed no acute intracranial process. (Id. at 1171-73.)
Neurologist Dr. Jason Chang determined that there was no evidence of neurologic
disease, beyond small vessel disease, and that petitioner’s reports did not constitute
9 Kenalog is a triamcinolone acetonide that is applied topically as an anti-inflammatory or administered by

intra-articular, intradermal, intralesional, intramuscular, intrabursal, or tendon sheath injection as an anti-
inflammatory and immunosuppressant. Kenalog, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=26808 (last visited June 27, 2024); Triamcinolone
acetonide, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=114887 (last visited June 26, 2024).

9
transient ischemic attack or stroke. (Id. at 1171.) He also noted that, although
petitioner claimed to have a history of stroke, an MRI performed in 2006 was negative
for stroke. (Id. at 1169, 1171-73.) Dr. Chang stated, “Unclear if this is a psychosomatic
presentation based on her past medical history.” (Id. at 1169.) On May 9, 2014,
petitioner reported that her shortness of breath, chest soreness, and lightheadedness
had resolved. (Id. at 1156.) Her EKG results were normal. (Id.)

On May 14, 2014, petitioner reported continued fatigue and palpitations. (Ex. 2,
p. 1213.) An event monitor was ordered to track the episodes in an attempt to uncover
whether these reported episodes were related to recurrence of arrhythmia, the ablation,
or some other medical issue. (Id. at 1207-13.) Two days later, on May 16, 2014,
petitioner reported continued palpitations, lightheadedness that was worse when
standing up, shortness of breath with exertion, and chest pain that was unrelated to
exertion. (Id. at 1216.) She described difficulty walking due to fatigue and
lightheadedness. At-home blood pressure checks were normal. (Id.)

Petitioner’s next encounter was on June 2, 2014. (Ex. 2, pp. 1269-70.) She
reported lightheadedness, weakness, headache, and intermittent palpitations since her
ablation. (Id.) She further complained of continued fatigue. (Id. at 1290.) Dr. Tran
deferred making an assessment as to petitioner’s heart condition until her monitoring
period concluded but determined that petitioner’s fatigue was likely due to normal
recovery after her ablation. (Id. at 1270-71.) A chest x-ray showed no acute
cardiopulmonary disease, and an echocardiogram was unremarkable. (Id. at 1276-78,
1282-87.) A progress note recorded on June 17, 2014, reported that the event monitor
did not “auto capture” any triggered events for the period of May 14, 2014, through June
14, 2014. (Id. at 1199-200.) Petitioner reported 37 triggered events: 9 episodes with no
associated symptoms, 16 episodes with associated “palpitations,” 2 episodes of
lightheadedness, and 10 episodes of dizziness. (Id. at 1199-200.) Throughout these
reported episodes, petitioner’s heart rate did not drop below 59 bpm or rise above 102
bpm. (Id.) Dr. Vu Ta determined that the events did not constitute significant
arrhythmia and explained that, although it was not clear what was causing petitioner’s
symptoms, her symptoms did not appear to be the result of a cardiac issue. (Id. at
1119, 1298.)

On June 23, 2014, petitioner presented to Dr. Ta for an urgent follow up
regarding her shortness of breath, intermittent palpitations, and generalized fatigue.
(Ex. 2, p. 1302.) Petitioner was diagnosed with dyspnea of unknown etiology; however,
Dr. Ta noted that the symptoms were probably not cardiac-related. (Id. at 1305.)

Petitioner attempted to call her primary care physician on September 3, 2014,
with complaints of palpitations, discomfort, and difficulty breathing. (Ex. 2, pp. 1332-33.)
Petitioner indicated that she did not want to go to the emergency department for her
symptoms because she “has gone many times and the ER MD tells her the same thing.”
(Id.) Petitioner’s primary care physician, Dr. Tran, returned her call the following day
and informed her that the symptoms were likely normal and caused by anxiety. (Id. at
1334.) On September 5, 2014, petitioner had a telephone encounter with her

10
dermatologist. (Id. at 1339.) It was noted that petitioner “has many concerns, seems
anxious.” (Id. at 1339-40.) Her dermatologist noted, “[P]atient ‘allergic’ to doxy. . . .
Otherwise, considered having patient apply topical sulfur sulfacetamide cleanser but
patient allergic to sulfa.” (Id. at 1340.)

On September 18, 2014, petitioner presented to the emergency department with
complaints of unprovoked episode of palpitations, shortness of breath, and dizziness
that lasted 6-7 seconds. (Ex. 2, p. 1349.) She reported that she was taking atenolol, 10
but she discontinued the prescription because it made her feel “weak.” (Id.) A chest x-
ray again showed no acute cardiopulmonary process. (Id. at 1353, 1359.) Petitioner
was diagnosed with palpitations and discharged home. (Id. at 1353.) The next day, on
September 19, 2014, petitioner called her primary care physician to report continued
weakness, fatigue, lightheadedness, and shortness of breath, but no further
palpitations. (Id. at 1393-94.) She explained that her episodes were increasing in
frequency and length, though the episodes were still under a minute long. (Id.) Dr.
Tran noted petitioner’s normal workup before prescribing a low dose of Coreg. 11 (Id. at
1397.) She further noted that petitioner claimed taking Atenalol “caused [her heart rate]
to go down too much.” (Id.)

Petitioner presented for a routine exam with Dr. Fletcher on October 6, 2014.
(Ex. 2, pp. 1408-09.) She complained of “her usual intermittent pelvic and abdominal
pains,” which she attributed to her fibromyalgia. She further reported weight gain and
abdominal bloating since her ablation in May of 2014. (Id.) Dr. Fletcher assessed
petitioner’s abdominal bloating as likely due to weight gain. (Id. at 1409.) On October
9, 2014, petitioner had a telephone encounter with Dr. Tran, during which she
complained of “pain all over her body with spasms and fluttering of muscles as well as
pain in the ball of the feet, worse in the morning, in the last 1-2 weeks.” (Id. at 1432.)
Petitioner’s symptoms were attributed to her fibromyalgia and elevated stress. (Id.)

On October 13, 2014, petitioner presented for a regular checkup with Dr. Tran.
(Ex. 2, pp. 1439-40.) Petitioner reported that she discontinued Coreg because “it
caused more lightheadedness and headache.” (Id. at 1440.) Dr. Tran reiterated
petitioner’s complaints of fatigue, dizziness, and palpitations since the ablation, but
questioned whether petitioner’s reported symptoms were the result of anxiety. (Id. at
1440-42.) Petitioner returned to Dr. Tran on January 10, 2015, with complaints of pain
in the balls of her feet when walking. (Id. at 1566-67.) She was diagnosed with bilateral
metatarsalgia. (Id. at 1568.) During a telephone encounter with Dr. Tran on March 13,
2015, petitioner reported a four-day history of “heaviness” in the head and
lightheadedness, as well as intermittent mid back pain and GERD for a few days. (Ex.

10 Atenolol is an orally or intravenously administered treatment for hypertension, myocardial infarction,

and cardiac arrhythmias. Atenolol, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=4665 (last visited June 27, 2024).

11 Coreg is another orally administered treatment for hypertension.Coreg, DORLAND’S MEDICAL
DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=11137 (last visited June 27,
2024); Carvedilol, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=8176 (last visited June 27, 2024).

11
2, p. 1608.) Dr. Tran assessed petitioner’s headache as likely due to allergies and
suggested treating with an over-the-counter allergy medication. (Id.)

On January 15, 2015, petitioner’s husband sent a message on petitioner’s behalf
to Dr. Tran with complaints of elevated blood pressure, dizziness, weakness, pain (all
over her body but especially on her right side), shaking, and confusion. (Ex. 2, p. 1580.)
He stated that petitioner refused to go to the emergency department “due to her bad
experience in the past.” That same day, petitioner had a telephone encounter with Dr.
Tran. (Id.) Dr. Tran noted that petitioner “[h]as been filing a grievance against the ER
yesterday; felt anxious and then this happened. Feels better today; just a little tired and
some generalized weakness. . . . Likely anxiety attack.” (Id. at 1580-81.) Dr. Tran
advised treatment with rest, stress reduction, and Atvian as needed. (Id. at 1581.)

Petitioner sent a message to Dr. Fletcher on April 29, 2015, with complaints of
memory loss that had been persistent for several months. (Ex. 2, p. 1626.) She
explained that she was no longer taking any of her prescribed medications, with the
exception of an estrogen cream, due to her “sensitivity to drugs.” Citing a commercial
that warned of the cream’s potential side effects, which included abdominal pain and
memory loss, petitioner was concerned that her memory loss could be a reaction to
continued use of the estrogen cream. Dr. Fletcher reassured petitioner that the cream
was unlikely to cause memory loss or abdominal pain and explained that topical
application results in minimal absorption of the active medication into the bloodstream.
(Id.)

In a telephone encounter on July 9, 2015, petitioner reported that her
palpitations, body pain, and memory loss was progressing such that her activities of
daily living were now affected. (Ex. 2, p. 1653.) Petitioner presented to Dr. Tran on July
13, 2015, with complaints of memory loss and itchy rash. (Id. at 1662.) Dr. Tran noted
petitioner’s normal neurologic exam and assessed petitioner with a mild cognitive
impairment that was likely due to a mood problem. (Id. at 1662-63.) A CT scan of
petitioner’s head and brain again revealed no acute intracranial pathology. (Id. at 1684-
90.)

b. Post-vaccination medical records

Petitioner received the subject flu vaccination on October 10, 2015. (Ex. 2, p.
1693; Ex. 13.)

One day later, in a telephone encounter on October 11, 2015, petitioner reported
“new onset of dizziness and headache” since her flu vaccination. (Ex. 2, p. 1696.) She
further complained of generalized weakness and impaired vision. (Id.) Petitioner was
diagnosed with dizziness and headache, and it was noted that her symptoms could be a
“[p]ossible side effect from her flu shot.” (Id. at 1699.) She declined to go to an after-
hours clinic and was advised to treat with hydration and rest. (Id.)

12
On October 13, 2015, petitioner had a telephone encounter with Dr. Tran, in
which she reported dizziness, weakness, and headache since her flu vaccination. (Ex.
2, p. 1705.) She further reported experiencing a sore throat following her vaccination
that eventually resolved. Dr. Tran’s assessment was weakness, but she questioned
whether petitioner’s symptoms were a reaction to the flu vaccine or a viral syndrome.
Noting that petitioner was feeling “somewhat better,” Dr. Tran recommended continued
treatment with hydration and rest. (Id.) On October 28, 2015, petitioner called to make
an appointment with Dr. Tran because she was still feeling lightheaded and weak. (Id.
at 1723.) She attributed her symptoms to her October 10, 2015 flu vaccination. She
also reported a problem with her left fifth toe. (Id.)

Petitioner had another telephone encounter with Dr. Tran on October 29, 2015, in
which she complained of intermittent weakness and dizziness since her flu vaccination.
(Ex. 2, p. 1733.) Dr. Tran noted that petitioner “also has this with most meds in the
past” and that she appeared to be improving. Dr. Tran diagnosed petitioner with fatigue
and noted that “this is a chronic condition for this patient but she did say it got worse
after her flu vaccine.” (Id.) Petitioner further reported that she hit her left fifth toe on a
table five days earlier, causing some swelling, which Dr. Tran assessed to be a sprain.
(Id. at 1733-34.) A day later, on October 30, 2015, petitioner presented for a well-
woman exam with Dr. Fletcher. (Ex. 2, p. 1737.) She reported a flare of her
fibromyalgia symptoms and continued weakness following a “reaction to flu vaccine
earlier this month.” (Id.)

On November 3, 2015, petitioner sent a message to her primary care physician,
providing an update on her “allergic reaction” to the flu vaccine. (Ex. 2, p. 1762.)
Although she was feeling “a lot better than the first week,” she reported that she was
“still suffering from weakness, dizziness, headaches, intermittent palpitations, fatigue
and body pains,” and she was not yet “back to baseline.” Dr. Tran suggested that
petitioner try taking Relafen 12 for her pain and inflammation. She ordered lab tests to
check for an infection or electrolytes problem. (Id.)

The next day, on November 4, 2015, petitioner sent another message to her
primary care physician. (Ex. 2, p. 1777.) She reported that she had been taking
Relafen without improvement in her pain. She further reported that she was
experiencing pain at the base of her fingers that sometimes radiated to her wrists, which
she suspected to be arthritis. She indicated that the symptoms were worse in her left
hand and that her toes were sometimes affected. She also described intermittent
“shooting pains” in her ankles, arms, shoulder joints, and back. (Id.)

Petitioner sent yet another message to her primary care physician on November
16, 2015. (Ex. 2, p. 1803.) She reported that her weakness, dizziness, and headaches

12 Relafen is an orally administered nonsteroidal anti-inflammatory drug that is used in treatment of

osteoarthritis and rheumatoid arthritis. Relafen, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=43268 (last visited July 1, 2024); Nabumetone,
DORLAND’S MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=33049
(last visited July 1, 2024).

13
had improved, but she was still not back to normal or fully functional. She described
feeling nauseous, fatigued, confused, clumsy, off-balance, and as if her head was “big
and swollen.” She reported “shaking” of her bilateral thumbs, which was more
pronounced in the left thumb, since the ablation; however, she described how the
symptom had gotten worse since the flu vaccination. She also described weakness in
her hands and jitters in her teeth and lip. Finally, she reported that her memory issues
had progressed, but she had “not started on the dementia medication due to [her]
sensitivity to meds.” Dr. Tran responded that petitioner’s nonspecific symptoms and
normal lab results indicated that petitioner’s symptoms could be psychosomatic. Dr.
Tran suggested that petitioner see a therapist. (Id.) Petitioner replied, “It’s so
unfortunate that I truly am suffering from symptoms that started and are still persisting
after the flu vaccine,” and requested a second opinion. (Id. at 1807.)

On December 10, 2015, petitioner called her primary care physician with reports
of progressing dizziness, lightheadedness, and syncope since her flu vaccination. (Ex.
2, p. 1828.) In a telephone encounter the following day, petitioner further reported that
her balance was off and “drifted” left and that she had gotten lost while driving home.
(Id. at 1837.) Petitioner’s differential diagnosis was ongoing dizziness, but she was
referred to a neurologist for an evaluation for dementia. (Id. at 1839.)

Petitioner presented to Dr. Tran on December 30, 2015, with complaints of
“many nonspecific symptoms x a few months,” which she attributed to her flu
vaccination. (Ex. 2, pp. 1888-89.) She described weakness, shakiness, memory
issues, and palpitations. (Id. at 1889.) Dr. Tran noted that petitioner also had
unfounded complaints of palpitations following her ablation and that petitioner declined
to treat with Atenolol. (Id.) Dr. Tran’s assessment was somatoform disorder, given
petitioner’s normal workup. (Id. at 1889-90.) She advised that petitioner treat with
meditation, mindfulness exercises, and stress reduction. (Id. at 1890.)

On January 12, 2016, petitioner sent a message to her primary care provider,
requesting a referral to a neurologist for evaluation of her ongoing weakness, irregular
heart rate, dizziness, blurry vision, and tingling in her fingers and toes. (Ex. 2, p. 1920.)
Petitioner also questioned whether a GBS panel had been ordered in the course of her
treatment. (Id.) On January 12, 2016, petitioner presented for a consultation with
neurologist Dr. Suzanne Koopmans. (Id. at 1924-25.) Dr. Koopmans briefly described
petitioner’s medical history. She noted that petitioner experienced numbness,
dysphagia, vertigo, and falls in 2006 and was initially thought to have suffered a stroke.
(Id. at 1925.) It was eventually determined that petitioner had a somatoform disorder.
Dr. Koopmans then described petitioner’s course since her flu vaccination:

Received flu shot on 10/10/2015. Onset of symptoms was same day, a few
hours later. Felt a bad headache. Then weakness, nausea, very dizzy.
She stayed in bed. She said she couldn’t even put her head up. Since then
has had bad pains in legs and feet. Intermittent (not all the time) numbness
in legs. Sometimes has pain and numbness in limbs and shoulder. Also
c/o hands shaking/tremoring. This is when she is tired or cooking. At times

14
she drops things. Sometimes swallowing is hard as well. Also occasional
slurred speech.

Since her cardiac ablation, still has palpitations from time to time.

At times has urinary urgency . . . . Feels so weak. Also c/o issues
with memory. She thinks since the shot the memory is worse.

(Id.) Dr. Koopmans reviewed petitioner’s most recent brain MRI and found only
scattered white matter ischemic changes, and petitioner’s neurologic exam was normal.
(Id. at 1927.) She did not find any signs of dementia and reassured petitioner “that the
flu shot did not cause any of her symptoms.” (Id.)

Petitioner sent a message to her primary care physician in early February of
2016, complaining of progressing memory issues and continued pain, tingling,
weakness, and numbness. (Ex. 2, p. 1967.) She described how her symptoms were
intermittent but aggravated by exhaustion. She also reported continued palpitations.
(Id.)

On February 10, 2016, petitioner completed a Vaccine Adverse Event Reporting
System (“VAERS”) report, alleging that she experienced an adverse reaction to the flu
vaccine approximately two hours post-vaccination. (Ex. 9, p. 4.) She reported
headache, dizziness, nausea, weakness, palpitations, and pain throughout her body,
including her back and bilateral extremities. As pre-existing conditions, petitioner listed
hypertension, hyperlipidemia, mild neurocognitive disorder, fibromyalgia, GERD,
osteoporosis, and “high sensitivity + allergies to medications.” (Id.) On a separate
sheet of paper, petitioner listed 25 medications “with adverse reactions.” (Id. at 5.)

Petitioner saw primary care physician, Dr. Winnie Gandingco, on February 19,
2016, with complaints of weakness, “pins and needles” sensation in her bilateral
extremities, and generalized myalgia. (Ex. 2, pp. 1990-92.) In a follow up message to
Dr. Gandingco, petitioner reported excruciating pain in her hands, fingers, and arms;
tingling in her fingers and arms; and some swelling and redness in the palms of her
bilateral hands, but especially in her right palm. (Id. at 2005.) Dr. Gandingco
responded that petitioner’s workup was normal and “there is still no explanation for [her]
symptoms except for the mildly elevated eosinophils which is a marker for allergies.”
She suggested treatment with an over-the-counter allergy medication. (Id.) The next
day, petitioner sent another message to Dr. Gandingco, reporting additional symptoms.
(Id. at 2028.) She described tingling and numbness in her face, which resolved after a
couple days, and pain that caused weakness, tingling, and aches. She also stated that
her chest felt “weird.” (Id.)

On March 1, 2016, petitioner reported a three-month history of “[d]isabling axial
pain,” and underwent an MRI of her lumbar spine that was unremarkable. (Ex. 2, pp.
2037-41, 2045-51.) Petitioner’s differential diagnosis was myofascial pain syndrome,
which Dr. Gandingco explained is the same as fibromyalgia. (Id. at 2045-46, 2136.)

15
Petitioner indicated her disagreement with her diagnosis. (Id. at 2045.) She described
her condition as including persistent and unbearable pain, tingling, pricking, shooting,
deep aches, and weakness throughout her body. (Id. at 2047.) She also reported
memory issues, fatigue, irregular heart rate, and coldness in her hands and feet. She
explained that her symptoms were worse at night and that her pain was aggravated by
touch. (Id.)

In a telephone encounter on March 4, 2016, petitioner complained of pain,
numbness, and tingling since her flu vaccination in October of 2015. (Ex. 2, p. 2062.)
She reported a one-day onset of pain following her vaccination, but she explained that
she ignored her symptoms because she believed they were associated with her
fibromyalgia. She described worsening numbness and tingling in her bilateral
extremities, torso, and spine. (Id.) On March 16, 2016, petitioner sent a message to Dr.
Gandingco, complaining of swollen gums and rashes around her mouth. (Id. at 2090.)
Petitioner also explained, “I’ve had so [many] problems in my body since after the flu
shot in October 2016. . . . I truly believe that the vaccine had adverse effects on my
body.” She requested that the flu vaccine be included in the allergy list on file. (Id.)
Later that month, on March 29, 2016, petitioner sent another message to Dr.
Gandingco, requesting that the recent diagnoses of peripheral neuropathy, chronic
fatigue syndrome, fibromyalgia, myofascial pain, and mild neurocognitive disorder due
to multiple etiologies be added to her file. (Id. at 2136.) Dr. Gandingco added
peripheral neuropathy, chronic fatigue syndrome, and fibromyalgia to petitioner’s chart,
but she explained that she did not include myofascial pain due to its similarity with
fibromyalgia or mild neurocognitive disorder because it “is a vague diagnosis and does
not really mean anything.” (Id.)

On April 16, 2016, petitioner sent another message to Dr. Gandingco, describing
stabbing pains in her upper back and lungs, which began in the early morning hours on
April 15, 2016, and continued throughout the day. (Ex. 2, p. 2202.) In the afternoon, on
April 15, 2016, petitioner noticed swelling and greyish tint in the three middle fingers of
both hands. She noticed the greyish tint in her lips as well. She further described an
increase in fatigue and weakness as a result of the aggravated pain. By the evening,
petitioner was experiencing upper chest heaviness and tightness, prompting her to go to
the emergency department. (Id.) Petitioner underwent a deep venous sonogram of her
bilateral lower extremities, which was unremarkable. (Id. at 2239-40.)

Petitioner sent another message to Dr. Gandingco on May 16, 2016, this time
reporting constant numbness; tingling and deep aching in fingers, hands, toes, and feet;
and fatigue and weakness in the bilateral extremities, although the latter two symptoms
had been generally less intense. (Ex. 2, p. 2295.) She further reported improvement in
frequency of “shooting, pinching and prickling pains.” However, she explained that
these symptoms were “disabling” and interfering with her activities of daily living. (Id.)

The next day, on May 17, 2016, petitioner presented to Dr. Irina Williams for
evaluation of chronic pain that she attributed to her flu vaccination. (Ex. 2, pp. 2303-
07.) Dr. Williams noted that petitioner suffered “chronic pain involving all extremities

16
with some [on the] trunk. Non-specific. Fibromyalgia? Myofascial pain? Also has
features of chronic fatigue.” (Id. at 2303.) Petitioner reported generalized body pain
that was worse over the bilateral arms, hands, and feet. (Id. at 2303-04.) She
described the pain as “sharp” and “burning,” and she reported that it was associated
with widespread paresthesia. (Id.)

On July 6, 2016, petitioner sent a message to Dr. Gandingco, reporting persistent
weakness, fatigue, and exhaustion. (Ex. 4, p. 78.) These symptoms were both
aggravated by and interfering with her activities of daily living. She described how,
“[e]ven with modifications on the stretches from the Chronic Pain Class, it still caused
prickling, tingling and stabbing pains which got worse overnight. It rendered me very
weak, fatigued, exhausted and with bad aching pains today . . . . I can’t help but take my
pain medication which I try to avoid . . . .” (Id.) Later that month, on July 14, 2016,
petitioner sent a message to Dr. Williams, providing an update on her condition. (Id. at
95.) She reported that she was “still in a lot of pain (mostly deep aches which are
constant; intermittent shooting, pricking, tingling and numbness on my fingers, hands,
toes, feet and extremities on both sides . . . . Weakness, exhaustion and fatigue are still
constant . . . .” She again reported that she modified the chronic pain class exercises,
but the exercises caused tingling and shooting pains in her fingers, toes, feet,
extremities, and back. (Id.)

On August 15, 2015, petitioner sent another message to Dr. Gandingco,
providing the following update:

It has been over 10 months since the flu vaccination on October 10, 2015.
Weakness is still constant daily . . . , with tingling, pricking and aching pains
. . . still persisting. It’s been a struggle inching back to more house and
social activities. All of these with extreme difficulties, pains, weakness,
anguish, frustration and depression. It shoots my symptoms up to the roof
. . . . And it takes days, sometimes weeks to get better. I am not even back
to my regular activities yet.

(Ex. 4, p. 202.) Later that same day, petitioner presented to the emergency department
with complaints of syncope. (Id. at 164; Ex. 30, p. 8.) She reported that she woke up
with a headache in the front of her head. (Ex. 4, p. 164.) Then, in the early afternoon,
petitioner had an episode of syncope. She described walking upstairs, laying down in
bed with her feet elevated, and fainting upon standing up from her prone position. She
reported that she landed face down on her bed without injury, but she could not recall
how long the episode lasted. Since then, she continued to experience headache and
tingling in her extremities, though she reported that she had been experiencing common
headaches lately. She further reported experiencing intermittent palpitations for the
past few weeks, though it was noted that there had been no objective evidence of
supraventricular tachycardia since her ablation in May of 2014. Finally, petitioner
reported that she “[h]as had numbness and tingling in her hands and feet since Oct
2015. She associates this with her influenza shot. Sitting on the toilet seems to make it
worse. Starts in the tips of her toes, then in her finger tips.” (Id.) Petitioner’s physical

17
and neurologic exams were normal, and her lab and EKG results were unremarkable.
(Id. at 167-69.) She was discharged home with a diagnosis of syncope. (Id. at 169.)
On August 18, 2016, petitioner had a telephone encounter with behavior medicine
specialist Dr. Bradley Kuper, who diagnosed her with pain disorder associated with
medical and psychological disorders. (Id. at 221.)

On August 22, 2016, petitioner presented to Dr. Gandingco for a routine follow up
appointment. (Ex. 4, pp. 231-32.) She reported continued muscle weakness,
numbness or tingling sensation, and pain in the hands and feet. (Id. at 231.) Dr.
Gandingco noted, “When asked to give details of the pain, patient becomes very vague.
When asked to localize the pain she will point to multiple areas but unable to give
details and then moved back to getting more testing done . . . Patient feels that her
symptoms are related to the flu shot[.]” (Id.) Dr. Gandingco further noted that “most of
[petitioner’s] symptoms pre-date the flu vaccine including her fatigue, numbness and
weakness.” (Id. at 232.) Petitioner was diagnosed with persistent somatic symptom
disorder. (Id. at 233.)

Petitioner presented to neurologist Dr. Amir Sabouri on October 31, 2016, for an
evaluation of pain. (Ex. 5, p. 29.) She described how she developed weakness,
generalized pain, and an upset stomach within “26 hours” of her flu vaccination. She
complained of pain and numbness in her extremities, as well as generalized fatigue.
However, she denied weakness in the extremities and headache. (Id.) Dr. Sabouri
noted that petitioner presented “with a constellation of findings suggestive of idiopathic
small fiber neuropathy (pain in lower extremities, worse at night, numbness, gradient
sensory loss to pinprick and temperature) and otherwise unremarkable neurological
examination.” (Id. at 31.) He suggested treatment with a neuropathic pain medication,
but petitioner was hesitant due to her sensitivity to medications. (Id.) When petitioner
inquired into whether the flu vaccine could have triggered the small fiber neuropathy, Dr.
Sabouri indicated determining whether the vaccine could have caused small fiber
neuropathy would not change the treatment or prognosis of her condition. (Id. at 32.)

Petitioner’s next encounter was for an evaluation of peripheral neuropathy with
neurologist Dr. Ryan Armour on April 18, 2017. (Ex. 6, p. 5.) Petitioner reported

that her symptoms started around 2006. She reports that symptoms started
with decreased coordination and a feeling of heaviness in her legs with
some confusion. She was admitted to the hospital and had a workup that
was negative for stroke. She was diagnosed with somatiform [sic] disorder.

She reports that she felt totally normal between 2006 and 2015. She
got a flu vaccine in October 2015. She says that in the first few hours after
the flu vaccine she got dizzy, nauseated and felt a headache with severe
generalized muscle weakness that prevented her from walking unassisted.
She says that she called her doctor the following day and was told that she
was having a severe allergic reaction to the flu shot.

18
Since the episode with the flu shot she reports that she has had the
following problems: . . . She reports that she has chronic severe weakness
and fatigue in the extremities. Walking short distances is difficult for her.
Walking just across a building makes her feel like she has run a marathon.
. . . She reports that she has frequent urination up to 9 times per day. . . .
Chest discomfort with palpitations, but other times she feels like her heart
is “slow and weak, like my heart is dying.” She feels weak when this occurs.
. . . She reports that she has labile blood pressure, ranging from 100/60,
which she described as “low,” up to 170/90. . . . Low back pain and bilateral
leg pain, feeling like electricity and tingling along with a deep ache in the
back that shoots into the legs. Initially this was intermittent but now is
constant. . . . Numbness in the toes that has progressed to include the entire
lower limb on both sides as well as the fingers, hands, arms, shoulders and
low back.

The patient reports that she saw a neurologist in 2016 and was told
she was normal and there was no neurological problem present. She says
that she got another opinion from a neuromuscular specialist. She did an
EMG/NCS and was told that she did not have any problem with the large
fibers. She did not have any testing for small fiber polyneuropathy but she
received a diagnosis based on clinical history and examination.

(Id. at 5-6.) Dr. Armour noted that petitioner presented for a neurologic opinion
regarding chronic fatigue, numbness, and weakness of the extremities with a variety of
other non-neurological symptoms. (Id. at 11.) Finding that there was no objective
evidence of GBS or small fiber polyneuropathy, he determined that petitioner most likely
suffered from a combination of somatoform disorder and fibromyalgia. (Id. at 11-12.)
He noted that petitioner was “resistant to try any treatment due to concern about side
effects.” (Id. at 12.)

Petitioner returned to Dr. Armour on May 30, 2017, for a follow up. (Ex. 6, p. 36-
45.) She reported continued fatigue, weakness, exhaustion, and pain in her extremities
and low back, as well as difficulty with balance and coordination. (Id. at 36.) She also
continued to report that the flu vaccine exacerbated all of her symptoms. Dr. Armour
listed several treatments that petitioner tried and explained why each treatment was
discontinued. (Id.) He noted that all testing for neurological disorders had been normal
and stated, “I still believe symptoms are due to a combi[n]ation of somatization and
fibromyalgia.” (Id. at 44.) Petitioner denied all offered interventions. (Id.)

On January 30, 2018, petitioner presented to Dr. David Lee with complaints of
“all over pain.” (Ex. 7, p. 19.) She reported pain and tingling across her abdomen,
shooting pain in her feet and back, memory issues, “‘fireworks type’ pain” in her finger
and hands, pins and needles sensation in her eyelids, fatigue, and weakness. (Id.)
Petitioner returned to Dr. Armour on May 8, 2018, for an evaluation of generalized pain
and fatigue. (Id. at 13.) Dr. Armour noted, “Diagnosis is likely fibromyalgia.
Somatoform disorder is on the differential as well. Sensation remains decreased in the

19
distal extremities. It is unclear if there is a small fiber polyneuropathy contributing to her
symptoms. Patient would like a definitive diagnosis.” (Id. at 17.) He suggested that a
skin biopsy or other quantitative sensory testing could confirm diagnosis, but such
testing was not covered by petitioner’s insurance. (Id.)

On October 3, 2018, petitioner presented to neuromuscular disease and EMG
specialist and neurologist Dr. Jonathan Katz for “[m]ultiple complaints stemming from a
vaccine.” (Ex. 15, p. 9.) Petitioner described onset of headache, inability to hold her
head up, nauseousness, and dizziness the day after her flu vaccination. When she
called her primary care physician, she was told that she had a severe allergic reaction
to the vaccine that would soon improve. However, she reported persistent weakness
and shooting pain in her back, arms, and legs that she attributed to her history of
fibromyalgia. The tingling progressed to her toes and hands. She eventually
experienced “an ‘explosion of pain’ including sharp pains in the toes that made her have
to walk with the toes bent upwards” and resulted in limited gait, and she cannot move
some of the toes on her left foot. (Id.) Petitioner told Dr. Katz that she was bedridden
after a mild stroke in 2001 and “had one more mild period of being bedridden last year,
when she got the flu and it felt like this problem was starting again.” (Id. at 10-11.)
Despite seeing several doctors and undergoing various testing, but no neurological
problem was identified. (Id.) Dr. Katz noted,

These are interesting complaints but I am of the belief that she is physically
okay with respect to the nervous system. Took a fairly detailed history and
spent time explaining how she is doing to her, and tried to tie this in with
some of her other symptoms.

. . . Fibromyalgia from her vaccine. I do think that independent of her
concerns and needing to reassure that she does not have some sort of
severe illness or degeneration, there is a basic issue of why she has so
much pain, and I think this fits best with her history.

(Id. at 12.) Petitioner returned to Dr. Lee on October 16, 2018, for follow up
appointment. (Ex. 16, p. 50.) She reported that the intensity of pain fluctuated and
remained “electric and sharp” in character. She described numbness in her toes. (Id.)
It was noted that petitioner “continues to be adamant against any medications at this
point.” (Id. at 51.)

Petitioner next saw Dr. Lee on February 15, 2019, for another follow up
appointment. (Ex. 16, p. 56.) Petitioner reported that she was treating with over-the-
counter supplements and declined additional medications, but she was still experiencing
fatigue throughout the day that was aggravated by exertion. Although she continued to
experience pain throughout her body, she reported that her symptoms were “somewhat
improved from before.” (Id.) Petitioner returned to Dr. Lee on June 6, 2019, with
complaints of sluggishness and lightheadedness. (Id. at 41.) She described numbness
affecting both sides of her body, nauseousness, sluggishness, and tingling in her toes,
feet, and fingertips. (Id.)

20
On July 19, 2019, petitioner saw nurse practitioner Julie Amoruso with
complaints of a three-day history of shooting pain in her bilateral wrists and grip
weakness. (Ex. 16, p. 35.) She described anxiety regarding a possible right lateral
wrist fracture due to digging motion “and this anxiety has made her
weak/fatigued/chronic pain worse.” (Id.) She was given wrist splints and diagnosed
with chronic fatigue syndrome with fibromyalgia. (Id. at 36.) On August 21, 2019,
petitioner saw Dr. Lee with complaints of weakness in all extremities; pain in her toes,
feet, and upper limbs; and numbness. (Id. at 19.) Somatoform disorder is listed in her
ongoing problem list for this appointment. (Id.) Petitioner returned to Dr. Lee on
September 10, 2019. (Id. at 30-31.) Dr. Lee noted, “Continued paresthesias per patient
and aggravated more so on left side of face again . . . . She continues to defer on
additional medications for this.” (Id. at 31.)

Petitioner presented for a skin biopsy for evaluation of generalized tingling and
painful paresthesia on October 18, 2019. (Ex. 56, pp. 13-14.) The results revealed no
evidence of small fiber neuropathy. (Id. at 13.) On December 13, 2019, petitioner
returned to Dr. Katz with complaints of numbness, difficulty breathing, and palpitations.
(Ex. 15, p. 13.) She further reported brain and memory issues, red spots on her fingers,
and vision issues. (Id.) Dr. Katz noted, “Multiple complaints, but mainly numbness in
the setting of a normal exam. This is similar to when I last saw her. I still suspect this is
an undifferentiated somatiform [sic] disorder.” (Id. at 16.)

Petitioner’s next encounter was a follow up appointment with Dr. Armour on
February 12, 2020. (Ex. 56, p. 7.) She reported burning pain, numbness, and tingling
in her hands and feet, as well as intermittent neck and low back pain and occasional
tingling on the left side of her head. (Id.) She further reported tremors in her hands,
though there was no evidence of tremor on exam. (Id. at 7, 11.) Dr. Armour listed the
various treatments that petitioner tried and why she discontinued them. (Id. at 7-8, 11.)
He noted that petitioner had been evaluated by three other neurologists with no clear
neurological diagnosis and that, on examination, petitioner’s memory and speech were
normal. (Id. at 8-11.) He determined that petitioner’s likely diagnosis was fibromyalgia,
but somatoform disorder was on the differential as well, and that petitioner had either
not tolerated or refused to try medical management of her fibromyalgia. (Id. at 11.)

On March 24, 2020, petitioner had a virtual encounter with Dr. Lee, during which
she described an episode of “a bit of blacking out,” a feeling of fullness in her head,
sweating, palpitations, and mild shortness of breath. (Ex. 57, p. 27.) Her symptoms
resolved after resting and elevating her legs, but her blood pressure was still elevated.
(Id.) Dr. Lee’s assessment was near syncope. (Id. at 28.) On May 15, 2020, petitioner
returned to Dr. Lee with complaints of lightheadedness upon waking up in the morning
and fluctuating blood pressure. (Id. at 7.) She further reported that her sense of taste
diminished for a week before slowly resolving. She also experienced some upper back
and abdominal pain, tightness, and tremor in her left index finger. (Id.) Dr. Lee’s
assessment was chronic fatigue syndrome with fibromyalgia and tremor, despite normal
exam. (Id. at 8.)

21
Petitioner had another virtual encounter with Dr. Lee on October 12, 2020. (Ex.
57, p. 38.) She reported improvement in her fatigue and “less pain in general from
fibromyalgia but somewhat aggravated if she does too much or with increased stress.”
However, she reported ongoing numbness in her fingers. Somatoform disorder was
listed on her ongoing problem list. (Id.) Regarding petitioner’s chronic fatigue
syndrome with fibromyalgia, Dr. Lee noted: “Slowly improving per patient.” (Id. at 39.)
He recommended incremental increases in endurance activities. Regarding her tremor,
Dr. Lee noted that petitioner deferred further medical treatment. (Id.) Petitioner
returned to Dr. Lee on November 16, 2020, complaining of pain and numbness in her
left fingers. (Id. at 12.) She reported that her symptoms, including left hand and arm
tremors, were aggravated by exertion. (Id.) Dr. Lee’s assessment was tremor and
stable chronic fatigue syndrome with fibromyalgia. (Id. at 13.)

On December 31, 2020, petitioner presented for a virtual appointment with Dr.
Lee. (Ex. 57, p. 42.) She reported flu-like symptoms, fatigue, “slight breathing
tightness,” and pain in her back and sides. Somatoform disorder remained on
petitioner’s ongoing problem list. (Id.) Dr. Lee diagnosed her with flu syndrome. (Id. at
43.) As for petitioner’s chronic fatigue syndrome with fibromyalgia, Dr. Lee stressed
that petitioner rest and not overexert herself. (Id.) Petitioner returned for another virtual
appointment with Dr. Lee on January 13, 2021. (Id. at 51.) She reported an overall
improvement in her blood pressure and that her energy level was almost back to
baseline. (Id.) Dr. Lee noted that petitioner’s anxiety was stable, and her chronic
fatigue syndrome with fibromyalgia was “[s]lowly improving per patient to prior baseline.”
(Id. at 52.) Petitioner again deferred medical treatment of her tremor. (Id.)

On May 14, 2021, petitioner presented for another virtual appointment with Dr.
Lee. (Ex. 57, p. 17.) Petitioner reported “ongoing tremoring and weakness at times in
both hands, left > right,” as well as numbness and throbbing in the left hand. Her
physical examination revealed a very mild resting tremor in the left hand. Petitioner’s
differential diagnosis was essential tremor, coupled with somatic factors. (Id.)
Petitioner also reported short-term memory issues, but Dr. Lee deferred evaluation until
further testing was complete. (Id. at 18.)

Petitioner presented for an in-person appointment with Dr. Lee on June 21, 2021,
with complaints of continued pain in left fingers with numbness, tightness, and burning.
(Ex. 57, p. 55.) She was unaware of any specific activities or positioning that could be
provoking her symptoms. Although she was not treating with medication, she tried
supplements and reported some improvement in her symptoms. Somatoform disorder
continued to be included on petitioner’s ongoing problem list. (Id.) Dr. Lee’s
assessment included carpal tunnel syndrome and tremor. (Id. at 56.)

On December 3, 2021, petitioner presented for a Medicare wellness exam with
Dr. Lee. (Ex. 57, p. 21.) Due to continued imbalance, weakness, and lack of
endurance, petitioner reported needing the support of a cane to ambulate at home and
a wheelchair when going out for extended periods. She reported stress, and

22
somatoform disorder continued to be listed as an ongoing problem. (Id.) Dr. Lee
assessed petitioner with chronic fatigue syndrome with fibromyalgia and tremor. (Id. at
22.) He noted that petitioner was resistant to trying medication. (Id.)

During her next encounter with Dr. Lee on March 4, 2022, petitioner reported a
one-day onset of headache along the back of the neck and head, resulting in
exhaustion and lightheadedness. (Ex. 57, p. 34.) She described feeling “a bit of
pressure swelling in her head,” intermittent stress, and episodes of misspeaking. (Id.)
Dr. Lee’s assessment included chronic fatigue syndrome with fibromyalgia and tension
headache. (Id. at 35.) He noted that her symptoms were likely exacerbated by her
headache and recent increase in activities. (Id.) Somatoform disorder was again listed
as an ongoing problem. (Id. at 34.) Petitioner returned to Dr. Lee on July 14, 2022, with
reports of left rib pain that radiated to her back and was aggravated by certain
movements. (Id. at 46.) Her pain was the likely result of trauma from “jamming her
cane into [the] left chest area.” She further reported feeling intermittent tightness across
the base of her left ring and pinkie fingers and memory issues. (Id.) Dr. Lee’s
assessment included rib injury, trigger finger of the left hand, and anxiety that was likely
contributing to her reported memory issues. (Id. at 47.) Somatoform disorder was
again listed as an ongoing problem. (Id. at 46.)

On October 12, 2022, petitioner presented to Dr. Lee with reports of falling off the
bed, landing on her back, and potentially losing consciousness. (Ex. 57, p. 60.) Dr.
Lee’s assessment included near syncope and chronic fatigue syndrome with
fibromyalgia that was exacerbated by her recent fall. (Id. at 61.) Somatoform disorder
continued to be included in petitioner’s ongoing problem list. (Id.)

c. Petitioner’s affidavit

In her affidavit, petitioner states that she began to experience severe headache,
dizziness, nausea, weakness, and balance issues within a couple hours of receiving the
flu vaccine on October 10, 2015. (Ex. 1, ¶¶ 3-4.) She reports that she was bedridden
for the rest of the day and could only tolerate liquids due to her nausea. (Id. ¶ 5.) Upon
waking up the next morning, petitioner describes feeling “shooting and deep aching
pains” in her back, shoulders, and sides, as well as stiffness and numbness in her
limbs, which made her feel weak and exhausted. (Id. ¶ 6.) She reports that she
deferred going to the hospital, but her husband called Kaiser Permanente and the on-
call physician suggested that petitioner may have suffered from a severe allergic
reaction to the flu vaccine. (Id. ¶ 7.) Petitioner was told that her symptoms would
resolve after a couple of days. (Id.)

Petitioner reports that she called her primary care physician, Dr. Tran, on
October 13, 2015, and was advised that her symptoms could be “a possible reaction to
the flu vaccine,” and that her symptoms may continue for two months before eventually
subsiding. (Ex. 1, ¶ 8.) Petitioner states that, at that point, she was hopeful that her
pains were due to her pre-existing fibromyalgia. Despite not being asked about the
specifics of her pain at that time, petitioner recalls that it was radiated up her arms and

23
legs and into her back. She did however report irregular heart rate and feeling as
though she had a weak pulse. She claims that her fibromyalgia and irregular heart rate
“were worse after the vaccination.” (Id.)

Later that month, petitioner states that she called her primary care physician
again with complaints of weakness, dizziness, and extreme fatigue. (Ex. 1, ¶ 9.) The
following day, on October 30, 2015, petitioner presented for a woman annual exam and
reported that she was experiencing what she believed to be a flare of fibromyalgia and
that she had an adverse reaction to the flu vaccine. (Id. ¶ 10.) Thereafter, petitioner
states that she continued to report pain in her fingers, wrists, toes, ankles, limbs,
shoulders, back, mid-body, and spine, as well as tingling in her cheeks, numbness,
drooling, and urinary issues. (Id. ¶ 11.) She also reported mood changes and less
feeling in her palms and feet. (Id.)

Petitioner states that, at some point prior to January 2016, Dr. Tran informed her
that it would be difficult to link her symptoms to the flu vaccination but, given petitioner’s
medical history and “high sensitivity to medications,” it was possible that she suffered an
allergic reaction to the flu vaccine. (Ex. 1, ¶ 12 (emphasis omitted).) Dr. Tran further
informed her that her symptoms could last for a year or two and ordered lab tests, which
were normal. (Id.) Petitioner describes how her symptoms prevented her from going on
vacation with her family in January 2016 and notes that Dr. Tran provided a note
detailing why her tachycardia warranted cancellation. (Id. ¶ 13.) During a neurology
appointment that same month, petitioner reports that there was no evidence of
neurological disorder, or any other injury caused by the flu vaccine, as her reflexes
remained intact. (Id. ¶ 14.) However, petitioner states that her treating neurologist, Dr.
Koopmans, did not credit her description of the events following her vaccination and
“was not specific and thorough with the examination.” (Id.)

On February 19, 2016, petitioner presented for an appointment with her new
primary care physician, Dr. Gandingco, who reassured her that her symptoms “are real
and not just a product of [her] mind.” (Ex. 1, ¶ 15.) Dr. Gandingco diagnosed myalgia;
however, petitioner states that Dr. Gandingco “was not specific with the evaluation and
pain interview.” Petitioner further notes that her lab tests showed elevated markers for
allergies and that Dr. Gandingco indicated that medications and vaccines can trigger
this elevation. (Id.)

Petitioner reports that Dr. Gandingco was more thorough in a subsequent
examination. (Ex. 1, ¶ 16.) During this encounter, petitioner reported tingling, prickling,
shooting, stabbing, and deep-aching pain throughout her body but especially in her
three middle fingers and toes. (Id.) Dr. Gandingco diagnosed peripheral neuropathy,
fibromyalgia, and chronic fatigue syndrome. (Id.) She explained that peripheral
neuropathy has no known cause or treatment. (Id. ¶ 17.) Because Dr. Koopmans
found no evidence of neurologic disorder, petitioner’s referral for further testing was
declined. (Id.) Dr. Gandingco reiterated Dr. Tran’s suggestion that petitioner’s
symptoms could persist for one to two years and that it would be hard to prove that they
were linked to her flu vaccination. (Id. ¶ 23.)

24
Petitioner states,

I am very disappointed that when some doctors are unable to find or make
a firm diagnosis, they could be quick at using Somatoform as a diagnosis.
I was misdiagnosed with this when they were unable to catch my
Tachycardia. It took months before this was caught in the ER, when my
palpitation was exceeding 100 to over 200 per minute, lasting over 1 hour
to more than 2 hrs.

. . . I read my medical record and found that some doctors referred
to and might have considered Somatoform. Sadly, I find it like a way of
escape when there is no clarity or clear-cut symptoms and diagnosis.

(Ex. 1, ¶¶ 18-19.) She explains that she was originally diagnosed with somatoform
disorder after suffering from a stroke for which there was no objective evidence. (Id. ¶
20.) She states that some doctors reviewed her previous MRI results and determined
that there was some evidence of stroke. She further indicates frustration because,
despite uncertainty among treaters about her correct diagnosis, she has been denied
insurance due to this prior stroke. (Id.)

During the first two months following vaccination, petitioner describes the
following additional symptoms: frequent urination, difficulty controlling her urination,
numbness, occasional and mild tingling of the cheeks, worsening memory issues, and a
weaker immune system as evidenced by frequent rashes, swelling, coldness, paleness,
and reduced sensation to touch and taste. (Ex. 1, ¶ 21.) She describes depression,
crankiness, and anxiety that negatively affect her familial relationships. (Id. ¶ 22.) She
notes that there is a “long list of medications that cause allergies and severe reactions
documented on [her] medical file.” (Id. ¶ 25.) Petitioner explains that patients with
sensitivities are usually administered a “Flu Shot without Preservatives,” but she
received a “Regular Strength Flu Shot” or a “Flu Shot with Preservatives Added.” (Id. ¶
24.) She states that she usually receives the flu vaccine without preservatives and that
she has never suffered an adverse reaction. (Id.)

Petitioner reports that she was denied a second opinion due to unavailability of
neurologists to take her case. (Ex. 1, ¶ 26.) By December 2016, petitioner reports that
she got the flu and experienced symptoms that were similar to those experienced after
receiving the flu vaccine in October 2015. (Id. ¶ 27.) She describes weakness, fatigue,
pain, dizziness, nausea, and frequent urination, as well as new onset of fever. Her
fatigue, pain, and weakness were so severe that she was confined to her bed. She was
eventually seen on December 23, 2016, for respiratory infection. (Id.)

Petitioner attended home physical therapy in the January and February of 2017.
(Ex. 1, ¶ 28.) She reports that her physical therapist informed her that strenuous
exercises would do more harm than good and suggested that her problems may be
neurologic in nature. (Id.) At discharge, petitioner describes how her physical therapist

25
pushed her to walk up and down the stairs, intensifying her symptoms, and causing a
loss in progress towards recovery. (Id. ¶ 29.) It was suggested that both her inability to
ambulate on stairs and to maintain balance without falling backwards were signs of
petitioner’s weakness and poor balance. (Id. ¶¶ 30-31.)

Petitioner states that neuromuscular specialist, Dr. Armour, diagnosed her with
chronic fatigue syndrome, paresthesia, and severe fibromyalgia, which could have been
exacerbated by the flu vaccine. (Ex. 1, ¶ 34.) She explains that Dr. Armour believed
that she also presented with symptoms consistent with small fiber neuropathy, although
this differential diagnosis was never confirmed because her insurance denied coverage
of testing. (Id. ¶ 35.) Petitioner underwent her first spinal tap in May 2017, “over a year
after the vaccination,” and the results showed an elevated total protein count. (Id. ¶ 36.)

In October 2018, petitioner presented to Dr. Jonathan Katz at Sutter Pacific
Medical Group who agreed that the flu vaccine “gravely exacerbated” petitioner’s
fibromyalgia and fatigue. (Ex. 1, ¶ 37.) However, he explained that petitioner’s
symptoms belong to the broad family of fibromyalgia and their relationship to petitioner’s
flu vaccine was unclear, given that it had been nearly three years since the vaccination.
(Id.) Petitioner reports that Dr. Katz’s primary diagnosis was vaccination complication.
(Id. ¶ 39.)

Despite some improvement, petitioner reports that her symptoms are persistent
and disabling. (Ex. 1, ¶ 41.) She explains that, on top of aggravating her fibromyalgia,
the flu vaccine caused pain that was different and more constant than the pain
associated with her fibromyalgia. (Id. ¶¶ 42-43, 45.) She describes “pin prick pain
(almost constant, intensity is like a roller coaster) radiating from toes up and down the
legs (both sides) and fingers, hands, and arms,” as well as “sharp and shooting pains in
the same places.” (Id. ¶ 44.) She further describes numbness in her legs, feet, and
toes (especially her three little toes) on both sides. (Id.) Although she is able to
ambulate short distances with support, petitioner explains that she still requires a
wheelchair for long walks. (Id. ¶ 46.) She states, “I have never been back to my
baseline before the Flu Shot. Weakness, fatigue and pains are still part of my daily
living (4 to 10 on the pain scale).” (Id.) She reports that she still experiences
“aggravations due to activities and for unknown reasons.” (Id. ¶ 47.)

d. Affidavit of petitioner’s husband, Arthur Valdez

Petitioner’s husband, Arthur Valdez, submitted an affidavit on her behalf. (Ex.
10.) In his affidavit, Mr. Valdez states that he also received the flu vaccine on the
morning of October 10, 2015, but by the afternoon, petitioner began complaining of
extreme headache, dizziness, nausea, weakness, and imbalance. (Id. at 1.) He
describes how she was unable to open her eyes, speak, or move due to the dizziness
and nausea. By the next day, petitioner was suffering deep, shooting pains and aches
throughout her body. Mr. Valdez explains that he was worried about her condition, but
petitioner refused to go to the emergency room due to “[h]er previous traumatizing
experience at Kaiser Emergency Room.” He states that, although petitioner has

26
“serious susceptibility to medications,” her reaction to the flu vaccine “was the worst and
longest allergic reaction she ever had and is still having residual up to present.” He
explains, “I am a witness to this as she experienced danger from different medications
before the Flu Shot. Unlike other people, her body reacts quicker to medications.” He
further states that petitioner “never got back to how she was before the administration of
the Flu Shot.” (Id.)

Mr. Valdez reiterates many of petitioner’s assertions concerning the quality of her
symptoms and the effect that they have had on her life. He describes “shooting pains,
pin prick, tingling, burning and deep aches, fatigue, weakness, numbness and poor
balance” throughout petitioner’s body. (Ex. 10, p. 1.) He notes that she continues to
tire easily, which limits her ability to ambulate and perform activities of daily living. (Id.
at 1-2.) He explains that she eventually resorted to using an electric toothbrush, doing
sponge baths, and sitting on a chair while performing personal hygiene activities. (Id. at
1.) She had trouble holding things, especially skinny objects like silverware, and
experienced frequent urination. (Id. at 1-2.) Eventually, petitioner stopped driving due
to the pain, numbness, fatigue, and weakness in her bilateral extremities. (Id. at 1.) Mr.
Valdez reports that petitioner’s skin was sensitive to the slightest touch, causing electric
and burning pains, and that “[t]here were months of sleepless nights.” (Id. at 2.)

Mr. Valdez states that petitioner’s treaters associated her symptoms with her flu
vaccination. (Ex. 10, p. 2.) He describes how, despite experiencing some
improvements, petitioner still complains that her symptoms are aggravated by activity
and “some unknown reasons.” He notes that her symptoms prevent her from traveling,
performing activities of daily living, and attending church, family gatherings, and holiday
celebrations. He concludes that petitioner’s condition “was never like this before the Flu
Shot” and that she is still “far away from how she was before the Flu Shot.” (Id.)

IV. Expert Summaries

a. Petitioner’s expert, W. Curt LaFrance, Jr., M.D., M.P.H. 13

Dr. LaFrance filed three reports in this case. (Exs. 17, 34, 45.) Dr. LaFrance
notes that petitioner had a medical history inclusive of a number of issues, including
back pain, lightheadedness, tachycardia, fibromyalgia, headaches, anxiety, and
depression. (Ex. 17, p. 32.) He explains that she is a patient “who has a longstanding
history of physical symptoms, who describes development and worsening of her
symptoms after a 10/10/2015 Fluvirin injection.” (Id.) However, he agrees that “[h]er
workup does not reveal a medical or neurological etiology for her symptoms, and her

13 Dr. LaFrance received his medical degree from the Medical College of Georgia before completing an

internship in internal medicine, a residency in neurology and psychiatry, and a fellowship at Brown
University School of Medicine. (Ex. 18, p. 1.) He maintains an active medical license in Rhode Island.
(Id. at 2.) He currently works as a professor of psychiatry and neurology at Brown University, a staff
neurologist and psychiatrist at Rhode Island Hospital, a neuropsychiatrist at Rode Island Hospital, a staff
psychiatrist at Miriam Hospital, a staff physician at Providence Veterans Administration Medical Center,
and a director of the Division of Neuropsychiatry and Behavioral Neurology at Rhode Island Hospital. (Id.
at 3.) He has published over a 125 peer-reviewed articles, 6 books, and 29 book chapters. (Id. at 7-20.)

27
symptoms have persisted years after the 2015 injection.” (Id.) He opines that petitioner
meets the DSM-V diagnostic criteria for a somatic symptom disorder, which “consists of
one or more somatic (bodily) symptoms that are distressing or result in significant
disruption of daily life; excessive thoughts, feelings, or behaviors related to the somatic
symptoms or associated health concerns; present persistently (typically more than 6
months).” (Id.) He notes that petitioner was first diagnosed as having a somatoform
disorder (as per the prior DSM-IV) in 2006 and that she has subsequently had
intermittent somatic presentations. (Id.) According to Dr. LaFrance, somatic symptom
disorder is distinguished, not by the symptoms per se, but by how the symptoms
present and how the patient interprets them. (Id.) The development of somatic
symptom disorder is influenced by a number of factors, including genetic and biologic
vulnerability (e.g., increased sensitivity to pain), early traumatic experiences, learning,
and cultural or societal norms that place greater weight or value on physical suffering as
compared to psychological suffering. (Id.)

In his first report, Dr. LaFrance addresses each of the six parts of the Loving test
for assessing significant aggravation claims in this Program.

Under the first three Loving prongs, a petitioner must show that a comparison
between her pre- and post-vaccination condition represents a significant aggravation of
her pre-existing condition. Dr. LaFrance indicates that petitioner had a prior history
notable for the following symptoms: headaches, feet pain, dizziness, weakness, pain all
over her body especially on her right side, shaking, confusion, and memory complaints.
However, he stresses that, in the year prior to the vaccination at issue, petitioner had
not been seen medically for any complaints of shooting pains or gait instability. (Ex. 17,
pp. 32-33.) Regarding her post-vaccination condition, he explains that petitioner
“described dizziness, headache and weakness the day of the 10/10/15 injection, which
persisted, and in subsequent days, she reported developing debilitating symptoms,
which interfered with daily activities, as noted in medical records and communications in
2016, 2017, and 2018.” (Id. at 33.) Dr. LaFrance explains that petitioner’s flu vaccine
did not cause either her pre-existing somatic symptom disorder or fibromyalgia.
However, he opines that her pre-existing somatic symptom disorder was significantly
aggravated. He explains that petitioner has had several “time-limited” aggravations of
her somatic symptom disorder (in 2012, 2014, and 2015) with periods of recovery in
between. Prior to vaccination, she had experienced periods of recovery from prior
episodes and “the decline since the 10/15 injection does not represent the natural
course of her disorder.” (Id.)

Regarding the fourth Loving prong – a medical theory of vaccine causation, Dr.
LaFrance invokes the “fear-avoidance model.” (Ex. 17, p. 33 (citing Johan W.S.
Vlaeyen et al., Fear of Movement/(Re)injury in Chronic Low Back Pain and Its Relation
to Behavioral Performance, 62 PAIN 363 (1995) (Ex. 21); W. Curt LaFrance Jr. & Helge
Bjønæs, Designing Treatment Plans Based on Etiology of Psychogeneic Nonepileptic
Seizures, in GATES AND ROWAN’S NONEPILEPTIC SEIZURES 283 (W. Curt LaFrance Jr. &
Steven C. Schachter eds., 4th ed. 2018) (Ex. 22)).) According to Dr. LaFrance, this
model explains that, for a somatic symptom disorder, a precipitating event is a

28
contributing factor in the causal chain of events for subsequent symptoms additional to
the predisposing and perpetuating factors. Together, these three factors constitute the
“3Ps.” (Id. (citing W. Curt LaFrance Jr. & Orrin Devisnky, Treatment of Nonepileptic
Seizures, 3 EPILEPSY & BEHAV. S19 (2002) (Ex. 23)). 14) Applying this theory to
petitioner’s case under Loving prong five, Dr. LaFrance asserts that “the record
demonstrates that symptoms (dizziness, headache and weakness) occurred the day of
the 10/10/15 injection and increased and morphed (pain, paresthesias, gait imbalance)
as time passed, post-injection, showing a logical sequence of cause and effect
demonstrating that the injection worsened the pre-existing disorder.” Dr. LaFrance
asserts the timing of petitioner’s significant aggravation is medically appropriate to infer
causation; however, he does not explain the basis for that opinion. (Id.)

Dr. LaFrance indicates that petitioner’s condition is unlikely to improve absent
treatment for the predisposing and perpetuating factors contributing to her symptoms.
However, he notes that this has not been done in this case. With treatment, she would
have a guarded prognosis for some improvement; however, “[w]eighing against
symptomatic improvement is that she had a grievance against the emergency
department in 2015, which preceded the October 2015 flu injection, and also the
amount of time she has gone untreated with targeted psychotherapy.” (Ex. 17, p. 33.)

In his second report, Dr. LaFrance addresses in greater detail how to distinguish
a precipitating event from a merely preceding event. (Ex. 34.) Dr. LaFrance
acknowledged that accepting a preceding event as causal would be to accept the
logical fallacy of “post hoc ergo propter hoc” (i.e., “after this, therefore because of this”).
(Id. at 1.) A precipitating event, by contrast, is “a specific event or trigger to the onset of
current symptoms.” He asserts that “[n]either a needle jab, nor a flu vaccine, are a
cause by itself. The jab; however, in the context of predisposing, precipitating, and
perpetuating factors, may be a link in the causal chain, for somatic symptoms . . . .”
(Id.) The “3Ps” concept on which Dr. LaFrance relies originated in the context of post-
traumatic symptoms. Under this concept, temperament and past history are
predisposing, or predictive, factors of post-traumatic morbidity, precipitating events are
specific triggering events, and perpetuating factors maintain dysfunction once
established. (Id. at 2.) Dr. LaFrance cites examples from the literature involving
anticipatory distress to painful medical procedures, insomnia, nonepileptic seizures,
post-concussive symptoms, and chronic fatigue syndrome. (Id. (citing Nicole M. Racine
et al., Systematic Review: Predisposing, Precipitating, Perpetuating, and Present
14 In a subsequent order, I indicated that it was unclear how this article – which discusses precipitating

events in the context of seizures – relates to this case. (ECF No. 54, n. 1.) In his second report, Dr.
LaFrance explained that this article has been cited for its explanation of the “3Ps” concept – that is,
predisposing, precipitating, and perpetuating factors. (Ex. 34, p. 2.) He explains that the seizures
discussed in this paper are psychogenic non-epileptic seizures, which are also a form of somatic
symptom disorder. (Id.) Dr. Dimsdale challenged this latter point, and Dr. LaFrance further stressed that
non-epileptic seizures are categorized as a form of conversion disorder, which is in turn included among
somatic symptoms disorders in the DSM-V. (Ex. 45, p. 2.) It should be noted, however, that conversion
disorders are distinguished from other somatization disorders because they have an acute presentation
that contrasts from the more chronic presentation of other somatization disorders. (Lesley A. Allen &
Robert L. Woolfolk, Cognitive Behavioral Therapy for Somatoform Disorders, 33 PSYCHIATRIC CLINICS N.
AM. 579 (2010) (Ex. 24).)

29
Factors Predicting Anticipatory Distress to Painful Medical Procedures in Children, 41 J.
PEDIATRIC PSYCH. 159 (2016) (Ex. 41); Jason G. Ellis et al., The Natural History of
Insomnia: Predisposing, Precipitating, Coping, and Perpetuating Factors over the Early
Development Course of Insomnia, SLEEP, Sept. 2021, at 1 (Ex. 36); Markus Reuber et
al., Non-Epileptic Seizures and Other Functional Neurological Symptoms: Predisposing,
Precipitating, and Perpetuating Factors, 48 PSYCHOSOMATICS 230 (2007) (Ex. 42); Tyler
A. Rickards, Persistent Post-Concussive Symptoms: A Model of Predisposing,
Precipitating, and Perpetuating Factors, 29 APPLIED NEUROPSYCHOLOGY: ADULT 284
(2022) (Ex. 43); Kate Lievesley et al., A Review of the Predisposing, Precipitating and
Perpetuating Factors in Chronic Fatigue Syndrome in Children and Adolescents, 34
CLINICAL PSYCHOLOGY REV. 233 (2014) (Ex. 39)).) He further notes that the World
Health Organization has identified immunization anxiety as a cause of somatoform
presentations in the form of what it calls “Immunization Stress Related Responses” or
“ISRRs,” which can include more immediate responses such as vasovagal responses,
but also dissociative neurologic symptoms that can develop days after vaccination. (Id.
at 3 (citing WORLD HEALTH ORG., CAUSALITY ASSESSMENT OF AN ADVERSE EVENT
FOLLOWING IMMUNIZATION (AEFI): USER MANUAL FOR THE REVISED WHO CLASSIFICATION
(2d ed. 2019) (Ex. 47)).)

Dr. LaFrance suggests that, practically speaking, this case boils down to an
“eggshell” plaintiff type of scenario. (Ex. 34, p. 3.) He is critical of Dr. Dimsdale’s
conclusion that petitioner’s condition is “in her imagination,” noting that this could apply
to all psychological disorders. (Id. at 4.) He states: “It is correct that there is no physical
damage associated with the flu vaccine in this case, as noted by neurologist, Dr.
Bromberg. It seems incorrect; however, to opine that a psychological impact from the
jab, as benign as it is, was not a contributory factor to ongoing symptoms of her pre-
existing symptoms, in this case.” (Id.)

In his third and final report, Dr. LaFrance disagrees with Dr. Dimsdale’s assertion
that unusual or severe events are more likely to be precipitating events. Dr. Dimsdale
cited the Holmes and Rahe Scale for rating stressful events, suggesting vaccination
was a low stress event. In response, Dr. LaFrance stresses that this scale includes
minor life events that can nonetheless be significant stressors (for example, Christmas
or a vacation), “demonstrating that even regular, expected, common events can be
stressors to specific people.” (Ex. 45, p. 2.) Dr. LaFrance stresses that he is not
opining that the flu vaccine caused petitioner’s somatic symptom disorder. He explains
that “[t]he claim is not that the shot caused the disorder, rather that the shot, as minor of
an event as it is to many people, aggravated her pre-existing condition, as noted in her
history and symptom pattern documentation before and after the injection.” (Id.)

Dr. LaFrance cites two papers documenting four case reports of psychogenic gait
disorders and an additional case of a psychogenic movement disorder following H1N1
influenza vaccination. (Ex. 45, pp. 2-3 (citing Jung Ho Ryu & Jong Sam Baik,
Psychogenic Gait Disorders After Mass School Vaccination of Influenza A, 3 J.
MOVEMENT DISORDERS 15 (2010) (Ex. 48); Chien-Yu Lin et al., Letter to the Editor,
Psychogenic Movement Disorders After H1N1 Influenza Vaccination, 22 J.

30
NEUROPSYCHIATRY & CLINICAL NEUROSCIS., Summer 2011, at E37 (Ex. 49)).) He further
cites case reports of somatic symptom disorders arising after Covid-19 vaccination. (Id.
at 3 (citing Matthew Butler et al., Functional Neurological Disorders After SARS-CoV-2
Vaccines: Two Case Reports and Discussion of Potential Public Health Implications, 33
J. NEUROPSYCHIATRY & CLINICAL NEUROSCIENCES, Fall 2021, at 345 (Ex. 51); Tommaso
Ercoli et al., Functional Neurological Disorder After COVID-19 Vaccination, 42
NEUROLOGICAL SCIS. 2989 (2021) (Ex. 52)).) Additionally, he cites a paper
demonstrating that over 30% of placebo recipients (who thought they received the
Covid-19 vaccination) suffered systemic adverse effects including headaches, fatigue,
pain, tenderness, and diarrhea. (Id. at 3 (citing Julia W. Haas et al., Frequency of
Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials: A Systematic Review
and Meta-Analysis, JAMA, Jan. 18, 2022, at 1 (Ex. 50)).) Finally, Dr. LaFrance cites
two publications that he indicates specifically cite vaccination as among the possible
precipitating events for somatic symptom disorders. (Id. (citing David Dongkyung Kim
et al., Helping the Public Understand Adverse Events Associated with COVID-19
Vaccinations: Lessons Learned from Functional Neurological Disorder, 78 JAMA
NEUROLOGY 789 (2021) (Ex. 53); Matt Butler et al., Considerations for Causality
Assessment of Neurological and Neuropsychiatric Complications of SARS-CoV-2
Vaccines: From Cerebral Venous Sinus Thrombosis to Functional Neurological
Disorder, 92 J. NEUROLOGY NEUROSURGERY & PSYCHIATRY 1144 (2021) (Ex. 54)).)

b. Respondent’s expert, Joel Dimsdale, M.D. 15

Dr. Dimsdale filed two reports. (Exs. A, E.) Dr. Dimsdale explains that

[t]he record is abundantly clear that the patient was intensely focused on
her symptoms, spending considerable time on the internet and in support
groups, and doing literature searches. She developed a conviction about
many illnesses and pressed her doctors for further tests. Some doctors
described her as being ‘fixated’ on her conviction that her symptoms
resulted from the flu shot.

(Ex. A, p. 28.) He notes that petitioner embellished her past medical history,
exaggerated symptoms, rejected medications, and “[e]ven when tests came back as

15 Dr. Dimsdale received his medical degree form Stanford University before completing a residency in

psychiatry at Massachusetts General Hospital and a clinical fellowship in psychiatry at Harvard Medical
School. (Ex. B, p. 1.) He is board certified by the American Board of Psychiatry and Neurology and
maintains a medical license in California and Massachusetts. (Id.) He is currently employed as Regent
Edwards A. Dickson Emeritus Professor and Distinguished Professor of Psychiatry Emeritus at the
University of California, San Diego; an adjunct professor of psychology at San Diego State University;
and a consultant to the Behavioral Medicine Branch of the National Heart, Lung, and Blood Institute. (Id.
at 1-2.) Previously, Dr. Dimsdale was a member of the taskforce that wrote the DMS-V and chaired the
somatic symptoms disorders workgroup of that taskforce, as well as the American Psychiatric Association
Council of Psychosomatic Medicine. (Id.; Ex. A, p. 1.) He has published over 450 journal articles, as well
as 43 chapter articles and non-refereed reports, 272 abstracts and meeting papers, 18 book reviews, and
9 books and monographs. (Ex. B, pp. 11-57.) Notably, Dr. Dimsdale was a section editor for somatic
symptom disorders of UpToDate and authored chapters on such disorders in textbooks, such as The
Comprehensive Textbook of Psychiatry and Merck Manual. (Ex. A, p. 1)

31
normal, she was not reassured and instead focused on findings that were of borderline
significance.” (Id.) When she was unable to persuade her doctors to attribute her
somatic complaints to her vaccine, she changed doctors. (Id. at 28-29.) Dr. Dimsdale
stresses that these behaviors are consistent with her prior medical history. For
example, in 2006, she was diagnosed with a somatoform disorder after she persisted in
reporting she had suffered a stroke, even after a complete work up had ruled out any
stroke. (Id. at 29.) She was diagnosed with depression and anxiety in 2008 and 2011,
respectively, and, even prior to vaccination, she reported many symptoms and her
records reflect physician commentary that she was “very hypervigilant about her
symptoms.” (Id.) Dr. Dimsdale agrees with Dr. LaFrance that petitioner’s primary
diagnosis is somatic symptom disorder, which he further notes to be severe. (Id. at 30.)
Especially given the extent of her history, he does not believe that petitioner’s case
represents malingering (i.e., pursuing secondary gain in the form of compensation).
(Id.) However, he disagrees with Dr. LaFrance’s assessment of the role of petitioner’s
vaccination in her condition.

First, Dr. Dimsdale disagrees with Dr. LaFrance’s assessment (under Loving
prongs one and two) regarding petitioner’s condition pre- and post-vaccination.
Whereas Dr. LaFrance had suggested she had not been experiencing symptoms,
namely shooting pains and gait instability, in the year prior to vaccination, Dr. Dimsdale
stresses that she had an episode about four months prior to vaccination, in June of
2015, wherein she had attributed pain and memory loss to a steroid injection. He also
stresses that at least some of petitioner’s post-vaccination treatment records, such as
an August 22, 2016 note by Dr. Gandingco, explained that “most of her symptoms pre-
date the vaccination.” In suspecting petitioner’s symptoms were functional, he
described the symptoms as having persisted ever since her “stroke” in 2006. (Ex. A,
pp. 30-31.) Dr. Dimsdale does, however, “agree that she reported an enormous array
of symptoms following the flu shot.” (Id. at 31.)

Second, Dr. Dimsdale disagrees that petitioner’s post-vaccination condition
constitutes a “significant aggravation” of her prior condition. He opines that, given gaps
in petitioner’s treatment records and the lack of any psychosocial history, it is impossible
to conclude that she ever recovered from the purported “stroke” episode documented in
2006. (Ex. A, p. 32.) He explains, “I don’t think it is possible to conclude what the
natural course of her disorder is, in the absence of such information. This is a disorder
that fluctuates.” (Id.) Although he agrees that petitioner experienced prior episodes of
medically unexplained symptoms that were “briefer in duration,” he does not think it is
accurate to conclude that “medical interventions ‘aggravated’ her symptoms.” (Id. at
32.) He explains that “[p]atients with somatic symptom disorders typically have a
fluctuating course. There was nothing about the flu shot which led to her symptoms.
Rather, she just thought that the symptoms were a consequence of the flu shot and
fought off any disconfirming evidence from numerous treating physicians.” (Id.)
According to Dr. Dimsdale, “[t]he only thing that can be comfortably concluded is that
the patient received an injection and in ensuing years developed multiple symptoms,
many of which made no sense and were not supported by the numerous medical tests
and examinations that were conducted by many physicians, including specialists.” (Id.

32
at 31.) He notes that doctors repeatedly concluded that any connection between
petitioner’s vaccination and symptoms was coincidental. (Id.)

Third, Dr. Dimsdale disagrees with Dr. LaFrance’s asserted theory of causation.
Dr. Dimsdale agrees that the 3Ps (i.e., predisposing, precipitating, and perpetuating
factors) are useful as a heuristic framework, but he does not agree that they represent a
causal chain as Dr. LaFrance asserts. (Ex. A, p. 33.) Instead, these factors simply
result in vulnerability to somatic symptom disorder when they converge. While there are
some instances in which a clear precipitant can be identified, it is often the case that
precipitating factors are not identified. Therefore, precipitating events are not causally
necessary, and it can be difficult to distinguish a precipitating event from a merely
preceding event, even if the preceding event is a stressor. (Id.) Although the DSM-V
has moved away from the term “hypochondria” to avoid stigmatizing patients, the
concept remains causally important. (Id. at 30, 32-33.) Specifically, hypochondria
involves a “health anxiety disorder.” (Id. at 33.) It is anxiety-driven “catastrophizing”
that causes patients to misattribute the meaning of their symptoms, commonly
interpreting minor symptoms as harbingers of disaster. (Id. at 32-33.) In some
instances, secondary issues such as deconditioning from inactivity or secondary gains
(e.g., being relieved of burdens by friends and family) can reinforce the patient’s
distorted view and create a vicious cycle. (Id. at 33.)

Fourth, Dr. Dimsdale disagrees with Dr. LaFrance’s identification of a logical
sequence of cause and effect implicating petitioner’s vaccination in her condition. (Ex.
A, pp. 33-34.) Dr. Dimsdale explains that knowing whether a given stressor is a
“precipitating” versus merely a “preceding” event creates a definitional problem. People
experience stressors daily. In attempting to deal with this issue, researchers rely on
rating scales for stressful events to distinguish the profoundly disturbing from mere
annoyances – for example, the death of a spouse would be rated as a greater source of
stress than receiving a parking ticket. (Id. at 33.) Nonetheless, he acknowledges that,
although there may be general consensus in rating the severity of the stress related to
life events, the individual’s own personal interpretation of the event is “enormously
important.” It is not the event itself, but the individuals’ construal of the event, that leads
to stress. (Id.) In this case, he asserts “there was no major stressful life event. The
patient merely thought there was; she was mistaken.” (Id. at 34.) And, although
petitioner did report more symptoms as time went on, “the record also demonstrates
that she was a poor historian – vague about important medical details (e.g. side effects
of medications), inaccurate in reporting her medical history (e.g. repeatedly referring to
having had strokes when the record indicates she was told she never had a stroke).”
According to Dr. Dimsdale, what actually happened in this case is that petitioner had
longstanding “strong expectations of harm from most medical interventions” and then
“distorted information from medical staff to support her views.” The flu vaccination was
not a contributor to this process in any meaningful way (only “in her imagination”). (Id.)

In his second report, Dr. Dimsdale discussed the concept of precipitating factors
in greater detail. (Ex. E.) Dr. Dimsdale explains that a “precipitating factor” is defined
by the APA Dictionary of Psychology as a “particular factor, sometimes a traumatic or

33
stressful experience, that is the immediate cause of a mental or physical disorder. A
single precipitating event may turn a latent condition into the manifest form of the
disorder.” (Id. at 1.) However, he identifies Dr. LaFrance’s opinion – that the
vaccination was a precipitant “because it was uniquely stressful to her, given her
predisposing and perpetuating factors” – as problematic because it is an example of a
non-falsifiable contention, which is inherently unscientific. 16 (Id. at 2.) Dr. Dimsdale
explains that this problem requires researchers to weigh various stressful events
differently. In that regard, the most commonly used tool for measuring stress is a rating
scale created by Holmes and Rahe. (Id. (citing Thomas H. Holmes & Richard H. Rahe,
The Social Readjustment Rating Scale, 11 J. PSYCHOSOMATIC RES. 213 (1967) (Ex. E-
1)).) “With such criteria, one is on firmer ground testing whether a stressful precipitant
occurred.” (Id.) Based on the resulting research, Dr. Dimsdale asserts that “[t]he case
for a precipitating stressor is strongest when it is an unusual and severe event (e.g.
death of a spouse). . . . A flu shot voluntarily sought by the patient is not a major
stressful life event.” (Id.)

Upon review of the papers cited by Dr. LaFrance, Dr. Dimsdale questions their
relevance, noting that they examined non-epileptic seizures (Exs. 37, 42), head trauma
(Ex. 43), pain in children (Ex. 41), PTSD in firefighters (Ex. 40), chronic fatigue
syndrome (Ex. 39), bus accidents (Ex. 38), and insomnia (Ex. 36). (Ex. E, pp. 3-4.)
Further, he stresses that these papers do not strongly support the importance of
stressful precipitating events. The studies involving insomnia and PTSD in firefighters
in particular appear to have disclaimed any finding that precipitating events were an
important variable. (Id.) According to Dr. Dimsdale’s reading of the WHO Causality
Assessment cited by Dr. LaFrance, the WHO would not causally attribute petitioner’s
condition to her vaccination precisely because she was already suffering a somatic
symptom disorder prior to vaccination. (Id. at 4.)

V. Analysis

As explained above, the test for determining whether a vaccine has significantly
aggravated a pre-existing condition is the six-part Loving test. In this case, I will first
address general causation under Loving prong four – petitioner’s medical theory
explaining how a vaccine can in general aggravate the condition at issue. Under that
analysis, although I recognize that functional symptoms occurring post-vaccination are a
reported phenomenon, I find that petitioner has not preponderantly established that a
vaccine can significantly aggravate a somatic symptom disorder. This could have been
the end of the analysis; however, it is also important to observe that, even if accepting
petitioner’s theory arguendo, there would still be good reason to doubt that petitioner’s
own vaccination aggravated her condition based on her own clinical history. Turning to
Loving prongs one through three, I explain why the facts of this case do not
preponderantly support the assertion that what petitioner experienced was any
aggravation of her somatic symptom disorder. Under Loving prong five, I further explain
why, even though petitioner attributed her somatic complaints to her vaccination,

16 To be clear, Dr. Dimsdale identifies this as a known, fundamental issue in the field of stress research,

not a specific criticism of Dr. LaFrance. (Ex. E, p. 2.)

34
petitioner has not demonstrated a logical sequence of cause and effect implicating her
vaccination as the cause of those complaints. Finally, under Loving prong six, I
recognize that, had petitioner’s expert been persuasive regarding the preceding five
analytic prongs, the onset of petitioner’s post-vaccination somatic complaints in this
case is consistent with what her expert theorized.

a. Loving prong four

Petitioner’s burden under the first Althen prong/fourth Loving prong is to provide,
by preponderant evidence, “a medical theory causally connecting the vaccination and
the injury.” Althen, 418 F.3d at 1278. Such a theory must only be “legally probable, not
medically or scientifically certain.” Knudsen, 35 F.3d at 548-49. Moreover, scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the
laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant
evidence standard.” Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1380 (Fed. Cir. 2009). However, to satisfy this prong, petitioner’s theory
must be based on a “sound and reliable medical or scientific explanation.” Knudsen, 35
F.3d at 548; Boatmon, 941 F.3d at 1359. Petitioner’s burden under Loving prong four
varies from her burden under Althen prong one in that a significant aggravation claim
requires petitioner only to show that the vaccine at issue can worsen the condition at
issue, rather than being its cause. Sharpe v. Sec’y of Health & Human Servs., 964 F.3d
1072, 1083 (Fed. Cir. 2020) (explaining that “[u]nder Loving prong 4, a petitioner need
only provide ‘a medical theory causally connecting [petitioner]’s significantly worsened
condition to the vaccination.’”).

Under the DSM-V, “somatic symptom and related disorders” are a category of
disorders that involve prominent somatic symptoms that cause significant distress and
impairment. (AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL
DISORDERS (5th ed. 2013) [hereinafter DSM-V] (Ex. 20, p. 1).) This categorization
replaced the diagnosis of “somatoform disorder” from the DSM-IV. (Id.) “Somatic
symptom disorder” is the primary disorder under this category of disorders. Others
include conversion disorders and pseudocyesis. (Id.) In addition to better clarifying the
conditions, the DSM-V sought to reduce the focus on unexplained medical symptoms.
In particular, somatic symptom disorders may or may not accompany diagnosed
medical disorders. (Id.) However, whereas unexplained symptoms still remain a key
characteristic of conversion disorders and pseudocyesis, somatic symptom disorder is
characterized by distressing somatic symptoms with abnormal thoughts, feelings, and
behaviors in response to these symptoms, rather than by whether the symptoms are
medically unexplained. (Id.)

In this case, petitioner has not alleged that any of her somatic symptoms were
vaccine caused in themselves. (ECF No. 77, p. 1.) Instead, petitioner argues that the
fact of the vaccination aggravated her underlying psychological condition, i.e., acted
upon petitioner’s pre-existing somatic symptom disorder to trigger the attendant

35
abnormal thoughts and behaviors in response to symptoms. 17 (ECF No. 69, p. 43.) In
order to explain how an event such as vaccination could be a triggering or precipitating
event in the context of an ongoing somatic symptom disorder, Dr. LaFrance cites the
fear avoidance model. According to Dr. LaFrance, this model supports the “3Ps” –
predisposing, precipitating, and perpetuating factors – as combining to cause such
disorders. However, based on my review of the literature that has been filed and the
competing expert opinions, I find that Dr. Dimsdale is more persuasive in opining that,
while valid as a heuristic, the “3Ps” do not establish precipitating factors as causes of
somatic symptom disorders.

Although predisposing and perpetuating factors are important, the literature
explaining somatic symptom disorders does not as a whole implicate triggering or
precipitating events in the course of disorder. (DSM-V, supra, at Ex. 20, pp. 1-5; Lesley
A. Allen & Robert L. Woolfolk, Cognitive Behavioral Therapy for Somatoform Disorders,
33 PSYCHIATRIC CLINICS N. AM. 579 (2010) (Ex. 24).) Somatic symptom disorders can
arise spontaneously, and their causes can remain obscure, though they have high rates
of comorbidity with anxiety and depressive disorders. (DSM-V, supra, at Ex. 20, pp. 1,
5.) While some somatic symptom disorder patients do experience “exacerbations” of
their presenting symptoms when new interventions occur, this is part of the overall
pattern of such patients finding that high levels of medical care utilization do not
alleviate the symptoms. (Id. at 3.) In fact, somatic symptom disorder patients are at
increased risk of iatrogenic illness due to disproportionate use and misuse of health
care services. (Allen & Woolfolk, supra, at Ex. 24, p. 3.) By contrast, recognized
“course modifiers” of the somatic symptom disorder itself focus on demographic
features, history of abuse or chronic physical or psychologic illness, social stress,
reinforcing social factors, and cognitive factors, but not specific triggering events.
(DSM-V, supra, at Ex. 20, p. 4.) Instead, somatic symptom disorders involve ongoing
anxiety regarding one’s health that leads to a persistent and distressing focus on
somatic symptoms. (Id. at 3.) The disproportionate focus on somatic symptoms, rather
than the underlying reason for the somatic symptoms, is the primary feature of the
disorder. The patient may or may not attribute their somatic symptoms to some other
aspect of their lives and the symptoms may be normal bodily sensations. (Id. at 2.)

Consistent with this understanding of somatic symptom disorders, Dr. Dimsdale
persuasively opines that, even as the DSM-V has moved away from terms such as
hypochondria, somatic symptom disorders fundamentally remain a condition of ongoing
health anxiety. (Ex. A, pp. 30, 32-33.) In that context, he opines that the underlying
anxiety and c

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10734573. Public record. Not legal advice.