Valdez v. Secretary of Health and Human Services

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,

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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 catastrophizing by the patient is what explains the course of the condition.

(Id.) As the literature cited by Dr. LaFrance similarly summarizes it: “A distinctive

17 Temporary discomfort, whether in the form of arm soreness or more generalized constitutional

symptoms, is not unusual following vaccination. However, it should be noted that, because somatic

symptoms do not necessarily have to be medically unexplained to be implicated within a somatic

symptom disorder (DSM-V, supra, at Ex. 20, p. 1), it is immaterial whether petitioner’s initial report of

weakness and headache the day after vaccination could plausibly have represented a transient vaccine

reaction. The overall relationship between petitioner’s vaccination and her somatic symptom disorder as

discussed by the experts and throughout this decision is the same regardless of whether any of her initial

symptoms might be attributed to her vaccination.

36

characteristic of many individuals with somatic symptom disorder is not the somatic

symptoms per se, but instead the way they present and interpret them.” (DSM-V,

supra, at Ex. 20, p. 1.) Dr. LaFrance’s focus on cognitive therapy as the determinant of

petitioner’s prognosis is also consistent with this understanding. (Ex. 17, p. 34.) That

is, given this petitioner’s own fluctuating history, Dr. LaFrance implicitly recognizes that

the outward presentation of somatic symptoms does not neatly correlate with the

presence of the disorder. Rather, “[v]ariations in symptom presentation are likely the

result of the interaction of multiple factors within cultural contexts that affect how

individuals identify and classify bodily sensations, perceive illness, and seek medical

attention for them.” (DSM-V, supra, at Ex. 20, p. 1.) It is the natural course for these

types of conditions for symptoms to wax and wane and for new unexplained symptoms

to arise over time. (Allen & Woolfolk, supra, at Ex. 24, p. 2.)

While the “3Ps” concept is a valid framework for understanding the various

factors involved in some psychologic conditions, Dr. LaFrance’s application of it as a

causal concept to explain vaccine-aggravated somatic symptom disorder is weakly

supported at best. Citing Vlaeyen et al., Dr. LaFrance grounds his reliance on the 3Ps

in the fear-avoidance model, which was first explored with respect to fear of pain or

reinjury in those suffering chronic musculoskeletal pain. However, the paper he cites

regarding avoidance of chronic pain supports Dr. Dimsdale’s explanation of anxiety-

driven catastrophizing while also cautioning against assuming that precipitating events

are causal. The authors explain:

Several clinical disorders, such as hypochondriasis, are assumed to be

reflective of catastrophizing cognitions in combination with a strong internal

focus. A 3rd explanation could be that catastrophizing cognitions trigger

unnecessary sympathetic arousal which results in the subjective feeling of

anxiety. Of course, positive correlations may not be confused with causal

effects. Catastrophizing can lead to increased fear, but the opposite might

be true as well. Catastrophizing can also be part of the cognitive responses

associated with fear of movement/(re)injury, or both may be related to a 3rd

variable (e.g., a traumatic experience).

(Vlaeyen et al., supra, at Ex. 21, p. 7 (emphasis added) (internal citations omitted).)

Additionally, as Dr. Dimsdale points out, other studies cited by Dr. LaFrance

likewise do not support precipitating events as causal. (Ex. E, pp. 3-4.) Specifically,

Ellis et al. set out to examine whether the 3Ps concept was applicable to insomnia.

(Ellis et al., supra, at Ex. 36.) Although they found that anxiety scores were higher

among those with insomnia, there was no difference between insomnia patients and

controls when applying a “Life Events Scale” to assess prior life experiences. (Id. at 8.)

This appears to be more consistent with the above discussed understanding of somatic

symptom disorders as broadly anxiety-driven than it is with Dr. LaFrance’s theory of

causation. McFarlane set out to examine the role of the 3Ps by following firefighters

who had “extreme exposure” to a bushfire disaster. (Alexander C. McFarlane, The

Aetiology of Post-Traumatic Morbidity: Predisposing, Precipitating and Perpetuating

37

Factors, 154 BRIT. J. PSYCHIATRY 221 (1989) (Ex. 40, p. 1).) The study found, contrary

to its hypothesis, that “[n]euroticism and a past history of treatment for a psychological

disorder were better predictors of post-traumatic morbidity than the degree of exposure

to the disaster or the losses sustained. These results raise doubts about the postulated

central aetiological role a traumatic event plays in the onset of morbidity.” (Id.) Racine

et al. examined the 3Ps with respect to anticipatory distress in children facing painful

medical procedures. (Racine et al., supra, at Ex. 41.) The study identified two types of

precipitating event: prior painful events and prior childhood behaviors. (Id. at 10.)

However, the authors distinguished prior injections from other prior painful events. They

noted that studies have shown a negative relationship between routine medical

injections (such as insulin or immunotherapy) and anticipatory distress. (Id. at 18.)

It must also be noted that much of the literature Dr. LaFrance has cited is not

directly on point. For example, although Dr. LaFrance has submitted a paper that

identifies anxiety as frequently comorbid to chronic fatigue syndrome, that paper does

not present chronic fatigue syndrome as a somatic symptom disorder. (Lievesley et al.,

supra, at Ex. 39.) He also cites literature discussing precipitating factors relative to

head trauma (Ex. 43), PTSD in firefighters (Ex. 40), and a bus accident (Ex. 38).

However, citing the Holmes and Rahe scale for measuring stressful events, Dr.

Dimsdale explains that the case for labeling something as a precipitating factor is

strongest when the event is unusual or severe. (Ex. E, p. 2.) Given that context, it is

not readily apparent that observations related to trauma from bush firefighting, a bus

accident, or head trauma, are informative of what occurs in the circumstance of a

routine vaccination. Although Dr. LaFrance maintains that minor life events can be

stressors under the Holmes and Rahe scale, he does not dispute the validity of the

Holmes and Rahe scale or its relative ranking of differing stressful events. (Ex. 45, p.

2.) To the extent Dr. LaFrance contends that minor life events “can be stressors to

specific people” (Id.), this caveat still tends to point to the features of the underlying

somatic symptom disorder, rather than the nature of the purported triggering event, as

the driving causal force that explains why a given individual will idiosyncratically interact

with the minor event as a stressor.

Perhaps the most prominent example Dr. LaFrance cites for reliance on the 3Ps

is non-epileptic seizures. (Ex. 17, p. 33 (citing LaFrance & Bjønæs, supra, at Ex. 22;

LaFrance & Devisnky, supra, at Ex. 23).) In fact, Dr. LaFrance cites literature

suggesting that non-epileptic seizures have been documented as occurring post-

vaccination. (WORLD HEALTH ORG., supra, at Ex. 47, p. 62-63; Butler et al., supra, at Ex.

54, pp. 5-7.) Importantly, however, Dr. LaFrance acknowledges that non-epileptic

seizures are conversion disorders. (Ex. 45, p. 2.) Dr. LaFrance suggests that, because

conversion disorders are a form of somatic symptom disorder, they are merely

“variations on a theme.” (Id.) But this is not persuasive because the literature he has

cited identifies critical distinctions between conversion disorders and somatic symptom

disorders. First, “[t]he excessive thoughts, feelings, and behaviors characterizing

somatic symptom disorder are often absent in conversion disorder.” (DSM-V, supra, at

Ex. 20, p. 13.) Second, it is specifically explained under the DSM-V, in contrast to

somatic symptom disorder, that in conversion disorders “[o]nset may be associated with

38

stress or trauma, either psychological or physical in nature. The potential etiological

relevance of this stress or trauma may be suggested by a close temporal relationship.”

(Id.) Third and relatedly, conversion disorders are known for having an acute

presentation whereas somatic symptom disorders are generally chronic. (Allen &

Woolfolk, supra, at Ex. 24, p. 4.) Accordingly, it is not clear that the phenomenon

observed by this literature is generalizable to somatic symptom disorder. There

appears to be a stronger basis for associating conversation disorders to specific

stressors or triggers.

The literature cited by Dr. LaFrance does seem to support the proposition that

post-vaccination conversion disorders are a recognized phenomenon in at least some

circumstances. 18 (WORLD HEALTH ORG., supra, at Ex. 47, pp. 62-63; Butler et al., supra,

at Ex. 54, pp. 5-7; Ryu & Baik, supra, at Ex. 48; Lin et al., supra, at Ex. 49; Ercoli et al.,

supra, at Ex. 52.) In that regard, Dr. LaFrance points out that the World Health

Organization has concluded that immunization stress related responses – or ISRRs –

are among adverse events that have a “consistent causal association to immunization.”

(WORLD HEALTH ORG., supra, at Ex. 47, p. 59.) The WHO defines ISRRs as “[adverse

events following immunization] arising from anxiety about the immunization.” (Id. at 16.)

According to Dr. Dimsdale, however, a close reading of the WHO methodology for

assessing causality distinguishes between acute stress-related responses to

immunization (such as vasovagal syncope, i.e. fainting) on the one hand and anxiety-

related dissociative neurological symptoms on the other hand. (Ex. E, p. 4; WORLD

HEALTH ORG., supra, at Ex. 47, pp. 62-63.) In contrast to the former, the latter is

specifically noted to have no apparent physiologic basis. 19 (WORLD HEALTH ORG.,

supra, at Ex. 47, pp. 62-63.) In either event, although the WHO categorizes ISRRs as

consistently associated with immunization, nothing in the accompanying discussion

identifies the vaccination itself as causal. (WORLD HEALTH ORG., supra, at Ex. 47, pp.

62-63.) Instead, the WHO identifies stress – which may involve biological factors

combined with psychological factors and vulnerabilities within the specific social context

– as causal. (Id. at 44.) Even to the extent the WHO acknowledges “triggering”

factors, it characterizes the factors that may be triggering or may shape symptom

manifestation as involving the “situations, circumstances” that surround the vaccination

rather than the vaccination itself. (Id. at 63.) Thus, for example, these phenomena

18 Because I find this literature to be distinguishable from the circumstances presented by this case, my

analysis is limited to acknowledging that the cited literature does identify instances of post-vaccination

functional neurologic disorders as Dr. LaFrance asserts. I do not reach the question of whether the

literature is persuasive in presenting these observed disorders as vaccine caused.

19 The WHO’s identification of acute, transient physical stress response as the underlying cause of

vasovagal syncopal reactions is consistent with the Vaccine Injury Table for this program, which includes

vasovagal syncope as a Table Injury. (WORLD HEALTH ORG., supra, at Ex. 47, p. 62; 42 C.F.R. §

100.3(a).) The WHO also indicates that “dissociative neurological symptom reaction,” including non-

epileptic seizures and weakness or gait difficulties, can arise post-vaccination. (WORLD HEALTH ORG.,

supra, at Ex. 47, pp. 62-63.) Consistent with that, petitioner has filed several publications observing post-

vaccination functional neurologic disorders, primarily case reports involving temporary gait abnormalities

in children. (Butler et al., supra, at Ex. 54, Ryu & Baik, supra, at Ex. 48, Lin et al., supra, at Ex. 49, Ercoli

et al., supra, at Ex. 52.) However, the WHO assessment in particular focuses on non-epileptic seizures,

which, as discussed above, Dr. LaFrance has identified as a form of conversion disorder.

39

often arise in the context of mass immunization. In that context, the spread of the

condition within the immunized population is explained by mass psychogenic illness due

to witnessing others having what are perceived to be vaccine reactions, rather than

one’s own initial physiologic response to vaccination. (Id. at 44-45; Butler et al., supra,

at Ex. 54, p. 6.) Ultimately, because the WHO methodology for assessing causality in a

given case requires considering, among other things, pre-existing illness, and because

the WHO focuses causality on the factors affecting stress and anxiety, Dr. Dimsdale is

persuasive in observing that the WHO causal assessment does not readily implicate a

vaccine as the cause of symptoms otherwise attributable to the anxiety related to an

ongoing somatic symptom disorder as opposed to the type of de novo conversion

disorder cited within the publication. (Butler et al., supra, at Ex. 54, p. 6; see also

WORLD HEALTH ORG., supra, at Ex. 47, pp. 25, 36 tbl.1.)

Thus, for all of the reasons discussed above, petitioner has not presented a

preponderantly supported theory demonstrating that a vaccination can be a substantial

contributing factor in the significant aggravation of an ongoing somatic symptom

disorder. Therefore, petitioner has failed to meet her burden of proof under Loving

prong four.

b. Loving prongs one through three

Under the Vaccine Act, a “significant aggravation” of a condition is “any change

for the worse in a preexisting condition which results in markedly greater disability, pain,

or illness accompanied by substantial deterioration of health.” § 300aa-33(4). In order

to assess when this has occurred, the first three Loving prongs examine (1) the

vaccinee’s condition prior to the administration of the vaccine and (2) the vaccinee’s

current condition, and then (3) assess whether a comparison of the pre- and post-

vaccination conditions constitutes a “significant aggravation” of the condition. W.C., 704

F.3d at 1357. Although petitioner need not prove the expected outcome of her pre-

vaccination condition or that her post-vaccination condition is worse than the expected

outcome, petitioner still must show that her post-vaccination condition was affected by

his vaccination. Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1381 (Fed.

Cir. 2012); Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1082 (Fed. Cir.

2020).

i. Loving prong one

Regarding Loving prong one, both parties’ experts agree that petitioner suffered

an ongoing course of somatic symptom disorder first diagnosed in 2006. (Ex. 17, p. 32;

Ex. A, p. 29.) The experts further agree that, by the time of the vaccination at issue,

petitioner had an established pattern of misattributing symptoms to medical events and

procedures. (Ex. 34, p. 3; Ex. A, p. 31.)

Although Dr. LaFrance seeks to suggest petitioner was essentially free of

relevant complaints in the year preceding her vaccination, he focuses only on reported

symptoms of shooting pains or gait instability. (Ex. 17, pp. 32-33.) Overall, Dr.

40

Dimsdale persuasively opines that, especially in the absence of any psychosocial

evaluation, petitioner’s medical records are inadequate to conclude that she was

experiencing any relief from her somatic symptom disorder prior to the vaccination at

issue. (Ex. A, p. 32.) While Dr. LaFrance urges that petitioner experienced periods of

seeming recovery (Ex. 17, p. 33), this is not incompatible with the known fluctuating

presentation of somatic symptom disorders broadly (DSM-V, supra, at Ex. 20, p. 3;

Allen & Woolfolk, supra, at Ex. 24, p. 2). However, it is inconsistent with Dr. LaFrance’s

explanation of petitioner’s prognosis. Despite fluctuations, Dr. LaFrance opined that

petitioner’s condition would not actually improve without treatment, which he agreed she

had never received. (Ex. 17, p. 34.)

Thus, the evidence preponderates in favor of a finding under Loving prong one

that prior to vaccination petitioner had been experiencing a nine-year history of somatic

symptom disorder that included periodic episodes of misattributing somatic symptoms to

unrelated medical events and procedures. Although petitioner’s medical records reflect

less activity vis-à-vis potential somatoform symptoms just prior to the time of her

vaccination, the evidence does not preponderant in favor of a finding that she was

within a period of recovery from her somatic symptom disorder at the time of

vaccination.

ii. Loving prong two

Regarding Loving prong two, there is no dispute between the experts that

petitioner began complaining of new symptoms post-vaccination that she misattributed

to her flu vaccine. (Ex. 34, p. 3; Ex. A, p. 32.) However, these were subjective

complaints, and Dr. Dimsdale is persuasive in asserting that petitioner was not a reliable

historian. (Ex. A, pp. 31, 34; Ex. E, p. 2.) Moreover, there is no dispute that these

reported symptoms lacked any organic basis and that they were a consequence of her

ongoing somatic symptom disorder. (Ex. 34, pp. 3-4; Ex. 45, p. 2; Ex. A, p. 34; Ex. E, p.

2.) Although petitioner’s post-vaccination episode was more extensive than prior

episodes, her misattribution of symptoms to her flu vaccination was consistent with her

established prior pattern of misattribution.

iii. Loving prong three

Comparing petitioner’s pre- and post-vaccination conditions under Loving prong

three, Dr. LaFrance in effect concludes that because petitioner experienced her most

extensive episode of somatic symptoms and misattribution post-vaccination, her

condition necessarily had worsened following the vaccination. (Ex. 17, p. 33.) He

specifically opined that petitioner’s post-vaccination presentation was not the natural

course of her condition. (Id.) Dr. Dimsdale disagrees. He explains that petitioner’s

reporting of symptoms post-vaccination was never accurate. (Ex. A, p. 34.)

Accordingly, these reported symptoms do not in themselves represent a significant

aggravation of the somatic symptom disorder. Dr. Dimsdale opines that what petitioner

experienced post-vaccination was one episode of somatic symptom misattribution

consistent with her overall history of such episodes. (Ex. E, p. 2.) He explains that

41

somatic symptom disorders do generally have a fluctuating course as petitioner has

demonstrated. (Id.; Ex. A, p. 32.) I am persuaded by Dr. Dimsdale’s opinion.

Petitioner is clear in her motion for a ruling on the record that the condition she

contends was aggravated was the somatic symptom disorder itself. (ECF No. 69, p.

43.) “Petitioner does not claim that her ‘subjective and somatic complaints regarding

her flu vaccination’ are her vaccine injury . . . .” (ECF No. 77, p. 1.) In that regard, Dr.

LaFrance also confirms in his reports that he is not opining that the flu vaccine per se

caused petitioner’s reported symptoms. (Ex. 34, p. 1; Ex. 45, p. 2.) However, in

arguing she has satisfied Loving prong three, petitioner focuses on the fact that there

was a change in the frequency and severity of the subjective symptoms she reported

post-vaccination. (ECF No. 69, pp. 55-56.) Specifically, petitioner argues that the

worsening of her condition is evidenced

among other things, [by] her increased and disproportionate perseveration

on her somatic symptoms and the flu vaccine being a cause as a substantial

factor, increased doctor visits, increased embellishment of health history,

more severe and debilitating reported somatic symptoms, changes in

behavior (e.g., climbing stairs by crawling backwards or inability to stand

long enough to cook) that comport with reported increases in somatic

symptom severity and accompanying impairment, and increased anxiety

about her health and symptoms.

(Ex. 77, p. 3.) Yet, petitioner has not substantiated that these changes in presentation

indicate petitioner’s somatic symptom disorder was worse.

Although somatic symptoms are obviously a key feature of somatic symptom

disorder, unexplained symptoms are not sufficient to make a diagnosis of somatic

symptom disorder. (DSM-V, supra, at Ex. 20, p. 2.) As explained under Loving prong

four,

[a] distinctive characteristic of many individuals with somatic symptom

disorder is not the somatic symptoms per se, but instead the way they

present and interpret them. Incorporating affective, cognitive, and

behavioral components into the criteria for somatic symptom disorder

provides a more comprehensive and accurate reflection of the true clinical

picture than can be achieved by assessing the somatic complaints alone.

(Id. at 1.) There is some evidence to suggest that the number of somatic symptoms

reported correlates positively to the degree of psychological distress being experienced

(Allen & Woolfolk, supra, at Ex. 24, p. 3); however, “[t]he course of somatization

disorder tends to be characterized by symptoms that wax and wane, remitting only to

return later or be replaced by new unexplained physical symptoms. Thus, somatization

disorder is a chronic, polysymptomatic disorder whose requisite symptoms need not be

manifested concurrently” (Id. at 2). Therefore, petitioner has not substantiated that the

mere fact that she was experiencing an episode of somatic symptoms that she actively

42

misattributed to her flu vaccine indicates that the mental state underlying her somatic

symptom disorder had actually changed or worsened.

Petitioner’s reporting of subjective complaints did increase post-vaccination.

However, even while accepting that somatic complaints represent genuine suffering,

petitioner’s limitations as a historian indicate that these complaints were not necessarily

reliable, as Dr. Dimsdale explains. 20 Moreover, the specific pattern of her complaints is

not explained by her disorder alone. Dr. Dimsdale has explained that a feature of

petitioner’s condition is active resistance to confounding medical information. (Ex. A,

pp. 31-33.) Aspects of her clinical history, such as increased doctor visits and

embellishment of her history, may speak to the level of resistance she received while

interacting with her treaters as much or more so than the fundamentals of her condition.

(Accord Allen & Woolfolk, supra, at Ex. 24, p. 3 (explaining that “[t]hese patients

disproportionately use and misuse health care services. When standard diagnostic

evaluations fail to uncover organic pathology, patients with somatization tend to seek

additional medical procedures, often from several different physicians.”).) And, in any

event, somatic symptom disorders are known to fluctuate. (DSM-V, supra, at Ex. 20, p.

3; Allen & Woolfolk, supra, at Ex. 24, p. 2.) Overall, petitioner’s post-vaccination

behavior was consistent with the previously established pattern of her own somatic

symptom disorder. That is, her pattern of symptom presentation and attribution both

before and after vaccination demonstrates a consistent way of interpretating her

symptoms within the context of a somatic symptom disorder. Therefore, Dr. Dimsdale is

persuasive in opining that what petitioner has experienced is a continuous yearslong

course of a severe somatic symptom disorder that was ongoing both before and after

vaccination. (Ex. A, p. 34; Ex. E, p. 2.) Consistent with that opinion, Dr. LaFrance

likewise noted that petitioner was first diagnosed with somatic symptom disorder in

2006, had multiple subsequent episodes, and would not have improved without targeted

psychotherapy treatment, which he acknowledged she had not received. (Ex. 17, pp.

32-34.)

For all these reasons, even if petitioner had successfully demonstrated that a

stressful trigger event can theoretically aggravate a somatic symptom disorder,

petitioner has not demonstrated that she herself suffered a significant aggravation of her

somatic symptom disorder. This conclusion is consistent with Locane, 685 F.3d 1375. I

am not requiring petitioner to demonstrate that the actual course of her condition is

worse than otherwise would have been expected. See Sharpe, 964 F.3d 1072. Nor am

I requiring petitioner to prove that her post-vaccination condition is not explained by her

preexisting condition. Id. Rather, I have concluded that petitioner has failed to

20 In her reply, petitioner argues that it is irrelevant whether her complaints were credible because

increased embellishment of her medical history is part of the basis for concluding that her somatic

symptom disorder had worsened. (ECF No. 77, pp. 3-4.) This is not an entirely unreasonable point, but it

ultimately presents a conundrum. While embellishment of her medical history may be consistent with her

somatic symptom disorder, it is still admitted embellishment that makes it more difficult to accept the

medical records at face value with respect to any subjective symptom. Because petitioner bears the

burden of proof regarding the factual question of whether her condition worsened, and because no

organic cause is available to correlate or confirm her reported symptoms, the consequences of this

conundrum fall on petitioner to resolve, if resolution is even possible.

43

distinguish her post-vaccination episode of somatic symptom complaints from her

overall pattern of such episodes, which otherwise constitute the natural, fluctuating

course of her ongoing somatic symptom disorder. In other words, the outward

presentation of petitioner’s complaints of somatic symptoms is not coextensive with her

psychologic state and petitioner has not demonstrated that her psychological condition

– which is the condition that underlies her claim – actually worsened post-vaccination.

Although this is a distinct analysis from the analysis under Loving prong five, the Loving

prong five analysis also further explains why petitioner’s vaccination did not affect her

condition.

c. Loving prong five

The second Althen prong/fifth Loving prong requires proof of a logical sequence

of cause and effect showing that the vaccine was the reason for the injury, usually

supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at

1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1317, 1326; Grant, 956

F.2d at 1148. However, medical records and/or statements of a treating physician do

not per se bind the special master to adopt the conclusions of such an individual, even if

they must be considered and carefully evaluated. See 42 U.S.C. §300aa-13(b)(1)

(providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or

summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health

& Human Servs., 88 Fed. Cl. 706, 745 n.67 (2009) (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”). The special master is required to

consider all the relevant evidence of record, draw plausible inferences and articulate a

rational basis for the decision. Winkler v. Sec’y of Health & Human Servs., 88 F.4th

958, 963 (Fed. Cir. 2023) (citing Hines, 940 F.2d at 1528).

Petitioner’s medical records reflect that her treating physicians largely focused on

addressing petitioner’s assertions of vaccine-causation in the context of whether her

symptoms had any organic basis. To the extent some of the treating physicians did

recognize that petitioner’s presentation was consistent with a somatic symptom

disorder, they did not opine that petitioner’s condition was caused by her vaccination

despite acknowledging that she attributed her symptoms to the vaccination. That

leaves petitioner’s claim dependent on the opinion of her expert. Dr. LaFrance contends

that petitioner experienced her vaccination as a stressful event that triggered her

underlying vulnerability to cause her to experience psychosomatic effects of the

vaccination. (Ex. 34, pp. 1-4.) This line of reasoning contemplates that petitioner’s

somatic symptom disorder had been in some form of stasis, that her vaccination then

produced a new anxiety, and that this anxiety led to her increased symptoms. As a

threshold matter, this premise is not well supported as a matter of clinical history for the

reasons discussed under Loving prongs one through three, above. Furthermore, and

consistent with the discussion of the nature of somatic symptoms disorders under

Loving prong four above, Dr. Dimsdale is also persuasive in essentially indicating as a

further matter that Dr. LaFrance has the sequence of cause and effect backward.

44

Dr. LaFrance suggests that a vaccination could theoretically be anxiety inducing

and that this anxiety could in turn result in somatic symptoms. However, there is no

evidence to suggest that this is what actually happened in this case. Nothing in the

record suggests that petitioner suffered any particular apprehension or anxiety

regarding her vaccination. Rather, petitioner received the vaccination voluntarily and,

as Dr. Dimsdale suggested, vaccination would be exceptionally low on the Holmes and

Rahe scale of stressful events. (Ex. A, pp. 33-34; Ex. E, p. 2.) Nor, despite her ongoing

somatic symptom disorder, is there any evidence that petitioner had any prior vaccine

hesitancy. In fact, as respondent stresses, petitioner had a history of receiving

vaccinations without issues. (ECF No. 75, p. 45 (citing Ex. 2, p. 5).) Instead, the

medical records confirm that petitioner simply suffered a somatic symptom disorder and

general ongoing anxiety and depression, all of which were diagnosed pre-vaccination.

If anything, Dr. LaFrance suggests that the record reflects that petitioner’s ongoing

anxiety around the time of vaccination may have been related to a separate grievance

relating to a prior emergency department visit. (Ex. 17, p. 34.) Specifically, he identified

petitioner’s reported grievance against the emergency department noted in January of

2015 as a relevant course modifier that would weigh against any prognosis for

improvement in her somatic symptom disorder. (Id.)

Thus, rather than the vaccination being a precipitating event, it is more likely, as

Dr. Dimsdale explains, that the vaccine was merely a preceding event that then became

an object of petitioner’s fixation as a result of her somatic symptom disorder. (Ex. E, pp.

2, 4.) As previously explained, Dr. Dimsdale indicates that somatic symptom disorders

operate as anxiety disorders. (Ex. A, p. 33.) Although petitioner’s symptoms are real

despite lacking an organic cause, they are caused by her ongoing anxiety. (Id. at 33-

34.) Thus, according to Dr. Dimsdale, it is not that the flu vaccine caused anything, it is

that petitioner’s somatic symptom disorder caused her to fixate on the vaccination as a

perceived explanation for her somatic symptoms which, in turn, had been caused by her

underlying anxiety. (Id.) That is, to the extent there is any causal chain at all, the flu

vaccine is the end of the chain, not it’s beginning.

This reasoning is illustrated by petitioner’s prior established pattern of behavior.

For example, petitioner had a prior history of repeatedly attributing many symptoms to a

stroke. However, her physicians came to the conclusion that petitioner had never

actually suffered any stroke. Therefore, it would be impossible to assemble a sequence

of cause and effect that implicated a stroke as a cause of either petitioner’s symptoms

or her mental state. The idea of a stroke became an object of fixation as a

consequence of her condition; however, there was no stroke that could have served as

the beginning of any causal chain. There is no basis on this record for supposing that

any different dynamic applies to the fact of petitioner’s vaccination. Indeed, Dr.

LaFrance has himself cited literature confirming that anxiety and depression alone can

cause somatic symptoms and that somatic symptoms can also occur spontaneously.

(DSM-V, supra, at Ex. 20, p. 1.) Accordingly, it is patently not the case that petitioner’s

presentation requires an explanatory trigger.

45

For these reasons, petitioner has failed to preponderantly establish a logical

sequence of cause and effect suggesting that her flu vaccination significantly

aggravated her somatic symptom disorder.

d. Loving prong six

The third Althen prong/sixth Loving prong requires establishing a “proximate

temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d

at 1281. That term has been equated to the phrase “medically-acceptable temporal

relationship.” Id. A petitioner must offer “preponderant proof that the onset of

symptoms occurred within a timeframe for which, given the medical understanding of

the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y

of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for

what is a medically acceptable timeframe must also coincide with the theory of how the

relevant vaccine can cause an injury. Id.; Shapiro v. Sec’y of Health & Human Servs.,

101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d

per curiam, 503 Fed. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human

Servs., No. 11-355V, 2013 WL 3214877, at *26 (Fed. Cl. Spec. Mstr. May 30, 2013),

aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

Petitioner called her primary care provider the day after her vaccination to

complain about new symptoms of dizziness, headache, generalized weakness, and

fluctuating vision. (Ex. 2, p. 1696.) This timing is consistent with what Dr. LaFrance has

theorized. Specifically, the WHO causality assessment cited by Dr. LaFrance indicates

that ISRRs, including the non-epileptic seizures cited by Dr. LaFrance as an example of

a conversion disorder, can occur within hours to days of vaccination. (WORLD HEALTH

ORG., supra, at Ex. 47, pp. 62-63.) Dr. LaFrance also cited a paper featuring four case

reports of post-H1N1 vaccination psychogenic gait disorders that arose between hours

to 14 days post-vaccination. (Ryu & Baik, supra, at Ex. 48, p. 2 tbl.1.) However,

because petitioner has not met her burden of proof with respect to Loving prongs three,

four, or five, this is effectively immaterial. These preceding analyses establish that the

vaccination was merely a preceding, rather than precipitating, event.

Dr. LaFrance acknowledges that ascribing causation to a merely preceding event

would be a logical fallacy – post hoc ergo propter hoc. (Ex. 34, p. 1.) This is also

consistent with well-established program precedent. Veryzer v. Sec’y of Health &

Human Servs., 100 Fed. Cl. 344, 356 (2011) (explaining that a “temporal relationship

alone will not demonstrate the requisite causal link and that petitioner must posit a

medical theory causally connecting the vaccine and injury”), aff’d per curiam, 475 Fed.

App’x 765 (Fed. Cir. 2012); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355,

1364-65 (Fed. Cir. 2012) (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).

46

VI. Conclusion

I am mindful of the fact that petitioner’s condition is genuine and her suffering is

very real. Nothing in this decision is intended to minimize petitioner’s suffering or the

impact her condition has had on her life. However, for all the reasons discussed above,

I cannot conclude that petitioner has demonstrate

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