Boyd v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-1342V

Filed: April 21, 2026

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LATISHE BOYD, *

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Petitioner, *

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v. *

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SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

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Respondent. *

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Brian Cinelli, Schiffmacher Cinelli Adoff LLP, Buffalo, NY, for Petitioner.

Alexa Roggenkamp, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

Shah, Special Master:

On August 31, 2018, Latishe Boyd (“Petitioner” or “Ms. Boyd”) filed a petition for

compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10,

et seq.2 (the “Vaccine Act” or “Program”). The petition alleges that a tetanus-diphtheria-acellular

pertussis (“Tdap”) vaccine Ms. Boyd received on September 4, 2015, caused a “significant

aggravation of her existing lupus condition which resulted in multiple seizures and/or caused her

to develop a seizure disorder with related sequelae.” Pet. at 1. In her briefing, Petitioner more

1

Because this Decision contains a reasoned explanation for the action 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 has 14 days to identify and move to redact medical or other information,

the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that

the identified material fits within this definition, I will redact such material from public access.

2

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. For ease of citation,

all “§” references to the Vaccine Act in this Decision will be to the pertinent subparagraph of 42 U.S.C. §

300aa (2012).

specifically alleges the vaccination caused “development of seizure disorders and . . . caused

significant aggravation of existing illnesses such as lupus, cerebritis or posterior reversible

encephalopathy (PRES).” Pet.’s Pre-Hrg. Br. at 1 (ECF No. 42). She also alleges she sustained

the Vaccine Table Injury of encephalopathy following Tdap vaccination. Pet.’s Post-Hrg. Br. at 3

(ECF No. 59).

I have reviewed the evidence presented in this case. Although I sympathize with Ms. Boyd

and the ordeal she has undergone, I conclude that she has not established by preponderant evidence

that the vaccine she received caused or significantly aggravated her condition, nor has she

established that she sustained an injury compensable under the Vaccine Table.

I. PROCEDURAL HISTORY

On August 31, 2018, Petitioner filed her petition. ECF No. 1. On August 20, 2019,

Respondent filed a Rule 4(c) Report (“Report”) recommending that compensation be denied and

the case dismissed. Report at 1, 13. On July 6, 2020, Petitioner filed an expert report from James

Valeriano, M.D. Ex. 20. On February 8, 2021, Respondent filed expert reports from Miles Evans,

M.D., M.S, and Chester Oddis, M.D. Exs. A, C. Petitioner filed a supplemental report from Dr.

Valeriano on July 23, 2021. Ex. 20.

Former Special Master Katherine E. Oler conducted an entitlement hearing on February

15-16, 2023. After the hearing, Special Master Oler ordered Petitioner to file potentially missing

medical records. ECF No. 51. On April 20, 2023, Petitioner filed a status report stating the

medical records were complete. ECF No. 56.

On August 21, 2023, Petitioner filed a post-hearing brief. ECF No. 59. On November 20,

2023, Respondent filed a post-hearing brief. ECF No. 61. On December 20, 2023, Petitioner filed

a post-hearing reply brief. ECF No. 61. The parties confirmed the record was complete on January

3, 2024. ECF No. 63.

On August 13, 2024, this case was reassigned to my docket. ECF No. 64. The case is ripe

for adjudication.

II. FACT EVIDENCE

A. Petitioner’s Affidavit and Testimony

Petitioner signed her affidavit on August 29, 2018. Ex. 1 at 6. She was married with two

children.3 Id. at 1. Before the vaccination, she was studying at the University of Baltimore for a

joint Master’s and J.D. degree. Transcript (“Tr.”) at 100. She had completed three years of the

four-and-a-half-year program. Id. at 101. She was working full time and in school part time. Id.

At the time of hearing, she was working for the Food and Drug Administration (“FDA”) as a

3

The marital status of Ms. Boyd and Mr. White is unclear from the record. While they stated in their

affidavits that they were married, they identified as long-term partners during the February 15-16, 2023

entitlement hearing. Tr. at 100, 130.

2

regulatory counsel, which entailed analyzing compliance with FDA rules and regulations. Id. at

101-02. She previously worked as a paralegal for the U.S Department of Justice, Securities and

Exchange Commission, and Drug Enforcement Administration. Id. at 102.

Ms. Boyd was diagnosed with lupus in 2012 or 2013. Tr. at 103. It started with bad joint

pain that would spread. Id. Mr. White would frequently take her to the ER at Prince George’s

Hospital (“PGH”) for her debilitating pain, and they would send her home with pain medications

without providing additional care. Id. Eventually, Mr. White recommended she go to a different

hospital since she was not getting better. Id. She was ultimately referred to Washington Hospital

Center (“WHC”) and underwent blood tests, where she was diagnosed with lupus. Id. at 104. Her

lupus symptoms fluctuated over the years, but medication did stabilize most of her symptoms. Id.

at 105.

Around the time of vaccination, Ms. Boyd developed an ingrown hair on the left side of

her face, near her hairline. Tr. at 107-08. She had developed ingrown hairs on several previous

occasions and had them removed at PGH without complications. Id. at 107. On September 4,

2015, she went to PGH to get the hair removed. Id. at 108-09. After the procedure, the doctor

recommended she get a tetanus shot to prevent future infections, because her lupus had

“compromised [her] immune system.” Id. at 110-11. She was hesitant to get the tetanus shot

because her lupus symptoms were stabilized and she did not want anything to change, but after

speaking with her doctor, she decided to get the vaccination. Ex. 1 at 2. She left the hospital and

arrived home very late. Tr. at 111.

Early the next morning, Petitioner woke up and vomited a yellow and white liquid. Ex. 1

at 2; Tr. at 111-12. She remembered falling to the floor trying to get out of bed because she was

in immense pain and could not walk; the pain was similar to other lupus flares she had experienced.

Tr. at 111-12. The site of the ingrown hair did not emit any pus or colored discharge and was not

red, swollen, malodorous, or warm to the touch. Id. at 113.

Ms. Boyd’s condition deteriorated to the point that she could not walk, and Mr. White had

to carry her to the car to go to the hospital. Ex. 1 at 2. While waiting at the ER at PGH, she had a

seizure. Id. She woke up at the University of Maryland Medical Center (“UMMC”). Id.

Petitioner had no personal or family history of seizures. Ex. 1 at 2. She had a total of eight

seizures during her hospital stay. Ex. 1 at 3. When she was discharged from the hospital, she had

to undergo therapy to learn how to walk and talk again. Id. After she had seizures, she would slur

her words and was unable to communicate well verbally. Id. She has permanent vision loss from

her seizures, requiring her to wear glasses and making it difficult to see or drive at night. Id. Also,

due to repeated intubations and extubations, she lost two of her front teeth, requiring her to undergo

multiple dental procedures. Id.

Ms. Boyd’s recovery was long. She returned to work part time in April 2016, seven months

after her seizures began; she did not resume driving until May 2016; and she resumed full-time

work in July 2016. Ex. 1 at 3. She has work restrictions. Id. at 3-4. The seizures also affected

her studies: prior to her injury, she had been working on a master’s degree in Legal Ethics and

3

Studies at the University of Baltimore. Id. at 4. She has not attempted to complete her degree due

to concerns about her workload and fear of future seizures. Id.

Ms. Boyd said her family was also deeply affected by her injury. Her mother-in-law moved

into her home for about six to eight weeks to help with household chores. Tr. at 120. As a result

of her seizures, she has lingering eyesight issues, which require her to wear glasses daily. Id. at

122. She also experiences brain fog and sometimes loses her train of thought. Id. at 123. She has

memory problems and has to write things down and set reminders on her phone to keep track of

tasks and deadlines. Id. at 123-24. Her children now need to be aware of signs of seizures, and

they have had to curtail family activities to decrease stressors to prevent seizures. Ex. 1 at 4. She

used to be very adventurous, participating in skydiving, hiking, and swimming, but she can no

longer engage in these activities. Id. at 5. Her family has experienced financial pressure due to

her medical bills and missed time from work. Id.

B. Affidavit and Testimony of Mr. Gerard White

Mr. White testified that he works as an accountant. Tr. at 128-29. On September 4, 2015,

Petitioner returned home from work and said she was going to the hospital for removal of a lesion;

Mr. White stayed at home with their kids. Tr. at 132. When she returned home that night, she

reported being pressured by the nurse to get a tetanus shot. Id. at 135.

Mr. White recalled that the next morning, he woke up to hear Ms. Boyd “groaning in pain.”

Ex. 5 at 1. He told Petitioner that he was leaving to run some errands. Tr. at 136. When he

returned around noon, she was still lying in bed, moaning. Id. Later that day, they decided to go

to PGH; Mr. White had to carry Petitioner down the stairs to get to the car. Id. at 138.

In the ER, Petitioner seemed to be in significant pain. Ex. 5 at 2. She became less

responsive and eventually became completely unresponsive, only moaning occasionally. Id. After

she was admitted to the hospital, she experienced a seizure for the first time. Tr. at 140-41. When

she regained consciousness after her first seizure, she could not remember what happened. Ex. 5

at 2. Later, as Mr. White and Petitioner were having a conversation, she had another seizure. Tr.

at 142-43. Shortly thereafter, she was transferred to UMMC for specialized care. Id.

At UMMC, Petitioner had five additional seizures, one of which was a grand mal seizure.

Tr. at 145. She was discharged from UMMC but had another seizure at home, after which she was

taken to PGH and then back to UMMC again via helicopter. Id. at 146-47.

After her discharge, Petitioner began inpatient therapy at Washington Rehabilitation

Center to learn how to walk again, as the seizures had caused her to have equilibrium problems.

Tr. at 147. When she returned home, she used a cane and a brace. Id. at 148. She continues to

have memory and vision issues, which were not present before her seizures. Id. at 148-51.

Mr. White recalled that their children were extremely scared and concerned about Ms.

Boyd’s health. Ex. 5 at 2. Her ability to remember things has been affected by her seizures, and

the whole family does everything they can to minimize her chances of suffering any further

seizures. Id.

4

C. Medical Records

1. Pre-Vaccination Medical Records

Petitioner was diagnosed with systemic lupus erythematosus (“SLE” or “lupus”) in October

2012, at the age of 28. Ex. 4 at 62. She had a number of lupus flares in 2013. See Ex. 4. She was

prescribed Plaquenil and Imuran but still reported significant lupus symptoms. See generally id.

During 2015, Petitioner was seen for lupus at WHC. See Ex. 4. On August 24, 2015, she

saw rheumatologist Anastasia Markopoulou, M.D. Id. at 345-50. She was taking Plaquenil,

Imuran, prednisone, and Benlysta. Id. at 345. She reported that she experienced chest pain about

once a month at night and had concerns about ongoing resting tachycardia. Id. She had undergone

a cardiac workup, which was normal. Id. The pain in her hands, feet, hips, and knees was

improving. Id. Her lupus was noted to be “clinically stable,” with her dsDNA4 and complement5

levels improving. Id. at 349. The plan was to continue with the prescribed medications. Id.

2. Vaccination and Post-Vaccination Medical Records

At about 9:40 p.m. on September 4, 2015, Petitioner visited the ER at PGH for an “infected

ingrown hair” located on the left side of her hairline. Ex. 3 at 1-2. She reported: “[P]ain and

swelling to left hairline. Started as small bump, expressed pus, now larger in size.” Id. at 2. She

had no systemic complaints. Id.

After examination, Petitioner was diagnosed with an abscess. Ex. 3 at 1. An incision and

drainage procedure was performed on the abscess, and Petitioner was given the subject Tdap

vaccination. Id. at 3. The record indicated that she was given “Adacel (Tdap),” which consisted

of diphtheria toxoid, acellular pertussis, and tetanus toxoid, at 11:53 p.m. Id. She was also

prescribed two different antibiotics. Id. She was then discharged home. Id. at 4.

a. Hospitalization at PGH: September 6-11, 2015

At about 8 a.m. on September 6, 2015, Petitioner returned to the ER at PGH, reporting

arthralgias, abdominal pain, emesis, and headaches. Ex. 3 at 21-25. She was seen by Brad

Schwartz, M.D., who noted that her chief complaint was “[p]ain all over body [sic] trouble walking

4

Anti-dsDNA antibody: a type of antinuclear antibody specific for double-stranded DNA, found in the

serum of patients with systemic lupus erythematosus. Anti-dsDNA antibody, DORLAND’S MEDICAL

DICTIONARY ONLINE (“DORLAND’S”), https://www.dorlandsonline.com/dorland/definition?id=56790 (last

accessed on April 2, 2026).

5

Complement (condensed definition): a term originally used to refer to the heat-labile factor in serum that

causes immune cytolysis, the lysis of antibody-coated cells. It is now used to refer to the entire functionally

related system comprising at least 20 distinct serum proteins, their cellular receptors, and related regulatory

proteins that is the effector not only of immune cytolysis but also of other biologic functions, including

anaphylaxis, phagocytosis, opsonization, and hemolysis. Complement, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=10705 (last accessed on April 2, 2026).

5

after tetanus shot.” Id. at 21. The triage record stated: “Onset of pain 5 [d]ays.” Id. The history,

however, stated that Petitioner complained of two days of symptoms “status post” her Tdap

vaccination. Id. at 23. Petitioner stated she believed she was having a lupus flare caused by the

Tdap vaccination. Id.

On exam, Petitioner was noted to be alert and oriented to person, place, and time. Ex. 3 at

26. The area of her abscess was red, with “possible fluctuance.” Id. Dr. Schwartz commented:

“Most likely lupus flare that was incited by tetanus shot. [Patient] has joint pains, [abdominal]

pain, and myalgias…. Other possible [diagnoses] include viral infection, meningitis, [urinary tract

infection], pyelo6, appendicitis…. Viral infection possible.” Id. at 23.

While Petitioner was in the ER, she “became acutely tachycardic and hypotensive.” Ex. 3

at 23. Blood tests revealed a high C-reactive protein (“CRP”) level of 268.9mg/L,7 an elevated

erythrocyte sedimentation rate (“ESR”), elevated white blood cell (“WBC”) count, elevated

neutrophils, slightly elevated level of blood urea nitrogen (“BUN”), high levels of lactic acid and

creatinine, and low chloride and calcium levels. Id. at 35-36. Treatment was begun with

antibiotics, antivirals, and steroids, and Petitioner was admitted to the hospital for “septic shock.”

Id. at 40.

By the time Petitioner was examined as an inpatient, she was lethargic. Ex. 3 at 132. Mr.

White gave the history of her condition to Leopoldine Kenmogne, M.D. Id. The record stated:

[S]ymptoms started [two] days ago. [S]he had an [abscess] on left

temporal, that was incised in the ED on 9/4/15 and was given a

tetanus [s]hot. During the same [night] she started having

generalized pain 10/10 sharp, associated with [nausea] and

vomiting. [S]he initially [thought] it was the side [effect] of the

[shot]. Symptoms progressively got worse she took the

[Prednisone] she ha[s] for the lupus, and visited the ED this am,

because there was [no] relie[f].

Id. The impression was “[p]ossible septic shock [p]robably due to the incised abscess,

[hemodynamic] instability [in] the ER, fever, CRP elevated 268, ESR elevated 250.” Id. at 136.

Lupus flare or lupus nephritis, encephalitis, non-anion gap metabolic acidosis, deep vein

thrombosis, and gastrointestinal prophylaxis were other potential diagnoses. Id. at 136-37.

By September 7, 2015, Petitioner’s blood pressure was noted to be stabilized with

Levophed. Ex. 3 at 143. Laboratory results were positive for methicillin-resistant Staphylococcus

6

“Pyelo” likely referred to pyelonephritis, an inflammation of the kidney and renal pelvis because of

bacterial infection; it begins in the interstitial tissues (interstitial nephritis) and rapidly extends to involve

the tubules (tubulointerstitial nephritis), glomeruli (glomerulonephritis), and then the renal blood vessels.

Pyelonephritis, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=42228 (last accessed

on April 2, 2026).

7

The normal range was between 0.5-5mg/L. Ex. 3 at 35.

6

aureus (“MRSA”) by PCR test via nasal swab. Id. at 146, 420. The test report commented that a

positive PCR result might not correlate to a positive bacterial culture, “since positive test results

do not always indicate the presence of viable organisms.” Id. at 420.

On September 8, Oleksandr Semeniuk, M.D., documented that Petitioner was alert and

oriented and had improved clinically. Ex. 3 at 178-79. He diagnosed her with resolved distributive

shock of unclear etiology, with septic shock versus anaphylactic shock versus endocrine shock on

the differential. Id. at 181. He also noted altered mental status, SLE that was dsDNA positive

with low complement levels, anemia, and an acute kidney injury. Id. at 182.

Petitioner’s regular rheumatologist, Dr. Collins, called PGH on September 8, 2015, to

inform them he last saw Petitioner on August 24, 2015, and that her bloodwork then “was

consistent with… the current lab[s].” Ex. 3 at 179. Petitioner continued to be treated for possible

lupus flare, encephalopathy, septic shock, or metabolic acidosis and was “on broad spectrum

[antibiotics] and herpes simplex virus (“HSV”) coverage with Zosyn and acyclovir.” Id. at 183-

84. She was noted to have altered mental status with minimal ability to communicate. Id. at 243.

She reported continued joint pain, but the pain had lessened since her admission. Id.

On September 9, 2015, Petitioner had two tonic-clonic seizures. Ex. 3 at 241. The first

seizure resolved on its own, but the second seizure required treatment with Ativan. 8 Id. at 221.

An EEG revealed moderate encephalopathy. Id. An MRI of the brain was interpreted to indicate

posterior reversible encephalopathy syndrome (“PRES”),9 with primary causes including

hypertension, lupus, and others. Id. at 190. Hypoglycemia was “an important differential

consideration.” Id.

On September 10-11, 2015, Petitioner had several further seizures, one lasting 5-10

minutes. Ex. 3 at 188, 191. At that point, her team concluded she needed continuous EEG

monitoring, necessitating a transfer to UMMC. Id. at 191. Her discharge diagnoses included

seizure, high blood pressure, resolved possible septic shock, and an SLE flare. Id. at 909.

b. First Hospitalization at UMMC: September 11-21, 2015

8

Ativan: trademark for preparations of lorazepam. Ativan, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=4704 (last accessed on March 9, 2026); lorazepam:

a benzodiazepine with anxiolytic and sedative effects, administered orally in the treatment of anxiety

disorders and short-term relief of anxiety symptoms and as a sedative-hypnotic agent, and intravenously or

intramuscularly for preanesthetic medication; used also intravenously to control status epilepticus and as

an antiemetic in cancer chemotherapy. Lorazepam, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=28747 (last accessed on March 9, 2026).

9

Posterior reversible encephalopathy syndrome or reversible posterior leukoencephalopathy syndrome: a

syndrome resulting from leukoencephalopathy with edema in posterior parts of the occipital and parietal

lobes, characterized by headaches, confusion, seizures, and visual disturbances; the brain lesions are most

often related to hypertension, and sometimes to use of certain immunosuppressive drugs or to some other

cause. Called also posterior leukoencephalopathy s., posterior reversible encephalopathy s., and posterior

reversible leukoencephalopathy s. Reversible posterior leukoencephalopathy syndrome, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=111286 (last accessed on April 14, 2026).

7

On September 11, 2015, Petitioner was transferred to the ICU at UMMC. Ex. 6 at 18. She

was noted to be drowsy but could wake up, follow instructions, and speak normally, and she had

no focal neurological deficits. Id. Her medical records also noted “recent septic shock acute

kidney injury (“AKI”)10 recovered possibly lupus cerebritis.11 MRI findings hypoglycemia due to

possible poor [oral] intake at hospital.” Id. On a different page, it was noted that “MRI showed

vasogenic edema consistent with lupus flare.” Id. at 19.

At UMMC, the history noted that Petitioner had presented to the ER at PGH and “was

found to be in shock,” and she may have had “lactic acidosis/sepsis/[acute renal failure].” Ex. 6

at 20. She was started on pressors, vancomycin, Zosyn, and steroids; when she was weaned off

pressors, she had two seizures on September 9. Id. She seized again on September 10 and was

given an increased dose of Keppra.12 Id. Her MRI and CT of the head showed vasogenic edema,

and she was transferred to UMMC for EEG monitoring. Id. She was also noted to have memory

issues. Id. at 23.

On September 12, 2015, Petitioner was seen by Daniel Harrison, M.D. (attending), and

Mark Leekoff, M.D./M.P.H. (resident), for a neurology consultation. Ex. 6 at 41-45. They noted

that Petitioner had presented with new-onset seizures “in the setting of [a] lupus flare up.” Id. at

44. The physicians commented:

The seizures in the setting of MRI imaging and lupus flare [are]

concerning for lupus cerebritis. However[,] PRES and viral

encephalopathy could also be in the differential given

immunosuppression and the immunosuppression medications she is

on. While the WBC [in] [cerebrospinal fluid] was 18 and is high, it

would be expected if the [lumbar puncture (“LP”)] was done after

10

Acute kidney injury or acute renal failure: renal failure of sudden onset, such as from physical trauma,

infection, inflammation, or toxicity; symptoms include uremia and usually oliguria or anuria, with

hyperkalemia and pulmonary edema. Three types are distinguished: prerenal, associated with poor systemic

perfusion and decreased renal blood flow, such as with hypovolemic shock or congestive heart failure;

intrarenal, associated with disease of the renal parenchyma, such as tubulointerstitial nephritis, acute

interstitial nephritis, or nephrotoxicity; and postrenal, resulting from obstruction of urine flow out of the

kidneys. Acute renal failure, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=74624

(last accessed on April 2, 2026).

11

Lupus cerebritis: general term for the pathologic manifestations of systemic lupus erythematosus

affecting the brain, most of which actually result from inflammation or thrombosis of the cerebral

vasculature. Lupus cerebritis, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=64722

(last accessed on April 7, 2026).

12

Keppra: trademark for a preparation of levetiracetam. Keppra, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=26816 (last accessed March 9, 2026);

levetiracetam: an anticonvulsant administered orally as an adjunct in the treatment of partial and myoclonic

seizures and idiopathic generalized epilepsy. Levetiracetam, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=28136 (last accessed March 9, 2026).

8

the seizure. Patient did have a breakthrough seizure on [D]ilantin

and Keppra but perhaps the dose at the time was suboptimal.

Id. Dr. Harrison felt lupus cerebritis was the most likely diagnosis, but he did not rule out an

infectious or inflammatory condition, or less likely acute disseminated encephalomyelitis

(“ADEM”), “given the temporal association with tetanus vaccination.” Id. at 45. The plan was to

repeat the brain MRI with and without contrast, perform an [magnetic resonance angiograph

(“MRA”)] of the head, repeat the LP, and treat with high-dose steroids. Id.

The same day, Petitioner was seen for a rheumatology consult. Ex. 6 at 37. The physician

suspected her seizures had an infectious or inflammatory cause. Id. at 40. She was also seen by

neurologist Wei Zheng, M.D. Id. at 46. During that exam, she informed the nurse that she felt

like she was going to have a seizure and then developed seizure-like movements on her right side.

Id.

Petitioner underwent another brain MRI, with and without contrast, on September 13,

2015, which was interpreted to show lupus-related leukoencephalopathy. Ex. 6 at 51. An EEG

conducted on September 15-16, 2015, showed she had experienced focal motor seizures on the

right side of her body. Id. at 55-56.

On September 15, 2015, Petitioner underwent a repeat LP to rule out encephalitis, the

results of which were “not consistent with an infectious etiology.” Ex. 6 at 53, 97. She was

transferred out of the ICU on September 17, 2015. Id. at 110. The next day, she had a

rheumatology follow-up, at which it was documented that there were “[n]o findings suggestive of

infection in this hospitalization. Symptoms could be [secondary to] lupus.” Id. at 102.

Dr. Zheng saw Petitioner on September 18, 2015. Ex. 6 at 110. He noted the EEG,

completed on September 15, 2015, was “concerning for an epileptogenic pattern.” Id. He noted

that, after the doses of Petitioner’s Keppra and Dilantin13 were increased, she did not have any

seizures and “was completely back to her baseline with no neural deficit.” Id.

Petitioner was discharged from UMMC on September 21, 2015. Ex. 6 at 3. The discharge

summary stated:

31 [year old female] with [past medical history] of Lupus on

immunosuppression, presented to [PGH] with [complaint] of

headache, found to be in septic shock, requiring intubation, pressors,

admission to MICU. Patient was weaned and extubated. On 9/9

had 2 seizures, was loaded with AEDs. Patient had additional

13

Dilantin: trademark for preparations of phenytoin. Dilantin, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=14147 (last accessed March 9, 2026); phenytoin:

an anticonvulsant used in the treatment of epilepsy other than the petit mal type, the treatment of status

epilepticus, and the prevention and treatment of seizures associated with neurosurgery; administered orally.

Phenytoin, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=38541 (last accessed

March 9, 2026).

9

seizure on 9/10, with [altered mental status] after, then transferred

to [UMMC] for further [evaluation]. After initial seizures, CT and

MRI of head was completed, with vasogenic edema as the primary

finding. [Lumbar puncture] was non diagnostic and cultures [had]

no growth.

Id.

c. Second Hospitalization at UMMC: September 23-October 6, 2015

On September 23, 2015, Petitioner had a grand mal seizure and was taken back to PGH via

ambulance. Ex. 7 at 1-2. She was then taken by helicopter to UMMC. Ex. 3 at 261-62; Ex. 8. At

UMMC, Petitioner was admitted for seizures, encephalopathy, septic shock, lactic acidosis, sinus

tachycardia, hypotension, elevated lactate dehydrogenase14/transaminitis, and lupus. Ex. 6 at 208.

Petitioner was intubated and sedated. Id.

Petitioner experienced additional seizures on September 23, 29, and 30, 2015, while at

UMMC. Ex. 6 at 210, 316, 333. She tested negative for West Nile virus, and tests for other causes

for her seizures were inconclusive. Id. at 876. A September 25, 2015 CT was interpreted as

consistent with PRES, and an MRI taken that day showed improvement of PRES, along with vessel

narrowing “presumably related to lupus vasculopathy.” Id. at 235, 238.

On September 30, 2015, Petitioner’s treating neurologist assessed lupus cerebritis. Ex. 6

at 333. A record dated October 3, 2015, showed that her current diagnosis was a seizure disorder

that was likely secondary to lupus cerebritis. Id. at 373.

d. Later Treatment

On October 6, 2015, Petitioner was discharged from UMMC and admitted to MedStar

Washington Hospital (“MedStar”) for occupational and physical therapy. See Ex. 9. Her history

stated:

31 [year old] right handed [female] with [past medical history of]

SLE since 2012 who presented to UMMC 9/11 new onset witnessed

seizures. MRI revealed cerebral and cerebellar

leukoencephalopathy likely from SLE. EEG was abnormal. After

work up [patient] thought to have had lupus cerebritis versus lupus

flare. She was discharged to home on Keppra, Dilantin after being

seizure free for several days on 9/21. On 9/23 [patient] was noted

14

Lactate dehydrogenase: an enzyme of the oxidoreductase class that catalyzes the reduction of pyruvate

to (S)-lactate, using NADH as an electron donor. The reaction is the final step in glycolysis (white fibers).

The reverse reaction is the first step in the combustion of lactate (heart, red fibers) or its conversion to

glucose (liver). The enzyme occurs in the cytoplasm of nearly all cells. It is a tetramer containing M

(muscle) and H (heart) subunits; it exists as five distinct isozymes (M4, M3H, M2H2, MH3, H4). Identification

of isozyme types in serum is used for clinical diagnosis. Lactate dehydrogenase, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=27400 (last accessed on April 2, 2026).

10

to not feel well and EMS was called. When EMS arrived [patient]

was [found] [seizing]. Seizures [lasted] >10 minutes and required

Ativan during transport to [PGH]. [Patient] was intubated for

hypoxia then developed [supraventricular tachycardia (“SVT”)] to

180s that was unresponsive to Adenosine15 and electric

cardioversion. She was then place[d] on Amiodarone16 drip and

admitted to NCCU. Infectious disease and rheumatology consulted

for evaluation[,] felt presentation consistent with SLE cerebritis.

LP performed, high opening pressure 45, after CSF culture negative

[antibiotics] discontinued. [Patient] stated on cyclophosphamide17

infusion and was noted to have mental status improvement. Her

hospital course was complicated by right [intrajugular deep vein

thrombosis] that was treated with heparin drip then transitioned to

therapeutic [L]ovenox.18

15

Adenosine (second definition): a preparation of adenosine, which acts as a cardiac depressant of

automaticity in the sinus node and conduction in the atrioventricular node and also as a vasodilator; used

as an antiarrhythmic in the treatment of paroxysmal supraventricular tachycardia and as a diagnostic

adjunct, in conjunction with myocardial perfusion imaging, to induce coronary artery vasodilation in

patients unable to exercise adequately to undergo an exercise stress test; administered intravenously.

Adenosine, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=976 (last accessed on

March 9, 2026).

16

Amiodarone hydrochloride: a potassium channel blocking agent that prolongs the action potential

duration and refractory period of all cardiac fibers; administered orally or by intravenous infusion in the

treatment and prophylaxis of ventricular arrhythmias. Amiodarone hydrochloride, DORLAND’S

https://www.dorlandsonline.com/dorland/definition?id=2253 (last accessed March 9, 2026).

17

Cyclophosphamide: a cytotoxic alkylating agent of the nitrogen mustard group, used as an antineoplastic,

often in combination with other agents, for a wide variety of conditions, including Hodgkin disease,

lymphosarcoma, acute lymphocytic leukemia, Burkitt lymphoma, carcinoma of the breast, multiple

myeloma, chronic lymphocytic leukemia, bronchogenic carcinoma, neuroblastoma, ovarian carcinoma, and

carcinoma of the uterine cervix; also used as an immunosuppressive agent to prevent transplant rejection

and in the treatment of certain diseases with abnormal immune function. Cyclophosphamide itself is

pharmacologically inert; several active metabolites are produced by the microsomal enzyme systems in the

liver. Cyclophosphamide, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=12166

(last accessed March 9, 2026).

18

Lovenox: trademark for a preparation of enoxaparin sodium. Lovenox, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=28781 (last accessed March 9, 2026); Enoxaparin

sodium: a low-molecular-weight heparin, prepared from porcine intestinal mucosa, that binds to and

potentiates the action of antithrombin III, used to prevent pulmonary embolism and deep vein thrombosis

following hip or knee replacement or high-risk abdominal surgery; administered subcutaneously. It is also

used in conjunction with warfarin in the treatment of deep vein thrombosis, and in conjunction with aspirin

in the prevention of coronary thrombosis associated with unstable angina or non–Q wave myocardial

infarction. Enoxaparin sodium, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=16506 (last accessed on March 9, 2026).

11

Ex. 9 at 1.

Petitioner was discharged from inpatient rehabilitation on October 20, 2015. Ex. 9 at 60.

She was noted to have made excellent progress but was advised not to drive or return to work. Id.

at 63. She continued physical therapy on an outpatient basis until November 16, 2015. Id. at 74-

87.

On October 27, 2015, Petitioner followed up with rheumatologist Arthur Weinstein, M.D.

Ex. 4 at 361. She reported that she was hospitalized “[a]fter having a fever after tetanus shot she

received as prophylaxis for scalp infection?” and was treated for neuropsychiatric lupus at UMMC.

Id. Her rheumatologist recommended that she continue prednisone and start IV Rituxan.19 Id. at

363.

On November 10, 2015, Petitioner saw Martin P. Kolsky, M.D., for a neuro-

ophthalmologic evaluation. Ex. 10 at 9. Dr. Kolsky noted a visual field defect and advised that

Petitioner should not drive. Id. On November 17, 2015, Petitioner saw a rheumatology fellow for

a “carbuncle and furuncle.” Ex. 4 at 397. She was taken off Benlysta and prescribed Rituxan. Id.

at 399. She was also prescribed doxycycline for a right axillary abscess and referred to surgery

for incision and drainage. Id. The boil was drained on November 23, 2015, with no complications.

Id. at 403-04.

On December 5, 2015, Petitioner saw Dr. Zheng for an initial outpatient consultation. Ex.

6 at 424. Dr. Zheng noted she had been stable since her discharge from rehabilitation. Id. Her

neurological examination was normal. Id. at 426. Dr. Zheng remarked that Petitioner was

“completely back to her baseline.” Id.

Petitioner returned to Dr. Kolsky on December 10, 2015. Ex. 10 at 13. She “continue[d]

to demonstrate a rather dense left lower homonymous quadrantanopsia [sic].”20 Id.

On December 24, 2015, Petitioner saw neurologist Mohamad Koubeissi, M.D., who

recommended a one-hour EEG and seizure protocol MRI. Ex. 11 at 5. She was advised not to go

in a bathtub or swim alone, climb to high elevations, ride a bicycle without a helmet, or operate

heavy machinery. Id. A January 12, 2016 MRI showed a few nonspecific discrete foci of T2

hyperintensity in petitioner’s subcortical matter, which the interpreting radiologist noted could

“represent sequela of [an] inflammatory process.” Id. at 8; Ex. 12 at 3.

19

Rituxan: trademark for a preparation of rituximab. Rituxan, DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=43976 (last accessed on April 6, 2026).

Rituximab: a chimeric murine/human monoclonal antibody that binds the CD 20 antigen; used as an

antineoplastic in the treatment of CD20-positive, B-cell non-Hodgkin lymphoma; administered

intravenously. Rituximab, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=43977

(last accessed on April 6, 2026).

20

Quadrantanopia: hemianopia in one-fourth of the visual field, bounded by a vertical and a horizontal

radius. Quadrantanopia, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=42516 (last

accessed on April 3, 2026).

12

On January 26, 2016, Petitioner discontinued Imuran and was advised to continue

prednisone. Ex. 4 at 415. On March 8, 2016, she saw neurologist Mark M. Lin, M.D., who

diagnosed her with epilepsy of unknown etiology secondary to an occipital lesion, as well as SLE.

Id. at 483.

On March 24, 2016, Petitioner returned to Dr. Koubeissi, who noted that a January 2016

EEG was within normal limits. Ex. 11 at 10, 13. Dr. Koubeissi advised that she could drive once

six months had passed after her last seizure. Id. at 12.

Petitioner saw rheumatologist Dr. Collins on August 30, 2016. Ex. 4 at 496. She said she

was feeling well. Id. She was diagnosed with lupus cerebritis. Id. at 499.

On January 26, 2017, Petitioner saw neurologist Robert Laureno, M.D., for epilepsy. Ex.

22 at 3. Her neurologic examination was normal, and Dr. Laureno advised that she continue her

current medication regimen. Id. at 5.

On August 8, 2017, rheumatologist Michael Belsky, M.D., noted good compliance with

her current medications, though she reported intermittent swelling in her hands up to twice per

month. Ex. 22 at 35.

On February 7, 2019, rheumatologist Mark Biro, M.D., commented that Petitioner’s lupus

was “currently stable.” Ex. 23 at 39. At a February 24, 2020 neurology follow-up, Petitioner

noted that she ran out of Keppra and did not notice a difference when she stopped taking the

medication. Id. at 158. She and her neurologist, Ahmareen Baten, M.D., discussed weaning off

epilepsy medications, as she had been seizure-free for four years. Id. at 161.

A rheumatology visit with Dr. Collins on March 3, 2020, was normal, with no signs of

active SLE observed. Ex. 23 at 186.

III. EXPERT EVIDENCE

A. Expert Reports

1. Petitioner’s Expert James Valeriano, M.D.: First Expert Report

Dr. Valeriano authored two expert reports.21 Ex. 20 (“First Valeriano Rep.”); 21 (“Second

Valeriano Rep.”). He earned his M.D. from the University of Pittsburgh and completed his

residency and a clinical neurophysiology fellowship at Georgetown University Medical Center.

Ex. 20-1 (“Valeriano CV”) at 1. He has served as the Director of the Comprehensive Epilepsy

Program and Chairman of the Department of Neurology at Allegheny General Hospital in

Pennsylvania, among other positions. Id. at 1-2. He has also held several academic positions,

including Associate Professor of Neurology at Drexel University College of Medicine and

Professor of Neurology at Temple University School of Medicine. Id. at 2-3. He is board certified

in neurology and clinical neurophysiology. Id. at 3. He has published peer-reviewed papers and

21

Dr. Valeriano did not cite any medical literature in support of his first expert report.

13

book chapters about seizures. Id. at 10-12. At hearing, Special Master Oler recognized Dr.

Valeriano as an expert in neurology. Tr. at 12.

In describing Petitioner’s medical history, Dr. Valeriano stated that she was given a

“DPT/Tdap” vaccination on September 4, 2015. First Valeriano Rep. at 1. Petitioner experienced

“a devastating neurological event after her DPT injection.” Id. Petitioner suffered either lupus

cerebritis, “an inflammation of the blood vessels of the brain which led to multiple infarcts, and/or

posterior reversible encephalopathy syndrome (PRES) which can be associated with lupus.” Id.

at 1-2. Lupus cerebritis and PRES can be difficult to distinguish on MRI. Id. at 2.

Dr. Valeriano noted that Petitioner was diagnosed with ADEM at UMMC. First Valeriano

Rep. at 2. He disagreed with this assessment, although he acknowledged that PRES and ADEM

might appear similar on MRI. Id. In his view, the MRI images were more consistent with PRES,

which he opined was caused by a severe lupus flareup. Id. The proximate cause of the lupus flare

-up was the DTP vaccination.22 Id.

On causation, Dr. Valeriano pointed to the timing of Petitioner’s symptoms in relation to

the vaccination: “I believe the evidence is that the proximate cause of the flareup was the

vaccination given the timing of the onset of symptomology and the stability of her lupus before

this occurred.” First Valeriano Rep. at 2. Notably, a treating physician at PGH assessed that

Petitioner had “most likely [a] lupus flare up that was incited by tetanus shot.” Id.; see also Ex. 3

at 23. Also, Petitioner tested negative for infectious causes of her symptoms. First Valeriano Rep.

at 2. Overall, “the timing of the onset of initial symptoms and subsequent development of seizure

activity after the administration of the vaccine on September 4, 2015 is appropriate and consistent

with an auto-immune response and resulting lupus flare up and/or development of PRES syndrome

following the DTP administration.” Id.

Additionally, the pertussis component of the subject vaccine has “epileptogenic potential,”

and “Ms. Boyd’s strong proclivity toward auto-immune disease cannot have helped.” First

Valeriano Rep. at 2. The pertussis toxin, when mixed with adjuvants, can “stimulate aberrant

immunologic/inflammatory responses in the brain.” Id.

Dr. Valeriano further opined that Petitioner’s condition qualifies as a Vaccine Table injury.

First Valeriano Rep. at 2 (citing 42 C.F.R. § 100.3). He explained that the Table includes

encephalopathy or encephalitis occurring within 72 hours of the administration of any vaccine

“containing whole cell pertussis bacteria, extracted or partial cell pertussis bacterial, or specific

pertussis antigens (e.g., DTP, DTaP, P, DPT-Hib)[.]” Id. Petitioner experienced an

encephalopathy as defined by the Table’s Qualifications and Aids to Interpretation (“QAI”),

because her condition met the criteria for an “acute encephalopathy” that resulted in a “chronic

encephalopathy.” Id. at 2-3. Specifically, she exhibited altered consciousness, lethargy, and loss

of memory at the time of the initial presentation at PGH. Id. at 3. These were new symptoms for

her. Id. Her altered mental status persisted, and an EEG “showed evidence of moderate

encephalopathy.” Id. (citing Ex. 3 at 241). Furthermore, Petitioner “overtly meets the above

requirements for chronic encephalopathy as well since her change in mental or neurological status

has persisted for more than 6 months.” Id. at 4. “Her chronic encephalopathy is an epileptic

22

Petitioner received a Tdap, not a DTP, vaccination.

14

encephalopathy and is specifically listed as a contraindication for pertussis containing vaccines.”

Id. Petitioner continued on an antiepileptic medication regimen for more than six months, and her

seizures left her with cognitive, vision, motor and balance impairments. Id.

2. Respondent’s Expert Miles Evans, M.D.: Expert Report

Dr. Evans authored one expert report. Ex. A (“Evans Rep.”). He received his M.D. and

M.S. in physiology from the University of Louisville. Ex. B (“Evans CV”) at 1. He completed a

residency in neurology and a fellowship in neuropharmacology at the Washington University

School of Medicine. Id. He has held a number of academic and hospital positions and currently

serves as the Clinical Neurophysiology Fellowship Program Director, Professor of Medicine in

Neurology, and Director of the Epilepsy and Neurophysiology Program at the University of

Louisville. Id. at 2-3. He is board certified in neurology and clinical neurophysiology. Id. at 4.

Dr. Evans has led studies relating to seizures and epilepsy and has published 39 peer-

reviewed papers. Evans CV at 7-9, 10-12. He was recognized at hearing as an expert in neurology.

Tr. at 279.

Dr. Evans included a detailed summary of Petitioner’s medical history. Evans Rep. at 1-

11. Before the vaccination, her lupus symptoms included joint pain, along with chest pain

sometimes severe enough to require ER visits. Id. at 2. She was treated with hydroxychloroquine

(Plaquenil), Benlysta infusions, and prednisone. Id. As of May 2015, Petitioner’s blood work

revealed that her lupus was “active and not entirely controlled disease.” Id. at 11. However, at

her last rheumatology visit before her vaccination on August 24, 2015, she reported improved joint

pain and less frequent chest pain. Id. at 2. Dr. Evans agreed with the lupus diagnosis. Id. at 11.

In addition to her lupus, Petitioner had several other medical conditions that pre-dated her

vaccination, including hypertension, constipation with rectal bleeding, pneumonia, cystitis,

alopecia, and sinus tachycardia, among others. Evans Rep. at 2-3. She also suffered from recurrent

boils beginning in 2013. Id. at 3. She did not have a history of seizures or epilepsy. Id.

Dr. Evans noted that the subject vaccine contained diphtheria toxoid, acellular pertussis,

and tetanus toxoid. Evans Rep. at 4. Petitioner was given the vaccination during a visit to PGH

for treatment of a boil along her left hairline. Id. The boil was observed to have overlying

cellulitis. Id. The boil was incised and drained. Id. Petitioner was given antibiotics, “presumably

because of her lupus and immunosuppressive treatment.” Id.

Although the bacteriology of boils is not known, the most common causal bacterium is

Staphylococcus aureus. Evans Rep. at 13 (citing Djillali Annane et al., Septic shock, LANCET 365:

63–78 (2005) (Ex. C-2) (“Annane”)). On September 7, 2015, Petitioner tested positive for MRSA,

a strain of Staphylococcus aureus. Id. (citing Ex. 3 at 146, 420). Dr. Evans believed that a MRSA

infection associated with Petitioner’s facial abscess probably caused her to develop septic shock.

Evans Rep. at 13. He stated:

The evidence is strongly in favor of the ED physician's diagnosis of

septic shock. The patient clearly had shock, as shown by her low

15

blood pressure, tachycardia and evidence of end organ dysfunction.

Dysfunction of the brain in shock produces mental status changes or

frank loss of consciousness. Her mental status in the ED is not

clearly documented, but changes are referred to in the medical

record. The petitioner's affidavit indicates she has no memory [of]

the ED after leaving the triage area, and her husband's affidavit

states that while in the waiting room she stopped talking or

answering questions. Both of these indicate brain dysfunction at

that time. Kidney dysfunction, which is very common in shock,

was also present—her creatinine level was 3.0, very elevated for a

person without renal disease, and after admission she developed the

syndrome of acute kidney injury (AKI).

Id. at 12. Her laboratory results were also consistent with septic shock, including her elevated

lactic acid and low bicarbonate and CO2 levels. Id. at 12-13. Her WBC and neutrophil levels were

elevated for a patient on immunosuppressive drugs, potentially signifying a “catastrophic

infection.” Id. at 13. The presence of banded neutrophils was indicative of bacterial sepsis. Id.

Also, sepsis and septic shock are relatively common conditions and result in many hospitalizations

and high rates of death, including in lupus patients and patients who are immunosuppressed. Id.

(citing Hearns W. Charles, Abscess drainage, SEMIN. INTERVENT. RADIOL. 29, 325-336 (2012)

(Ex. C-7) (“Charles”)); Greg S. Martin et al., The Epidemiology of Sepsis in the United States from

1979 through 2000, N. ENGL. J. MED. 348; 1546-1554 (2003) (Ex. C-21) (“Martin”); Arthur

Mageau et al., Septic shock among patients with systemic lupus erythematosus: Short and long-

term outcome. Analysis of a French nationwide database, J. INFECT. 78, 432-438 (2019) (Ex. C-

19) (“Mageau”); Fabio E. Ospina et al., Distinguishing infections vs flares in patients with systemic

lupus erythematosus, RHEUMATOLOGY 56, i46-i54 (2017) (Ex. C-23) (“Ospina”)).

Sepsis can result from many types of infections, including abscesses. Evans Rep. at 13.

Given that Petitioner was positive for MRSA, which can cause facial abscesses, and given the

severity of her condition, Dr. Evans felt her sepsis was likely caused by MRSA infection. Id. He

pointed out that although Petitioner’s blood cultures came back negative for any specific infectious

organism, positive cultures are not required for a sepsis diagnosis, and culture-negative sepsis is

common. Id. (citing Shipra Gupta et al., Culture-Negative Severe Sepsis: Nationwide Trends and

Outcomes, CHEST 150, 1251-1259 (2016) (Ex. C-10) (“Gupta”)). Additionally, Petitioner’s

cultures might have been negative because she was taking antibiotics before the onset of her

symptoms. Id.

Dr. Evans commented that Petitioner developed mental status changes while hospitalized,

including two seizures that occurred on September 9, 2015. Evans Rep. at 13-14. An MRI of the

brain showed cerebral leukoencephalopathy, indicating damage to the white matter appearing as

vasogenic edema concentrated in the posterior region of the brain. Id. at 14. This was consistent

with PRES. Id. Further MRIs were also interpreted to show PRES. Id. Petitioner’s other clinical

signs, including mental status changes, visual deficits, focal neurological deficits, and seizures,

were also suggestive of PRES. Id. (citing Archana Hinduja, Posterior Reversible Encephalopathy

Syndrome: Clinical Features and Outcome, FRONT NEUROL. 11, 71 (2020) (Ex. C-12)

(“Hinduja”)).

16

PRES has been described in many different conditions, including sepsis, septic shock,

autoimmune disorders, and in association with the use of immunosuppressive drugs. Evans Rep.

at 14. PRES is very commonly associated with seizures and can be associated with brain

hemorrhage. Id. Petitioner suffered both seizures and a hemorrhage that caused a permanent

visual field defect. Id.

Dr. Evans felt Petitioner’s MRIs “were less consistent with lupus cerebritis, and instead

were entirely consistent with PRES.” Evans Rep. at 14. He did not believe she had ADEM. Id.

at 18. He disagreed that her initial complaints were suggestive of a lupus exacerbation; the pain

she experienced was far more severe than that associated with her previous flareups. Id. at 15.

Also, her complement and dsDNA levels at the time of her hospitalization did “not support a severe

exacerbation” of lupus. Id. Her CRP and ESR rates were high in the hospital, which was consistent

with sepsis but not an acute lupus flareup. Id.

Dr. Evans did not agree with the diagnosis of neuropsychiatric lupus (“NPSLE”), assigned

by some of Petitioner’s treating physicians. Evans Rep. at 16. Instead, he felt her condition was

better explained by a PRES diagnosis. Id. To the extent she had NPSLE, it manifested as PRES,

which is a separate diagnosis that fully explained her condition. Id. Her PRES was “more likely

to have resulted from sepsis and septic shock,” which in turn was triggered by infection. Id. at 16-

17.

Similarly, Dr. Evans opined that Petitioner’s seizures were caused by PRES. Evans Rep.

at 17. PRES causes seizures in a large majority of patients. Id. (citing Hinduja). Her visual

impairment was due to the brain hemorrhage she suffered due to PRES. Id.

Dr. Evans pointed out that Petitioner received an acellular version of the pertussis vaccine,

as opposed to the older, whole cell pertussis vaccine, DPT. Evans Rep. at 18-19. Dr. Valeriano’s

discussion of the potential toxicity of the DPT vaccine was therefore inapplicable. Id. (citing

Karina A. Top and Scott A. Halperin, Pertussis and Other Bordetella Infections, HARRISON'S

PRINCIPLES OF INTERNAL MEDICINE. McGraw-Hill Education, pp.1-8 (2015) (Ex. C-25) (“Top and

Halperin”); Katrina Kretsinger et al., Preventing tetanus, diphtheria, and pertussis among adults:

use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations

of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP,

supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use

of Tdap among health-care personnel, MMWR RECOMM. REP. 55, 1-37 (2006) (Ex. C-17)

(“Kretsinger”)). The Tdap vaccine has been well studied for the potential to cause seizures, with

reassuring results. Id. at 19 (citing William E. Barlow et al., The risk of seizures after receipt of

whole-cell pertussis or measles, mumps, and rubella vaccine, 9 N. ENGL. J. MED. 345, 656-661

(2001) (Ex. C-4) (“Barlow”); Natasha J. Brown et al., Vaccination, seizures and 'vaccine damage',

CURR. OPIN. NEUROL. 20, 181-187 (2007) (Ex. C-6) (“Brown”)). There is no clinical data linking

the Tdap vaccine to PRES, though there are a few case reports describing PRES after MMR

vaccinations. Id. (citing Kursad Aydin et al., Reversible posterior leukoencephalopathy and Adie's

pupil after measles vaccination, J. CHILD NEUROL. 21, 525-527 (2006) (Ex. C-3) (“Aydin”);

Tadanori Hamano et al., Posterior reversible encephalopathy syndrome following measles

vaccination, J. NEUROL. SCI. 298, 124-126, (2010) (Ex. C-11) (“Hamano”)). In any event, her

17

PRES was more likely caused by Petitioner’s sepsis, septic shock, lupus, and/or

immunosuppression. Id.

Dr. Evans concluded:

It is clear that Ms. Boyd suffered a very severe acute illness shortly

after [incision and drainage (“I&D”)] and vaccination. Within

hours after her I&D she developed symptoms, and approximately 32

hours after her I&D she returned to the ED where she developed

septic shock, causing encephalopathy and the other signs of shock.

About 3 days after that she had her first seizure, which was

determined by MRI scanning of the brain to be due to PRES.

Because of the sepsis, PRES and recurrent seizures, as well as

possible lupus exacerbation, she had a prolonged hospital course.

Despite the severity of her illness she has had substantial clinical

recovery. Her last brain MRI scan five months after onset of her

illness showed good resolution of the PRES. The timing and clinical

course of all of this is typical for these conditions. It is

understandable that she might associate her severe acute illness with

vaccination, but the evidence in the case is conclusively against

vaccination having a causative role.

Evans Rep. at 20.

3. Respondent’s Expert Chester Oddis, M.D.: Expert Report

Dr. Oddis authored one report. Ex. D (“Oddis Rep.”). Dr. Oddis received his M.D. from

Pennsylvania State University. Ex. E (“Oddis CV”) at 1. He completed his internal medicine

internship and residency at Pennsylvania State University and a fellowship in rheumatology at the

University of Pittsburgh. Id. He is the Director of the Myositis Center and a Professor of Medicine

at the University of Pittsburgh School of Medicine. Id. at 3. He is board certified in internal

medicine and rheumatology. Id. at 3. He estimated that he has published over 150 peer-reviewed

papers. Tr. at 155. He was recognized as an expert in rheumatology. Id. at 158.

Dr. Oddis agreed with Petitioner’s lupus diagnosis. Oddis Rep. at 2. He believed that

Petitioner’s lupus disease course would be “classified as stable with previous episodes of mild to

moderate flares of SLE,” but requiring several different medications to control. Id. at 5, 7. At her

last rheumatology appointment before the vaccination, she was clinically stable with improving

ds-DNA and complement levels. Id. at 4. She had a low WBC count at that time, which was not

unusual in a lupus patient. Id.

Dr. Oddis commented that at the time of Petitioner’s hospital admission on September 6,

2015, her elevated WBC count of 10.2 and her “markedly elevated CRP ‘should raise the suspicion

for infection in a patient with SLE.’” Oddis Rep. at 5. He agreed with Dr. Evans that her scalp

abscess likely led to sepsis and then septic shock. Id. at 8. The acuteness and severity of the septic

shock led to seizures. Id. Also, seizures occur in 20% or more of lupus patients. Id. (citing Peter

18

H. Schur, Neurological manifestations of systemic lupus erythematosus, UpToDate (Ex. F-1) at 7;

Daniel J. Wallace and Dafna D. Gladman, Clinical manifestations and diagnosis of systemic lupus

erythematosus in in adults, UpToDate (Ex. F-3) (“Wallace and Gladman”) at 6). Thus, the

infection was the likely trigger of Petitioner’s seizures; whether the seizures are characterized as

“PRES” or “lupus cerebritis” is immaterial from a causation standpoint. Id. at 5-6.

Dr. Oddis disagreed that Petitioner’s condition was caused by the Tdap vaccination,

explaining that a vaccine would be highly unlikely to trigger a lupus flare of this magnitude. Oddis

Rep. at 8-9. “[H]er condition was most likely triggered by sepsis, as symptoms, labs, and clinical

course were entirely consistent when a physiological response to an overwhelming bacterial

infection (i.e. the scalp abscess).” Id. at 8. He cited to the Wallace paper to opine that vaccines

generally do not have any impact on the natural course of SLE. Id. at 8-9 (citing Daniel J. Wallace,

Overview of the management and prognosis of systemic lupus erythematosus, UpToDate (Ex. F-

1) (“Wallace”)).

4. Dr. Valeriano’s Second Expert Report

In reply to Respondent’s experts, Dr. Valeriano opined that he did not believe Petitioner

had sepsis; instead, she had a lupus flareup caused by her Tdap vaccination. Second Valeriano

Rep. at 1. Although sepsis was part of the differential diagnosis, that did not explain her condition.

Id. The nature of Petitioner’s abscess was superficial, requiring only a minor procedure to address,

and she was afebrile at the time of the procedure. Id. She was given oral antibiotics, which would

have prevented sepsis. Id. Her symptoms the following day, which included arthralgias and

abdominal pain, would be uncommon in sepsis. Id. at 2. Lastly, her blood cultures were negative.

Id.

In Dr. Valeriano’s view, Petitioner’s WBC count of 10.2 and high CRP levels were non-

specific, as high CRP levels are evidence of inflammation, which was likely caused by her PRES.

Second Valeriano Rep. at 2. The strongest indicator of possible sepsis in Petitioner was

hypotension, but that also could have been caused by other factors such as dehydration, stress, or

pain. Id. She was “afebrile and had significant arthralgias, which are much more common to lupus

flares.” Id.

Dr. Valeriano pointed out that Petitioner had three diagnoses on her differential: PRES,

ADEM, and lupus cerebritis. Second Valeriano Rep. at 3-4. Both ADEM and lupus cerebritis

involve an immune response that, in his view, would suggest her condition was precipitated by a

lupus flareup “directly related to the vaccine.” Id. at 4. “If it were PRES syndrome, this could be

caused either by sepsis or by a lupus flare-up,” but a lupus flareup was the more likely trigger. Id.

Regarding causation, the Tdap vaccine includes the pertussis toxin, which is a known

neurotoxin and “can elicit an epileptogenic response in a susceptible adult individual such as Ms.

Boyd.” Second Valeriano Rep. at 4. Petitioner’s lupus made her more susceptible to an

inflammatory trigger. Id. The “[p]ertussis toxin, mixed with adjuvants, [was] designed to elicit a

serological antibody response, [and] can stimulate aberrant immunologic/inflammatory responses

in the brain and can cause seizure activity.” Id. Dr. Valeriano cited medical literature

demonstrating that the pertussis toxin can cause lethal encephalopathy in mice. Id. at 5 (citing

19

DeRen Huang et al., Pertussis Toxin-Induced Reversible Encephalopathy Dependent on Monocyte

Chemoattractant Protein-1 Overexpression in Mice, J. NEUROSCI. 22(24), 10633–10642 (2002)

(Ex. 21-2) (“Huang”)). He also pointed out that the CDC contraindicates the diphtheria, tetanus,

acellular pertussis (“DTaP”) vaccine for infants who have previously suffered collapse/shock-like

state, seizure, or inconsolable crying within 2-3 days of receiving a prior dose of the vaccine. Id.

He opined:

The animal model studies in combination with the clinical

observations of vaccinated infants, strongly indicate that the

Pertussis Toxin has the capacity to elicit neurological side-effects in

adults, especially in those individuals whose background make them

particularly sensitive and/or who have pre-existing immune

responses to common biomolecules, or who have underlying

medical issues that increase[] the propensity for adverse reactions to

the vaccine. Just as SLE may make one more prone to infection, it

certainly makes one more prone to an adverse autoimmune

response.

Id. at 6.

B. Expert Testimony

1. Dr. Valeriano

Dr. Valeriano testified on the first day of the entitlement hearing and discussed the

symptoms of lupus, which include arthralgias, arthritis, and myalgias. Tr. at 13. Less common

effects of lupus include renal failure, cardiomyopathies, or serositis pericarditis. Id. Prior to

vaccination, Petitioner suffered from periodic lupus flares/arthralgias, but no other symptoms. Id.

at 14. Her lupus was stable before the vaccination. Id. at 15-18. The day after vaccination,

however, she reported generalized joint and muscle pain. Id. at 19-20. Dr. Valeriano felt it was

significant that Petitioner described her symptoms as similar to lupus flareups she had experienced

in the past. Id. at 21.

Petitioner also developed seizures after vaccination. Tr. at 21. Dr. Valeriano broadly

defined a seizure as an electrical storm in the brain that causes brain cells to discharge, with

symptoms that are dependent on which neurons are discharged. Id. at 22. Seizures are usually the

result of an injury to the brain, but one can lose neurons if there are numerous seizures. Id. at 23.

Cumulatively, repeat seizures, particularly in quick succession, can lead to general cognitive

issues, affecting memory and the ability to multitask, make decisions, and plan. Id. at 23-24. Dr.

Valeriano believed that the number of seizures Petitioner experienced led to permanent injuries,

including epilepsy. Id. at 25-26.

Dr. Valeriano testified that Petitioner had three potential diagnoses: lupus cerebritis,

ADEM, and PRES. Tr. at 26-28. Lupus cerebritis is “a fairly unusual condition” associated with

lupus that is caused by inflammation of blood vessels in the brain. Id. at 26. It can present with

encephalopathy and/or with micro-infarcts that “can lead to strokes.” Id. at 26-27. ADEM is an

20

immune mediated condition that causes inflammation of the brain. Id. at 27. PRES is associated

with lupus and other immune mediated conditions, which often presents with seizures. Id. at 28-

29. These conditions are difficult to discern from one another clinically, but on MRI, one might

be able to distinguish ADEM from PRES. Id. at 29.

Dr. Valeriano opined that, based on Petitioner’s MRI, her condition was most consistent

with PRES. Tr. at 28, 30. Any of the three conditions on her differential, however, could have

been triggered by the Tdap vaccination. Id. at 31.

Dr. Valeriano believed the onset of Petitioner’s condition was signified by the diffuse

muscle and joint pain that she experienced the morning of September 6, 2015. Tr.at 33. Her

nausea and vomiting could have been part of her presentation as well. Id. These symptoms were

consistent with a lupus flareup. Id.

Several of Petitioner’s treating physicians associated her generalized pain with her tetanus

vaccine. Tr. at 35-37. Testing in the hospital ruled out infections. Id. at 40-41. Ultimately, most

of Petitioner’s physicians believed that her symptoms were caused by a lupus flareup, but Dr.

Valeriano did not believe that was an adequate explanation for what happened. Id. at 41. At least

some of her treating providers believed the vaccine was responsible. Id. at 42.

Regarding the specific mechanism, Dr. Valeriano admitted he was not a vaccine expert.

Tr. at 42-43. Pertussis is a neurotoxin, but he did not believe Petitioner’s condition was directly

caused by the toxin. Id. Instead, the vaccine started “an immune reaction in a woman who was

prone to immune reactions,… activating [her] lupus.” Id. at 43-44. Petitioner’s symptomology

was consistent with a lupus flareup, indicating that the vaccine exacerbated or flared up her lupus.

Id. at 44.

Dr. Valeriano disagreed with Respondent’s experts that Petitioner’s presentation could be

explained entirely by septic shock. Septic shock usually occurs in the setting of an overwhelming

infection. Tr. at 44. It often presents with hypotension, fever, confusion, aches and pains, and

increased heart rate. Id. at 44-45. Seizures are not commonly associated with septic shock, but

they can occur. Id. at 46. Petitioner was afebrile when she arrived at PGH, which would be an

atypical presentation of septic shock. Id. at 46-47. Also, although Petitioner was on prophylactic

antibiotics at the time of onset, her blood cultures were completely negative, which would be

unusual in sepsis. Id. at 50-51.

Petitioner had low blood pressure, which can be caused by septic shock, but could also

have been caused by dehydration or pain. Tr. at 52-53. She reported several days of vomiting

since receiving the tetanus vaccination, which could have led to dehydration, and her creatinine

levels were low, also consistent with dehydration. Id. at 54-55.

Dr. Valeriano acknowledged that Petitioner’s low oxygen saturation and low oxygen levels

could be a part of septic shock presentation. Tr. at 47. Also, the fact that Petitioner was on

immunosuppressants for her lupus could have affected her ability to produce white blood cells, so

while her WBC was not particularly high, that did not rule out septic shock caused by infection.

Id. at 56. However, high WBC and CRP levels could be seen in a wide variety of conditions,

21

including a lupus flare. Id. at 58.

Petitioner’s incision and drainage procedure, performed on September 4, 2015, appeared

to be a minor procedure and therefore was unlikely to have led to something as severe as septic

shock. Tr. at 60-61. Nothing in the medical records indicated that there was a severe infection at

the site of her abscess, which he would expect if she had sepsis. Id. at 62. Dr. Valeriano believed

the abscess was superficial and cutaneous, rather than subcutaneous. Id. at 63, 65.

Petitioner had signs of acute encephalopathy in the hospital, including significant changes

in mental status, decreased level of consciousness, difficulty with concentration, lethargy, and

sluggish pupillary reactions. Tr. at 67-68. The records document that she had an altered mental

status (“AMS”) with minimal communication that occurred within 72 hours of vaccination. Id. at

70; see also Ex. 3 at 243. As such, Dr. Valeriano concluded that Petitioner suffered an

encephalopathy consistent with the Vaccine Injury Table. Id. at 71. Petitioner’s EEG “was

somewhat confirmatory for encephalopathy.” Id. at 72; see also Ex. 3 at 241. Her neurological

issues continued for quite some time, with additional seizures, cognitive difficulties, and visual

impairment. Id. at 73-74.

On cross examination, Dr. Valeriano confirmed he was not board certified in

rheumatology. Tr. at 76. He confirmed that Petitioner’s abscess had fluctuance and overlying

cellulitis. Id. at 81-82; see also Ex. 3 at 3. He also acknowledged that Petitioner’s treating

physicians entertained septic shock as a diagnosis. Id. at 82-83; see also Ex. 3 at 22, 132, 136. He

agreed that some of Petitioner’s treating physicians believed she developed sepsis as a result of

her incised abscess. Id. at 84; see also Ex. 3 at 136, 141.

Dr. Valeriano summarized his theory as: the Tdap vaccine, in a patient with an autoimmune

disease, set off an immune response that exacerbated her underlying lupus, which led to the

cascade of events and symptoms Petitioner suffered. Tr. at 86. Her initial complaints of muscle

aches and pain, joint aches, were evaluated and seen as a possible lupus flare. Id. While both

lupus and sepsis were plausible, the clinical facts “fit[] better with the lupus.” Id. at 87.

When asked specifically what in the Tdap vaccine caused the lupus flare, Dr. Valeriano

stated that any vaccine stimulates the immune system and that similar to vaccine-induced Guillain-

Barré syndrome, the “immune system attacks your nervous system.” Tr. at 88. The lupus flare

was then the proximate cause of the PRES. Id. Dr. Valeriano could not name any specific

antibodies, cytokines, or immunoglobins in the immunological process to explain how the Tdap

vaccine caused the lupus flare, since he was not an immunologist. Id. at 89. He also conceded

that had Petitioner’s blood cultures been indicative of sepsis, he would not have concluded her

condition was vaccine induced. Id. at 90.

On redirect, Dr. Valeriano reiterated that encephalopathy and prolonged seizures were

listed as contraindications on the Tdap vaccination package inserts, especially for the pertussis

component; some patients should receive the TD vaccine, rather than the Tdap vaccine, because

the pertussis component could cause issues in patients like Ms. Boyd. Tr. at 91-92.

2. Dr. Oddis

22

Dr. Oddis explained that lupus/SLE is a systemic, autoimmune disease that attacks the

body in many different ways, with symptoms that can range from mild to life-threatening. Tr. at

159-60. Lupus flares are common in a patient’s disease course; they can have either a slow onset

or a rapid development of symptoms, which tends to be more serious. Id. at 160. Symptoms of a

flare can include rash, fatigue, joint pain, mouth sores, shortness of breath, serositis (pain with

breathing), heart problems, and kidney and/or respiratory failure. Id. at 160-61. Neurological

symptoms can also occur, “from actually just depression all the way up to seizures.” Id. at 161.

The diagnosis of SLE requires a positive ANA test, and C3, C4, dsDNA, and inflammatory marker

levels are typically monitored for disease activity. Id. at 161-62. Doctors treat lupus patients with

hydroxychloroquine, prednisone, and sometimes Benlysta, methotrexate, Imuran, and other

immunosuppressive drugs. Id. at 163-64.

Dr. Oddis opined that as of August 2015, Ms. Boyd’s lupus was not overtly or severely

active, but it was “smoldering.” Tr. at 164. She was on four different medications (prednisone,

Imuran, hydroxychloroquine, and Benlysta). Id. at 165. Her symptoms included arthritis, rash,

and serositis, and her bloodwork never totally normalized even with immunosuppressive

medications. Id. at 165. She had a persistently low WBC count before vaccination, indicating a

“low level of immunity.” Id. at 165-66.

Petitioner’s rapid deterioration on September 6, 2015, was consistent with septic shock

caused by infection. Tr. at 167. She had low blood pressure and required pressors to keep her

blood pressure stable. Id. She also had lactic acidosis, worsening kidney function, an increased

WBC count (from 2.4 to 10.2), and increased “bands.”23 Id. Petitioner’s bandemia (elevated

bands), combined with her elevated CRP level of 269, indicated she had an infection. Id. at 167-

68. Once her infection was under control, her WBC count returned to a normal level of 2.2. Id.

at 168.

Petitioner’s presentation and rapid decompensation were more consistent with an infection

than a lupus flare. Tr. at 178. Dr. Oddis cited the rapid improvement of her kidney function in

response to treatment and extremely elevated CRP levels, which were “over a hundred times

23

Dr. Oddis later explained:

So whenever you have a white blood cell count, that white blood cell count

has several different components. There's neutrophils, there's leukocytes,

and then one of the components are called bands, and whenever you have

an elevated band count, that means your bone marrow is putting out white

blood cells that are immature, and that doesn't occur with lupus. That

occurs with infection. So whenever you have an elevated -- a relatively

elevated percentage of band cells in the distribution of the types of white

blood cells, then that is supportive of infection, not supportive of a lupus

flare.

Tr. at 251.

23

normal CRP.” Id. at 180-81, 187. She was also treated with Levophed, a blood pressure

medication that is only administered for “serious sepsis and serious hypotension.” Id. at 182. In

his opinion, the “clinical presentation [was] overwhelmingly in support of infection[.]” Id. at 169.

Dr. Oddis also pointed out that a severe infection could cause a lupus flare, so the two conditions

are not mutually exclusive. Id. at 183. Here, to the extent Petitioner suffered symptoms of lupus,

they were likely triggered by her infection. Id. at 190.

Dr. Oddis noted that Petitioner was on three immunosuppressive medications for her lupus.

Tr. at 184-85. As a result, she was at higher risk for an infection. Id. at 182. Her negative blood

cultures were consistent with her ingestion of two antibiotics. Id. at 185. Finally, he noted that a

patient with sepsis will “feel like a truck hit them…. They ache all over. Their muscles hurt. Their

joints hurt. [It] can be a pretty dramatic presentation of musculoskeletal symptoms.” Id. at 186.

This was congruent with Petitioner’s clinical picture. Id. at 187-88.

Dr. Oddis disagreed with Dr. Valeriano’s assessment that Petitioner’s abscess was

superficial and could not have caused an infection. Tr. at 172-74. The abscess was a “significant

inflammatory skin problem” because there was cellulitis, meaning soft tissue inflammation, around

the abscess, indicative of infection. Id. at 172. The abscess was draining pus. Id. Petitioner was

prescribed two different antibiotics because “they [were] treating an infection.” Id. at 173. A

surgical consultation was requested, indicating that the abscess was abnormal. Id. at 175-76. Also,

Petitioner tested positive for MRSA on September 7, 2015. Id. at 176-77. Dr. Oddis explained:

If you're colonized with MRSA -- that's Methicillin-resistant

staphylococcus aureus, MRSA -- and there is the risk that you could

be colonized with MRSA and then that could again cause an

infection. And the reason that that might be important is that

although she's cultured negative from a blood culture perspective,

remember, this patient was given two antibiotics, both of which will

suppress the growth of staph in the blood, but yet if your body is

already colonized with MRSA -- and it could be colonized because

she's on multiple immunosuppressive medications anyway that

allows your body to be colonized with MRSA -- then she is at risk

for a MRSA infection because of the colonization.

Id. at 177.

Dr. Oddis noted that Petitioner had a seizure on September 9, 2015, and her imaging

showed PRES. Tr. at 168, 193-94. He agreed with Dr. Valeriano that PRES was a more accurate

diagnosis than lupus cerebritis, in part because seizures are more common with PRES than lupus

cerebritis. Id. at 196. PRES is associated with lupus, hypertension, and immunosuppressive

medications. Id. at 168-69. In his view, Petitioner’s PRES was likely triggered by her septic

shock, given the totality of the clinical course. Id. at 193.

24

Dr. Oddis opined that it was unlikely the vaccine could have caused “the degree of

catastrophic change that was observed in this case.” Tr. at 199. He had not heard about or

experienced such an occurrence in his clinical practice. Id. Vaccination is typically recommended

in lupus patients, unless they are in the midst of a major flare. Id. He concluded that Petitioner

suffered an infection, leading to septic shock and PRES. Id. at 201. Her injury did not meet the

criteria for a Table injury because there was another cause of encephalopathy (infection and septic

shock). Id. at 202.

On cross, Dr. Oddis acknowledged that several treating physicians attributed or temporally

related Petitioner’s condition to the Tdap vaccine. Tr. at 227-29. He also admitted that Petitioner’s

WBC count was, on several occasions before the vaccination, higher than 2.4, suggesting her WBC

in the hospital was not markedly elevated from baseline. Id. at 231-34. However, he argued that

a lupus flare would not have caused the WBC level that was seen in Petitioner. Id. at 234.

Similarly, her elevated CRP level was not a reliable marker of a lupus flare. Id. at 234-35. He

acknowledged Petitioner was afebrile on admission, but he believed that was explained by her use

of prednisone and other immunosuppressive drugs. Id. at 236; see also id. at 249 (“So that's a --

and this is a common problem that we see in patients with lupus and other autoimmune diseases

that are on chronic prednisone, along with other immunosuppressants. Their bodies oftentimes do

not mount the febrile response with infection that we see in patients that have normal immune

systems.”). Also, while fever is more likely than not in sepsis, “[o]verwhelming sepsis patients

can be afebrile.” Id. at 236.

In response to questioning from Special Master Oler, Dr. Oddis testified that Petitioner’s

vomiting on the day after vaccination was more suggestive of sepsis than a lupus flare, because

she did not previously complain of gastrointestinal symptoms associated with lupus flares. Tr. at

246. He disagreed with Dr. Valeriano that Petitioner’s low blood pressure could have been caused

by a “pain response” or dehydration, as it required treatment with Levophed, which is only given

for severe hypotension. Id. at 247. Furthermore, Petitioner’s elevated creatinine levels were not

consistent with lupus nephritis, because they normalized quickly with treatment; “if lupus is

attacking your kidney, it would not reverse the elevated creatinine in a matter of days.” Id. at 248.

Her dsDNA level was better than it had been before the vaccination, which would not suggest she

was having a lupus flare. Id. at 250. Her CRP level was dramatically elevated, indicating a strong

likelihood of infection given the immunosuppressive medications she was taking. Id. at 253. The

fact that Petitioner had negative blood cultures for MRSA, but a positive nasal swab, could be

explained by the fact that the tests were done at different times and while Petitioner was on

antibiotics. Tr. at 254-55. Dr. Oddis explained:

So, again, putting the totality of everything together -- the low blood

pressure, the lack of a fever response, the elevated creatinine, the

need for pressors, the higher white blood cell count, the CRP that's

off the wall -- again, that all points to an infectious process as

opposed to any element of a lupus flare.

25

Id. at 249.

3. Dr. Evans

Dr. Evans believed Petitioner’s medical course to be consistent with a localized infection

represented by the abscess on her forehead that developed into septic shock. Tr. at 281. She then

experienced a number of seizures caused by PRES. Id. at 282. One of her seizures resulted in

status epilepticus, which necessitated her second hospital admission. Id. Dr. Evans did not believe

Petitioner’s condition had anything to do with the Tdap vaccine; rather, her localized infection

spread to the blood, causing sepsis, septic shock, and a “post-reversible septic shock syndrome.”

Id. at 283. Her MRIs confirmed the PRES diagnosis; when the imaging of PRES cleared up, her

clinical signs also improved. Id.

Dr. Evans opined that Petitioner’s symptoms on September 6, 2015, were explained by

sepsis. Tr. at 286. Her myalgia (muscle pain) was consistent with sepsis; myalgia is more

suggestive of infection than joint pain, but both myalgia and joint pain can occur with sepsis. Id.

Her WBC count of 10.2 also suggested sepsis. Id. at 287. Because she was taking

immunosuppressive drugs, this count qualified as significantly elevated. Id. Her high lactic acid

level was a sign that her tissues were not getting enough oxygen. Id. at 288. Her manual count of

segmented neutrophils was elevated, consistent with sepsis or bacterial infection. Id. at 289-90.

Lastly, she had a “highly abnormal” count of bands, or immature white blood cells, also a sign of

bacterial infection. Id. at 290-91.

According to Dr. Evans, Petitioner had a localized infection, which presented as an

abscess/boil, which could have spread to her blood, leading to sepsis and septic shock. Tr. at 291-

92. Her positive MRSA finding supported this conclusion. Id. at 293. Everyone has staph aureus

on their skin, but MRSA is highly prevalent in hospitals because of its resistance to antibiotics. Id.

at 293-94.

Petitioner’s negative blood cultures did not affect Dr. Evans’s opinion that she had sepsis.

Tr. at 294. About 30-50% of patients with sepsis will have a negative blood culture because of the

antibiotics they are taking for treatment. Id. at 297-98. Antibiotics are better at inhibiting growth

in a culture than inhibiting growth in the bloodstream. Id. at 298.

Regarding whether an abscess could lead to sepsis, Dr. Evans admitted it was unusual but

possible, which is why Petitioner was given antibiotics after the incision and drainage of her

abscess. Tr. at 299. The record of the incision and drainage procedure noted that there was

fluctuance and some cellulitis of the skin, suggesting infection. Id. at 301. It also documented

that Petitioner’s skin was cold, clammy, mottled, and blue, which are signs of poor blood flow to

the skin and are also signs of shock, including possible septic shock. Id. at 302. There was also

mention of a rash and signs of infection on the left side, indicative of continued cellulitis. Id. at

302-03.

Dr. Evans described PRES as fluid leaking into the brain, which has distinctive features on

MRI. Tr. at 306-07. Symptoms of PRES include encephalopathy, seizures, and visual disturbance.

Id. at 307. It is a reversible condition, but a complete recovery might not occur. Id. Petitioner

26

had the typical signs of PRES on MRI. Id. at 307. Her lesion resolved within several weeks. Id.

at 307-08.

Dr. Evans was not sure whether Dr. Valeriano’s assessment of epilepsy in Petitioner was

accurate. Tr. at 308. She had a number of seizures and was treated with anti-epileptic medication,

but it is unclear whether Petitioner continued to have seizures after resolution of her PRES. Id. at

308-09. She continued to take anticonvulsant medications, but she had not undergone an EEG to

observe seizures or confirm epilepsy. Id. at 309. Because Petitioner suffered from such extreme

seizures, treatment with anti-seizure medications was proper, but there was not enough information

to make a definitive epilepsy diagnosis. Id.

On cross-examination, Dr. Evans clarified that his opinion that Petitioner had sepsis was

not dependent on her positive MRSA swab, but the positive swab indicated it was highly likely

she had a MRSA infection. Tr. at 317. He did not agree with Dr. Valeriano that Petitioner’s lupus

was clinically stable prior to receipt of the Tdap vaccination; he believed that she was improving,

and therefore not stable. Id. at 324. He confirmed that Petitioner was transported to UMMC for

better care, they discharged her with a diagnosis of “seizures secondary to lupus cerebritis,” and

several physicians believed Petitioner’s seizures were related to either a lupus flare or lupus

cerebritis. Id. at 326-27, 329-31. Most of Petitioner’s physicians did not believe her seizures were

caused by sepsis. Id. at 328. One physician believed that Petitioner’s seizures were “[m]ost likely

lupus flare that was incited by a tetanus shot.” Id. at 331; see also Ex. 3 at 67.

Dr. Evans admitted that, had lupus cerebritis been the correct diagnosis, that would have

been a severe exacerbation of her underlying lupus. Tr. at 314. He acknowledged that Petitioner

did suffer six months of sequelae and that her neurological deficits could be permanent. Tr. at

320-21.

Answering questions from former Special Master Oler, Dr. Evans defined an

encephalopathy as altered mental status. Tr. at 351. Petitioner’s condition probably did fit the

definition of encephalopathy. Id. Her memory issues, however, did not constitute an

encephalopathy but were instead the result of specific focal brain damage. Id. at 355. The timing

and development of PRES were consistent with infection and septic shock. Id. ADEM was

properly considered as an alternative diagnosis but was eliminated based on her MRI, as it presents

a distinctive picture. Id. at 356.

Dr. Evans explained that shock is defined as a condition of low blood pressure that

compromises organ function, typically with brain dysfunction as a first sign. Tr. at 357. Petitioner

had two episodes of shock, one caused by status epilepticus, and another caused by septic shock.

Id. at 358. While there are many causes of shock, it is notable that Petitioner showed improvement

when she was treated for sepsis. Id. Petitioner had many signs of septic shock, like elevated lactic

acid, neutrophils, band forms, and reduced bicarbonate. Id. at 361. Her response to treatment, and

rapid recovery within two days, is indicative of sepsis, not a lupus exaggeration. Id. at 361-62.

IV. LEGAL FRAMEWORK

A. Petitioner’s Burden in Vaccine Program Cases

27

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may

demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table

—that occurred within the time provided in the Table. § 11(c)(1)(C)(i). “In such a case, causation

is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006);

see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury Table, a

petitioner may demonstrate that she suffered an “off-Table” injury caused or significantly

aggravated by the vaccination. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. § 13(a)(1). That is, a petitioner must offer evidence that leads

the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before

[he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010); see

also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation

is insufficient under a preponderance standard). The petitioner must demonstrate that the vaccine

was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the

injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d

1344, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355

(Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on her own

assertions; rather, the petition must be supported by either medical records or the opinion of a

competent physician. § 13(a)(1).

To establish entitlement to a Vaccine Program award of compensation for a non-Table

claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen

v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005). Althen requires a

petitioner to establish by preponderant evidence that the vaccination she received caused her injury

“by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical

sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a

showing of a proximate temporal relationship between vaccination and injury.” Id. at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioner

must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the

type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Such a theory

must only be “legally probable, not medically or scientifically certain.” Id. at 549; Bunting v. Sec’y

of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991) (proof of medical certainty is not

required).

Petitioner may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or presentation of a generally

accepted medical theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed.

Cir. 2009) (citing Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are

not empowered by statute to conclusively resolve what are complex scientific and medical

questions, and thus the scientific evidence offered to establish Althen prong one is viewed “not

28

through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s

preponderant evidence standard.” Id. at 1380. Special masters must take care not to increase the

burden placed on petitioners in offering a scientific theory linking vaccine to injury, but this does

not negate or reduce a petitioner’s ultimate burden to establish her overall entitlement to damages

by preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.

2013) (citations omitted).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as 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’”) (quoting Althen, 418 F.3d at 1278). Medical records are generally viewed

as particularly trustworthy evidence, because they are created contemporaneously with the

treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed.

Cir. 1993). However, medical records and/or statements of a treating physician’s views do not per

se bind the special master to adopt the conclusions of such an individual, even if they must be

considered and carefully evaluated. § 13(b)(1) (providing that “[a]ny such diagnosis, conclusion,

judgment, test result, report, or summary shall not be binding on the special master or court”);

Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing …

that mandates that the testimony of a treating physician is sacrosanct–- that it must be accepted in

its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of

causation, the opinions or diagnoses of treating physicians are only as trustworthy as the

reasonableness of their suppositions or bases. The views of treating physicians should also be

weighed against other, contrary evidence also present in the record -- including conflicting

opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’

conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Health

& Hum. Servs., No. 06-522V, 2011 WL 1935813 at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.

for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x. 765 (Fed.

Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1278. That term has been equated to

the phrase “medically acceptable temporal relationship.” Id. at 1281. A petitioner must offer

“preponderant proof that the onset of symptoms occurred within a timeframe which, given the

medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de

Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation

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

vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of

Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand on other grounds,

105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x. 952 (Fed. Cir. 2013); Koehn v. Sec’y of

Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013),

mot. for review den’d, 113 Fed. Cl. 757 (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir.

2014).

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B. Significant Aggravation Claims

The Vaccine Act defines significant aggravation as “any change for the worse in a

preexisting condition which results in markedly greater disability, pain, or illness accompanied by

substantial deterioration of health.” 42 U.S.C. § 300aa-33(4). In Loving, the United States Court

of Federal Claims established the governing six-part test for off-Table significant aggravations.

Petitioner must prove by a preponderance of the evidence:

(1) The person’s condition prior to administration of the vaccine, (2)

the person’s current condition (or the condition following the

vaccination if that is also pertinent), (3) whether the person’s current

condition constitutes a ‘significant aggravation’ of the person’s

condition prior to vaccination, (4) a medical theory causally

connecting such a significant worsened condition to the vaccination,

(5) a logical sequence of cause and effect showing that the

vaccination was the reason for the significant aggravation, and (6) a

showing of a proximate temporal relationship between the

vaccination and the significant aggravation.

Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009); see also W.C. v. Sec’y of

Health & Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (adopting this test for significant

aggravation claims brought under the Vaccine Act). Loving prongs four, five, and six are derived

from the Federal Circuit’s test for off-Table actual causation cases. Althen v. Sec’y of Health &

Hum. Servs., 17 F.3d 374 (Fed. Cir. 1994).

In Sharpe, the Federal Circuit clarified the Loving prongs and what is required by

petitioners to successfully demonstrate a causation-in-fact significant aggravation claim. Sharpe

v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020). Loving prong three only requires

a comparison of a petitioner’s current, post-vaccination condition with his pre-existing pre-

vaccination condition. Id. at 1082; Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099

(Fed. Cir. 1996). A petitioner is not required to demonstrate an expected outcome or that his post-

vaccination condition was worse than such an expected outcome. 964 F.3d at 1081. Further, a

petitioner is not required “to disprove that a pre-existing genetic mutation caused [his] significant

aggravation.” Id. at 1087.

Under Loving prong four, a petitioner need only provide a “medical theory causally

connecting [petitioner’s] significantly worsened condition to the vaccination.” Sharpe, 964 F.3d

at 1083; see also Loving, 86 Fed. Cl. at 144. In other words, petitioner is required to present a

medically reliable theory demonstrating that a vaccine “can cause a significant worsening” of the

condition. Sharpe, 964 F.3d at 1083 (citing to Pafford ex. rel. Pafford v. Sec’y of Health & Hum.

Servs., 451 F.3d 1352, 1356-57 (Fed. Cir. 2006). A petitioner may be able to establish a prima

facie case under Loving prong four without eliminating a pre-existing condition as the cause of her

significantly aggravated injury. Id.; citing Walther v. Sec’y of Health & Hum. Servs., 485 F. 3d

30

1146, 1151 (Fed. Cir. 2007) (noting that “the government bears the burden of establishing

alterative causation. . . . once petitioner has established a prima facie case”).

Loving prong five requires a petitioner to show “a logical sequence of cause and effect

showing that the vaccination was the reason for the significant aggravation.” Loving, 86 Fed. Cl.

at 144. In other words, petitioner must show that the vaccination “did” cause a worsening of

[petitioner’s underlying disorder]. Id. Finally, Loving prong six, similar to Althen prong three,

requires a medically appropriate temporal interval between the vaccination and the worsening of

the petitioner’s pre-existing condition. Id.

C. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with

analyzing the medical records, which are required to be filed with the petition. § 11(c)(2). The

special master is required to consider “all [] relevant medical and scientific evidence contained in

the record.” § 13(b)(1)(A). This includes “any diagnosis, conclusion, medical judgment, or

autopsy or coroner’s report which is contained in the record regarding the nature, causation, and

aggravation of the petitioner’s illness, disability, injury, condition, or death,” and the “results of

any diagnostic or evaluative test which are contained in the record and the summaries and

conclusions.” Id. The special master is then required to weigh the evidence presented, including

contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3

F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to

afford greater weight to contemporaneous medical records than to other evidence, such as oral

testimony surrounding the events in question that was given at a later date, provided that such

determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are generally

trustworthy, because they “contain information supplied to or by health professionals to facilitate

diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby

v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021) (citing Cucuras, 993 F.2d

at 1528). Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. See generally Lowrie v. Sec’y of Health & Hum. Servs., No. 03-

1585V, 2005 WL 6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous

medical records are often found to be deserving of greater evidentiary weight than oral testimony–

- especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;

see also Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,

968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United

States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common

sense and experience, this rule should not be treated as an absolute and must yield where the factual

predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten

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records which are, themselves, inconsistent, should be accorded less deference than those which

are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination

regarding a witness’s credibility is needed when determining the weight that such testimony should

be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,

1575 (Fed. Cir. 1993).

In determining the accuracy and completeness of medical records, the Court of Federal

Claims has listed four possible explanations for inconsistencies between contemporaneously

created medical records and later testimony: (1) a person’s failure to recount to the medical

professional everything that happened during the relevant time period; (2) the medical

professional’s failure to document everything reported to her or him; (3) a person’s faulty

recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of

symptoms that did not exist. LaLonde v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-

04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In deciding whether to afford greater weight to

contemporaneous medical records or other evidence, such as testimony, a rational analysis must

be explicated. Burns, 3 F.3d at 417.

D. Analysis of 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 & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony

is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert

v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.

Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195

F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony

are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or

technique has been subjected to peer review and publication; (3) whether there is a known or

potential rate of error and whether there are standards for controlling the error; and (4) whether the

theory or technique enjoys general acceptance within a relevant scientific community.” Terran,

195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than in other

federal judicial proceedings. Those factors are employed by judges to exclude evidence that is

unreliable and potentially confusing to a jury. In Vaccine Program cases, the factors are used in

the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health & Hum. 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”). The flexible use of the Daubert factors to evaluate persuasiveness and

reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 743. In

this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the

threshold to determine what evidence should be admitted, but instead to determine whether expert

testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master’s decision may be “based on the

32

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). 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, 88 Fed. Cl. at 743 (quoting

Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to require some

indicia of reliability to support the assertion of the expert witness.” Moberly, 592 F.3d at 1324.

Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s

credibility, is part of the overall reliability analysis to which special masters must subject expert

testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the reliability of expert

testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Hum.

Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special

masters are expected to consider the credibility of expert witnesses in evaluating petitions for

compensation under the Vaccine Act”).

E. Consideration of Medical Literature

Finally, although this decision discusses some but not all the record evidence in detail, I

have reviewed and considered all the materials submitted in this matter. See Moriarty v. Sec’y of

Health & Hum. 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 & Hum. 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. ANALYSIS

Petitioner makes several claims. She first alleges she sustained the Table Injury of

encephalopathy within 72 hours of her Tdap vaccination. Pet.’s Post-Hrg. Br. at 3. Second, she

alleges she suffered a significant aggravation of her lupus, which led to her development of PRES

and a seizure disorder, that was caused in fact by the vaccination. Id. at 10. Lastly, she alleges

that she developed the primary injury of “seizures and related sequelae” caused in fact by the

vaccination. Id.

The record evidence established that Petitioner most likely suffered septic shock as a result

of an infected abscess, which in turn caused her to develop PRES. Her condition did not meet the

Table criteria for encephalopathy following Tdap vaccination, because her symptoms were fully

explainable by an acute infectious disease. The evidence did not preponderantly show that her

acute or ongoing symptoms were caused by the Tdap vaccination, either directly or through a

significant aggravation of her pre-existing lupus. I conclude that Petitioner has failed to

preponderantly prove any of her claims.

A. Diagnosis

As a threshold matter, a petitioner must establish that he suffered the injury for which he

seeks compensation. Broekelschen, 618 F.3d at 1346. “[T]he function of a special master is not

33

to ‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record as a whole and

the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine

caused the [petitioner]’s injury.’” Andreu, 569 F.3d at 1382 (quoting Knudsen, 35 F.3d at 549).

“Although the Vaccine Act does not require absolute precision, it does require the petitioner to

establish an injury – the Act specifically creates a claim for compensation for ‘vaccine-related

injury or death.’” Stillwell v. Sec’y of Health & Hum. Servs., 118 Fed. Cl. 47, 56 (2014) (quoting

42.U.S.C. § 300aa-11(c)). Accordingly, the Federal Circuit has concluded that it is “appropriate

for the special master to first determine what injury, if any, [is] supported by the evidence presented

in the record” before applying a causation analysis pursuant to Althen. Lombardi v. Sec’y of Health

& Hum. Servs., 656 F.3d 1343, 1351-53 (Fed. Cir. 2011).

Petitioner contended that her medical course was more consistent with a severe

exacerbation of her lupus and/or a primary seizure disorder/epilepsy, and it was not explained by

septic shock with neurological sequelae. Respondent and his experts contend that the overall

clinical picture was entirely explainable by septic shock triggered by overwhelming infection,

likely originating with Petitioner’s facial abscess.

1. Petitioner was susceptible to infection, sepsis, and septic shock because of her

SLE and the immunosuppressive medications she was taking.

At the outset, I note that Petitioner’s expert, Dr. Valeriano, is not an expert in

rheumatology, and therefore he was not as well qualified to opine on lupus as Dr. Oddis, who sees

40-50 patients a year with lupus and was a principal investigator on a study involving Rituximab,

one of the medications Petitioner used. Tr. at 156-57. Dr. Valeriano reported that he sees

approximately 25-30 lupus patients a year but does not treat their lupus, just their neurological

symptoms. Tr. at 78.

All of the experts and treating physicians agreed that Petitioner had pre-existing lupus. As

Dr. Oddis explained, lupus is a systemic autoimmune condition that can cause a variety of

symptoms ranging from mild to life-threatening. Tr. at 159-60; see Wallace and Gladman at 2.

Because the disease involves immune system attacks on the body’s own tissues, it is frequently

treated with immunosuppressant therapies. Tr. at 163-64. These treatments, as the name suggests,

suppress the immune system. One marker of this is a relatively low WBC count, which is

commonly seen in immunosuppressed patients. See Oddis Rep. at 4.

Because lupus involves immune dysfunction and often requires treatment with

immunosuppressants, patients are at higher risk for infections of all types, including sepsis, and

septic shock. Tr. at 184-85 (Dr. Oddis’s testimony); see also Ospina at 2 (noting that

approximately 25% of lupus patients die of infections; risk factors for infection in such patients

include use of immunosuppressive treatments); Mageau at 432 (“SLE patients are prone to

infection, as well as septic shock, either because of immunosuppressive treatment or intrinsic

dysregulation of the immune system.”). Septic shock in SLE patients is associated with worsened

morbidity and mortality. Mageau at 437. Also, in the Mageau study, septic shock patients with

SLE were “younger and more often female” compared to the general population of patients with

septic shock. Id. at 436.

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2. Petitioner’s facial abscess signified that she was suffering from an infection on

September 4, 2015.

The day of vaccination, Petitioner sought treatment in the ER for an ingrown hair on her

face. Ex. 3 at 1-2. She reported there was “pain and swelling to left hairline. Started as small

bump, expressed pus, now larger in size.” Id. at 2. She had no systemic complaints such as fever

or myalgias. Id. An exam showed a 2x2-cm lesion with fluctuance and overlying cellulitis. Id. at

3.

Petitioner was diagnosed with a facial abscess. Ex. 3 at 1. An incision and drainage

procedure was performed, and she was given the subject Tdap vaccination. Id. at 3. She was also

given two separate antibiotics. Id.

Dr. Valeriano opined that Petitioner’s abscess was relatively minor and not indicative of

an active infection likely to lead to sepsis. He described the lesion as cutaneous and superficial.

Tr. at 364. The incision and drainage procedure was also quite routine and unlikely to have led to

something as severe as septic shock. Tr. at 60-61. Nothing in the medical records indicated that

there was a severe infection at the site of her abscess. Id. at 62.

The evidence showed that facial abscesses are generally caused by bacterial infections,

including MRSA. Evans Rep. at 13; Oddis Rep. at 8-9. Immunosuppression is a risk factor for

abscess. See Denis Spelman and Larry Baddour, Cellulitis and skin abscess: Epidemiology,

microbiology, clinical manifestations, and diagnosis, UPTODATE (Ex. C-26) (“Spelman”) at 3.

Facial abscesses can lead to sepsis through leakage of bacteria into the bloodstream, though this is

unusual. Evans Rep. at 13; Tr. at 299 (Dr. Evans’s testimony); see Charles at 325 (noting that

abscesses can cause sepsis). In Petitioner’s case, as Respondent’s experts persuasively

commented, the facial abscess showed evidence of infection, such as fluctuance and cellulitis, at

the time it was drained. Tr. at 172 (Dr. Oddis’s testimony); 299 (Dr. Evans’s testimony). It was

treated as an active infection: two antibiotics were prescribed to prevent the development of sepsis.

Id. at 173, 299. Dr. Oddis characterized the abscess as a “significant inflammatory skin problem.”

Id. at 172.

3. Petitioner’s symptoms and lab results at the time of her hospitalization were

indicative of an overwhelming infection and septic shock.

Petitioner testified that after the incision and drainage procedure and vaccination, she woke

up to immediately vomit a yellowish-white fluid. Tr. at 112. She was in immense pain and could

not walk. Id. When she looked at her abscess, she did not observe colored discharge or pus, nor

was it red, swollen, malodorous, or warm to the touch. Id. at 113.

The medical records documented that Petitioner presented back to the PGH ER at about 8

a.m. on September 6, 2015, about 32 hours after the incision and drainage procedure and Tdap

vaccination. Ex. 3 at 21. Her chief complaint at that time was “[p]ain all over body [sic] trouble

walking after tetanus shot.” Id. She reported vomiting since she received her “tetanus” vaccination

“3 days ago,” and she said she was not tolerating fluids, had myalgias, and had weakness in her

legs. Id. at 23.

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At first, Petitioner was noted to be alert and oriented to person, place, and time. Ex. 3 at

26. She did not have a fever. Id. The area of her abscess was red, with “possible fluctuance.” Id.

While Petitioner was still in the ER, she became acutely hypotensive and tachycardic. Id. at 23.

The treating physicians had to administer Levophed, a pressor given for severe hypotension. Id.

at 143. She became lethargic and minimally responsive. Id. at 132. In her affidavit, she stated

she could not recall what happened in the ER after she was triaged. Ex. 1 at 2.

Petitioner had highly abnormal lab tests in conjunction with her symptoms, including an

extremely elevated CRP of 268.9 mg/L, an elevated ESR of 250, critically elevated lactic acid,

elevated creatinine, low chloride, low calcium, and elevated BUN. Ex. 3 at 35. Her blood also

showed high levels of segmented and banded neutrophils. Id. at 36. Her WBC count was 10.2.

Id. at 34. She was presumptively diagnosed with septic shock.

Sepsis is defined as “infection with evidence of systemic inflammation, consisting of two

or more of the following: increased or decreased temperature or leucocyte count, tachycardia, and

rapid breathing. Septic shock is sepsis with hypotension that persists after resuscitation with

intravenous fluid.” Annane at 63. About 2% of hospital admissions are for sepsis. Id.

Dr. Valeriano acknowledged that some of Petitioner’s symptoms and signs were consistent

with septic shock, but he disputed that interpretation of the overall constellation of symptoms. He

did not construe the records to document signs of a severe infection at the site of the abscess, and

he opined that the procedure done on September 4, 2015, was minor and unlikely to result in septic

shock. Tr. at 60-62. Petitioner did not have a fever, which would be expected in septic shock. Id.

at 46-47. She reported to the examining physicians that she believed she was having a lupus

flareup, and her symptoms, such as joint and muscle pain, could occur in a flareup or with vomiting

and dehydration. Id. at 21. Her hypotension in the ER likewise could have been triggered by pain

from a lupus flareup or dehydration. Second Valeriano Rep. at 2; Tr. at 52-53. Her high CRP and

elevated WBC count were non-specific for sepsis and could have been caused by a range of

conditions. Tr. at 58.

The literature in the record indicated that a lupus flareup can be difficult to distinguish from

an infection like sepsis. Ospina at i46 (“[T]he initial clinical presentation of a patient with lupus

is very similar to the acute febrile phase of an infection (such as sepsis).”). Nonetheless, Drs.

Evans and Oddis persuasively explained that Petitioner’s clinical picture was entirely consistent

with septic shock and inconsistent with a lupus flareup. Petitioner’s initial symptoms, including

her vomiting and severe myalgias, were indicative of infection and sepsis. Tr. at 186 (Dr. Oddis’s

testimony that sepsis patients can have “a pretty dramatic presentation of musculoskeletal

symptoms.”); id. at 286 (Dr. Evans’s testimony that her myalgias were consistent with sepsis).

Vomiting was not a typical symptom associated with Petitioner’s previous lupus flareups. Id. at

246. Also, at the time of admission, her facial abscess was observed to have slight redness and

possible fluctuance, suggestive of infection; a surgical consultation was also requested for possible

repeat drainage. Ex. 3 at 141; see Tr. at 175-76.

Petitioner’s rapid decompensation in the ER, including tachycardia and loss of blood

pressure requiring administration of pressors, signified that she was in septic shock. Tr. at 167,

36

182 (Dr. Oddis’s testimony); id. at 281 (Dr. Evans’s testimony); see Annane at 63. Her

hypotension was severe enough that she was treated with Levophed, which Dr. Oddis explained is

“such a powerful medication to bring up blood pressure that it’s often a terminal intervention.” Tr.

at 247. This magnitude of hypotension would not occur with pain, dehydration, or a lupus flareup.

Id. The fact that she was afebrile did not rule out septic shock, because (1) Petitioner was

immunosuppressed and might not mount a fever response; and (2) fever might not occur in the

setting of overwhelming infection. Tr. at 236, 249; Annane at 63. Her altered mental status was

also consistent with shock. Evans Rep. at 12.

Respondent’s experts were also persuasive in explaining why Petitioner’s lab results were

indicative of septic shock. Dr. Oddis testified her CRP level was “off the wall” and signified

“infection until proven otherwise.” Tr. at 167-68, 253. It was not consistent with a lupus flareup.

Id. at 234-35; see Ospina at i47 (“CRP increases significantly in SLE patients with concomitant

infection, but increases only slightly or not at all in patients with a lupus flare and no infection[.]”).

Her dsDNA and complement levels during admission were not suggestive of a severe lupus

flareup. Evans Rep. at 15; Tr. at 250 (Dr. Oddis’s testimony). Her elevated lactic acid level

indicated that her body was not producing enough oxygen, and her creatinine level showed acute

kidney dysfunction, a common symptom of septic shock. Id. at 288; Evans Rep. at 12-13. Dr.

Oddis pointed out that the kidney function was quickly restored with treatment, which would not

happen with a lupus flareup/lupus nephritis. Tr. at 248. Her blood tests were also highly

suggestive of severe infection: the WBC count of 10.2 was very elevated for an immunosuppressed

patient. Oddis Rep. at 7-8; Evans Rep. at 13 (Petitioner’s high WBC and neutrophil levels were

consistent with a “catastrophic infection.”). Even though her WBC count had fluctuated before,

the level recorded during her hospitalization was substantially elevated from her baseline, which

would not occur with a lupus flareup. Tr. at 234. Lastly, she had high segmented neutrophils and

a “highly abnormal” level of banded neutrophils, evidence that her bone marrow was producing

new, immature white blood cells, as occurs in sepsis. Tr. at 167, 251 (Dr. Oddis’s testimony); id.

at 289-91 (Dr. Evans’s testimony); Evans Rep. at 13; Annane at 67 (“Sepsis is associated with

migration of activated leucocytes from the bloodstream to inflammatory tissues, and with

intensified bone-marrow production of leucocytes that are released into the blood as newly

differentiated or immature cells.”). Dr. Valeriano did not attempt to dispute the significance of the

immature white blood cells.

4. Petitioner tested positive for MRSA, and her negative blood cultures did not

rule out sepsis.

On September 7, 2015, Petitioner tested positive for MRSA via a PCR test on a nasal swab

sample. Ex. 3 at 146, 420. Her blood cultures, however, showed no growth of MRSA or any other

organism. Id. at 142. Dr. Valeriano opined that the negative blood cultures suggested Petitioner

did not have sepsis. Second Valeriano Rep. at 2; Tr. at 50-51.

This opinion was unpersuasive. The filed literature was clear that culture-negative septic

shock (“CNSS”) is a common phenomenon. See Gupta at 1251 (study finding that 47.1% of

patients with sepsis had CNSS). This could be explained by the clinical practice of giving

antibiotics before taking cultures, as was done in Petitioner’s case. Id. at 1252; see Ex. 3 at 3

(recording that Petitioner was given two antibiotics, Keflex and Bactrim, at the time of her incision

37

and drainage procedure on September 4, 2015); id. at 38 (recording Petitioner was started on

vancomycin, Zosyn, and acyclovir in the ER at PGH). As Dr. Evans testified, Petitioner’s

prophylactic use of antibiotics could have rendered her blood cultures negative. Tr. at 177, 185,

198. Also, as Dr. Oddis remarked, Petitioner’s positive PCR test for MRSA likely meant she was

colonized with MRSA bacteria, which put her at risk of an active MRSA infection due to her

immunosuppression. Id. at 177. Thus, Respondent’s experts were persuasive in opining that, more

likely than not, Petitioner’s sepsis resulted from a MRSA infection, despite her negative cultures.

5. Petitioner developed PRES, which can be caused by septic shock.

A few days after Petitioner was admitted to PGH, she experienced two seizures. Ex. 3 at

241. An EEG revealed moderate encephalopathy. Id. An MRI of the brain was interpreted to

show PRES, possibly caused by hypertension, lupus, or other factors. Id. at 190. On September

10-11, 2015, Petitioner had several further seizures, one lasting 5-10 minutes. Id. at 188, 191. At

that point, her team concluded she needed continuous EEG monitoring, prompting a transfer to

UMMC. Id. at 191.

Petitioner’s treating neurologists at UMMC believed her MRIs and seizures “in the setting

of [a] lupus flare up” were concerning for lupus cerebritis, but PRES and viral encephalopathy

were also in the differential in light of the immunosuppressive medications she was on. Ex. 6 at

44. ADEM was also on the differential, though it was considered less likely. Id. at 45. A second

MRI done on September 13, 2015, “showed striking cerebral and slight cerebellar

leukoencephalopathy apparently a result of [SLE].” Ex. 6 at 46. Later imaging was read to show

PRES. See Ex. 6 at 235 (September 20, 2015 MRI interpreted to be “highly suggestive of PRES”).

PRES, or posterior reversible encephalopathy syndrome, is

an acute neurotoxic syndrome that is characterized by a spectrum

neurological and radiological feature from various risk factors.

Common neurological symptoms include[] headache, impairment in

level of consciousness, seizures, visual disturbances, and focal

neurological deficits. Common triggering factors include blood

pressure fluctuations, renal failure, eclampsia, exposure to

immunosuppressive or cytotoxic agents and autoimmune disorders.

The classic radiographic findings include bilateral subcortical

vasogenic edema predominantly affecting the parieto-occipital

regions but atypical features include involvement of other regions,

cortical involvement, restricted diffusion, hemorrhage, contrast

enhancement.

Hinduja at 1. Although some of Petitioner’s treating physicians considered her condition to be

more consistent with lupus cerebritis than PRES, both parties’ experts in this case agreed that

PRES was a more appropriate diagnosis based on the imaging. Tr. at 28, 30 (Dr. Valeriano’s

testimony); id. at 196 (Dr. Oddis’s testimony); id. at 283 (Dr. Evans’s testimony).

38

The evidence showed that PRES can be induced by septic shock. Evans Rep. at 16-17; Tr.

at 193 (Dr. Oddis’s testimony); Hinduja at 1 (blood pressure fluctuations and renal failure can

cause PRES). PRES also has been reported in conjunction with lupus. See Ishimori at 441

(reporting that 26 cases of PRES in lupus patients were described in the literature; all of the

reported cases were in people under 40, the majority of whom were female). Overall, while it was

not dispositive of the issue, Petitioner’s development of PRES was fully consistent with the

conclusion that she suffered sepsis and septic shock, as Respondent’s experts persuasively opined.

6. The assessment by some of Petitioner’s treating physicians of a lupus flareup

was not supported by her overall clinical picture.

The records show that some of Petitioner’s treating physicians believed her presentation

was probably caused by a lupus flareup and not infection/sepsis. When she first presented to the

ER at PGH, Dr. Schwartz commented that she was most likely experiencing a lupus flareup caused

by the Tdap vaccination. Ex. 3 at 23. However, after Petitioner experienced extreme hypotension

and tachycardia and was admitted, and after her lab results showed highly elevated CRP and ESR,

hospitalist Dr. Kenmogne assessed “[p]ossible septic shock [p]robably due to the incised abscess.”

Id. at 136. Similarly, on September 8, 2015, Dr. Semeniuk diagnosed resolved distributive shock

of unclear etiology. Id. at 181.

Dr. Harrison, the attending neurologist at UMMC, commented on September 12, 2015, that

Petitioner’s neurological symptoms occurred “in the setting of a lupus flareup” while she was at

PGH. Ex. 6 at 44. He believed her seizures were caused by lupus cerebritis but did not rule out

an infectious or inflammatory condition. Id. at 45. Other notes from the UMMC admission history

stated that Petitioner had experienced “recent septic shock” along with “possible lupus cerebritis.”

Ex. 6 at 19. Later, after a lumbar puncture found no signs of infection, a UMMC rheumatologist

commented that her symptoms could have been secondary to lupus. Id. at 102.

These somewhat conflicting statements underscore the clinical overlap between a severe

lupus flareup and sepsis, as described in the literature. See Ospina at i46 (“[T]he initial clinical

presentation of a patient with lupus is very similar to the acute febrile phase of an infection (such

as sepsis).”). In this case, however, as described above, Respondent’s experts persuasively and

comprehensively explained why, more likely than not, Petitioner experienced septic shock and not

a lupus flareup. Most notably, her lab values (i.e., WBC count, banded and segmented neutrophils,

lactic acid, CRP, dsDNA, and complement levels), severe hypotension, and rapid normalization

of kidney function with treatment pointed to septic shock and were less consistent with a lupus

flareup. Moreover, all of the experts, including Dr. Valeriano, agreed that Petitioner probably did

not develop lupus cerebritis at any time. See First Valeriano Rep. at 2; Evans Rep. at 14; Tr. at

196 (Dr. Oddis’s testimony). Finally, Dr. Oddis explained that, to the extent she had a flareup of

lupus symptoms in the hospital, it could have been secondary to her sepsis. Tr. at 190.

B. Theories of Entitlement

1. Table Encephalopathy

39

Petitioner alleges she sustained the Table Injury of encephalopathy within 72 hours of her

Tdap vaccination. Pet.’s Post-Hrg. Br. at 3.

a. Table Requirements

A petitioner who receives a vaccine “containing whole cell pertussis bacteria, extracted or

partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib)” can

establish the Table injury of encephalopathy if that injury acutely occurs within 72 hours of

vaccination. 42 C.F.R. § 100.3(a)(II)(B). According to the Table Qualifications and Aids to

Interpretation (“QAIs”), encephalopathy is compensable as a Table injury if the acute

encephalopathy occurs within the 72-hour period and evolves into a chronic encephalopathy. Id.

§ 100.3(c)(2).

The QAIs provide that an “acute encephalopathy” in an adult is

one that persists at least 24 hours and is characterized by at least two

of the following: (1) A significant change in mental status that is not

medication related (such as a confusional state, delirium, or

psychosis); (2) A significantly decreased level of consciousness

which is independent of a seizure and cannot be attributed to the

effects of medication; and (3) A seizure associated with loss of

consciousness.

42 C.F.R. § 100.3(c)(2)(i)(B). A chronic encephalopathy occurs when

a change in mental or neurologic status, first manifested during the

applicable Table time period as an acute encephalopathy or

encephalitis, persists for at least 6 months from the first symptom or

manifestation of onset or of significant aggravation of an acute

encephalopathy or encephalitis.

Id. § 100.3(d)(1)(i).

The QAIs also set forth exclusionary criteria for encephalopathy, providing:

Regardless of whether or not the specific cause of the underlying

condition, systemic disease, or acute event (including an infectious

organism) is known, an encephalopathy shall not be considered to

be a condition set forth in the Table if it is shown that the

encephalopathy was caused by:

(A) An underlying condition or systemic disease shown to be

unrelated to the vaccine (such as malignancy, structural lesion,

psychiatric illness, dementia, genetic disorder, prenatal or perinatal

central nervous system (CNS) injury); or

40

(B) An acute event shown to be unrelated to the vaccine such as a

head trauma, stroke, transient ischemic attack, complicated

migraine, drug use (illicit or prescribed) or an infectious disease.

Id. § 100.3(c)(2)(ii) (emphasis added).

b. Petitioner’s condition is excluded from the QAI definition of

encephalopathy, because it was caused by an acute infectious disease.

The parties agree, and I concur based on my review of the record, that Ms. Boyd suffered

symptoms of an acute encephalopathy within 72 hours of her September 4, 2015 Tdap vaccination.

Dr. Valeriano pointed out that she exhibited altered consciousness, lethargy, and loss of memory

at the time of the initial presentation at PGH. First Valeriano Rep. at 3. These were new symptoms

for her. Id. Dr. Evans also observed that Petitioner developed encephalopathy shortly after she

returned to the ER about 32 hours after the vaccination. Evans Rep. at 20; see also Resp.’s Post-

Hrg. Br. at 25 (Respondent stating he “no longer argues that petitioner’s encephalopathy did not

develop within 72 hours of vaccination.”).

The key disagreement here is whether Petitioner’s encephalopathy qualified as a vaccine-

related Table injury or whether her condition fell within the QAI exclusionary criteria. This

question hinges on whether Petitioner’s encephalopathic symptoms had another cause – namely,

acute septic shock triggered by infection.

For the reasons described in detail above, I conclude that Petitioner’s sepsis and septic

shock caused her clinical presentation on September 6, 2015, including her acute encephalopathy,

and therefore her condition fell within the Table’s exclusionary criteria for encephalopathy.

Because I conclude she has failed to prove the Table injury of encephalopathy following her Tdap

vaccination, I need not resolve whether she developed a chronic encephalopathy under the QAI.

2. Significant Aggravation

Petitioner alternatively alleges that the subject Tdap vaccination significantly aggravated

her pre-existing lupus. Again, to establish entitlement under a significant aggravation theory,

Petitioner must prove by a preponderance of the evidence:

(1) The person’s condition prior to administration of the vaccine, (2)

the person’s current condition (or the condition following the

vaccination if that is also pertinent), (3) whether the person’s current

condition constitutes a ‘significant aggravation’ of the person’s

condition prior to vaccination, (4) a medical theory causally

connecting such a significant worsened condition to the vaccination,

(5) a logical sequence of cause and effect showing that the

vaccination was the reason for the significant aggravation, and (6) a

41

showing of a proximate temporal relationship between the

vaccination and the significant aggravation.

Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009); see also W.C. v. Sec’y of

Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (adopting this as the proper legal

standard for significant aggravation claims brought under the Vaccine Act).

I conclude that Petitioner has failed to prove a vaccine-caused significant aggravation of

her lupus. Most significantly, as discussed, she failed to demonstrate a significant aggravation of

her lupus following the vaccination, as was persuasively explained by Respondent’s experts.

Instead, her post-vaccination medical course was more likely related to septic shock caused by

infection. Thus, she did not satisfy Loving prong three.24

Even assuming arguendo that Petitioner satisfied Loving prong three, she also failed to

satisfy Loving prongs four, five, or six. Due to Dr. Valeriano’s self-admitted lack of expertise in

immunology, he was unable to provide a reliable causation theory for how the Tdap vaccine could

have exacerbated Petitioner’s lupus. Tr. at 42, 89. He could not identify any component of the

Tdap vaccine that likely caused the alleged significant aggravation of Petitioner’s lupus, stating

that it “really [was] beyond his expertise in vaccines.” Id. at 42. He summarily hypothesized that

the vaccine “set off an immune reaction which basically was an exacerbation of the underlying

condition,” without providing any further basis for that opinion. Id. at 86. He could not provide

a proposed mechanism by which the vaccine could have caused a significant aggravation of lupus,

other than an “immune stimulation” that acted pathologically on a susceptible person. Id. at 88.

He forthrightly admitted that he was not at the requisite “level of immunology” to discuss that

subject. Id. at 89. He also did not provide any persuasive clinical literature supporting the claim

that the Tdap vaccine can exacerbate lupus.25

Moreover, although Dr. Valeriano cited literature discussing the notion that pertussis could

have neurotoxic effects, he explicitly denied that he was proposing Petitioner was harmed by direct

neurotoxicity from that component of the vaccine. Tr. at 42-43. Overall, Dr. Valeriano’s failure

to propose any theory or data for how the Tdap vaccine could have significantly aggravated

Petitioner’s pre-existing lupus was fatal to her claim. Petitioner failed to satisfy Loving prong four.

Under Loving’s fifth prong, a petitioner must “prove a logical sequence of cause and effect

showing that the vaccination was the reason for the injury.” Loving, 86 Fed. Cl. at 144; Althen,

24

The experts debated whether Petitioner’s pre-vaccination lupus was “stable” or “smoldering.” See Tr. at

18-19 (Dr. Valeriano’s testimony that Petitioner’s lupus was stable); Tr. at 164-66 (Dr. Oddis’s testimony

that Petitioner’s lupus was smoldering). For the purposes of my analysis, the status of her lupus before

vaccination is not material, because I conclude Petitioner more likely than not developed septic shock,

which caused her PRES and seizures, and did not suffer a lupus flareup.

25

Petitioner did file four exhibits (Exs. 14-18), two of which were abstracts for studies involving lupus (not

full publications) (Exs. 14-15), one of which was an abstract related to PRES (Ex. 16), and one of which

was a printout of results of two VAERS database searches relating to DTP, Tdap, DTaP, and other tetanus-

containing vaccines and “seizures” and “aggravation” (Ex. 17). These exhibits do not even suggest a causal

association between Tdap and lupus exacerbation/seizures, much less meet the preponderance threshold.

42

418 F.3d at 1278. The sequence of cause and effect must be “'logical' and legally probable, not

medically or scientifically certain.” Id. A petitioner is not required to show “epidemiologic

studies, rechallenge, the presence of pathological markers or genetic disposition, or general

acceptance in the scientific or medical communities to establish a logical sequence of cause and

effect.” Id. (omitting internal citations); Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d

1317, 1325 (Fed. Cir. 2006). Instead, circumstantial evidence and reliable medical opinions may

be sufficient to satisfy the second Althen prong. Isaac v. Sec'y of Health & Hum. Servs., No. 08-

601V, 2012 WL 3609993, at *24 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev. den'd, 108

Fed. Cl. 743 (2013), aff'd, 540 F. App'x. 999 (Fed. Cir. 2013).

Because Petitioner did not meet Loving prong four, she also could not prove a logical

sequence of cause and effect between the subject vaccination and the purported exacerbation of

her lupus. Also, as discussed, the preponderant evidence showed Petitioner likely suffered septic

shock caused by infection, which led her to develop PRES, rather than a vaccine injury. I do note

that one of Petitioner’s treating physicians, Dr. Schwartz, stated: “Most likely lupus flare that was

incited by tetanus shot.” Ex. 3 at 23. Other treating physicians noted the temporal proximity

between Petitioner’s Tdap vaccination and the development of her symptoms without explicitly

attributing her condition to the vaccine. See Ex. 3 at 132; Ex. 6 at 45; Ex. 4 at 361. Dr. Schwartz’s

comment was made very early on in Petitioner’s clinical course, just after she presented to the

hospital complaining of symptoms that she perceived as a lupus flareup. Also, multiple other

physicians opined that her symptoms and sequelae were caused by septic shock. See Ex. 3 at 136,

181, 183-84, 909 (resolved possible septic shock); Ex. 6 at 3, 19. Finally, as detailed above, to the

extent Petitioner’s treating physicians believed she was suffering from a lupus flareup, those

opinions were not supported by the overall clinical record. Thus, Petitioner failed to prove Loving

prong five.

The sixth prong of Loving contains two parts. First, a petitioner must establish the

“timeframe for which it is medically acceptable to infer causation,” and second, he must

demonstrate that the onset of the disease occurred in this period. Shapiro v. Secʼy of Health &

Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105

Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x. 952 (Fed. Cir. 2013). Dr. Valeriano did not

identify an appropriate timeframe between Tdap vaccination and exacerbation of lupus, nor did he

comment on whether the onset of Petitioner’s post-vaccination symptoms fell within that

timeframe. Moreover, because Petitioner failed to provide a reliable theory for how the Tdap

vaccination could significantly aggravate lupus, she also could not show the appropriate post-

vaccination timeframe for such an injury.

3. Causation-in-Fact of Seizure Disorder

Lastly, Petitioner has argued that the subject Tdap vaccination caused-in-fact a primary

seizure disorder. See Pet.’s Post-Hrg. Br. at 10. This claim was very thinly supported. Notably,

Dr. Valeriano did not argue in his reports or testimony that the subject vaccination directly caused

the development of seizures. In fact, as discussed, he disclaimed holding the opinion that the

pertussis component of the vaccine directly caused neurotoxicity in Petitioner. He instead

contended that Petitioner’s vaccine-caused lupus flareup led her to develop PRES, which caused

43

her seizures.26 Respondent’s experts agreed Petitioner developed PRES, which caused seizures,

but again, they disagreed the PRES was triggered by lupus and instead persuasively argued it was

caused by septic shock. None of Petitioner’s treating physicians theorized that Petitioner

developed seizures directly caused by the vaccination. Petitioner vaguely argued in her briefing

that onset of seizures within three days of vaccination was appropriate, but this too was

unsupported by any medical record, literature, or expert evidence. See id. at 35.

Petitioner cited several cases concluding that pertussis-containing vaccines caused

seizures.27 See, e.g., Andreu, 569 F.3d at 1381-82 (finding petitioners preponderantly established

that the DPT vaccine caused a seizure disorder); Bunting v. Sec’y of Health & Hum. Servs., 931

F.2d 867 (Fed. Cir. 1991) (finding a preponderance of evidence that the DPT vaccine caused

encephalopathy and seizure disorder); Tembenis ex rel. estate of Tembenis v. Sec’y of Health &

Hum. Servs., No. 03-2820V, 2010 WL 5164324 (Fed. Cl. Spec. Mstr. Nov. 29, 2010) (finding the

DTaP vaccine caused a seizure disorder); Sucher v. Sec’y of Health & Hum. Servs., No. 07-58V,

2010 WL 1370627 (Fed. Cl. Spec. Mstr. Mar. 15, 2010) (finding the DTaP vaccine induced a fever

that triggered the onset of the minor’s seizures); Almeida v. Sec’y of Health & Hum. Servs., No.

96-412V, 1999 WL 1277566 (Fed. Cl. Spec. Mstr. Dec. 20, 1999) (finding the DPT vaccine

significantly aggravated petitioner’s preexisting seizure disorder). Notably, all of these cases

involved minors, and most involved the whole-cell pertussis vaccine, which is not analogous to

the case at hand. Only Sucher and Tembenis involved an acellular pertussis vaccine, DTaP, the

formulation of which was for children. Moreover, none of these cases are binding on me, nor can

their conclusions be extrapolated wholesale to prove Petitioner’s claim, which she has failed to

substantiate with expert or medical record evidence.

In sum, Petitioner did not put forward any reliable expert or medical record evidence

supporting a causation theory for how Tdap vaccination could cause a seizure disorder,

26

I note that Petitioner did not argue that the Tdap vaccine caused her to develop PRES. In another case

alleging vaccine-caused PRES, entitlement was denied where the petitioner presented a much more robust

causation theory than was proffered here. See Kaltenmark v. Sec’y of Health & Hum. Servs., No. 17-1362V,

2023 WL 8870299, at *30-35 (Fed. Cl. Spec. Mstr. Nov. 27, 2023).

27

In her briefing, Petitioner commented that before 1995, the Vaccine Injury Table provided for

compensation of “residual seizure disorders” occurring within three days of a DPT vaccination. Pet.’s Post-

Hrg. Br. at 15-16. When making this point, however, Petitioner replaced the acronym “DPT” with “TDaP”

without acknowledging that DPT and Tdap are different vaccines with materially different components. Id.

at 16. As the Federal Circuit explained in Andreu:

In recent years, most children in the United States have been inoculated

with the DTaP vaccine, which contains an acellular pertussis component,

as opposed to the DPT vaccine, which contains a whole-cell pertussis

component.

Andreu, 569 F.3d 1367, 1375 n.1. Tdap, the adult version of the DTaP vaccine, also contains acellular

pertussis. See Ex. 3 at 3 (listing components of the subject Tdap vaccine given to Petitioner). Given that

she ignored this important context, Petitioner’s suggestion that a “Tdap/seizure disorder” claim would have

been viable had it been brought before 1995 is unpersuasive.

44

demonstrating a logical sequence of cause and effect between the vaccination and the development

of her seizures, or showing that her seizures occurred in a medically acceptable timeframe after

vaccination.

VI. CONCLUSION

I am highly sympathetic to Petitioner’s ordeal. However, upon careful evaluation of all the

evidence submitted in this matter, including the medical records, Petitioner’s statement, the expert

reports, the testimony, and the medical literature, I conclude that she has not shown by

preponderant evidence that she is entitled to compensation under the Vaccine Act. The Clerk’s

Office is instructed to issue a judgment in accord with this decision.28

IT IS SO ORDERED.

s/ Jennifer A. Shah

Jennifer A. Shah

Special Master

28

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly

or separately) a notice renouncing their right to seek review.

45