# Boyd v. Secretary of Health and Human Services

> United States Court of Federal Claims · June 4, 2026

URL: https://www.frixlaw.com/law-library/cases/11338206

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** June 4, 2026
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Jennifer A Shah
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/11338206

## How later opinions describe it (automated extraction)

- finding petitioners preponderantly established that the DPT vaccine caused a seizure disorder

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1342V
Filed: April 21, 2026

************************* *
*
LATISHE BOYD, *
*
*
Petitioner, *
*
v. *
*
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
*
Respondent. *
*
************************* *

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

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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

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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

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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 leucocyte

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/11338206. Public record. Not legal advice.