Autry v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 16-785V

Filed: July 19, 2024

Reissued for Public Availability: August 13, 2024

* * * * * * * * * * * * * * *

E.A., *

*

Petitioner, *

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

* * * * * * * * * * * * * * *

E.A., pro se.

Alexis B. Babcock, U.S. Dept. of Justice, Washington, DC, for respondent.

DECISION DISMISSING PETITION1

Roth, Special Master:

On June 30, 2016, E.A. (“petitioner”) filed a petition for compensation in the National

Vaccine Injury Compensation Program (“the Program”), 2 alleging that a varicella vaccination

administered on July 2, 2013 resulted in her development of seizure disorder, cerebral injury,

Major Neurocognitive Disorder, athetosis, chorea, and/or neurologic, psychiatric, and physical

impairments and other injuries that were “caused-in-fact” by the vaccination or resulted in

significant aggravation to petitioner’s previous seizure disorder, cerebral injury, Major

Neurocognitive Disorder, athetosis, chorea, and/or neurologic, psychiatric, and physical

impairment that were present to a lesser extent prior to vaccination. Petition, ECF No. 1.

On March 4, 2020, respondent filed his Motion to Dismiss “on the ground that petitioner

has failed to prove that her varicella vaccination was the cause-in-fact of any of her alleged

1

Because this Decision 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 Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),

petitioner had 14 days to identify and move to redact medical or other information, the disclosure of which would

constitute an unwarranted invasion of privacy. This Decision originally issued on July 19, 2024, and neither party

proposed redactions. Accordingly, this Decision is reissued in its original form for posting on the Court’s website.

2

The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat.

3755, codified as amended, 42 U.S.C. §§ 300aa-10 et seq. (2018) (hereinafter “Vaccine Act” or “the Act”). Hereafter,

individual section references will be to 42 U.S.C. § 300aa of the Act.

1

injuries.” Respondent’s Motion to Dismiss (“Resp. Motion”), ECF No. 61. Petitioner’s responses

and filings will be detailed in the procedural history below.

After carefully analyzing and weighing the evidence presented in this case in accordance

with the applicable legal standards, I find that petitioner has failed to submit sufficient proof of a

vaccine related injury. Therefore, her petition must be dismissed.

I. Procedural History

Petitioner was represented by counsel when the petition was filed on June 30, 2016.

Medical records, an affidavit of petitioner, and a statement of completion were filed on July 7,

2016. Petitioner’s Exhibits (“Pet. Ex.”) 1-14, ECF Nos. 6-8.

Following a status conference on August 3, 2016, additional medical records, letters, and

affidavits were filed. Pet. Ex. 15-35, ECF Nos. 11-16.

Respondent filed his Rule 4(c) Report on April 3, 2017, stating that the case was not

appropriate for compensation. ECF No. 20. Petitioner was ordered to file additional medical

records, which she did on June 20 and September 7, 2017. Pet. Ex. 36-37, ECF Nos. 22, 24.

On October 16, 2017, petitioner filed a status report, advising that her counsel intended to

withdraw and requested sixty days to “either obtain new counsel, dismiss the case, or otherwise

advise the Court that she intends to proceed pro se.” ECF No. 25.

Petitioner’s counsel then filed a Motion for Attorneys’ Fees and Expenses, a Motion for

Extension of Time to obtain new counsel, and a Motion to Withdraw, all of which were granted.

ECF Nos. 27, 29, 31-32, 34.

On April 9, 2018, petitioner filed a status report detailing a host of personal and family

struggles including illness of her mother (“the mother”), whom she claimed held Power of

Attorney for handling her case because of petitioner’s inability to do so. An additional ninety days

was requested to secure counsel, which was granted. ECF Nos. 38-41. Petitioner failed to comply

with the Court’s deadline and an Order to Show Cause issued on October 16, 2018. ECF No. 42.

This case was then plagued by missed deadlines, late requests for extensions of time,

explanatory status reports, letters filed by the mother, claims of unreceived mail from the Clerk’s

office and emails from Chambers, and filings of additional evidence. Finally, an Order for

respondent to file a Motion to Dismiss was issued. ECF Nos. 43-49, 51-57.

Respondent filed his Motion to Dismiss on March 4, 2020. Resp. Motion, ECF No. 61.

Thereafter, due to additional personal and family hardships and illnesses precluding the mother or

petitioner from responding to the Motion to Dismiss, the case was stayed from September 16, 2020

until November 16, 2020. Petitioner was then ordered to respond to the Motion to Dismiss by

March 1, 2021. ECF Nos. 71-73.

2

On March 1, 2021 petitioner filed an “expert opinion” from Dr. Lacayo, a “Response to

DOJ” with an attached “Rebuttal of Respondent’s Analysis” written by the mother, 3 along with

photographs of petitioner. Pet. Ex. 41-45, 51-54, 4 ECF No. 76-80.

On May 17, 2021, respondent filed an expert report and CV from Dr. Wiznitzer.

Respondent’s Exhibit (“Resp. Ex.”) A-B, ECF No. 82. Supporting literature was filed on May 24,

2021. Resp. Ex. A Tab 1-5, ECF No. 84.

Petitioner was ordered to file a response from her expert. The order explained that “If Dr.

Lacayo remains petitioner’s expert in this matter, petitioner must provide a copy of Dr. Wiznitzer’s

report to Dr. Lacayo for consideration and response. Any response filed by petitioner in response

to this Order and Dr. Wiznitzer’s report must be from Dr. Lacayo directly. Petitioner and/or

petitioner’s mother are not to respond to Dr. Wiznitzer’s report with their personal opinions or

disagreements with Dr. Wiznitzer’s report; only a response from Dr. Lacayo is appropriate.” ECF

No. 83 (emphasis added).

Despite clear instructions to the contrary, petitioner’s mother filed a status report on July

16, 2021, in which she took issue with the content of Dr. Wiznitzer’s opinions and his failure to

respond to petitioner’s “expert reports” or to Pet. Ex. 41-54, 5 which in part included the petitioner’s

response to the Motion to Dismiss, a medical history, flow sheet, immunology history and medical

theories expressed by petitioner’s mother, who named herself an expert being “a registered

professional nurse,” and scientific data and citations from public health authorities, “all meeting

the Althen standard.” ECF No. 85 at 2 (emphasis in original). She concluded that, since respondent

failed to respond to the foregoing, it would be premature to address Dr. Wiznitzer’s opinion. Id. at

3.

Petitioner was again ordered to file a response to Dr. Wiznitzer’s report from Dr. Lacayo

by October 18, 2021, along with any outstanding medical records she intended to file. ECF No.

86.

Petitioner failed to file anything further by the Court-ordered deadline and the record was

closed on November 2, 2021. ECF No. 87.

The Motion to Dismiss is ripe for ruling.

II. Factual Background

A. Petitioner’s Medical History

3

The mother “represented” petitioner in this case, despite her daughter being named the pro se petitioner. The mother

also provided most of petitioner’s medical history to providers even after petitioner reached adulthood. From the

records filed, it does not appear that petitioner has been declared incompetent or is incompetent. The mother

represented that she is a registered nurse (“RN”). See Pro Se Report.

4

In numbering the exhibits, petitioner skipped 46-50. She also filed two exhibits numbered 45.

5

In the status report, the mother listed the exhibits filed with the corresponding number of the exhibit. In her list, she

included Exhibits 46-50, none of which were filed into the record. See ECF No. 85.

3

In order to appreciate the conclusions reached in this matter, a detailed recital of

petitioner’s medical history must be included. Because this decision will be available to the public,

petitioner will be referred to as E.A. and her mother, who provided most of the information and

evidence, will be referred to only as “the mother”.

i. Medical History Pre-Vaccination

Petitioner was born on March 30, 1997. Pet. Ex. 2 at 5. She was adopted through a closed

adoption with little known about her family medical history. Pet. Ex. 15 at 7. By January 13, 1999,

she had received all necessary vaccines for her age without reported event. See generally Pet. Ex.

34; Pet. Ex. 15 at 11-12, 14; Pet. Ex. 16 at 3.

Petitioner had a complicated childhood medical and psychological history. Hearing testing

was conducted on May 19, 1999 at Cincinnati Children’s Hospital. The results were normal. Pet.

Ex. 33 at 27-28. In 2002, she underwent occupational therapy (“OT”) evaluation and demonstrated

sensory, tactile, texture, vibratory and localization disturbances, and numbness. She was five years

old and only recognized about 5 letters. Id. at 6-21. Her treatment focused on praxis difficulties,

sensory processing/modulation difficulties, postural control to promote fine motor skills, visual

perception, and oculomotor skills with home programming. Id. at 42.

From 2004 until June 2008, petitioner received pediatric care from Montgomery

Pediatrics. 6 She had learning issues and allergies and was homeschooled. Pet. Ex. 16 at 6. On

August 16, 2004, petitioner underwent another audiologic assessment at the University of Florida.

The mother reported petitioner to be easily distracted, inattentive to sounds with difficulty

localizing sounds, confused by directions/commands, reversed letters, and intolerant of loud

sounds since age 3. Pet. Ex. 18 at 3-6. The auditory evaluation revealed normal hearing sensitivity

bilaterally and “no clear pattern of auditory processing disorder.” Id. at 2, 7. The evaluation showed

difficulty in maintaining attention. Id. It was recommended that she be assessed for attention deficit

disorder (“ADD”). Id.

Petitioner underwent visual testing in Michigan on October 7, 2004 which showed deficits

in visual tracking and binocularity with visual sequential memory 20 months below average and

overall visual motor integration 15 months below average. Pet. Ex. 33 at 53. At an otolaryngology

evaluation on January 8, 2005 at Cincinnati Children’s Hospital, the mother reported that petitioner

had sensory integration and “visual and auditory processing disorder.” Id. at 38; but see Pet. Ex.

18 at 2, 7, testing showed no auditory processing disorder. The mother reported that,

“psychological testing by Dr. Paul Cates (Tennessee) revealed a significant deficit in left brain

function, learning disability, Attention Deficit Disorder with hyperactivity.” Pet. Ex. 33 at 53. At

an OT evaluation in February 2005, petitioner was noted to be a 7 year 11-month-old with

significant attention deficits, increased activity level, difficulties with bilateral coordination and

upper extremity speed/dexterity; difficulty with visual perception, motor tasks that required

balance, and motor planning skills, all of which were expected to impact her as she gets older. Id.

at 54.

6

The family moved often and to different states.

4

The mother filled out a Health Questionnaire at a December 20, 2005 medical visit,

documenting that “[s]ince the age of 2 many out of the norm things were noted…After much

testing [and] learning she is now managed on a very unique plan made just for her.” Pet. Ex. 15 at

7-8. The mother also reported that petitioner had an auditory and visual processing disorder,

dyslexia, ADD, multiple delays, and asthma. Id. at 8-9.

Petitioner received all childhood vaccinations without documented event. Pet. Ex. 16 at 3.

Petitioner received MMR vaccines on January 13, 1999 and June 18, 2002 and a varicella vaccine

on October 30, 2008. Pet. Ex. 15 at 3. The dates of these vaccination are specifically noted because

of the claims made by the mother years later regarding these vaccinations, which are detailed

below.

Petitioner underwent allergy testing on April 6, 2011 for a long history of allergies. Pet.

Ex. 17 at 7. The mother described petitioner as a sniffly child who was hyper and acted out when

younger. When they moved to Alabama in 2005, she could not breathe and went to the ER where

she was diagnosed with reactive airway disease and treated with albuterol. The trigger was

unknown. Id. The mother reported that petitioner had hives last summer and took Zyrtec and

Zantac with no hives since. Some days she had chest and throat problems and needed to take a

huge breath to feel like she gets full breaths. She occasionally had shortness of breath when she

sings. Skin testing was positive for dust mites, cats, dogs, and grass. Id. Current symptoms included

nasal congestion, mouth/throat swelling, feeling of chest tightness, shortness of breath, cough with

exercise, pneumonia/bronchitis, coughing spells with gagging, vomiting, and nausea. Id. She had

just completed 8th grade with As and Bs. The examination that day was normal. Id. The assessment

was allergic rhinitis, 7 history of chronic urticaria, 8 and shortness of breath. Id. at 8. Zyrtec, Zantac,

Albuterol puffs, and Singulair were recommended. Id.

ii. Medical History Post-Vaccination

There were no medical records filed between May 2011 and petitioner’s first visit in July

2013 9 with Groff Family Practice (“Groff”) in Georgia. Pet. Ex. 2 at 37-43. The mother claims

petitioner required no medical care between 2010 and July 2013. Pet. Ex. 35 at 5-6.

Petitioner was accompanied by her mother to her first visit at Groff on July 2, 2013. Pet.

Ex. 2 at 42. She was 16 years old. Id. She was noted to have been adopted and had a history of

asthma and allergies to dust mites and cats, cough with exertion and shortness of breath when

running. She was homeschooled. Id. at 43. Petitioner reported “wiggling of her fingers lately, and

her handwriting has apparently interfered with that.” Id. On examination, “she [had] a little bit of

motion in her hands when she [held] them out front. I don’t know if that’s a conversion reaction10

7

Rhinitis is inflammation of the mucous membrane of the nose. Dorland’s Illustrated Medical Dictionary 1613 (33rd

ed. 2019) [hereinafter “Dorland’s”].

8

Urticaria is a vascular reaction in the upper dermis, usually transient, consisting of localized edema caused by

dilatation and increased capillary permeability with wheals. Dorland’s 1981.

9

It appears that an appointment was scheduled at Groff for October 16, 2012 but was cancelled. Pet. Ex. 2 at 48.

10

Conversion disorder is a mental disorder characterized by conversion symptoms (loss or alteration of voluntary

motor or sensory functioning suggesting physical illness, such as seizures, paralysis, dyskinesia, anesthesia, blindness,

or aphonia) having no demonstrable physiologic basis and whose psychological basis is suggested by (1) exacerbation

of symptoms at times of psychological stress, (2) relief from tension or inner conflicts (primary gain) provided by the

5

or whether she’s getting athetosis 11 or developing Chorea.” 12 Id. She was assessed as generally

healthy. “She also has a history of this peculiar movement disorder which I think is reasonable to

have her go on and see the Neurologist.” Id. The mother expressed concern that petitioner was

having a reaction to Zantac because she complains she feels early satiety and fullness at times. Id.

at 43-44. Testing of stool antigen for H-Pylori was ordered. Id. at 44. Petitioner received the subject

varicella vaccine at this visit. Id. at 1, 36.

Three days later, on July 5, 2013, the mother presented petitioner to Clearview Regional

Medical Center Emergency Room, reporting that petitioner had a varicella vaccine 4 days ago, had

a sore throat this morning with swollen uvula, 13 and a scratchy throat last night. Pet. Ex. 3 at 2.

The chief complaint was noted as “Allergic Reaction-breathing difficulty.” Id. at 10. The medical

record documents, “no signs or symptoms of anaphylaxis were noted”, she was in “no apparent

distress”, and her “[a]irway was patent mildly swollen uvula Respiratory effort is even,

unlabored”. Id. at 2, 3. She did “not display signs of respiratory distress” and there was no shortness

of breath, cough, or wheezing. Id. at 8. A rapid strep test was positive, but a throat culture was

negative. She was administered Bicillin and Solu-Medrol by injection. Pet. Ex. 2 at 29-30; Pet. Ex.

3 at 11. The discharge diagnosis was pharyngitis and strep. Pet. Ex. 3 at 6.

The mother and petitioner returned to Groff on July 12, 2013 for follow up. The mother

reported that petitioner was seen in the ER for sore throat, trouble swallowing, and choking; “up

to that time, she’d been just kind of feeling vaguely ill for a couple of weeks.” Pet. Ex. 2 at 24. A

rapid strep test was positive, she received penicillin and steroids. She also had a “little headache

and a low grade fever”. Id. Examination that day revealed some exudate on the left side of her

throat, but the remainder of the exam was normal/negative. Id. “Persistent vague symptoms” were

also documented and since the rapid strep test was positive but strep culture was negative, it was

unclear whether she actually had strep. Blood work and a Mono Spot were ordered. The mother

asked for a referral to Dr. McKean for petitioner’s “chronic allergies”. Id. Lab results showed

mildly elevated monocytes 14 of 0.8 on a 0.1-0.7 range. Id. at 27. The Mono Spot test was negative.

Id. at 28.

The mother and petitioner presented to Dr. McKean on July 16, 2013, reporting a history

of asthma triggered by exercise, urticaria, and difficulty breathing when they moved to Alabama.

She previously tested positive for allergies to dust mites, cats, dogs, grass, and pollen. Pet. Ex. 2

at 18. She had been taking Xopenex, loratadine, and ranitidine. Id. Dr. McKean noted that

petitioner had Pressure Equalizing tubes placed at age 7. Id. at 19. The mother reported that

petitioner had received a varicella vaccine on July 2, 2013, followed by breathing difficulty,

symptoms, or (3) secondary gains (support, attention, avoidance of unpleasant responsibilities) provided by the

symptoms. Dorland’s 543.

11

Athetosis is a form of dyskinesia marked by ceaseless occurrence of slow, sinuous, writhing movements, especially

severe in the hands, and performed involuntarily. Dorland’s 169.

12

Chorea is the occurrence of a variety of continual, rapid, highly complex, jerky, dyskinetic movements that look

well-coordinated but are actually involuntary. Dorland’s 349.

13

The uvula palatina is the small, fleshy mass hanging from the soft palate above the root of the tongue, composed of

fibers of the levator and tensor veli palatini muscles and the musculus uvulae, connective tissue, and mucous

membrane. Dorland’s 1983-84.

14

Monocytes are formed in the bone marrow then are transported to tissues such as the lung and liver, where they

develop into macrophages. Dorland’s 1159.

6

dysphonia, and enlarged uvula. She was given steroid and penicillin injections due to a positive

strep test. Id. at 18. She then had “mood changes”, urticaria on her hands and neck, and GI

problems. Epstein Barre Virus testing was negative, and CBC showed elevated monocytes. The

record included that “[s]he started to have a tremor about 2 months ago. She is seeing a

neurologist.” Id.; Pet. Ex. 4 at 33.

The mother and petitioner presented to neurologist Dr. Lacayo on July 18, 2013 and

reported chorea like tremors, which she was born with but was worse with stress, fatigue, or heavy

lifting. Pet. Ex. 5 at 13-15. Dr. Lacayo ordered testing of copper levels, ceruloplasmin, and ASO

titer. She displayed laxity of the joints. Id. at 15. Dr. Lacayo noted the tremor to be “unremarkable”

and that irregular small movements can occur due to muscle weakness, but there were no

choreaform or athetotic movements. “Huntington’s is quite rare but a consideration if movements

progress with imbalance.” He documented that petitioner had cognitive deficits, laxity of joints,

and flat feet. He considered “unspecified diffuse connective tissue disease” due to laxity of her

joints with suspected laxity in her airway. He agreed that cardiac testing should be done since

cardiac conduction deficits can be associated with connective tissue disease. He also recommended

that genetic testing be done in the future, as well as a sleep study. Id. Tissue disease, autoimmune

mediated process, or neurodegenerative condition like Wilson’s disease were included in his

differential. Id.

Petitioner and the mother presented to Dr. Dyer on July 24 and 26, 2013, for “an updated

psychological assessment to evaluate cognitive and academic functioning, particularly in the area

of reading.” Pet. Ex. 6 at 10. The mother reported that petitioner avoided eye contact as an infant,

did not like cuddling or interactive play, was easily distracted, did not respond to pain normally,

and struggled to follow direction as a young child. She met her developmental milestones on time.

She takes ranitidine and loratidine for allergies. She was homeschooled for two years of pre-

kindergarten in Ohio and displayed delayed comprehension of tasks. Id. She attended Faith

Christian Academy for kindergarten with an IEP developed due to severe intellectual delay. Id. at

10-11. The family moved often, and she attended various schools and was homeschooled between

kindergarten and 10th grade. Id. at 11. Public school was considered for 11th grade, but end of year

testing and lack of special educational services resulted in her continuing to attend a school called

Faith Academy and home schooling. Petitioner was involved in year-round education and

consistently struggled, primarily in math and reading, self-direction, organization, and

independence in academics. The mother described petitioner as kind but with difficulties with task

persistence, frustration, and following directions; she was easily angered, defiant at times, and

struggled to control negative mood. She said petitioner worries about social interaction and

academic performance, and her attention and auditory processing are an issue. Id.

Dr. Dyer referenced petitioner’s extensive testing over the years. Pet. Ex. 6 at 11-12. Dr.

Dyer’s testing over two days showed weak verbal memory, reading comprehension, spelling, and

math skills. Id. at 12, 16. She was diagnosed with “Unspecified Anxiety Disorder.” Id. at 16.

Petitioner reported feelings of sadness, anger, disengagement from family and friends, and

isolation, but these feelings do not significantly impair functioning. She displayed attention-based

disorder, but additional testing would be required for a diagnosis. Id. A list of recommendations

was provided, including classroom accommodations, an attention assessment, and therapy to learn

coping skills. Id. at 16-18.

7

A sleep study performed in the summer of 2013 showed insomnia and essential tremors. 15

Pet. Ex. 5 at 6, 11, 12.

Dr. Lacayo conducted an EEG on January 23, 2014 which he read as “abnormal” with

evidence of left hemisphere dysfunction and onset of seizure disorder in the left hemisphere. Pet.

Ex. 5 at 6, 11-12, 20; Pet. Ex. 2 at 12. Dr. Lacayo documented his findings in a letter indicating a

need for an MRI to evaluate for a seizure disorder. Pet. Ex. 2 at 11. The MRI was performed on

January 31, 2014 and was normal. Pet. Ex. 5 at 18; Pet. Ex. 2 at 10.

On March 4, 2014, petitioner presented to Dr. Lacayo for new abnormal movements and

past auditory/verbal processing impairment. Pet. Ex. 5 at 11. The mother reported changes in

petitioner’s behavior with increased rebellion, outbursts, and problems with rules which began

after the varicella vaccine. Pet. Ex. 2 at 6; Pet. Ex. 5 at 11. Dr. Lacayo’s assessment was possible

seizures, left hemisphere dysfunction, anxiety, learning disorders, and attention deficit disorder

with associated tics. Pet. Ex. 2 at 8. He wrote that he did not know whether the vaccine directly

caused these symptoms, “but the timing of such with her seems to have aggravated her condition,

with history of the same in the past. I would hold vaccines as much as possible.” Id.

The mother presented to Groff without petitioner on March 12, 2014 and wanted to discuss

Dr. Lacayo’s opinion of a relationship between the varicella vaccine and petitioner’s symptoms.

The Groff medical record documents, “She was trying to explain several things about what Dr.

Lacayo was doing and that [petitioner’s] issues were related to the Varicella vaccine she received

in July 2013. Dr. Lacayo’s note from 3/4/14 clearly states that the relationship between

[petitioner’s] issues and the vaccine are not known.” The mother became argumentative and was

asked to leave the office. Pet. Ex. 2 at 3, 5. The record documents that a staff member at Groff then

called Dr. Lacayo who advised that “there is no way to determine the relationship between the

vaccine and [petitioner’s] symptoms.” Dr. Lacayo said that petitioner had objective findings on

EEG, and he was treating her to see if there were any changes. Dr. Lacayo stated he advised the

mother “that [petitioner] may need a psychiatric evaluation to make sure there are no other

conditions that may be contributing to the problems.” Finally, Dr. Lacayo stated his only

recommendation to the mother regarding the vaccine was to file a report with the vaccine registry

of a possible reaction, if she chose to do so. Id. at 5. The Groff practice advised the mother to find

a new PCP. Id. at 3.

Dr. Lacayo conducted another EEG on March 24, 2014, which he read as abnormal and

supportive of a seizure disorder but improved from her prior EEG. Pet. Ex. 5 at 17.

On April 5, 2014, petitioner’s parents had petitioner admitted to Ridgeview Institute until

April 14, 2014 as a “last resort” for her anger and uncontrolled outbursts. Pet. Ex. 7a at 4, 6. The

parents reported that petitioner’s behavior issues began in September 2013, had intensified since,

and were suspected to be associated with a varicella vaccine. The mother reported a similar episode

of unexplained behavior following petitioner’s receipt of her first varicella vaccine. Id. at 6.

15

An essential tremor is a hereditary tremor with onset at varying ages, usually at about 50 years of age, beginning

with a fine rapid tremor of the hands, followed by tremor of the head, tongue, limbs, and trunk; it is aggravated by

emotional factors and is accentuated by volitional movement. Dorland’s 1927.

8

Petitioner however, reported “[s]ignificant current discord” with parents, which included her

parents locking her out of the house and police involvement after she presented to work with an

injury following an “altercation” with the mother. Id. She reported moderate anxiety, obsessive

thoughts, compulsive behaviors, feelings of hopelessness, trouble sleeping and eating, and mood

swings. Id. at 6-7. She wanted to find her biological parents. Id. at 104. The discharge summary

described petitioner as polite and cooperative without any out-of-control behavior noted on

admission or on the unit. Id. at 3. “She continue[d] to be sad and ha[d] difficulty expressing her

feelings, especially anger and impulse control issues. Anger is secondary to CNS dysfunction.” Id.

Consistent follow up with outside counselling was strongly recommended. Id. at 15.

The mother and petitioner presented to Eastern Atlanta Behavioral Health (“Behavioral

Health”) as a new patient on April 16, 2014. Her history was reported as episodes of staring,

obsessive thinking, erratic behavior, tremors, and temporal lobe seizures. She was recently

admitted to Ridgeview for “seizure induced personality changes”. Pet. Ex. 8 at 16. The mother

reported that the episodes began at age 5 after a chicken pox vaccination. 16 Id. The assessment was

severe mood swings, possibly caused by seizures, bipolar disorder, or borderline personality

disorder. Id. at 17.

A prolonged EEG performed at Emory on April 28, 2014 was normal when compared to

prior EEGs. Left hemisphere dysfunction had improved overall. There were brief episodes of

generalized slowing, which were nonspecific and possibly related to fatigue. There were no

abnormal EEG patterns associated with reported episodes of emotional outbursts, alteration in

awareness, and wandering, “indicating a non-epileptic cause” for those reported events. Pet. Ex. 5

at 16.

The mother presented to Behavioral Health on April 29, 2014 without petitioner and

advised that petitioner was having 30-second seizures and pathologically lying with personality

switches she did not remember. The mother reported a chicken pox booster in July 2013 and that

she believed that petitioner had developmental delays from vaccinations that “last for a couple of

years.” Her MRI was normal. Pet. Ex. 8 at 15.

Petitioner presented to Behavioral Health for follow up appointments on May 6, 2014, May

20, 2014, and June 19, 2014. She was taking Lamictal and Ativan and reported doing well. Pet.

Ex. 8 at 10-14.

At a July 10, 2014 visit with Dr. Lacayo, petitioner was noted to be a well-nourished 17-

year-old with a normal examination. Her hand tremor and athetoid movements had improved and

she was negative for both Wilson’s and PANDAS. Pet. Ex. 5 at 7. Dr. Lacayo’s assessment was

possible seizures, anxiety disorder, ADD with tics, and transient alteration of awareness. Id.

Petitioner was presented to Dr. Helmers, 17 an epileptologist at Emory Health (“Emory”),

on July 14, 2014 for an initial evaluation of “new onset partial seizures with most likely left

temporal focus” and a history of reading problems and psychiatric issues. Pet. Ex. 9 at 1; Pet. Ex.

5 at 46-47. The history was reported by the mother and petitioner and included an onset of seizures

16

Petitioner received an MMR vaccine at age 5—not a varicella. Pet. Ex. 15 at 3.

17

Unfortunately, Dr. Helmers has since passed away.

9

with “staring off” over the last 6-12 months with no such prior events. Pet. Ex. 9 at 2. These events

were without warning and lasted for a few seconds. An EEG showed left temporal sharps, an

AEEG was reported as unsuccessful, and an MRI was normal. Id. She has been taking Lamictal

for psychiatric issues and had reading comprehension problems. She was a rising Senior on A/B

honor roll and wanted to major in the performing arts. “Mom says she hmet (sic) developmental

milestones normally.” Id. The mother reported her first seizure was at age 16 without fever but

never diagnosed; her most recent seizure was four days ago. Id. Her seizures appear in clusters and

are triggered by lack of sleep and stress. Id. Examination that day was normal. Id. at 4-5. A 3T

epilepsy protocol MRI was ordered to assess for left temporal pathology/etiology. Id. at 5. A

psychiatrist knowledgeable about epilepsy and psychiatric disorders was recommended. Id.

Petitioner returned to Dr. Dyer on August 8 and 20, 2014, with reported decline in

emotional behavior over the past year. Pet. Ex. 6 at 1. The mother reported that petitioner suffered

physiological and psychological changes and cognitive decline following rounds of vaccinations

at ages 5, 6, and 16. Id. at 2. She further reported that Dr. Lacayo believed petitioner had a seizure

disorder that may be related to vaccination. She reported that petitioner had received a varicella

booster in July 2013, was taken to the ER for respiratory distress, and developed a tremor shortly

thereafter with psychological and cognitive issues over the next several months. She had a sleep

study at Emory but the doctors were unable to agree on the cause of her unusual patterns of brain

activity but were considering autoimmune encephalitis 18 and Wilson’s disease, which was

previously ruled out but being retested. Id. She was taking Lorazapam since August 2014 to

stabilize her mood and regulate brain activity. She had received several potential diagnoses

“including Dissociative Identity Disorder, Temporal Lobe Epilepsy with Behavioral Changes,

Vaccine Injury/Brain Injury, Rapid Cycling Bipolar Disorder, and Borderline Personality

Disorder, as provided by [the mother].” Id. According to Dr. Dyer, testing that day reflected a

decline in cognitive and academic functioning and as described by the mother, “there is evidence

that suggests a causative link between vaccinations and periods of cognitive decline, [but] such a

diagnosis is not available per diagnostic codes listed in the DSM-5.” Id. at 5-6.

Petitioner presented to Behavioral Health on September 15, 2014, reporting that she had

done well over the summer but recently had a “meltdown” and “other odd behaviors” and her

parents called the police. Pet. Ex. 8 at 10. She was to continue current medications and therapy.

Id. at 11.

Petitioner was returned to Emory on October 14, 2014. Pet. Ex. 9 at 7. The mother provided

the history since their last visit which included rapid eye flutter, vibrations, and tremor during an

EEG, and an IQ drop to “first grade level”. Id. Although the record appeared to repeat the history

provided on the July 14, 2014 visit, there were a few changes. For example, at the July 14, 2014

visit, there were no epilepsy risk factors noted and a list of dates of developmental milestones was

provided. Id. at 2. At the October 2014 visit, epilepsy risk factors now included that she “had the

same psychiatric and academic alteration at age 5 and neuro development therapy was started and

by age 11 she was back on track.” Id. at 8. In July 2014, her seizures were without warning and

lasted a few seconds with no pattern. Her psychiatric symptoms were rare while on Lamictal. Id.

at 2. In October 2014, her seizures were described as involving behavioral arrest and alteration in

awareness, lasting more than 30 seconds, occurring a couple times per day, and followed by a

18

Encephalitis is inflammation of the brain. Dorland’s 605.

10

couple of minutes of postictal confusion. Id. at 8. Petitioner and the mother then detailed numerous

events 19 they claimed occurred during petitioner’s long-term video EEG in September 2014, but

the record showed no EEG correlation concluding the reported episodes “are not epileptic in

origin.” Id. at 9. The focal slowing seen on EEG was also determined to be “non specific in

etiology.” Id. A 3T MRI was normal. Id.

A record dated December 8, 2014, documented that petitioner was under medical care for

medically refractory symptomatic generalized epilepsy. There were no neurological

contraindications to the patient having surgery as scheduled, but they “highly recommend[ed]”

that no Demerol be given. 20 Pet. Ex. 9 at 39.

On December 15, 2014, petitioner was presented to Emory for examination by neurologist

Dr. Silver. The mother provided a history of a previously healthy 17-year-old who had learning

difficulties when she was six and was diagnosed with autism spectrum disorder 21 but “overcame

this” with therapy. Pet. Ex. 9 at 13. She was a successful high school student with good grades and

enjoys singing. Id. The mother reported bilateral hand tremors since last fall which worsened with

writing or lifting and occasionally had larger “jerky” movements when playing the piano. Dr.

Lacayo referred to them as tremors, but they looked like athetosis. All testing was negative. The

mother further reported that a January 2014 EEG showed “focal slowing and electrographic

seizures per outside read.” Petitioner was started on Lamictal, titrated up, and the athetosis

improved. Id. Petitioner had a long EEG at the hospital to evaluate for possible seizure activity.

She was taken off her medication for the testing resulting in eye jittering, eye twitching, emotional

instability, and episodes of staring off. Id. at 14. However, the EEG did not correlate with any of

these behaviors. The mother added that petitioner had “extreme personality changes” and difficulty

with schoolwork in December 2013. Her reading spontaneously decreased to 1st grade level. She

went from an A/B honor student in 9th and 10th grade in private school to having to be

homeschooled senior year due to failing performance. Id. She was admitted to Ridgeview in April

2014 and started on Ativan for borderline personality disorder. Id. Dr. Silver’s examination was

normal/negative, as was an MRI performed. Id. at 16-17. Dr. Silver wrote that all testing thus far

was negative/normal. Id. at 17. He ordered additional testing for Wilson’s disease because it was

“the main diagnostic possibility here for an organic disorder. . . Psychogenic 22 certailnly (sic) is a

possibility.” Id. at 18.

Petitioner and her mother presented to Behavioral Health on February 18, 2015 and

reported that the testing at Emory was inconclusive. She was stable that day but still had episodes

of decreased cognitive function. Pet. Ex. 8 at 8. They discussed a gluten free diet. Id. at 9.

19

They claimed that, during the EEG, petitioner’s arms vibrated and were tremulous, her psychiatric/emotional state

changed, she had unusual eye movements, she had right arm twitching and bilateral feet twitching, was weak in the

head, and had eye blinking and facial twitching. Pet. Ex. 9 at 8.

20

It is unclear when and based on what testing petitioner was diagnosed with medically refractory symptomatic

generalized epilepsy or what surgery was being referred to. There were no records filed reflecting this.

21

A letter submitted by Dr. Cates states that, at age 5 or 6, petitioner exhibited signs of being on the autism spectrum

during an academic assessment to develop an IEP. Pet. Ex. 26. However, there are no contemporaneous records to

corroborate petitioner’s autism diagnosis.

22

Psychogenic refers to symptoms that are produced or caused by psychological factors. Dorland’s 1525.

11

Petitioner returned to Dr. Silver on March 26, 2015 at which time, Dr. Silver wrote that

petitioner had a history of complicated psychological and neurological symptoms, but it was

unclear whether her problems were “organic”. Pet. Ex. 9 at 19. The only subjective finding was an

EEG showing bilateral independent temporal slowing, which was sharply contoured but not

epileptiform. Id. All testing has been normal. Her psychiatrist reportedly thinks her issues are

neurological—not psychiatric. However, “[d]ifferent impressions had come from psych before

including the rapid-cycling bipolar and borderline personality disorder.” Id. According to Dr.

Silver, “[o]ne has to wonder if her family did not have the resources and knowledge that they have,

if this case would have been diagnosed as a mental illness and the neurological aspects of this

wouldn’t be addressed. . . We spent a lot of time talking about vaccines and gluten and other things

that her mother is concerned may be playing a role.” Id. at 23. Dr. Silver recommended she be

seen by the epilepsy department and noted that Lamictal “clearly helped her but of course this has

great psychiatric benefits as well”. Id. He recommended further psychiatric treatment. Id.

On May 8, 2015, the mother again presented to Behavioral Health without petitioner to

discuss several issues. The mother had emailed Behavioral Health the day before detailing recent

problems including that petitioner talked “as if everything is about her”, “insights (sic) chaos”, and

incites fear in her family members. Pet. Ex. 8 at 5-6. The mother believed petitioner needed intense

counseling and the parents were considering sending her to Mercy Ministries, a six-month

inpatient center. Id. at 6-7.

Petitioner then presented to Behavioral Health on May 21, 2015 reporting “a lot of

depression.” She refused medication. She was noted to be evasive and externalizing. Pet. Ex. 8 at

3. The assessment was worsening depressive symptoms. Id.

Petitioner and the mother presented to Dr. McKean on June 3, 2015. She had congestion

and frequent sniffling for which she took cetirizine every night. The mother reported that

petitioner’s tremors were exacerbated and “she was found to have a neurologic injury with absence

seizures and psychotic reactions.” Pet. Ex. 4 at 22; Pet. Ex. 19 at 5. The examination that day was

normal. Pet. Ex. 19 at 7. She had no restriction or airflow obstruction. Id. at 9. She was instructed

to continue her allergy medications. Id. at 8.

Petitioner and her mother returned to Dr. Lacayo on June 5, 2015. It had been a year since

her last visit. Inpatient care for depression was being considered. Pet. Ex. 5 at 1-2. Long term

monitoring at Emory showed no overt seizures. Id. at 2. Her tremors had improved. She graduated

this year. She was now being evaluated for immune issues. She saw an allergist for breathing

issues. Id. Examination on that day was normal/negative but for reduced reflexes. Id. at 2-3. Dr.

Lacayo wrote, “[i]t is unclear how much psychological issues are contributing to [her] spells.” Id.

at 3. In a separate handwritten form, Dr. Lacayo documented a normal examination including a

normal, intact neurological examination. Id. at 39.

Petitioner and her mother returned to Dr. Silver on June 11, 2015. She was now 18 years

old with a constellation of psychological and neurological symptoms. It was still unclear if her

symptoms were due to an “organic” cause because all testing was negative/normal. Pet. Ex. 9 at

25. Dr. Silver wrote that an outside EEG was read to have more concerning findings than what

was found on testing by Emory epileptologist Dr. Helmers. Id. She was seeing a psychiatrist, but

12

the parents planned to send her to residential care through Mercy Ministries. Id. “The issue of

whether she actually had seizures is still unclear.” Id. at 26. Dr. Silver wrote, “[o]n the urging of

her mother…exhaustive workup for causes” had been done with the most likely causes excluded.

Id. at 29. Her acetylcholine receptor (“AChR”) 23 came back positive with low titers, but she has

no symptoms of myasthenia gravis (“MG”). 24 Nonetheless, “[h]er mother has seen this and is

concerned that she could have myasthenia.” Id. Her tremors appear to be mild essential tremors

and not an important feature of her case. Id. Dr. Silver’s plan was for her to be seen at Emory

epilepsy, have the outside EEG read at Emory, and consider repeating AchRAb tests adding anti-

thyroglobulin testing. Id. at 30. Dr. Silver further noted that the “mother [is] insistent that there is

organic cause to her symptoms but nothing is turning up. It would have been better to have worked

her up when she had initial psych problems. [N]ow story is very convoluted and she has such mild

problems compared to before.” Id.

Petitioner was referred by her psychiatrist to Heather Richardson, Psy.D. on June 10, 2015

for psychological evaluation. Pet. Ex. 13 at 3. The mother provided a history of temporal lobe

epilepsy, but Dr. Richardson noted that “no documentation has been provided to support the

diagnosis.” Id. The mother further reported changes in petitioner’s personality including being

combative, having negative computer conversations, interacting with peers she was asked not to,

and rebelling for which the police have been called. Petitioner reported feeling lonely, isolated,

and distressed by the nature of her relationships with her family. Id. Testing revealed low

frustration tolerance and limited coping strategies. Id. at 4. She had elevated depression scores

consistent with her reports. Her profile suggested physical manifestations of her depressive

symptoms, consistent with “her frequent doctor’s visits, prompted by her mother who is seeking

an organic explanation for her emotional and behavioral difficulties.” Id. Continued private and

group therapy was recommended. Id. Petitioner attended sessions with Dr. Richardson through

September 10, 2015. Id. at 2. Petitioner traveled alone over the summer for several weeks and

returned in a positive mood. She had begun to attend college classes, and Dr. Richardson

documented that petitioner had been making progress in their sessions. Id. However, in a January

18, 2016 note, Dr. Richardson documented that petitioner and her father showed up to the office

for an unscheduled appointment, then petitioner “simply did not return after” so her sessions were

informally terminated. Id. at 1-2.

The mother provided the outside EEG which she claimed showed seizure activity to Emory

for review. Pet. Ex. 9 at 31-32, 40. However, the video EEG from September 2014 at Emory

showed no EEG correlate with the events petitioner reported. Id. at 33-34, 40.

23

The AChR antibody blocks neuromuscular transmission by interfering with the binding of ACh to AChR along the

muscle membrane, which prevents muscle contractions. The acetylcholine receptor antibody test is used to diagnose

myasthenia gravis and to monitor patient response to immunosuppressive therapy. The measured titer does not

correspond well with the severity of MG symptoms, though. It is important to note that false positives can occur in

patients for reasons including the use of muscle relaxant drugs or penicillamine. Kathleen Deska Pagana, PhD, RN &

Timothy J. Pagana, MD, FACS, Mosby’s Manual of Diagnostic and Laboratory Tests 22-23 (6th ed. 2018).

24

Myasthenia gravis is an autoimmune disease of neuromuscular function due to the presence of antibodies to

acetylcholine receptors at the neuromuscular junction; characteristics include muscle fatigue and exhaustion that

fluctuates in severity, without sensory disturbance or atrophy. It may be restricted to one muscle group or become

generalized with severe weakness and sometimes respiratory insufficiency. It may affect any muscle of the body, but

especially muscles of the eyes, face, lips, tongue, throat, and neck. Dorland’s 1197.

13

On August 3, 2015, petitioner and the mother returned to Emory. The record documents

that “mom states 7/2013 had a varicella booster and 3 days later had an anaphylactic reaction.”

Soon thereafter, petitioner started having tremors/choreoathetosis. About a month later, psychiatric

symptoms began which eventually required her to be hospitalized multiple times. She developed

insomnia and school performance worsened. Multiple EEGs were purportedly interpreted as

abnormal and showing epileptiform activity, and she was started on Lamictal in early 2014. Pet.

Ex. 9 at 33. She has had extensive workup, all of which was unremarkable. Id. at 34. The plan was

to stay on Lamictal since she felt better on it. Id. at 37. A neuroimmunology evaluation at the

University of Pennsylvania was recommended since her symptoms “may be related to the varicella

booster.” Id.

Petitioner and her mother presented to Dr. McKean on August 19, 2015 at which time the

mother reported that petitioner was examined by the Chief of Neurology at Emory who did not

feel she had epilepsy. She was found to have antibodies to acetylcholine receptor, but they did not

believe she had myasthenia gravis. She was fatigued with increased tremor and weakness after

exercising. Pet. Ex. 4 at 12, 16. She worked as an aide at a school for special needs children. She

had no asthma symptoms. Id. at 12. Spirometry was stable. Id. at 21.

Laboratory tests performed that day showed that she had sufficient protective antibodies

for tetanus toxoid and diphtheria but was negative for Varicella Zoster antibodies (IgM and IgG 25).

Pet. Ex. 14 at 4-5. She had a high level of AChR blocking and binding antibodies, which showed

borderline myasthenia gravis, and tested positive for Human Herpes Virus 6 (“HHV-6”). 26 Id. at

1, 4.

Petitioner returned with the mother to Dr. McKean on September 3, 2015 and it was

reported that she had constant fatigue requiring at least a two hour nap daily. She was more

irritable, emotional, and hostile over the past two weeks. She had chronic nasal congestion and

rhinorrhea. Pet. Ex. 4 at 9.

Petitioner was referred to Dr. Rivner, and presented on October 21, 2015. The history

provided included receipt of a vaccine during the summer of 2013 with difficulty breathing and

swallowing three days later and a swollen throat and uvula thought to be strep, which was treated

with penicillin and steroids. She then developed a bilateral arm tremor and was diagnosed with

athetosis. Pet. Ex. 12 at 65. Testing for Wilson’s disease was negative. Around December 2013,

she “started to act lethargic and strange” and had staring spells. EEG showed left-sided slowing,

but MRI was normal. Lamictal was started in January 2014 and titrated up in May. She was

admitted for psychiatric issues. She had “mental status problems”, did poorly in school, and was

thought to have autoimmune encephalopathy. 27 She had a positive AChR on paraneoplastic panel.

Id. She was seen at Emory taken off Lamictal but had seizures so it was restarted. She had diplopia

and her eyesight was worsening. Her neck gets tired when she has tremors. Her writing has

25

IgA, IgG, and IgM are all immunoglobulins that function as antibodies. Certain classes of antibodies can trigger

other processes when bound to antigen: IgM and IgG activate the classic complement pathway, IgA and IgG activate

the alternative pathway, and IgM, IgG1, and IgG3 act as opsonins, triggering phagocytosis of the bound antigens by

macrophages and neutrophils. Dorland’s 908-09.

26

The human herpes virus 6 is a virus of the genus Roseolovirus that is the etiologic agent of exanthema subitem.

Most healthy adults carry the virus and are asymptomatic, but infection results in lifelong persistence. Dorland’s 843.

27

Encephalopathy refers to any degenerative disease of the brain. Dorland’s 608.

14

worsened. Id. Following examination, Dr. Rivner’s impression was possible autoimmune

encephalitis manifested by seizures, athetosis, personality changes, and dementia; abnormal

AChR, CMV IgG, HHV6-possibly autoimmune etiology; clinically, no significant myasthenia

gravis. Id. at 70. Additional testing was ordered. Id. at 71. EMG/Nerve conduction testing was

normal. Id. at 75-76.

At her November 11, 2015 visit at Behavioral Health, the mother reported that petitioner

was diagnosed with myasthenia gravis and was being tested for NMDA receptor antibody

encephalitis. Pet. Ex. 8 at 1. She was psychologically stable and had fair attention, concentration,

and productivity at school. She had no mania, mood swings, anxiety, hallucinations, or delusions.

Id.

MRIs performed on December 11, 2015 were normal. Pet. Ex. 12 at 55, 57. A lumbar

puncture performed on December 23, 2015 and sent to the University of Pennsylvania did not

show antibodies to “any component of the autoimmune encephalitis”. Pet. Ex. 12 at 37, 49.

Petitioner and her mother then presented to a new neurologist, Dr. Dabas, on January 12,

2016 to rule out autoimmune encephalitis. She was reportedly referred to Dr. Dabas for chorea of

both hands that started 2 years ago after receipt of a varicella vaccine booster. Following receipt

of the varicella vaccine she developed a swollen uvula and was treated for an allergic reaction or

strep with penicillin and steroids. She also had breathing problems that lasted for a week. She

began having chorea of the hands and behavioral issues. Pet. Ex. 12 at 24. She was noted to have

staring spells and was diagnosed with seizures following EEG. Lamictal was started which

improved her staring, but her behavior continued to worsen. A psychiatrist increased the Lamictal

which helped. Id. Her school performance declined, and she was positive for ACHR but clinical

evaluation did not show myasthenia gravis. Id. at 25. She reportedly had similar behavioral

problems at age 5 after her first dose of varicella 28 and “likely had autism spectrum disorder. She

had sensory therapy at that time which as per mother has returned.” Id. Her levels of IgA and IgM

were low, but IgG levels were normal. Id. The diagnosis that day included memory decline, post-

vaccine behavior problems, and chorea. Id. at 28. She was to undergo CT of the abdomen and

pelvis to rule out tumor, a neuropsychiatric evaluation, and have her PTH and ionized calcium

levels checked. Id. A CT performed on January 27, 2016 was negative/normal. Id. at 19.

One week later, petitioner and her mother presented to Dr. Morgan who wrote an

addendum to Dr. Dabas’s visit note to include that according to mother, petitioner had a history of

sensory issues and is on the autism spectrum. Pet. Ex. 12 at 28. The mother then reported to Dr.

Morgan that petitioner had behavioral and cognitive changes at age 5, which did not resolve until

age 10 and presented again at age 16 after the varicella vaccine. Dr. Morgan noted a “completely

normal neurological exam” that day apart from some chorea in her fingers, a slight tremor, and

hyperflexible joints. Id. Dr. Morgan wrote this is a “[c]omplex story here with behavioral and

psychiatric components” and an exam not typical of chorea, encephalitis, or encephalopathy. Id.

at 29. He wrote that varicella meningoencephalitis can occur in patients, but petitioner’s MRI is

normal and “she never had devastating disease.” Id. Dr. Morgan was more worried about

petitioner’s behavioral components than an autoimmune encephalopathy. Id.

28

Petitioner received an MMR vaccine at age 5—not a varicella. Her first varicella vaccine was at age 11. Pet. Ex. 15

at 3.

15

Petitioner and her mother presented to Dr. McKean on March 3, 2016 for asthma. She was

18 years old. The history provided included seeing a neurologist at Georgia Regents University in

October and being found to have abdominal reflux, cerebellar damage, 29 and ataxia. 30 Pet. Ex. 4

at 1. A lumbar puncture in December of 2015 showed 7 WBCs and elevated albumin with no

evidence of autoimmune encephalitis. She was not diagnosed with myasthenia gravis. A MoCA

test showed dementia. 31 She was still working and had not been ill but complained of fatigue. Id.

Dr. McKean’s impression was mild, intermittent asthma and selective IgA and IgM

immunodeficiency. 32 Id. at 2. She received a pneumovax vaccine on that day. Id.

Petitioner and her mother returned to Dr. McKean on March 24, 2016 reporting increased

neurological symptoms following the pneumovax vaccine with staring episodes, irritability, and

being confrontational but overall the changes were not severe. Pet. Ex. 4 at 3. Examination was

normal/negative. Id. at 3-4.

Petitioner was returned to Dr. Morgan on March 16, 2016 for a neuropsychological

evaluation. The history provided included two episodes of behavior changes after MMR and

varicella vaccines at ages 5 and 16, both times with a decline in school achievement. Pet. Ex. 12

at 10. She was reportedly diagnosed with “putative complex partial seizures in early 2014 and

started on Lamictal.” Id. She had an extensive workup at Emory during the summer of 2015 for

autoimmune encephalitis. Incidental labs suggested myasthenia gravis although she had no

symptoms. Id. Cognitive complaints included forgetfulness, poor concentration, word finding

difficulties, and blank thoughts. She reported auditory hallucinations a year ago on more than one

occasion. Id. Petitioner had undergone several psychological evaluations with “highly variable

results”. Id. Dr. Morgan’s impression was deficits in attention and concentration and reduced

mental processing speed but an otherwise unremarkable cognitive examination. Id. at 11.

Intellectual function was average to low average while reading was borderline, and she had mild

symptoms of depression. Id. The pattern of cognitive deficits was “nonspecific with regard to

etiology”, inconsistent with limbic (anti-NMDA receptor) encephalitis, but most commonly seen

in patients with significant psychiatric disorders. Id. at 12. There were multiple symptoms of

significant personality disorder with many borderline traits on prior testing. The diagnostic

impression that day was unspecified mild neurocognitive disorder. Id.

Petitioner and her mother returned to Dr. Morgan on April 12, 2016. Pet. Ex. 12 at 1, 4.

The mother reported that petitioner had memory decline, behavioral issues, and chorea. Id. at 4.

She further reported that during a repeat EEG, petitioner had hand shaking, oscillating eyes and

29

The cerebellum is the part of the brain that occupies the posterior cranial fossa posterior to the brainstem and is

concerned in the coordination of movements. Dorland’s 327.

30

Ataxia refers to failure of muscular coordination or irregularity of muscular action. Dorland’s 168.

31

The MoCA test is used to interpret the level of cognitive impairment based on a score out of 30 possible points. A

score of 26 and above is considered “normal.” Shilpa Amin, M.D., CAQ, FAAFP, What is the MoCA Test for

Dementia?, MedicalNewsToday, https://www.medicalnewstoday.com/articles/moca-test-for-dementia#what-to-

expect. Petitioner received a score of 27. Pet. Ex. 12 at 65. (emphasis added)

32

IgA deficiency is the most common immunodeficiency disorder: deficiency of IgA with normal levels of the other

immunoglobulin classes and normal cellular immunity. It is marked by recurrent sinopulmonary infections and an

increased incidence of allergy, gastrointestinal disease, and autoimmune diseases. Many patients have anti-IgA

antibodies that can cause severe transfusion reactions. Dorland’s 472, 908-09.

16

uncontrolled blinking, Tourette-like symptoms, facial twitching, and significantly decreased IQ.

Id. Petitioner had seen an immunologist every three months since the summer of 2015 and was

found to have no immunity to varicella zoster and “activated” HHV6. Id. at 5. Tests showed low

IgA and IgM but normal IgG levels. She reported that Dr. McKean diagnosed petitioner as

immunocompromised and thought “her ‘encephalitis’ picture might be from HHV6 reactivation

from VZV vaccine”. The mother called the CDC and was told not to give petitioner any live

attenuated vaccines in the future. Id. Petitioner required special school accommodations after the

varicella vaccine and was later admitted to Athens Tech College for low remedial scores in all

subjects, but this was postponed until later. Petitioner works part-time at a special education

preschool and resides in a basement apartment at her parents’ house. The mother reported similar

behavior issues at age 5 following MMR vaccine. Id. Dr. Morgan’s impression remained fine

tremor in her hands not likely chorea, with an otherwise normal examination. Id. at 5-8.

Genetic testing performed on May 31, 2017 showed a normal female. Pet. Ex. 36 at 1, 3.

There was a gap in the medical records from May 2017 until February 2019, at which time

petitioner was pregnant. Her pregnancy was complicated by shortness of breath, psychiatric illness,

myasthenia gravis, “nervous system disease,” obesity, and other mental disorders. Pet. Ex. 45.1 33

at 4.

Petitioner and her mother presented to Dr. McKean on February 26, 2019 for difficulty

breathing over the past two months. The mother reported that petitioner had myasthenia gravis,

felt weak in the morning, and had difficulty with tremors in the past. Pet. Ex. 39 at 2. Dr. McKean’s

impression was moderate persistent asthma and immunodeficiency. Id. at 3. Dr. McKean discussed

at length with petitioner and the mother that petitioner’s baby may also have immune deficiencies.

Id.

Petitioner presented to Dr. Rivner on February 27, 2019. She was last seen in 2015. She

reportedly had psychiatric problems, muscle weakness, shortness of breath, and fatigue, and she

was pregnant. Pet. Ex. 38 at 1. She reported having encephalitis in the past and choreoathetosis.

She had no seizures but was on medication. Her IQ was improving, but she still had foggy memory.

Id. Examination that day was normal. Id. at 2. Dr. Rivner concluded that while it was possible she

had myasthenia gravis, she had atypical symptoms and IVIG was not a good treatment option for

her because she has IgA deficiency. Id. at 3.

Petitioner then presented to Dr. Lacayo on March 6, 2019 to discuss treatment for

myasthenia gravis in light of immune deficiency. PLEX was to be used in a crisis. IV steroids

could be used for acute weakness. It was reported that Dr. Rivner had recently conducted extensive

testing for myasthenia gravis, and the results were pending. Pet. Ex. 40 at 8.

Petitioner returned to Dr. McKean on March 26, 2019 doing better with medication but

with continued dyspnea at rest “likely due to a combination of pregnancy and myasthenia gravis.”

Pet. Ex. 39 at 7.

33

Petitioner filed two exhibits numbered 45 into the record. Thus, for ease of citation, “Pet. Ex. 45” refers to the filing

located at ECF No. 78, and “Pet. Ex. 45.1” refers to the filing located at ECF No. 79.

17

Petitioner and her mother returned to Dr. Rivner on March 27, 2019. He diagnosed her

with myasthenia gravis due to abnormal test results, even though she presented with “very

atypical” symptoms. Pet. Ex. 38 at 5, 7. He noted that she was a high risk delivery with a chance

of neonatal myasthenia gravis in the child. Id. at 7.

The mother called Dr. Lacayo’s office on April 2, 2019 to advise that petitioner was

scheduled to deliver her baby on April 10, 2019 by C-section, her immune labs were “bad”, and

her myasthenia gravis progressing. She reported positive neurofiber EMG testing with Dr. Rivner

and that IVIG was needed. Pet. Ex. 40 at 3; but see Pet. Ex. 38 at 3, where Dr. Rivner specifically

advised against the use of IVIG in petitioner. Petitioner was being admitted that day for a 3-day

course of IVIG. Pet. Ex. 40 at 3. Petitioner asked that Dr. Lacayo prescribe petitioner’s medications

because she had missed her last psychiatrist appointment, and the psychiatrist would not prescribe

the medication. Id.

Petitioner was admitted to Piedmont Healthcare on April 2, 2019 to receive IVIG prior to

delivery of her baby in order to reduce respiratory complications, risk of MG in the baby, and post-

delivery complications. Pet. Ex. 45.1 at 5, 9. Upon admission, the mother reported that petitioner

suffered an “immune mediated neuro injury after getting a vaccine booster for chicken pox at age

16 and has subsequently been diagnosed with autoimmune encephalitis, myasthenia gravis,

immunodeficiency including IgA deficiency and epilepsy.” Id. at 11.

Petitioner suffered from headache, chest pain, back pain, parasthesias, and tingling from

IVIG treatment, all of which are adverse reactions. The IVIG rate was slowed, and she was able

to finish treatment but had recurrent symptoms after discharge, requiring IV steroids and fluids.

Pet. Ex. 45.1 at 38, 41.

Petitioner’s baby was born on April 10, 2019. Pet. Ex. 45.1 at 72, 75. She continued to

complain of shortness of breath so pulmonary work up was conducted. Id. at 58-62. Chest x-ray

and CT angiogram ruled out pulmonary embolism and pneumonia. Id. at 65. Her shortness of

breath was believed to be multifactorial due to myasthenia gravis, asthma, and anemia. Id.

The mother called Dr. Lacayo on May 16, 2019 requesting that he write a letter stating that

petitioner is stable enough to take care of her baby and work in law enforcement. Pet. Ex. 40 at 5-

6. That letter, if written, was not filed.

Petitioner returned to Dr. Rivner on May 29, 2019 with complaints of fatigue and

generalized body weakness. Pet. Ex. 38 at 9. Dr. Rivner’s impression was asymptomatic

myasthenia gravis, side effects from IVIG and obstructive, not restrictive, airway disease. Id. at

11.

At her June 7, 2019 visit with Dr. Lacayo, her serology was reportedly positive for

myasthenia gravis and immune disorder. She had suffered from “chemical meningitis” as a

reaction to IVIG treatment. Pet. Ex. 40 at 1, 3. She complained of shortness of breath, fatigue,

dizziness, tremors, and numbness. Id. at 3. The baby was doing well. Id. Dr. Lacayo’s assessment

was myasthenia gravis, unremarkable tremor, and common variable immunodeficiencies. Id. at 4-

5.

18

B. Affidavits

i. Petitioner’s Affidavit

Petitioner filed an affidavit on July 7, 2016. Pet. Ex. 1. She stated she was generally healthy

at the time she received the varicella vaccination on July 2, 2013. Id. at 1. During that visit, she

reported wiggling in her fingers that she planned to see a neurologist for but confirmed no

significant medical history. Id. at 1-2.

Petitioner affirmed that she presented to the ER on July 5, 2013 complaining of an allergic

reaction to the vaccination with difficulty breathing and swallowing. Pet. Ex. 1 at 2. A rapid strep

test was positive, but a throat culture that was performed at her mother’s “insistence” was negative.

She was given steroid and antibiotic injections and sent home. Id.

Petitioner affirmed that she presented to Dr. McKean on July 16, 2013 for allergies and

asthma. Pet. Ex. 1 at 2. Dr. McKean noted her difficulty breathing and enlarged uvula after the

vaccination. Id. Two days later, she presented to Dr. Lacayo for her “new onset tremors.” Dr.

Lacayo diagnosed her with “essential and other specified forms of tremor and unspecified diffuse

connective tissue disease.” Id. at 2-3.

Following an assessment by Dr. Dyer on July 24 and 26, 2013, petitioner was diagnosed

with a reading and anxiety disorder. Pet. Ex. 1 at 3. Beginning in August 2013, she had “severe

emotional outbursts, anger issues, staring spells, and overall worsening behavioral issues that [she]

seemed unable to control.” She affirmed these problems worsened throughout the fall and winter

of 2013, eventually culminating in a “psychotic breakdown” in January 2014. Id.

Petitioner affirmed that an EEG performed in January 2014 was suggestive of a seizure

disorder and cerebral dysfunction. Pet. Ex. 1 at 3. Her neurologist then ordered an MRI and

concluded “she has a seizure disorder causing her behavior disorder including belligerence,

agitation and impaired insight.” Id. Petitioner started taking Lamictal. Id. at 4.

Petitioner affirmed that she presented to Dr. Lacayo on March 3, 2014, but he was unsure

of the “cause and effect relationship” between her symptoms and the vaccination, but “the timing

does suggest a correlation” and it seemed that the vaccination “aggravated her condition.” Pet. Ex.

1 at 4.

According to petitioner, she had another abnormal EEG on March 24, 2014. Pet. Ex. 1 at

4. She was placed in inpatient care between April 5 and 9, 2014 for continued erratic behavior and

angry outbursts, and was assessed as having a mood and seizure disorder. She affirmed her

physician during inpatient treatment found that her anger was due to central nervous system

dysfunction. Id.

Petitioner affirmed going to Eastern Atlanta Behavioral Health where she was noted to

have episodes of obsessive thinking, seizures, erratic behavior, suicidal ideations, and severe mood

swings due to multiple possible etiologies, including seizures. Pet. Ex. 1 at 4-5.

19

According to petitioner, she presented to Emory for evaluation of seizures and staring

spells over the last 6-12 months, with psychiatric symptoms which presented around the same

time. She was diagnosed with new onset partial seizures. Pet. Ex. 1 at 5.

Petitioner affirmed that in August of 2014, her psychologist noted a decline in her

behavioral and emotional functioning over the past year. Pet. Ex. 1 at 5. The psychologist wrote

“there is evidence to suggest a causative link between vaccinations and periods of cognitive decline

and diagnosed [her] with a Major Neurocognitive Disorder.” Id.

According to petitioner, her symptoms persisted over the next year, although some were

controlled by medication. Pet. Ex. 1 at 5. She was seen again at Emory in August 2015 and

diagnosed with a seizure disorder. Id. at 6. She was also referred for a neuroimmunology evaluation

because her symptoms may be related to the vaccination. Id.

Petitioner affirmed she was determined to be immunodeficient and her neurologist opined

that her symptoms in the context of her immunodeficiency were more likely than not caused by

the varicella vaccine. Pet. Ex. 1 at 6. Her immunologist’s opinion is also that she had a severe

adverse reaction to the varicella vaccine and should not have any live-virus vaccines in the future.

Id.

ii. The Mother’s Affidavit

The mother affirmed that petitioner received her first MMR vaccine at 22 months. Pet. Ex.

35 at 1. Petitioner then had “negative behavioral changes”, but the parents attributed it to “a case

of the ‘terrible twos.’” Id. at 2.

The mother affirmed that petitioner received a second MMR vaccine at age 5 in June 2002.

Pet. Ex. 35 at 1-2. After that vaccination, petitioner developed new cognitive and behavioral issues

that were not typical for a child her age, such as illogical behavior, inappropriate risk taking,

extreme disobedience, insomnia, screaming fits, attention issues, cognitive decline, and muscle

and coordination issues. She was referred for an occupational therapy evaluation as a result. Id. at

2.

According to the mother, in June 2003 when petitioner was 6 years old, she was taken for

psychological evaluation with Dr. Cates. Dr. Cates prepared a neurodevelopmental therapy

curriculum for use in homeschooling petitioner. Pet. Ex. 35 at 2-3. Dr. Cates retested petitioner in

June 2004 and she showed improvement, so he provided another customized curriculum to use at

a school he recommended, Basic Trust Child Development Center. Id. at 3. Dr. Cates also sent

petitioner for comprehensive audiologic assessment and auditory processing testing in August

2004 and for a vision therapy assessment in October 2004. Id. Petitioner had an OT evaluation in

February 2005. Id. at 3-4. Dr. Cates evaluated petitioner a third time in June 2005 and prepared a

curriculum to be used at Churchill Academy, a grade school run by the owners of Basic Trust

Child Development Center. Petitioner went there for the first half of the school year. Id. at 4. They

then moved to Alabama, and she attended Huntsville Christian Academy. Id.

20

According to the mother petitioner was homeschooled in 2008, due to the cost of private

school. In 2009, she was enrolled in The Ellis Academy for Girls where she went until 2011. She

excelled in the arts and was “acting like a normal child.” While in Alabama, petitioner was treated

at Millstone Pediatrics but had an aversion to male doctors. Pet. Ex. 35 at 4.

The mother affirmed that due to her own personal health issues, the family moved to

Georgia in 2011 to be closer to family. Petitioner was homeschooled during the 2011-2012

academic year. Pet. Ex. 35 at 4-5. In 2012, all of their children were enrolled in Trinity Prep School.

Petitioner did not enjoy that school, so she finished her sophomore year of high school at Faith

Academy, where she did well academically. Id. at 5.

The mother affirmed that for petitioner to attend public school for the 2013-2014 academic

year, she had to be up to date on her vaccinations. She was taken to Groff to establish a new

pediatric relationship on July 2, 2013 and was given the varicella vaccine. She was taken to the

ER “[o]nly days later…with a reaction to the vaccine.” Pet. Ex. 35 at 5.

According to the mother, petitioner had no significant medical appointments between May

10, 2010 and July 2, 2013. Since she had no serious health issues and an aversion to doctors, she

did not see any doctors during that time. Pet. Ex. 35 at 5-6.

C. Other Documentation and Evidence

i. Letter from Dr. Cates

Dr. Cates “worked with [petitioner] and her parents in a strictly academic capacity” through

Faith Christian Ministries. Pet. Ex. 26 at 1. According to his CV, Dr. Cates is the President and

Founder of Faith Christian Ministries where he provides Individual Cognitive Plans (“ICPs”) for

each student. Id. at 4. He has a Ph.D. in curriculum and instruction from Loyola University. Id.

Dr. Cates appears to have responded to a letter requesting him to provide information about

petitioner. In a letter dated September 30, 2016, he wrote about petitioner’s time as a student at

Faith Christian Ministries in 2003, 2004, and 2005 and the ICPs created for her based on testing.

Pet. Ex. 26 at 1. The family contacted Dr. Cates when they noted “extreme behavioral changes” in

petitioner at 5 and 6 years old. Testing showed signs of autism spectrum disorder. An educational

program was developed, and she was successful in her academic performance throughout 2003.

Id.

After further testing in 2004, Dr. Cates suggested she see Dr. Hall at the University of

Florida. Pet. Ex. 26 at 2. Following testing by Dr. Hall, petitioner was diagnosed with

hyperacusis. 34 He recommended OT and formal and comprehensive assessment of phonologic

awareness and reading comprehension by a speech pathologist. Petitioner had a “serious deficit in

maintaining attention during auditory tasks.” Id. Basic Trust Kindergarten in Kentucky was

recommended, and she was enrolled. She excelled in school in 2004. Id.

34

Hyperacusis is exceptionally acute hearing wherein the hearing threshold is unusually low. Dorland’s 875.

21

Petitioner was tested again by Dr. Cates in 2005, and a new educational plan was created

to be used at Churchill Academy. Pet. Ex. 26 at 2. He has not had regular contact with the family

since they pursued other educational options for petitioner. Id. at 3.

ii. School Records

Throughout her education, petitioner was homeschooled and attended various schools in

different states. Petitioner’s learning disabilities were evident early on and accommodations were

made to assist in her education.

Her records from Huntsville Christian Academy for 2005 showed that petitioner did well

despite “hardships on the rest of the family [that] were profound.” Pet. Ex. 20 at 11. Her records

for third and fourth grades (2005/2006 and 2006/2007) showed her to be an A student. Id. at 1.

She was withdrawn from Huntsville Christian Academy on January 22, 2007, and then

homeschooled. Id.; Pet. Ex. 23 at 6. She also attended Hope and A Future, Inc. during this

timeframe. See Pet. Ex. 22.

Petitioner attended The Ellis Academy from 2009-2011, where she was an average C+

student who excelled in the arts. Pet. Ex. 23 at 1, 3.

Petitioner attended Trinity Prep School from August 2012 through January 2013. Pet. Ex.

21 at 4, 13; Pet. Ex. 24. She took choir and dramatic arts at Master’s Academy of Visual &

Performing Arts and attended courses at Walton Youth Chorale. Pet. Ex. 21 at 5-8, 12.

Petitioner attended Strong Wall Academy in 2013-2014. Id. at 9; Pet. Ex. 25. The parent

questionnaire form includes that petitioner had “centralized auditory processing [and] visual

processing delays”. Pet. Ex. 25 at 4.

In addition to petitioner’s regular schooling, she also attended Faith Christian Academy,

which offers college-prep courses, from 2011-2014. Pet. Ex. 21 at 1.

iii. Pro Se Report

On December 5, 2019, petitioner submitted a 59-page document titled, “Pro Se Report -

Prong 1, 2 & 3 combined”. Pro Se Report, ECF No. 56-1. This document is authored by the mother.

She submits that Dr. McKean and Dr. Lacayo

. . . already expressed their confidence that it was more likely than not that the

vaccine and it’s (sic) components were the trigger that set off the catalyst of life

altering medical declines, but, the court felt that their documents, even coupled with

the vast amount of labs, and testing results that support their claims, were not

sufficient and that more expert witnesses were needed or those specialists needed

themselves to document how the Petitioner’s particular injury was caused or

triggered by the vaccine via the aforementioned mechanisms, including

requirements noted in Prong 3 that requires an expert to explain how the timing of

22

the onset of the Petitioners (sic) injuries supports a finding that the vaccine caused

the injury. Id. at 2.

In short, the mother argued that petitioner received a live vaccine contraindicated because

she is immunocompromised. The live vaccine triggered a “catalyst of Neuroimmune mediated

responses throughout her body and mind, that have permanently altered her life.” Pro Se Report at

54.

Much of the content of the Pro Se Report is repeated in the mother’s “Expert Opinion” and

petitioner’s response to the Motion to Dismiss, both of which are detailed below.

D. Expert Reports

i. Petitioner’s Experts/Treating Physicians

a. Letter from Dr. Juan Lacayo

Dr. Lacayo wrote two opinion letters. Pet. Ex. 10; Pet. Ex. 41.

In his first letter dated April 26, 2016, Dr. Lacayo wrote that petitioner presented to him

on July 18, 2013 with “dance-like tremors.” The only triggering mechanism identified was a

vaccine prior to the symptoms. Pet. Ex. 10 at 1. PANDAS and Wilson’s were excluded. Petitioner’s

condition then deteriorated with poor school performance and behavioral changes. An EEG

showed lateralized abnormality with epileptiform discharges. Id. She was prescribed Lamictal

from January to June of 2014 to stop epileptiform discharges from producing subclinical seizures.

She was evaluated by psychiatry as both an inpatient and outpatient. She could not maintain

enrollment in school. She was evaluated at Emory and had an improved EEG “when seizure

medication was increased to FDA-approved maximum dosage.” She continues to require treatment

for neuro-psychiatric disorders including but not limited to alteration in awareness and unspecified

tremors. She has recently been diagnosed with immune deficiencies which explains why her

neurological system responded adversely to live vaccines. Id.

Dr. Lacayo concluded that petitioner’s symptoms are due to the effects of the vaccine. He

recommended she have access to the vaccine compensation program because “the vaccine in [his]

medical opinion can be the causation of her symptomology.” Pet. Ex. 10 at 1.

In a second “Opinion Letter” dated January 25, 2021, Dr. Lacayo wrote that petitioner

presented on July 18, 2013 “with tremor” and “abnormal movements” and her “behavior

dramatically worsened during that time.” Pet. Ex. 41 at 1. An EEG performed in January 2014

showed “abnormal epileptiform activity”, but an MRI was normal. Seizure medication was started

based on the EEG results and reports of movements. Id.

Dr. Lacayo wrote that, in 2014, the mother advised him that petitioner’s tremor began in

July 2013—not earlier. Pet. Ex. 41 at 1. She advised him that petitioner received a varicella booster

on July 2, 2013 and presented to the ER within 72 hours with “uvula edema [and] respiratory

23

distress” requiring steroid injection. “It was after that time the tremor-like movements appeared.”

Work up for Wilson’s Disease and PANDAS were normal. Id.

Dr. Lacayo stated that after her ER visit, petitioner developed behavioral decline, severe

psychiatric problems, and cognitive decline, which he claimed was “evident by full scale IQ

change from 102 in July 2013 to 79 in August 2014”. Pet. Ex. 41 at 1. Medication showed some

clinical improvement. “It took 6 months for EEG to normalize…suspicion for encephalitis was

significant given the marked changes in a short period.” Id. She was “referred to Emory Epilepsy

Center” for continuing behavior problems and episodes of “’spacing out’”. Id. Emory’s test results

revealed epileptiform activity on EEG which had improved, but her behavior did not. Id.

According to Dr. Lacayo, throughout this time, petitioner took medications for “presumed

allergies”, and she was evaluated by Dr. Rivner for continued symptoms, and he diagnosed her

with myasthenia gravis. Pet. Ex. 41 at 1. A lumbar puncture showed “elevated WBCs and albumin,

confirming encephalitis, which is a condition in which the brain has diffuse inflammation causing

impairment in function as well as changes in behavior like agitation, behavior disturbances and

psychiatric disorders.” Id. at 1-2. Further, she was diagnosed with primary immunodeficiency by

Dr. McKean in 2015. Id. at 2. She had a difficult pregnancy due to myasthenia gravis, and the baby

had myasthenia gravis syndrome after delivery. Petitioner required IVIG due to her “MG crisis”

of profound weakness and decline in respiratory function. Id.

Dr. Lacayo added that with further history taking between himself and the mother, he

concluded that petitioner suffered a similar decline at age 5 following an MMR vaccine. Pet. Ex.

41 at 2. “Retrospectively, this may have been a similar, but milder, incident involving her immune

system which was evaluated but not diagnosed.” Id. Further research into her history was needed

to understand the changes that followed vaccinations. Id.

According to Dr. Lacayo, “immune-logically (sic) abnormal patients may experience more

adverse effects and are at a higher risk of adverse effects” from live attenuated vaccines like

varicella. Pet. Ex. 41 at 2. The package insert for varicella vaccine is associated with adverse

effects such as encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barre

syndrome, Bell’s palsy, ataxia, non-febrile seizures, aseptic meningitis, meningitis, dizziness, and

paresthesia. He claimed that the package insert also states that “[c]ases of encephalitis or

meningitis caused by vaccine strain varicella virus have been reported in immunocompetent

individuals previously vaccinated with VARIVAX months to years after vaccination.” Id. The

package insert was not filed into the record in this case.

Dr. Lacayo concluded that petitioner’s immune status was unknown when she received her

vaccines and “her neurological symptoms are a direct result from immune-mediated adverse

effects from vaccination; abnormal movements, abrupt behavior changes and epilepsy from

encephalitis, myasthenia gravis from abnormal immune system activation.” Pet. Ex. 41 at 2. Dr.

Lacayo added that petitioner’s diagnoses have accumulated since 2013 and include: anaphylactic

allergic reaction within 2-72 hours following vaccine; movement disorder with Chorea-Athetoid

Movements; Complex Partial Seizures with epileptiform discharges on EEG; neurocognitive and

IQ decline; exacerbation/aggravation of primary immune deficiency; immune related cerebral

injury; encephalitis; myasthenia gravis with acetycholine-receptor antibodies; major depressive

24

disorder; and psychosis. Id. at 2-3. He claimed “[s]he has permanent life plan alteration as a result

of the above diagnoses.” Id. at 3.

b. Letter from Dr. Lawrence McKean

On May 13, 2016, Dr. McKean wrote a letter stating that petitioner has primary immune

deficiency, specifically IgA, IgM, and Mannose Binding Lectin 35 Deficiency. Pet. Ex. 11 at 1. She

suffered an “adverse reaction to the Varicella Zoster (Shingles) vaccine” in July 2013. She then

had a decline in cognitive function and other neurological symptoms. “The fact that she was unable

to mount an immune response to the Varicella Zoster vaccine (negative IgG and IgM antibody to

varicella documented in 08/2015) provides further evidence that her immune deficiency is

clinically relevant. Indeed, it is an indication that she is at risk from any live virus vaccine.” Id.

(emphasis in original). Her immune deficiency was not known at the time she received the vaccine.

He concluded that petitioner “has had a severe adverse reaction from the Varicella Zoster vaccine.”

Id.

c. The Mother’s “Expert Opinion”

On March 2, 2021, the mother filed a document titled, “Various Medical Experts Combined

with Medical Theory, Logical Sequence with Temporal Relationship with Vaccine to Injury”. Pet.

Ex. 54. This 35-page document includes several embedded hyperlinks 36 to various sources to

satisfy the requirements set forth in Althen.

According to the mother, petitioner was unable to secure an attorney or an expert witness

“because of the wording of the Rule 4c, and the Petionn (sic) for Compensation.” Pet. Ex. 54 at 2.

Therefore, she cited that “[t]he leading experts on Vaccines are the CDC, ACIP and the Varicella

Vaccine Manufacturers”, who “testif[ied] in their own documentation of their medical theories

which more than causally connect the Varicella vaccine specifically to being INJURIOUS to those

who have Primary Immune Deficiency.” Id. at 1 (emphasis in original).

The mother submits that petitioner has Primary Immune Deficiency. The CDC

“contraindicates the administration of LIVE VACCINES (including MMR & Varicella) to

Primary/Congenital Immune Deficiencies children” and warns that the chicken pox vaccine is

contraindicated in those with a weakened immune system and history of immune system problems.

Pet. Ex. 54 at 2-3. 37 Additionally, the Pink Book provides that the most frequent complications

with varicella vaccine in immunocompromised individuals are pneumonia and encephalitis, which

35

Mannose Binding Lectin is a protein that is structurally similar to complement component C1 and recognizes many

microorganisms, including bacteria, fungi, parasites, and viruses. It initiates the lectin pathway of complement

activation, without the presence of antibody, by binding to carbohydrates on the microbial surface and activating C3.

Dorland’s 1003.

36

The various sources the mother cited to in this brief were embedded in the document but not filed into the record.

37

To support this statement, the mother cited to the following: Centers for Disease Control and Prevention,

Contraindications and Precautions, https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html;

Centers for Disease Control and Prevention, Chickenpox (Varicella) Vaccines,

https://www.cdc.gov/vaccinesafety/vaccines/varicella-

vaccine.html#:~:text=CDC%20recommends%20two%20doses%20of,age%204%20to%206%20years.

25

is what happened to petitioner. Id. at 3. 38 She further listed all the post-marketing adverse events

contained in the varicella vaccine insert. Id. at 4. 39

The mother argued that children are not tested for “Innate Immune system competency”

prior to being administered live vaccinations. Petitioner’s immunodeficiency was not discovered

“until the damage had already been done.” Pet. Ex. 54 at 4, 6. The mother claimed that petitioner

suffered many childhood illnesses but did not get an immune blood workup as a child, so she

received vaccines that were contraindicated for her, including the subject varicella vaccine at age

sixteen. Id. at 4-6; see also Pet. Ex. 52.

The mother submitted that petitioner obtained several diagnoses, “all of which were new

onset, following the July 2, 2013 Varicella Vaccine.” Pet. Ex. 54 at 5; see also Pet. Ex. 41 at 2-3.

The mother further claimed that Dr. Helmers, the Chief of Epilepsy at Emory, diagnosed

petitioner with “a Neuro-Immune mediated brain injury”, but informed the parents that there was

no one qualified at Emory or in the state of Georgia to treat petitioner. Thus, Dr. Helmers suggested

petitioner go to the University of Pennsylvania. Pet. Ex. 54 at 6.

The mother submits that petitioner was seen by Dr. Rivner, a leading specialist in

myasthenia gravis, who performed a lumbar puncture and sent her spinal fluid to the University of

Pennsylvania for testing. Pet. Ex. 54 at 6-7. Dr. Rivner diagnosed petitioner with myasthenia

gravis.

The mother further submits that Dr. McKean cautioned petitioner not to receive any more

live vaccines because “he was confident that Vaccine had done the damage.” Pet. Ex. 54 at 7; see

also Pet Ex. 11. The mother conceded that Dr. McKean’s letter did not provide a “mechanism by

which the vaccine does in fact harm primary immune deficiency patients” but stated that is because

it appears that no one knows the mechanism. Pet. Ex. 54 at 7.

The mother then proposed several medical theories in this case to satisfy Althen.

1. Medical Theory #1

The mother’s first theory was based on the contraindications for administering varicella

vaccine to those who are immunocompromised or have a family history of immunocompetence.

Pet. Ex. 54 at 9-10. 40 For Prong I, she argued that in immunocompromised individuals, live

vaccines may cause severe systemic disease and are documented as unsafe by the National Institute

of Health. Id. at 10, 21. She argued that petitioner has congenital B-cell immunodeficiency,

combined variable immunodeficiency, and quantitative immunoglobulin levels based on blood

work ordered by Dr. McKean and Dr. Rivner. Id. at 10-11. 41

38

To support this statement, the mother cited to the following: Adriana Lopez, MHS, et al., Varicella, in

EPIDEMIOLOGY AND PREVENTION OF VACCINE-PREVENTABLE DISEASES 329, 332 (14th ed. 2021).

39

The mother cited to the following: U.S. Food & Drug Administration, Package Insert – Varivax – Frozen Storage,

https://www.fda.gov/media/119865.

40

Supra, note 37.

41

The mother did not cite to petitioner’s medical records. Petitioner’s records show that she had mildly low levels of

IgA and IgM, normal IgG, and low Mannose-Binding Lectin. Pet. Ex. 39 at 7, 10.

26

For Prong II, she argued that upon receipt of the varicella vaccine on July 2, 2013,

petitioner suffered a “systemic inflammatory response” initially presenting as airway restriction

requiring the use of Albuterol via nebulizer “at 24 hours post vaccine, continuing for the next

week”. 42 Pet. Ex. 54 at 11. At 72 hours post-vaccination, petitioner had difficulty breathing, airway

restriction, and an enlarged uvula, prompting an ER visit. The ER doctor administered Solu-

Medrol for an allergic response. Neurological signs manifested that same week with a tremor that

had never been identified prior on the record; in the alternative, if the tremor was present prior to

vaccination, it was “severely aggravated”. Id. Petitioner developed other neurological signs of

inflammation, including “mood alterations, personality changes, agitation, irritability, mood

lability, aggressiveness, impaired insight”, which were “early indicators of CNS involvement and

likely early encephalitis, indicating the Blood brain barrier had likely failed to protect the CNS

from invasion due to the immunodeficient status of [petitioner].” Id. at 11-12. Progressive signs of

CNS inflammation continued with decline in IQ and academic performance, which suggested

encephalitis. Id. at 12. Brief stares and alteration of consciousness led to EEG testing, which

showed evidence of a systemic attack on the brain either from the live virus or its components

causing epileptiform discharges and cerebral dysfunction in the left hemisphere. Id. She developed

psychiatric issues and “[t]he formation of Autoimmunity by the appearance of AChR antibodies

manifesting as NEW ONSET Myasthenia Gravis.” Id. (emphasis in original). She also had

episodes of rashes, hives, urticaria, itching, and paresthesia. Id.

For Prong III, the mother argued that the “onset of complications in the form of allergic

reaction definitely correlates with the introduction of the contraindicated live vaccine on July 2,

2013, into the host and all diagnosis (sic) that follow.” Pet. Ex. 54 at 13. She had a severe

aggravation of a mild movement disorder which evolved into “worrisome chorea athetoid

movement disorder”. Id. Petitioner was diagnosed with several conditions after the

“contraindicated vaccination”, including epilepsy, seizure disorder, complex partial seizures,

nystagmus, ataxia, cerebral dysfunction, all psychiatric symptoms, myasthenia gravis, major

neurocognitive disorder/dementia, encephalopathy, encephalitis, major depressive disorder,

immune mediated brain injury, HHV6 reactivation, and personality disorder. Id.

2. Medical Theory #2

For her second medical theory, the mother argued that the varicella virus has been

documented as an etiology for myasthenia gravis via molecular mimicry. Thus, the vaccine could

cause a person to make auto antibodies to AChR via molecular mimicry, as well. Pet. Ex. 54 at 14.

The mother cited to an abstract of a case report 43 of a five-year-old presenting with oculobulbar

weakness two weeks after varicella zoster infection and a four-year-old who developed facial

diplegia and dysarthria several weeks after viral pharyngitis. Id. Molecular mimicry between

AChR and viral proteins was considered a possible immune response to the variant of myasthenia

gravis. Id.

42

Petitioner’s use of Albuterol one day after the vaccine is not documented in the medical records.

43

The mother cited to the following: Kevin J. Felice et al., Postinfectious Myasthenia Gravis: Report of Two Children,

20 J. OF CHILD NEUROLOGY 441 (2005).

27

For “MECHANISM 2”, the mother submitted that petitioner developed antibodies “as a

result of residual DNA ingredients in varicella vaccination that are human and cross reactive,

which resulted in neuropsychiatric manifestations, including epilepsy, and connective tissue

disorder and movement disorders.” Pet. Ex. 54 at 15. As “Proof”, she stated that the “varicella

vaccine (Varivax) contains ingredients, proteins and DNA that are human derived and can cause

autoimmunity, specifically, the MRC-5 cells, which the FDA acknowledges contains ‘small

amounts of residual cell substrate DNA in all viral vaccines.’” Id. 44 Citing Wikipedia, she listed

the ingredients of the varicella vaccine and stated that MRC-5 is a human diploid cell culture line

composed of fibroblasts from fetal lung tissue, with fibroblasts as the most common cell of

connective tissue in animals. Id. Further, the mother argued that an FDA Briefing Document 45

states that small amounts of residual cell substrate DNA occur in all viral vaccines and can be

oncogenic or infectious. Id.

3. Medical Theory #3

The third medical theory also involves petitioner being immunocompromised prior to her

being vaccinated with live vaccines and the lack of testing for “Immunocompetence” prior to

administering live vaccines to children. Pet. Ex. 54 at 16. She submits that the information given

to parents prior to vaccinations is inadequate. Id.

According to the mother, petitioner’s “fate [was] already known by all Vaccine authorities”

in that her immunodeficiency “would be immediately aggravated by an antibody Mediated

Autoimmune Response.” Pet. Ex. 54 at 16, 21 (emphasis in original). Citing an article 46 involving

anaphylaxis, the mother argued that petitioner’s initial “Insult” involved a “BiPhasic Anaphylactic

Reaction”, which included an asthma attack within an hour of receiving the varicella vaccine. Id.

at 16-17. She described the mechanism involved in an asthma attack and how an allergic response

occurs when antibodies mistakenly identify a harmless substance as an invader, like the antigen or

components of the live vaccine, and attempts to protect the body by binding to the allergen. Id. at

18. 47 She claimed that there are a few treatments that are designed to treat both asthma and

allergies, such as a leukotriene modifier. Id. at 22. 48

The mother stated that the cause of autoimmunity is not known but is theorized to be due

to environmental factors, like bacteria or viruses, that trigger “changes that confuse the immune

system.” Pet. Ex. 54 at 22. 49 In genetically susceptible people, environmental triggers may induce

44

It is not clear where this quote comes from.

45

FDA Briefing Document, Vaccines and Related Biological Products Advisory Committee Meeting: Cell Lines

Derived from Human Tumors for Vaccine Manufacture, https://wayback.archive-

it.org/7993/20170113080336/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Bl

oodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM319573.pdf.

46

James J. Arnold, D.O. & Pamela M. Williams, Col., Lt., USAF, MC, Anaphylaxis: Recognition and Management,

84 AM. FAMILY PHYSICIAN 1111 (2011).

47

The mother cited to the following to support this statement: James T.C. Li, M.D., Ph.D., Allergies and Asthma:

They Often Occur Together, https://www.mayoclinic.org/diseases-conditions/asthma/in-depth/allergies-and-

asthma/art-20047458.

48

Id.

49

The mother cited to the following to support this statement: National Library of Medicine: MedlinePlus,

Autoimmune Disorders, https://medlineplus.gov/ency/article/000816.htm.

28

the formation of neoantigens or autoantigens that are recognized by the body’s immune system.

The body’s inflammatory process creates antibodies in response. Id. at 23. 50

The mother then described several mechanisms by which an environmental trigger may

induce autoimmunity, beginning with molecular mimicry. Pet. Ex. 54 at 23. 51 The body’s immune

response to foreign antigens that “bear sufficient structural similarity to self-antigens” results in

the activation of T cells that cross react with self-antigens. Id. Next, epitope spreading is where

the “immune system expands its response beyond the original epitope recognized by T or B cells

to induce the release of non-cross-reactive epitopes that are recognized by the immune system

later.” Id. at 23-24. Bystander activation occurs when foreign antigens “stimulate toll-like

receptors and other pattern recognition receptors become activated in the inflammatory

environment” causing the release of proinflammatory cytokines that may damage tissues or release

antigens that activate autoreactive T cells. Id. at 24. Finally, polyclonal activation of B cells is due

to persistent viral infection, where “monospecific clones can emerge, accompanied by very high

levels of antibody production and the formation of circulating immune complexes . . . [and] may

cause the autoimmune disease”. Id. 52 The mother also included paragraphs related to “PNS”,

“PCD”, “peripheral blood lymphocytes”, and “anti-Hu syndrome” although the relevance of these

excerpts is never stated and is unclear. 53 Id. at 25-27.

The mother next explained that autoimmune encephalitis occurs when the immune system

“mistakenly attacks healthy brain cells, leading to inflammation of the brain.” Patients may present

with neurologic and psychiatric symptoms. Pet. Ex. 54 at 27. 54 She also included several excerpts

related to “Autoimmune Epilepsy”. Id. at 28. 55 Additionally, she provided a reference 56 that

explains the disease process of autoimmune myasthenia gravis and quoted excerpts from an

unknown source 57 regarding immune-mediated movement disorders. Neither source discusses

vaccines. Id. at 28-32.

Finally, the mother cited an article 58 that discusses a potential link between autoimmunity

and severe mood and psychotic symptoms. Pet. Ex. 54 at 33-34.

50

Aristo Vojdani, A Potential Link Between Environmental Triggers and Autoimmunity, 2014 AUTOIMMUNE DISEASES

1 (2014).

51

Id.

52

Id.

53

The mother argued that petitioner’s lumbar puncture showed pleocytosis with elevated white blood cells, evidencing

that her nervous system “had been infiltrated.” Pet. Ex. 54 at 25. The article she cited thereafter stated that pleocytosis

appears in patients with PNS. Id.; Mikolaj Piotr Zaborowski & Slawomir Michalak, Cell-Mediated Immune Responses

in Paraneoplastic Neurological Syndromes, 2013 J. OF IMMUNOLOGY RES. 1 (2013).

54

The mother cited to Genetic and Rare Diseases Information Center, Autoimmune Encephalitis,

https://rarediseases.info.nih.gov/diseases/11979/autoimmune-encephalitis.

55

The mother cited to Epilepsy Foundation, Autoimmune Epilepsy, https://www.epilepsy.com/causes/autoimmune.

56

Bastien Joubert & Jerome Honnorat, Autoimmune Channelopathies in Paraneoplastic Neurological Syndromes,

1848 ELSEVIER 2665 (2015).

57

The embedded hyperlink for this source does not work.

58

Giuseppe Quaranta et al., Psychotic and Nonpsychotic Mood Disorders in Autoimmune Encephalitis: Diagnostic

Issues and Research Implications, 2 NEUROSCIENCES 228 (2015).

29

The mother detailed events which she claims occurred in petitioner’s lungs immediately

following petitioner’s receipt of the varicella vaccine. 59 Pet. Ex. 54 at 20. The mother submits that

upon arriving home after receipt of the varicella vaccine, petitioner had to use her inhaler and her

sister’s nebulizer for the next three days with some improvement. Id. Petitioner did not inform the

mother of these symptoms and did not recall how soon after her vaccine she experienced the first

asthma attack. Nevertheless, the mother submits that “it is possible that she initiated the first pMDI

inhaler, within the first 30 min, because she report[ed] an ‘asthma attack’ soon after arriving

home.” Id. at 20-21. Petitioner then used the inhalers for over 48 hours since receiving the vaccine

and until the mother observed petitioner’s swollen airway and enlarged uvula within 72 hours of

the vaccine. Id. at 21. Petitioner visited the ER within 72 hours of the vaccination. Thus, the mother

concluded that “it is entirely possible and reasonable to deduct (sic) that the Petitioner was not

only experiencing signs of ANAPHYLAXIS BEFORE 4 HOURS FOLLOWING

VACCINATION, but, DID IN FACT CONTINUE to experience A BIPHASIC

ANAPHYLACTIC REACTION THAT BECAME MORE SEVERE after 48 hours and before 72

hours post Vaccination.” Id. at 21-22 (emphasis in original).

The mother claimed that the ER treaters failed to give petitioner the appropriate

medication. They did not administer epinephrine but instead gave a solu-medrol injection. Pet. Ex.

54 at 22.

i. Respondent’s Expert

a. Expert Report from Dr. Max Wiznitzer

Respondent submitted one report from Dr. Wiznitzer. Resp. Ex. A. Dr. Wiznitzer obtained

his medical degree from Northwestern University and completed a fellowship in pediatric

neurology at the Children’s Hospital of Philadelphia thereafter. Resp. Ex. B.

Dr. Wiznitzer provided a detailed summary of petitioner’s medical history. Resp. Ex. A at

1-10. Specifically, he documented petitioner’s below average scores on academic testing, sensory

disturbance, and evidence of abnormal attention prior to vaccination. Id. at 1-2. He also

documented that petitioner “had no signs or symptoms of anaphylaxis” when she presented to the

ER on July 5, 2013. Id. at 2; see Pet. Ex. 3.

Dr. Wiznitzer then summarized the letters submitted by petitioner’s treaters Dr. Lacayo

and Dr. McKean. Resp. Ex. A at 10-12.

Dr. Wiznitzer opined that petitioner had longstanding learning issues and fluctuating

grades prior to 2013. Her IQ test between July 2013 at 91 and March 2016 at 87 showed “no

significant difference”. Her transient lower IQ measured in August 2014 can be explained by her

mood and anxiety and known attention deficit disturbance, likely aggravated by her depression.

Thus, there was “no evidence of an actual neurocognitive/IQ decline as opined by Dr. Lacayo.”

Resp. Ex. A at 12.

59

The events she described are not contained in any medical record or petitioner’s affidavit and were presented for

the first time in this document. See Pet. Ex. 1.

30

Further, petitioner had long standing attention and anxiety disorders, described as a

“sensory disturbance” in records from Cincinnati Children’s Hospital in 2002, as well as

throughout her psychiatric and psychological assessment records prior to her vaccination in 2013.

Resp. Ex. A at 12. Contemporaneous medical records do not show any significant worsening in

her cognitive function, learning skills, or mental health following her childhood MMR vaccine or

her first varicella vaccine. Recurrent ear infections improved after her tonsils and adenoids were

removed, though she did not have an abnormal number of annual infections for a child. Id.

Petitioner’s emergency room visit on July 5, 2013 was not consistent with anaphylaxis.

She had an acute infection with small throat exudate still found on examination a week later.

Rather, her presentation was consistent with acute infection of strep. Further, even if it were

anaphylaxis, it was outside the timeframe considered to be medically reasonable for a vaccine

reaction. Resp. Ex. A at 12-13; Resp. Ex. A Tab 1 at 3. 60

Petitioner complained of a tremor during her visit on July 2, 2013 and prior to her

vaccination. The tremor was reported on July 18, 2013 as lifelong and unremarkable. In the fall of

2013, a differential diagnosis for her movements and mood disturbance included inborn error of

metabolism or autoimmune encephalitis. Testing ruled out both, “leaving the likely diagnosis of

psychogenic as the reason for the observed movements.” Resp. Ex. A at 13. Another possible

diagnosis was choreiform movements which are subtle neurologic signs that occur in those with

developmental challenges but are not vaccine related. Id. Petitioner was diagnosed with functional

neurological disorder (i.e. psychogenic disorder), which appeared several times in the medical

records. In combination with the physical manifestations of her mental health disorders, a

diagnosis of psychogenic disorder explains the fluctuating and, at times, non-physiological nature

of her complaints. Id.

Dr. Wiznitzer addressed petitioner’s behavioral changes observed around September 2013

that improved with lamotrigine and later in 2019 with fluoxetine. He opined that her behavioral

changes and improvement with these medications were consistent with a diagnosis of psychogenic

disorder. Resp. Ex. A at 13. Petitioner underwent extensive testing, which did not reveal any

evidence of immune mediated causation. Although petitioner attempted to characterize her mood

disorder as autoimmune encephalitis, her mood disorder was more likely the result of her ADHD

and anxiety with increasing demands as she grew older. Id. She improved without intervention,

which would not be expected if an autoimmune disorder were present. Specifically, her

improvement with the use of an antidepressant would not be expected if it were autoimmune

encephalitis. A “[m]ood disorder is a known comorbidity of ADHD that presents in the adolescent

years.” Id.

Dr. Wiznitzer further submitted that there was no support in the medical records for a

diagnosis of epilepsy. Extended EEG testing showed “no EEG changes consistent with seizures in

association with” any behavioral changes, such as staring/inattention, emotional changes,

repetitive blinking, and focal twitching. Resp. Ex. A at 13. On August 19, 2015, epilepsy was ruled

out at Emory based on a prolonged EEG. Id. at 13-14. Dr. Wiznitzer explained that “focal slowing

in the left more than right temporal areas and sharply contoured waveforms” are nonspecific in

etiology and occurred without clinical correlation. Epilepsy requires both a clinical description and

60

42 C.F.R. §100.3.

31

EEG correlate. Id. at 14. Here, the likely explanation for the EEG findings was her longstanding

history of learning and attentional challenges which long predated the subject vaccine. Id.; Resp

Ex. A Tab 3. 61

Dr. Wiznitzer pointed to the objective testing that showed no evidence of immune mediated

cerebral injury, autoimmune or infectious encephalitis, or any brain injury at all. Two MRIs in

2014 were normal with no evidence of acute or remote brain injury. Extensive testing for

autoimmune antibodies was negative. Lumbar puncture found no evidence of inflammatory

process. Resp. Ex. A at 14. Dr. Wiznitzer addressed Dr. Lacayo’s conclusion that petitioner had

encephalitis based on an elevated albumin level, explaining that this conclusion was flawed

because Dr. Lacayo failed to recognize that it is CSF protein—not serum albumin—that is the

potential marker for encephalitis; petitioner’s CSF protein was normal. Id.; Resp. Ex. A Tab 4. 62

Dr. Wiznitzer further noted that petitioner had no clinical features consistent with encephalitis as

noted by her treating physicians. Regardless, this testing was done two years after the vaccination,

so any findings could not be ascribed to the vaccination even if they had been abnormal. Resp. Ex.

A at 14.

Dr. Wiznitzer contends that petitioner experienced no worsening/exacerbation of her

immune deficiency between 2013 and 2019 until she was pregnant and when IgG levels are known

to decrease. Resp. Ex. A at 14; Resp. Ex. A Tab 5. 63

Dr. Wiznitzer discussed petitioner’s diagnosis of MG in 2019, noting that she had a positive

acetylcholine receptor antibody titer in 2015 with no clinical correlate. In 2019, she had subjective

complaints of fatigue/weakness but no muscle weakness on examination and borderline single

fiber EMG results. Resp. Ex. A at 14-15. Her breathing complaints improved with her asthma

treatments, which is not typical for MG-associated breathing problems. Even so, the diagnosis of

MG was more than five years after the subject vaccination and without biological process to

explain the association; thus, her MG is also unrelated to the subject vaccine. Id. at 15.

Further, Dr. Wiznitzer noted that petitioner had no features of encephalitis/meningitis that

can be attributed to either wild type varicella virus or the vaccine. He addressed Dr. Lacayo’s

reliance on the list of adverse reactions post marketing for Varivax vaccine, noting that Dr. Lacayo

did not include the sentence before that list in the insert that states that the listed adverse events

“are reported voluntarily from a population of uncertain size, [so] it is not always possible to

reliably estimate their frequency or establish a causal relationship to vaccine exposure.” Resp. Ex.

A at 15 (emphasis in original). Dr. Wiznitzer concluded that “[s]ince a causal relationship cannot

be established, the significance and applicability of the reported events cannot be used to prove a

cause-effect relationship.” Id.

61

Selim R. Benbadis, The EEG in Nonepileptic Seizures, 23 J. OF CLINICAL NEUROPHYSIOLOGY 340 (2006), filed as

“Resp. Ex. A Tab 3.”

62

Tania Cellucci, MD, MScCH et al., Clinical Approach to the Diagnosis of Autoimmune Encephalitis in the Pediatric

Patient, 7 NEUROLOGY NEUROIMMUNOLOGY & NEUROINFLAMMATION e663 (2020), filed as “Resp. Ex. A Tab 4.”

63

Zhang Tingting et al., Changes of Serum Immunoglobulin Level in Healthy Pregnant Women and Establishment of

Its Reference Interval, 46 J. OF CENT. S. U. (MED. SCI.) 53 (2021), filed as “Resp. Ex. A Tab 5.”

32

In concluding, Dr. Wiznitzer opined that no evidence exists in the record that the July 2,

2013 varicella vaccination caused or aggravated any of petitioner’s conditions. Neither Dr. Lacayo

nor Dr. McKean offered a plausible medical theory that reliably links her vaccinations to any of

her medical conditions. In short, “there is no evidence that any of [petitioner’s] vaccinations had

any adverse impact on her health.” Resp. Ex. A at 15.

III. The Parties’ Arguments

A. Respondent’s Motion to Dismiss

Respondent filed his motion to dismiss on March 4, 2020. He noted that petitioner alleged

that she suffered from “a seizure disorder, cerebral injury, Major Neurocognitive Disorder,

athetosis, chorea, and/or neurologic, physchiatric (sic), and physical impairments and other injuries

that were ‘caused-in-fact’” by the varicella vaccine received on July 2, 2013. Resp. Motion at 1;

Petition at 1. Respondent moved to dismiss on the grounds that petitioner has failed to prove her

varicella vaccination was the cause-in-fact of any of her alleged injuries. Resp. Motion at 1.

Respondent summarized the procedural history, including the Pro Se Report the mother

filed on December 5, 2019. Resp. Motion at 2-3; Pro Se Report. After summarizing petitioner’s

medical history, respondent provided the legal requirements for how a vaccine claim may be

proven, i.e. as an On-Table claim or as causation-in-fact claim requiring a petitioner to satisfy all

three Althen prongs. Resp. Motion at 11-12.

Respondent argued that it is the petitioner’s burden to prove that she suffered a vaccine

related injury and petitioner’s claims alone are not sufficient. Resp. Motion at 12. A petitioner’s

claims must be supported by the medical records and/or a credible expert opinion. Id.; § 13(a)(1);

Lett v. Sec’y of Health & Human Servs., 39 Fed. Cl. 259, 262-63 (1997). Here, although petitioner

believes she suffered from a vaccine related injury, her references to the record are unpersuasive

and it is unclear that she even suffered the injuries she alleged. Resp. Motion at 12; see Lombardi

v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1352-53 (Fed. Cir. 2011); Broekelschen v.

Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010).

Respondent addressed Dr. Lacayo’s records documenting “the cause and effect relationship

with [her varicella] vaccine is not known” which he discussed with petitioner’s pediatrician. Resp.

Motion at 13; Pet. Ex. 2 at 5, 8. Dr. Dyer was similarly unable to provide a specific connection or

diagnosis supported by the DSM-5, other than to write “evidence suggests a causative link between

vaccinations and periods of cognitive decline”. Resp. Motion at 13; Pet. Ex. 6 at 6. During

petitioner’s visit on July 3, 2018, five years later, Dr. Lacayo wrote that the onset of petitioner’s

tremors “could have been immune-related reaction to live vaccine”, but his reasoning seemed

“odd” in light of his prior skepticism about a potential link between the vaccination and petitioner’s

health. This conclusory opinion is unpersuasive. Resp. Motion at 13; Pet. Ex. 40 at 21. Respondent

argued that physicians’ conclusions are only as good as the evidence that supports them. Resp.

Motion at 13; Davis v. Sec’y of Health & Human Servs., 20 Cl. Ct. 168, 173 (1990); see also

Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1323 (Fed. Cir. 2010).

Thus, Dr. Lacayo’s conclusory opinion is unpersuasive. Resp. Motion at 13. Respondent argued

33

that none of the treating physicians “provide[d] a medical theory, much less a logical sequence of

cause and effect showing how the vaccination caused petitioner’s injuries.” Id. at 13-14.

Respondent highlighted the various notations in the record which were based on “assertions

made by petitioner’s mother.” Resp. Motion at 14. At the ER on July 5, 2013, the mother reported

that petitioner was having an allergic reaction to the varicella vaccine. Id.; Pet. Ex. 3 at 2-3. The

medical record documents no signs of anaphylaxis. Id. Nevertheless, on August 3, 2015, the

mother reported to Dr. Helmers that petitioner had an “anaphylactic reaction” three days after the

varicella vaccine. Resp. Motion at 14; Pet. Ex. 9 at 33. In March of 2014, the mother reported to

the pediatrician that Dr. Lacayo attributed petitioner’s symptoms to the varicella vaccine. Resp.

Motion at 14; Pet. Ex. 2 at 5. The pediatrician then telephoned and confirmed with Dr. Lacayo that

Dr. Lacayo was unsure of the relationship. Id.

Further, respondent detailed other inconsistencies of purported vaccine injuries reported to

various providers. In her first visit with Dr. Lacayo, petitioner and the mother reported hand

tremors since birth. Resp. Motion at 14; Pet. Ex. 2 at 14-16. In January 2016, petitioner and the

mother reported that the tremors began two years ago, after 64 the subject vaccination. Resp. Motion

at 14; Pet. Ex. 12 at 24. They also reported to Drs. Dyer, Helmers, and Rivner that petitioner

developed tremors shortly after the vaccination. Resp. Motion at 14; Pet. Ex. 6 at 2; Pet. Ex. 9 at

33; Pet. Ex. 12 at 65.

Respondent concluded that, without an expert report that explains how the varicella

vaccination caused petitioner’s injuries, petitioner is unable to meet her burden of proof. Resp.

Motion at 14. Petitioner’s Pro Se Report, in which the mother submitted her own opinions, is

insufficient. The mother is not a medical expert in this case, nor is she qualified to opine on issues

of medical causation. Id. at 14-15. Further, the Pro Se Report does not contain a medical theory or

offer a logical sequence of cause and effect. Id. at 15. At best, the Pro Se Report can be construed

as legal argument. Without an expert addressing the Althen prongs, petitioner has failed to establish

entitlement and the case should be dismissed. Id.

B. Petitioner’s Response

Petitioner filed a response on March 1, 2021, in which the mother stated that “[i]t is the

full intention of the petitioner to show by preponderance of evidence” that the vaccine caused

petitioner’s injuries. Pet. Response, ECF No. 77-1. Throughout the response, the mother

inaccurately referenced arguments made by respondent in his Motion to Dismiss as findings of the

Court. Id. at 2, 10, 12, 17-18, 22, 24-25, 26, 27, 31, 32, 33-34, 41-42, 44-45. 65 Additionally, the

mother seems to conflate the Court’s role with petitioner’s burden in prosecuting and proving her

own claims. Id. at 5 (The mother wrote that the court “did not reach out to [Dr. McKean] to explain

64

Respondent stated that petitioner and the mother reported hand tremors two years prior to the vaccination. Resp.

Motion at 14. However, the medical record he cited reflects that they reported the tremors began two years prior to

the visit, after the vaccine. See Pet. Ex. 12 at 24.

65

For example, the mother submitted that “The court charges that the petitioner has not met her burden of proof” and

that “The court falsely claims to not be able to find a vaccine related injury or death that occurred and implies that any

claims of injuries is or has been (sic) based solely upon the claims of the petitioner.” Pet. Response at 2. She later

argued that “The court again misrepresents the facts and the truth by stating, ‘the ER did not find any signs or

symptoms of anaphylaxis.’” Id. at 27.

34

prongs and the Althen criteria.”). Petitioner’s response relied on both the mother’s “expert report”

and the Pro Se Report. See Pet. Ex. 54; Pro Se Report.

The mother argued that petitioner’s medical records and physicians substantiate her claims

of various injuries, including but not limited to major neurocognitive disorder, myasthenia gravis,

epilepsy, complex partial seizures, neurological immune mediated brain injury, major depressive

disorder, borderline personality disorder, dementia, and encephalitis. Pet. Response at 3-9. She

contended that preponderant evidence shows that petitioner suffered at least twenty-one injuries

since the 2013 varicella vaccine, in addition to “countless more injuries identified from the

multiple ways those injuries have negatively impacted” her life. Id. at 10-11. The mother then

included portions of the medical records—without any citations—to support the claims of

petitioner’s numerous injuries.

The mother referenced Dr. Lacayo’s written opinion dated April 26, 2016, arguing that it,

in combination with information from the CDC and the vaccine package insert, is sufficient to

prove causation. Pet. Response at 22-25; see also Pet. Ex. 10. She concluded that “[m]uch data

have been gathered that more than suggested a correlation between the petitioners (sic)

immunodeficiency and her poor response to the live vaccine entering her body.” Pet. Response at

26.

Finally, the mother expressed her discontent with the healthcare system in the United

States, as physicians have little time with patients, records are difficult to access, and quality

physicians willing to treat rare conditions are difficult to come by. She also discussed the impact

petitioner’s various conditions have had on her and the rest of her family. Pet. Response at 38-46.

IV. Applicable Law

The Vaccine Act provides two avenues for petitioners to receive compensation. First, a

petitioner may demonstrate a “Table” injury—i.e., an injury listed on the Vaccine Injury Table

that occurred within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is

presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006);

see § 13(a)(1)(B). Second, where the alleged injury is not listed on the Vaccine Injury Table, a

petitioner may demonstrate an “off-Table” injury, which requires that the petitioner “prove by a

preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at

1320; see § 11(c)(1)(C)(ii). Initially, a petitioner must provide evidence that he or she suffered, or

continues to suffer, from a definitive injury. Broekelschen v. Sec’y of Health & Human Servs., 618

F.3d 1339, 1346 (Fed. Cir. 2010). A petitioner need not show that the vaccination was the sole

cause, or even the predominant cause, of the alleged injury; showing that the vaccination was a

“substantial factor” and a “but for” cause of the injury is sufficient for recovery. See Pafford v.

Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006); Shyface v. Sec’y of Health

& Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999).

To prove causation for an “off-Table” injury, petitioners must satisfy the three-pronged test

established in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen

requires that petitioners show by preponderant evidence that a vaccination petitioner received

caused his or her injury “by providing: (1) a medical theory causally connecting the vaccination

35

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 a proximate temporal relationship between vaccination

and injury.” Id. at 1278. Together, these prongs must show “that the vaccine was ‘not only a but-

for cause of the injury but also a substantial factor in bringing about the injury.’” Stone v. Sec’y of

Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quoting Shyface, 165 F.3d at 1352-

53). Causation is determined on a case-by-case basis, with “no hard and fast per se scientific or

medical rules.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).

Petitioners are not required to identify “specific biological mechanisms” to establish causation,

nor are they required to present “epidemiologic studies, rechallenge, the presence of pathological

markers or genetic disposition, or general acceptance in the scientific or medical communities.”

Capizzano, 440 F.3d at 1325 (quoting Althen, 418 F.3d at 1280). “[C]lose calls regarding causation

are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280.

Each of the Althen prongs requires a different showing. The first Althen prong requires

petitioners to provide a “reputable medical theory” demonstrating that the vaccines received can

cause the type of injury alleged. Pafford, 451 F.3d at 1355-56 (citation omitted). To satisfy this

prong, petitioners’ “theory of causation must be supported by a ‘reputable medical or scientific

explanation.’” Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379

(Fed. Cir. 2009) (quoting Althen, 418 F.3d at 1278). This theory need only be “legally probable,

not medically or scientifically certain.” Id. at 1380 (emphasis omitted) (quoting Knudsen, 35 F.3d

at 548). Nevertheless, “petitioners [must] proffer trustworthy testimony from experts who can find

support for their theories in medical literature.” LaLonde v. Sec’y of Health & Human Servs., 746

F.3d 1334, 1341 (Fed. Cir. 2014).

The second Althen prong requires proof of a “logical sequence of cause and effect.”

Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). In other words, even if the

vaccinations can cause the injury, petitioners must show “that it did so in [this] particular case.”

Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation omitted).

“A reputable medical or scientific explanation must support this logical sequence of cause and

effect,” id. at 961 (citation omitted), and “treating physicians are likely to be in the best position

to determine whether a logical sequence of cause and effect show[s] that the vaccination was the

reason for the injury,” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1385 (Fed. Cir.

2015) (quoting Andreu, 569 F.3d at 1375). Petitioners are not, however, required “to eliminate

alternative causes as part of establishing [their] prima facie case.” Doe v. Sec’y of Health & Human

Servs., 601 F.3d 1349, 1357-58 (Fed. Cir. 2010); see Walther v. Sec’y of Health & Human Servs.,

485 F.3d 1146, 1152 (Fed. Cir. 2007) (holding that a “petitioner does not bear the burden of

eliminating alternative independent potential causes”).

To satisfy the third Althen prong, petitioners must establish a “proximate temporal

relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This

“requires 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-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir.

2008). Typically, “a petitioner’s failure to satisfy the proximate temporal relationship prong is due

to the fact that onset was too late after the administration of a vaccine for the vaccine to be the

cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case, the

36

temporal relationship is not such that it is medically acceptable to conclude that the vaccination

and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Human Servs., 685

F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was administered,

logically, the vaccine could not have caused the illness.”).

A. Legal Standard Regarding Fact Finding

The process for making determinations in Vaccine Program cases regarding factual issues

begins with analyzing the medical records, which are required to be filed with the petition. §

11(c)(2). Medical records created contemporaneously with the events they describe are generally

considered to be more trustworthy. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525,

1528 (Fed. Cir. 1993); but see Kirby v. Sec’y of Health & Human Servs., 993 F.3d 1378, 1382-83

(Fed. Cir. 2021) (clarifying that Cucuras does not stand for proposition that medical records are

presumptively accurate and complete). While not presumed to be complete and accurate, medical

records made while seeking treatment are generally afforded more weight than statements made

by petitioners after-the-fact. See Gerami v. Sec'y of Health & Human Servs., No. 12-442V, 2013

WL 5998109, at *4 (Fed. Cl. Spec. Mstr. Oct. 11, 2013) (finding that contemporaneously

documented medical evidence was more persuasive than the letter prepared for litigation

purposes), mot. for rev. denied, 127 Fed. Cl. 299 (2014). Indeed, “where later testimony conflicts

with earlier contemporaneous documents, courts generally give the contemporaneous

documentation more weight.” Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69

Fed. Cl. 775, 779 (2006); see United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948).

Despite the weight afforded medical records, special masters are not bound rigidly by those

records in determining facts such as the onset of a petitioner’s symptoms. Vallenzuela v. Sec’y of

Health & Human Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30,

1991); see also Eng v. Sec’y of Health & Human Servs., No. 90-175V, 1994 WL 67704, at *3 (Fed.

Cl. Spec. Mstr. Feb 18, 1994) (explaining that § 13(b)(2) “must be construed so as to give effect

to § 13(b)(1) which directs the special master or court to consider the medical record...but does not

require the special master or court to be bound by them”); see also Burns v. Sec'y of Health &

Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master's

discretion to determine whether to afford greater weight to medical records or to other evidence,

such as oral testimony surrounding the events in question that was given at a later date, provided

that such determination is rational).

There are situations in which compelling oral testimony may be more persuasive than

written records. See Campbell, 69 Fed. Cl. at 779. When witness testimony contradicts medical

records, such testimony must be consistent, clear, cogent, and compelling to be persuasive. See

Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl.

Spec. Mstr. Apr. 10, 2013) (vacated on other grounds, Sanchez by & through Sanchez v. Sec’y of

Health & Human Servs., No. 2019-1753, 2020 WL 1685554 (Fed. Cir. Apr. 7, 2020), review

denied, Sanchez by & through Sanchez v. Sec'y of Health & Hum. Servs., 152 Fed. Cl. 782 (2021))

(quoting Blutstein v. Sec’y of Health & Human Servs., No. 90-2808V, 1998 WL 408611, at *85

(Fed. Cl. Spec. Mstr. June 30, 1998)); see, e.g., Stevenson ex rel. Stevenson v. Sec’y of Health &

Human Servs., No. 90-2127V, 1994 WL 808592, at *7 (Fed. Cl. Spec. Mstr. June 27, 1994)

(crediting the testimony of a fact witness whose “memory was sound” and “recollections were

37

consistent with the other factual evidence”). Special masters may also consider other types of

evidence, such as unsworn statements, on the grounds that the Vaccine Program was designed to

have “flexible and informal standards of admissibility of evidence.” 42 U.S.C. § 300aa-

12(d)(2)(B); see also Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 873 (Fed. Cir. 1992).

In short, “the record as a whole” must be considered. § 13(a).

B. Evaluating Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often

requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of

Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). The Supreme Court’s opinion in

Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), requires that courts

determine the reliability of an expert opinion before it may be considered as evidence. “In short,

the requirement that an expert’s testimony pertain to ‘scientific knowledge’ establishes a standard

of evidentiary reliability.” Id. at 590 (citation omitted). Thus, for Vaccine Act claims, a “special

master is entitled to require some indicia of reliability to support the assertion of the expert

witness.” Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed.

Cir. 2010). The Daubert factors are used in the weighing of the reliability of scientific evidence

proffered. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in

this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging

tool with respect to persuasiveness of expert testimony already admitted”). Where both sides offer

expert testimony, a special master’s decision may be “based on the credibility of the experts and

the relative persuasiveness of their competing theories.” Broekelschen, 618 F.3d at 1347 (citing

Lampe, 219 F.3d at 1362). And nothing requires the acceptance of an expert’s conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder ex rel. Snyder v. Sec’y

of Health & Human Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522

U.S. 136, 146 (1997)).

C. Consideration of Medical Literature

Finally, although this decision discusses some but not all of the literature and articles in

detail, the undersigned reviewed and considered all of the medical literature and articles submitted

in this matter. See Moriarty ex rel. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322,

1328 (Fed. Cir. 2016) (“We generally presume that a special master considered the relevant record

evidence even though [s]he does not explicitly reference such evidence in h[er] decision.”);

Simanski v. Sec’y of Health & Human Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master

is ‘not required to discuss every piece of evidence or testimony in her decision.’” (citation

omitted)), aff’d, 601 F. App’x 982 (Fed. Cir. 2015).

V. Discussion

Although respondent filed a Motion to Dismiss the petition, the submission is more

comparable to a Motion for Ruling on the Record consistent with Vaccine Rule 8(d), as he details

petitioner’s medical history and makes factual and legal arguments as to why petitioner’s claim

38

should be dismissed. Petitioner was afforded an entire year in which to respond to respondent’s

motion. Consistent with Vaccine Rule 3, I find that petitioner was given a full and fair opportunity

to present her case and develop the record.

Because petitioner does not allege an injury listed on the Vaccine Injury Table, her claim

is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, petitioner must

show by preponderant evidence that she suffered at least one defined and recognized injury and

that the injury was caused by the vaccination at issue. Capizzano, 440 F.3d at 1320. Although there

is support for some of the diagnoses alleged, petitioner failed to prove that they were caused by

the subject vaccine.

A. Defined and Recognized Injuries

An initial step in an off-Table claim is to “determine what injury, if any, was supported by

the evidence presented in the record”. Lombardi, 656 F.3d at 1353. The Vaccine Act “places the

burden on the petitioner to make a showing of at least one defined and recognized injury.” Further,

“[i]n the absence of a showing of the very existence of any specific injury[,] . . . the question of

causation is not reached.” Id.; Broekelschen, 618 F.3d at 1346 (explaining that a vaccine-related

injury “has to be more than just a symptom or manifestation of an unknown injury.”); Stillwell v.

Sec’y of Health & Human Servs., 118 Fed. Cl. 47, 56 (2014) (“[I]f the special master finds, as a

preliminary matter, that petitioner has failed to substantiate the alleged injury, the special master

need not apply the Althen test for causality.”). Thus, petitioner has the burden to demonstrate a

medically-recognized injury that she suffers from. Broekelschen, 618 F.3d at 1348; see also

Lasnetski v. Sec’y of Health and Human Servs., 128 Fed. Cl. 242 (2016).

When determining whether petitioner has adequately proven a demonstrable injury, special

masters analyze petitioner’s complete medical records filed into the record. § 11(c)(2).

Contemporaneous medical records created at the time of treatment are generally considered to be

trustworthy and are typically afforded more weight than statements made later, particularly when

there is a conflict between the two. Cucuras, 993 F.2d at 1528; Kirby, 993 F.3d at 1382-83;

Gerami, No. 12-442V, 2013 WL 5998109, at *4.

Here, respondent argues that petitioner has failed to meet her burden of showing at least

one defined and recognized vaccine related injury. Resp. Motion at 12-13. Petitioner argues that

she suffered over 21 injuries caused by the varicella vaccination she received on July 2, 2013. See

generally Pet. Response.

i. Injuries allegedly caused by the varicella vaccination that are unsupported by

the record

In support of her claim, petitioner relied on letters from two of her treating physicians. Pet.

Ex. 10; Pet. Ex. 11; Pet. Ex. 41. Dr. Lacayo wrote in a letter dated April 26, 2016, that petitioner

first presented on July 18, 2013 with “dance like tremors” and the only triggering mechanism was

a vaccine. Thereafter, petitioner’s condition deteriorated with poor school performance and

behavioral changes. An EEG showed lateralized abnormality with epileptiform discharges. Pet.

Ex. 10 at 1. She was prescribed Lamictal from January to June of 2014 to stop subclinical seizures.

She was evaluated by psychiatry and could not maintain enrollment in school. Her EEG was

39

improved “when seizure medication was increased to FDA-approved maximum dosage.” Id.

However, she continues to require treatment for neuro-psychiatric disorders including but not

limited to alteration in awareness and unspecified tremors. Id. She has recently been diagnosed

with immune deficiencies, which explains why her neurological system responded adversely to

live vaccines. Id. Dr. Lacayo did not refer to any definitive diagnoses, made general statements

about her conditions, and failed to reference the medical records in support of any of his opinions.

In a second letter dated January 25, 2021, Dr. Lacayo expressed the same opinion but added

more detail to petitioner’s medical history. Pet. Ex. 41. He then listed ten diagnoses petitioner

allegedly received since 2013. Id. at 2-3. Again, Dr. Lacayo failed to cite to any medical records

or objective testing to support any of his statements/opinions. He did, however, discuss his

collaboration with the mother when drafting the second letter, writing that upon “further history

taking between myself and her mother . . . I concluded that there was a similarity in her current

functional decline compared to what her mother noted following a MMR vaccine at the patient’s

age of 5.” Id. at 2. At no time did Dr. Lacayo indicate that he reviewed petitioner’s medical records

from childhood; rather, he relied on the mother’s recollection of her medical history.

Petitioner also provided a letter from her treating allergist, Dr. McKean, dated May 13,

2016. Dr. McKean wrote that petitioner has primary immune deficiency—specifically IgA, IgM,

and Mannose Binding Lectin Deficiency—that was not discovered before she received the

varicella vaccine. Pet. Ex. 11 at 1. He further wrote that she had a “decline in cognitive function

and other neurologic symptoms following the vaccine.” Id. Dr. McKean failed to provide any

evidence explaining primary immune deficiency, what causes it, or any evidence connecting it to

petitioner’s varicella vaccine.

In her submission, the mother detailed petitioner’s medical history and provided various

webpages and articles that discuss a host of conditions. See generally Pet. Ex. 54; Pro Se Report;

Pet. Response. In her “expert report”, the mother listed ten diagnoses that petitioner received that

were “new onset” after her receipt of the varicella vaccine. Pet. Ex. 54 at 5. In her Pro Se Response

to respondent’s Motion to Dismiss, she claimed that petitioner suffered “21 identified injuries”.

Pet. Response at 10-11. The mother failed to provide any references to test results or treating

physician opinions that confirmed the claimed diagnoses.

The majority of the claimed diagnoses are either inconsistent with the contemporaneous

medical records or are not cognizable injuries. For the most part, petitioner’s medical records

discussed symptoms or diagnoses reported by the mother and petitioner, as opposed to diagnoses

rendered by petitioner’s actual providers. As a general matter, a patient’s reporting of a diagnosis

is not the same as a physician or treating provider diagnosing a patient with a particular condition

or illness. See, e.g., Rothenberg v. Sec’y of Health & Human Servs., No. 15–696V, 2018 WL

2731639, at *16 (Fed. Cl. Spec. Mstr. Apr. 19, 2018).

Dr. Lacayo’s letters are inconsistent with petitioner’s medical history and contrary to his

office records. Thus, his opinions are unsubstantiated and fail to prove that petitioner suffered from

any definable injuries associated with the varicella vaccine. See R.K. v. Sec’y of Health & Human

Servs., 125 Fed. Cl. 57 (2016), aff’d, 671 Fed. Appx. 792 (Fed. Cir. 2016) (affirming a special

master’s determination that a petitioner failed to establish a definitive diagnosis after the special

40

master heard contradictory testimony from petitioner’s expert). Dr. McKean wrote that petitioner

had a “decline in cognitive function and other neurologic symptoms following the vaccine.” Pet.

Ex. 11. Dr. McKean failed to define any cognizable injury or objective testing upon which his

opinion was based. See Broekelschen, 618 F.3d at 1346. Neither doctor referred to any of

petitioner’s medical records showing any definable injuries associated with the varicella vaccine.

The mother’s submissions listed many conditions, most of which were ruled out by clinical

impression or objective testing. Thus, in discussing the specific conditions and injuries claimed to

be vaccine related, I afford more weight to the contemporaneous medical records.

The mother alleged that petitioner suffered an anaphylactic reaction within an hour and/or

within 72 hours of the subject vaccination. Pet. Ex. 54 at 20-21. Specifically, the mother claimed

in the Pro Se Report that petitioner self-treated for an asthma attack by using her own and her

sister’s inhalers within 24 hours of receiving the vaccine, without the mother’s knowledge. Id. This

course of events was not reported to any provider at any time, including at the ER. Further, this

information is not contained in petitioner’s own affidavit. See Pet. Ex. 1. Upon presentation to the

ER on July 5, 2013, the mother reported an allergic reaction, breathing difficulty, and a varicella

vaccine received 4 days ago. Pet. Ex. 3 at 2, 10. Following examination, the ER record specifically

documented that petitioner showed “no signs or symptoms of anaphylaxis” and was in “no

apparent distress”; her “[a]irway was patent [with] mildly swollen uvula”. Overall, her

“[r]espiratory effort [wa]s even, unlabored”, and she did “not display signs of respiratory distress”.

Id. at 2, 3, 8. She was diagnosed with and treated for a viral infection and was subsequently

discharged. Id. at 6, 11. A follow up appointment with Groff on July 12, 2013 revealed continuing

mild exudate on the left side of her throat, but otherwise the examination was normal/negative.

Pet. Ex. 2 at 24. Anaphylaxis occurring within four hours of vaccination is an On-Table injury. 42

C.F.R. §100.3. There is no corroborating evidence that petitioner had an anaphylactic reaction

whatsoever, much less one that occurred within four hours of the vaccine.

The medical records also do not support the alleged diagnoses of seizures, epilepsy, brain

injury, encephalitis, encephalopathy, or cerebral dysfunction following the subject varicella

vaccine. Pet. Ex. 5 at 18 (MRI performed in January 2014 was normal with no brain injury noted);

Pet. Ex. 9 at 8-9, 25-26, 37, 40 (MRI performed at Emory in July 2014 was normal; epilepsy was

ruled out at Emory following long term video EEG); Pet. Ex. 12 at 55 (MRI performed in

December 2015 was normal, showing “[n]ormal signal characteristics and morphology” in the

cerebellum); Resp. Ex. A at 13-14 (focal slowing seen on EEG was determined to be non-specific

in etiology). Despite Dr. Lacayo’s suspicion of seizure disorder in the left hemisphere based on

EEGs he reviewed, he later wrote that long term monitoring at Emory showed no overt seizures

and her neurological examination conducted by him was normal/negative. Pet. Ex. 5 at 1-2, 6, 11-

12, 17, 20. Dr. Lacayo also wrote, “[i]t is unclear how much psychological issues are contributing

to [her] spells.” Id. at 3. In a separate handwritten form, Dr. Lacayo documented a normal, intact

neurological examination. Id. at 39. An examination and testing performed by Dr. Silver at Emory

was negative/normal. Pet. Ex. 9 at 16-17. At a subsequent visit, Dr. Silver wrote that it was unclear

whether her problems were organic, as EEG showed no epileptiform activity and MRI was normal.

Id. at 18, 19, 25-26, 37-38, 40. He also noted that Lamictal “clearly helped her but of course this

has great psychiatric benefits as well.” Id. at 23. Dr. Silver later added, “[o]n the urging of her

mother…exhaustive workup for causes” had been done with the most likely causes excluded. Id.

at 29. Objective testing performed in December 2015 did not show antibodies to “any component

41

of the autoimmune encephalitis.” Pet. Ex. 12 at 37, 49; Pet. Ex. 4 at 1. Further, Dr. Morgan noted

in January 2016 that her presentation was not consistent with encephalitis or encephalopathy. Pet.

Ex. 12 at 29. Rather, his impression based on neuropsychological testing was that her pattern of

cognitive deficits was “nonspecific with regard to etiology” and inconsistent with limbic (anti-

NMDA receptor) encephalitis. Id. at 12. In April 2016, Dr. Morgan noted a normal neurological

examination. Id. at 5-8. Thus, based on the medical records and objective testing performed,

petitioner has not been diagnosed with seizures, epilepsy, brain injury, encephalitis, or

encephalopathy. The only support for cerebral dysfunction or deficits in petitioner’s left brain

function are attributed to the mother’s reporting of a finding by Dr. Cates in 2004. However, Dr.

Cates did not mention these deficits in his letter filed into the record, and he specifically noted that

his examination of petitioner was for academic purposes alone and not medical purposes. Pet. Ex.

33 at 53; see Pet. Ex. 26.

There is no definitive diagnosis of dementia. Pet. Ex. 12 at 65, 70. On October 21, 2015,

petitioner presented to Dr. Rivner reporting a history of a 2013 vaccine which caused difficulty

breathing, swollen throat and uvula thought to be strep, subsequent development of bilateral arm

tremor diagnosed as athetosis, acting strange, mental problems—all reportedly thought to be

autoimmune encephalopathy. Id. at 65. Dr. Rivner’s impression that day was possible autoimmune

encephalitis manifested by seizures, athetosis, personality changes, and dementia. Id. at 70-71. It

is unclear what Dr. Rivner based this impression on other than the mother’s history of symptoms.

A MoCA score of 27 was noted, but it is unclear from the record if the MoCA score was

information the mother provided to Dr. Rivner or if his office administered the test that day. Id. at

65. Moreover, a MoCA score of 26 or better is considered normal. 66 Petitioner scored a 27. Pet.

Ex. 12 at 65. The mother later reported to Dr. McKean in March 2016 that MoCA testing showed

dementia. Pet. Ex. 4 at 1. Without further explanation and this being the only mention of dementia

by any provider in the medical records filed, preponderant evidence does not support a diagnosis

of dementia.

Likewise, based on the medical records, the diagnoses of MG and immunodeficiency are

dubious. Two years after receipt of the subject varicella vaccine, petitioner was found to have high

levels of antibodies to acetylcholine on lab work in the summer of 2015. But because she was

asymptomatic, she was not diagnosed with MG at that time. Pet. Ex. 9 at 29; Pet. Ex. 4 at 12, 16.

Laboratory testing also showed sufficient protective antibodies for tetanus toxoid and diphtheria—

presumably from prior vaccination—but antibodies to varicella zoster (IgM and IgG) were low.

See generally Pet. Ex. 14. Dr. McKean diagnosed petitioner with selective IgA and IgM

immunodeficiency in March 2016. Pet. Ex. 4 at 2. In March 2019, Dr. Rivner diagnosed petitioner

with myasthenia gravis due to abnormal test results despite presenting with “very atypical”

symptoms. Pet. Ex. 38 at 3, 5, 7. Although these diagnoses are questionable, there is some

evidentiary support that petitioner has immunodeficiency and myasthenia gravis. In any event, her

immunodeficiency was diagnosed in March 2016—nearly three years after vaccination—and her

MG was diagnosed in March 2019—nearly six years after vaccination. It is unknown whether

these conditions pre-dated the vaccination or occurred at some point years after the receipt of the

subject vaccination around the time they were diagnosed. Pet. Ex. 4 at 2; Pet. Ex. 38 at 3; Pet. Ex.

39 at 3; Pet. Ex. 40 at 4-5.

66

Supra, note 31.

42

In addition, the mother alleged petitioner received several psychiatric diagnoses. At

petitioner’s initial assessment with Dr. Norniella in April 2014, she was assessed as having severe

mood swings, possibly caused by seizures, bipolar disorder, or borderline personality disorder.

Pet. Ex. 8 at 17. No definitive diagnosis was made, but Dr. Norniella related the symptoms

described to him by petitioner and the mother to several potential diagnoses. This isolated notation

in the medical records is insufficient to support a definitive diagnosis of either bipolar disorder or

borderline personality disorder. Both diagnoses appeared in Dr. Dyer’s medical records, but she

documented that Dr. Norniella diagnosed petitioner with “Dissociative Identity Disorder,

Temporal Lobe Epilepsy with Behavioral Changes, Vaccine Injury/Brain Injury, Rapid Cycling

Bipolar Disorder, and Borderline Personality Disorder, as provided by [the mother].” Pet. Ex. 6 at

2 (emphasis added). None of the diagnoses reported by the mother are contained in Dr. Norniella’s

records. Much like Dr. Dyer’s records, mentions of these diagnoses in Dr. Norniella’s records

appear to be based on reports from petitioner or the mother—if they appear at all. See generally

Pet. Ex. 8. Likewise, any mention of bipolar or borderline personality disorder contained in the

Emory records are found in the reported medical history provided by the mother but not in the

findings. Pet. Ex. 9 at 14, 19; see also Pet. Ex. 45.1 at 7 (hospital records from 2019 documenting

a diagnosis of—among several other things—“Bipolar disorder, unspecified (HC)” that was

present on admission; the source of these diagnoses is not clear, and some of the diagnoses listed

were previously ruled out). Further, there is no support in the records that any testing resulted in

diagnoses of either psychosis or schizophrenia. See generally Pet. Ex. 7. The only mentions of

either diagnosis came from reports of petitioner or the mother. Pet. Ex. 9 at 15; Pet. Ex. 40 at 7,

11, 15, 19. Dr. Morgan’s neuropsychological evaluation in March 2016 showed deficits in

attention and concentration and reduced mental processing speed. Pet. Ex. 12 at 11. Intellectual

function was average to low average while reading was borderline, with mild symptoms of

depression. Id. The pattern of cognitive deficits was “nonspecific with regard to etiology” but most

commonly seen in patients with significant psychiatric disorders. Id. at 12. There were multiple

symptoms of significant personality disorder with many borderline traits on testing, but she was

not administered a personality test that day. Dr. Morgan’s diagnostic impression was unspecified

mild neurocognitive disorder. Id. Thus, the objective evidence is insufficient to show that

petitioner was diagnosed with bipolar disorder, borderline personality disorder, schizophrenia, or

psychosis.

The mother also claimed that petitioner had extreme behavioral changes following the

vaccine. Pet. Response at 17, 23; Pet. Ex. 54 at 6, 27, 28; Pro Se report at 19-21. The mother seems

to argue that the behavioral changes were caused by autoimmune epilepsy, immune-mediated

encephalitis, and immunologically mediated dementia. See id. For the reasons detailed above, I do

not find any persuasive evidence in the record that petitioner was diagnosed with any of these

conditions. Further, behavioral issues or changes on their own are symptoms and do not themselves

amount to a diagnosis of a defined injury. Part of what is required under the Vaccine Act is that

petitioner show by preponderant evidence that she suffered from a medically recognized injury,

“not merely a symptom or manifestation of an unknown injury.” Lombardi, 656 F.3d at 1353. As

such, any behavioral issues or changes petitioner may have exhibited following the subject vaccine

do not amount to a defined and recognized injury.

Notably, petitioner’s childhood was replete with constant testing for various medical and

psychological issues, the majority of which showed normal results. However, conditions continued

43

to be reported to various providers even though they had been ruled out. See, e.g., Pet. Ex. 33 at

6-21, 27-28, 53; Pet. Ex. 18 at 2, 7; Pet. Ex. 15 at 8-9. As evidenced by the records filed and

described above, this pattern continued throughout petitioner’s life, even seen in her most recent

records filed when she was a legal adult. The contemporaneous medical records themselves, as

well as extensive objective test results, lack support for most of the injuries the mother claimed

occurred as a result of the subject vaccine.

ii. Injuries allegedly caused by the varicella vaccine that pre-dated or arose years

after petitioner’s receipt of the varicella vaccine

The medical records confirm that petitioner was diagnosed with an unremarkable essential

tremor that predated the subject vaccination. Pet. Ex. 2 at 18, 43; Pet. Ex. 5 at 6, 11, 12-15; Pet.

Ex. 9 at 29; Pet. Ex. 12 at 5-8, 28. As more specifically described above, petitioner’s questionable

diagnosis of myasthenia gravis arose years after her receipt of the varicella vaccines with

laboratory work revealing AChR antibodies. She was asymptomatic until at least 2019 when she

received the diagnosis despite atypical symptoms. Pet. Ex. 4 at 1, 12, 16; Pet. Ex. 9 at 25, 29; Pet.

Ex. 12 at 10, 25, 65, 70; Pet. Ex. 38 at 3; Pet. Ex. 39 at 7. Dr. McKean believed her fatigue was

due her testing positive for HHV-6—not related to MG. Pet. Ex. 4 at 6; Pet. Ex. 14 at 4. As such,

the medical records support these diagnoses, but the timing of the symptoms/diagnoses will be

discussed further below.

Petitioner also received diagnoses for an unspecified anxiety disorder shortly after

vaccination in July 2013; unspecified mood disorder during her time at Ridgeview Institute in

April 2014; and major depressive disorder in June 2015. Pet. Ex. 6 at 16; Pet. Ex. 7a at 2-4; Pet.

Ex. 13 at 3-4. Finally, the medical records support that petitioner received a diagnosis of a major

neurocognitive disorder of unspecified origin by Dr. Dyer in August 2014 and unspecified mild

neurocognitive disorder during her adult neuropsychological testing in March 2016. Pet. Ex. 6 at

6; Pet. Ex. 12 at 12. Notably, petitioner underwent the March 2016 neuropsychological exam “with

regard to two episodes of behavioral changes noted after receiving MMR and varicella

vaccinations”; Dr. Morgan, who administered the exam, wrote, “this pattern of cognitive deficits .

. . is by far most commonly obtained in patients with significant psychiatric disorders.” Pet. Ex.

12 at 10-12.

Based on the above analysis and appropriate weighing of the contemporaneous medical

records, the diagnoses supported by the medical records are unremarkable essential tremor,

myasthenia gravis, HHV-6, unspecified anxiety disorder, unspecified mood disorder, major

depressive disorder, and unspecified neurocognitive disorder. The question becomes whether any

of these conditions were caused by the varicella vaccine petitioner received on July 2, 2013.

B. Petitioner Has Failed to Meet Her Burden Under Althen

Althen requires that petitio

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