VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00285
Package ID: USCOURTS-cofc-1_20-vv-00285
Petitioner: Kimberly F. Flowers
Filed: 2020-03-13
Decided: 2024-05-08
Vaccine: influenza
Vaccination date: 2018-10-26
Condition: Guillain-Barré syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Kimberly Flowers, a 50-year-old female, received an influenza vaccine on October 26, 2018. She alleged that she developed Guillain-Barré Syndrome (GBS) as a result of this vaccination. The case was initially assigned to a Special Processing Unit due to the expectation of an easily established Table claim, but due to disputed fact issues, it was reassigned to the regular docket. The Chief Special Master (CSM) issued an order to show cause, questioning whether the claim could succeed given the apparent early onset of GBS post-vaccination. The CSM ultimately denied entitlement, concluding that the evidence preponderated in favor of an onset occurring too soon after vaccination to meet the Vaccine Injury Table timeframe. The CSM also found that such a short onset would not be medically acceptable even under a non-Table, causation-in-fact analysis. The CSM reviewed medical records indicating that Flowers reported symptoms beginning shortly after vaccination, with some records suggesting onset as early as the same day or within one to two days. The CSM found the testimony of Flowers' expert, Dr. David Simpson, unpersuasive regarding the onset timing, particularly his reliance on a Korean study. The CSM also noted that Flowers' treaters did not coalesce around vaccination as the reason for her GBS. The decision was later reviewed by a judge, who sustained the CSM's decision, finding it was not arbitrary or capricious. The judge agreed that the CSM rationally considered the evidence and found that Flowers failed to establish that her GBS onset occurred within the Table timeframe or was medically acceptable under a non-Table claim. Therefore, Flowers was not entitled to compensation.

Theory of causation field:
Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00285-0
Date issued/filed: 2024-06-03
Pages: 19
Docket text: PUBLIC DECISION (Originally filed: 05/08/2024) regarding 41 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
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Case 1:20-vv-00285-TMD Document 42 Filed 06/03/24 Page 1 of 19
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-285V
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
*
KIMBERLY F. FLOWERS, * Chief Special Master Corcoran
*
Petitioner, * Filed: May 8, 2024
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Jeremy McKenzie, McKenzie & Hart, LLC, Savannah, GA, for Petitioner.
Alec Saxe, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
Petitioner Kimberly Flowers filed this Petition on March 13, 2020, alleging that she suffered
from Guillain-Barré syndrome (“GBS”) as a result of an influenza (“flu”) vaccine she received on
October 26, 2018. Petition (ECF No. 1) at 1. The case was originally assigned to the “Special
Processing Unit” (“SPU”), based on the expectation that a Table claim might be easily established.
But a number of disputed fact issues prevented its easy resolution, and the claim was eventually
transferred to my regular docket. See Order, dated Sept. 6, 2023 (ECF No. 35).
I thereafter issued an Order to Show Cause why the claim should not be dismissed, given my
preliminary assessment that onset of Petitioner’s GBS appeared to have occurred too close in time
to the vaccination date to meet the Table requirement—and that a non-Table claim was also unlikely
to succeed, for largely the same reasons. Order, dated Sept. 18, 2023 (ECF No. 37). The parties have
now filed responses.
1 "Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential;
or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion
of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public in its present form. Id."

Case 1:20-vv-00285-TMD Document 42 Filed 06/03/24 Page 2 of 19
For the reasons set forth in more detail below, I hereby deny entitlement. The record
preponderates in favor of the conclusion that Petitioner’s GBS onset occurred too soon post-
vaccination to meet the Table timeframe—and given that record, such a short onset would also not
be medically-acceptable even under a non-Table, causation-in-fact analysis.
I. Fact History
Prior to the vaccination at issue, Petitioner had experienced a number of health issues.
Generally, her history includes obesity, irritable bowel syndrome, hypertension, type 2 diabetes,
bipolar disorder, and immune thrombocytopenic purpura—an autoimmune blood platelet deficiency
disease for which she received specific treatment. In January 2016 she was diagnosed with a lung
neuroendocrine tumor and had a resection, although the tumor proved to be nonaggressive. See
generally Ex. 8.
In addition, a month before the October 2018 vaccination, Petitioner obtained neurologic
treatment for chronic daily headaches she had been experiencing since 2014 but which responded to
certain medications specific to neurologic pain. Ex. 8 at 674–75. She also then reported left
anterolateral thigh numbness and tingling. Id. The neurologist who saw her, Dr. Yi Tsai, deemed the
headaches to be likely caused by cervical spondylosis, however, rather than migraine-related
(although EMG2 testing was ordered to more definitively rule out a neuropathic cause). Id. at 680–
81. Dr. Tsai also proposed that the thigh numbness was attributable to a condition involving sensory
nerve compression. Id. at 681.
Vaccination and Subsequent Neurologic Symptoms
On October 26, 2018, Ms. Flowers went to the TownPark Advanced Care Center (“TP-
ACC”) in Kennesaw, Georgia for a “wound check”—a blister on her right breast that she reported
had been present for a week, but which had enlarged despite her own home treatment. Ex. 1 at 4–5.
Her physical exam was normal and no other symptoms were reported at the visit, with the blister
deemed to be the product of a “mild secondary infection.” Id. at 5–6. Petitioner received the flu
vaccine at this time. Id. at 9, 13.
There is no immediate contemporary record evidence of any vaccine reaction. However,
eleven days later, on November 6, 2018, Ms. Flowers returned to TP-ACC with several complaints,
including cough, shortness of breath, and paresthesias she characterized as “tingling all over her
2 “Electromyography” is defined as “an electrodiagnostic technique for recording the extracellular activity (action
potentials and evoked potentials) of skeletal muscles at rest, during voluntary contractions, and during electrical
stimulation; performed using any of a variety of surface electrodes, needle electrodes, and devices for amplifying,
transmitting, and recording the signals.” Electromyography, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography (last visited May 8,
2024).
2

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body.” Ex. 2 at 11, 12. She specifically reported not only that these symptoms had begun “shortly
after” receiving the flu vaccine, but that (in her view) they had been caused by it. Id. at 11, 12.
Examination resulted in no specific findings, and Petitioner was discharged with the assessment
“adverse affect of flu Vaccine,” and directed to visit her primary care physician. Id. at 11.
Petitioner went back to TP-ACC on November 8, 2018, now complaining of weakness. Ex.
3 at 4. She specifically stated at this time that “since [her] flu vaccine on 27th (sic) [she] ha[d] been
ill with cough, fatigue, severe joint pain and [nausea/vomiting].” Id. And although her visit two days
prior had not resulted in any adverse findings, she could now barely walk and was experiencing
severe pain. Id. The physical exam performed at this time confirmed her complaints, revealing both
global weakness and a need for assistance in ambulation, although lab work was negative, and
Petitioner was discharged with an assessment of “musculoskeletal pain, pruritus.” Id. at 7, 11.
Suspicion of GBS and Hospitalization
The very next day (November 9, 2018), Ms. Flowers was transported by ambulance to Emory
St. Joseph’s Hospital’s Emergency Room. Ex. 7 at 1. She informed emergency treaters than she had
received the vaccine in October, but then (after some symptoms that seemed reflective of an upper
respiratory infection) began to experience body pain and generalized numbness/weakness,
progressing to the point where she had been unable to walk at all over the prior two to three days.
Id. at 5; see also Ex. 4 at 50 (Petitioner informing treaters of symptoms since vaccination) and 53,
90, 91. She also noted that initial numbness and tingling around her teeth and hands had progressed
to her entire body but mostly affecting her lower extremities. Id. at 50. The physical exam performed
by ER treaters demonstrated only trace deep tendon reflexes (“DTRs”) in her lower extremities, but
symmetric reflexes in her upper extremities, and her lower extremity motor strength was 3 out of 5.
Ex. 4 at 51. Petitioner was admitted to the hospital, with initial treaters expressing concern for the
need to “[r]ule out Guillain-Barre syndrome or other neurologic disorder.” Id. at 52.
During her early hospitalization, Petitioner continued to inform treaters that her symptoms
had begun not long after the October vaccination, although they had only become acute shortly
before her ER visit. See, e.g., Ex. 4 at 173 (November 10, 2018, neurology note stating that Petitioner
“presents due to acute onset of bilateral parethesias/weakness in ascending manner after flu
vaccination on 10/27”), 132 (November 13, 2018, nursing note stating petitioner “presented with
progressive neurologic decline over 2 weeks post flu shot and acute URI/diarrhea symptoms”). The
overall impression was deemed to be attributable to “some kind of demyelinating/inflammatory
process.” Id. at 93.
Petitioner had her first neurology consult with Dr. Ramesh Kumar early on during her in-
patient experience, again providing a comparable history (including onset of symptoms right after
vaccination) to what she had offered other treaters. Ex. 4 at 103. A neurology-oriented exam
3

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performed at this time revealed normal upper-extremity strength compared to absent lower-limb
strength, but only slightly-abnormal reflexes (1+) with no clonus. Id. at 105. And a lumbar puncture
performed on November 9, 2018, revealed elevated nucleated cells and protein levels. Id. at 88. Dr.
Kumar assessed Petitioner with “[p]ain/sensory symptoms/leg weakness/gait disorder [status post]
flu vaccine in Oct 2018 of unclear etiology,” adding that Petitioner’s overall presentation was “[n]ot
typical for GBS or [Miller Fisher Syndrome] variant,” with the reflex condition specifically
attributed to possibly chronic diabetes, but that out of an abundance of caution IVIG3 treatment
would be utilized. Id.
Petitioner received her first course of IVIG the next day. Ex. 4 at 87. However, the IVIG did
not ameliorate her bilateral lower extremity weakness, and on November 12, 2018, it was ceased,
and she was instead placed on PLEX4 (plasma exchange). Id. Around this initial treatment period,
Petitioner also experienced a seizure on November 10, 2018, and “had a prolonged post ictal period
with suspected airway edema.” Id. Petitioner was intubated, and treaters proposed she had acute
posterior reversible encephalopathy syndrome (“PRES”).5 Id. at 138.
On November 13, 2018, Ms. Flowers was transferred to Emory University Hospital Midtown
for further EEG monitoring and intensive care management, remaining there until the first week of
December, when she was discharged to the Shepherd Center, an in-patient rehabilitation center in
Atlanta, Georgia. Ex. 4 at 89; Ex. 10 at 534, 554, 1333. Petitioner’s initial neurologic work-up from
this time memorializes her report that the same day as vaccination, she had experienced “gradual
weakening to [bilateral lower extremities] that worsened to the point that her husband had to carry
her to the restroom,” later progressing the point where she sought emergency care earlier that month.
Ex. 10 at 554; Ex. 14 at 80.
3 “Intravenous immunoglobulin,” or “IVIG,” is a blood product used to treat patients with antibody deficiencies,
including neurological disorders. Clinical Use of Intravenous Immunoglobulin, NCBI (2005)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480/ (last visited on May 8, 2024).
4 “Plasma exchange” is defined as “the removal of plasma from withdrawn blood, usually to a greater extent than in
plasmapheresis, with retransfusion of the formed elements into the donor; done for removal of circulating antibodies or
abnormal plasma constituents. The plasma removed is replaced by type-specific fresh frozen plasma or albumin.”
Plasma Exchange, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=73970&searchterm=plasma+exchange (last visited May 8,
2024).
5 “Reversible Posterior Leukoencephalopathy Syndrome” is defined as “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., posteriors reversible
encephalopathy s., and posterior reversible leukoencephalopathy s.” Reversible Poster Leukoencephalopathy Syndrome,
Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111286 (last visited May
8, 2024).
4

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Treatment in 2019 and Beyond
Petitioner received ongoing rehabilitation therapy and treatments at the Shepherd Center
from December 6, 2018, until February 16, 2019. See generally Ex. 5. During her stay, she
experienced posterior laryngeal stenosis and required the placement of tracheal stents which were
removed before her discharge. Id. at 1888. By the time of her release, Petitioner was able to perform
all activities of daily living with supervision, and could ambulate with assistance (although she
mostly utilized a motorized wheelchair). Id. at 1899. Her discharge diagnosis was lengthy, but does
seem to accept GBS as explanatory of her presenting symptoms, while including diabetes plus the
concurrent, unrelated conditions she experienced during hospitalization, like PRES. Id. at 1886.
The next medical record bearing on the claim is from May 2019, when Ms. Flowers saw
neurologist Dr. Cui Yang at Kaiser Permanente/Townpark Medical Center. Ex. 14 at 79. The
“history of present illness” section from the record of this visit identified “the second day” from
vaccination as when Petitioner first began to experience weakness and paresthesias in her
extremities.” Id. It also noted that Petitioner reported since her Shepherd Center discharge that she
was still experiencing severe pain. Id. at 80. At the same time, however, Petitioner now displayed
greater strength in upper and lower extremities, as well as normal reflexes. Id. at 83–84. And a
sensory exam revealed normal/symmetric response to light touch in all extremities. Id. at 84.
In her assessment, Dr. Yang allowed for the possibility of GBS attributable to the flu vaccine,
but also noted that “normally [GBS] happened days or weeks after getting a vaccination, but her
symptoms started one day after her flu shot,” which “doesn’t fit the typical GBS.” Ex. 14 at 87. Also
inconsistent with a GBS diagnosis was the fact that Ms. Flowers had displayed in this exam normal
reflexes; even though Dr. Yang allowed that Petitioner’s reflexes might not have been the same at
the time of her hospitalization, GBS was more commonly characterized by persistent DTR deficits,
which sometimes never recovered (and usually were a final improvement after treatment). Id. And
while Petitioner did display elevated protein levels after her lumbar puncture, other imaging
performed in the course of Petitioner’s treatment had not revealed the presence of inflammation or
other corroborative factors. Id.
Dr. Yang subsequently recommended an NCS/EMG study to look for “evidence of GBS
(demyelinating features), [l]arge fiber [d]iabetic neuropathy or cervical/lumbar radiculopathy.” Ex.
14 at 87. That study was performed in mid-June 2019, and revealed abnormal results, with
“electrophysiological evidence of a generalized length-dependent sensorimotor polyneuropathy,
affecting the lower extremity, which is predominately axonal loss in type, and severe in degree
electrically.” Id. at 121–29. But these findings were interpreted by Dr. Yang to be consistent with
polyneuropathy seen in diabetes mellitus, rather than to reveal “typical demyelinating features” of a
condition like GBS. Id. at 123–24. As treatment, Dr. Yang proposed “diabetes control/rule out other
treatable causes/symptomatic treatment, plus pain management and PT, with a neurologic follow-up
5

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later. Id. at 124.
Records for treatment obtained in 2020 largely reflect concerns about diabetes-associated
symptoms. See, e.g., Ex. 15 at 54, 57–58 (February 2020 visit with primary care physician), 117–18
(April 2020 telehealth call), 153–54 (July 2020 visit to primary care physician). But no mention was
made in this time period of Petitioner’s GBS, or of any ongoing neurologic-associated symptoms.
Petitioner did, however, go to a follow-up neurologic treatment appointment in August 2020. Id. at
202. At this time, she reported ongoing neuropathic pain, and difficulty ambulating, with those
difficulties confirmed on exam. Id. at 203, 209. At the same time, however, the physical exam also
revealed only slightly decreased strength in lower extremities (4/5), along with normal reflexes and
normal response to sensory touch. Id. at 208–09.
II. Expert Report
Petitioner has offered a single expert report in this case, from David M. Simpson, M.D., a
neurologist. Report, dated Dec. 11, 2023, filed as Ex. 1 (ECF No. 39-1) (“Simpson Rep.”).
Dr. Simpson is a Professor of Neurology and the Director of the Neuromuscular Division
and Clinical Neurophysiology Laboratories at the Icahn School of Medicine at Mount Sinai, where
he has worked as an Attending Neurologist since 1984. Simpson Rep. at 1.6 He received his medical
degree from SUNY at Buffalo School of Medicine, and underwent residency and fellowship training
at Cornell University Medical Center and Massachusetts General Hospital. Id. He is certified by the
National Board of Medical Examiners, the American Board of Psychiatry and Neurology with
subspecialties in Clinical Neurophysiology and Neuromuscular Medicine, and the American Board
of Neuromuscular and Electrodiagnostic Medicine. Id. He has been published extensively, and has
given numerous presentations and lectures on the subject of neurological disorders, including
peripheral neuropathy. Id.
The first section of Dr. Simpson’s report summarizes the materials he reviewed for his
opinion, along with a brief review of Petitioner’s medical history. Simpson Rep. at 2–5. That history
includes the instances discussed above where Petitioner informed treaters that her neurologic, GBS-
related symptoms began shortly after vaccination. Id. at 2, 4. He then provided an overview of
GBS—and acute inflammatory demyelinating polyneuropathy, or “AIDP”—the GBS sub-variant he
seemed to embrace as applicable to Petitioner. Id. at 5. He also discussed biologic mechanisms by
which GBS might occur, as well as the basis for an association between it and the flu vaccine
(although this case does not turn on whether the flu vaccine “can cause” GBS—and hence I do not
include herein a detailed explication of this aspect of his opinion). Id. at 5–6. And Dr. Simpson
contended that nothing else in the record could explain Petitioner’s GBS, despite some nonspecific
6 Petitioner did not file a CV for Dr. Simpson, but his report contains a summary of his professional background, and I
am otherwise familiar with his career history from opinions he has offered in other cases.
6

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mention of URI-like symptoms before Petitioner’s hospitalization. Id. at 7.
Dr. Simpson’s report goes on to address the central issue in resolving this case: Petitioner’s
onset and its medical acceptability. Simpson Rep. at 6–7. He noted that Respondent seemed to accept
there was some ambiguity in the record regarding the actual onset for Petitioner’s GBS. Id. at 6. In
Dr. Simpson’s review of the record from “the early weeks” of Petitioner’s illness, there were only
references like “since” or “shortly after,” which he deemed temporally nonspecific. Id. Moreover,
to the extent Petitioner was later more precise in reporting a one to two-day post-vaccination onset,
those recollections had been obtained “many months following disease onset,” and should not be
considered accurate—especially since patients often had difficulty recalling “the precise timing of
onset of symptoms.” Id.
Because of such ambiguity, Dr. Simpson maintained that record evidence from her
November 2018 treatment was the better way to assess “the timing and progression of symptoms
and signs.” Simpson Rep. at 6. That evidence revealed Petitioner began experiencing neurologic
symptoms, like paresthesias or ambulation difficulties, between November 6-8, 2018—thus no
sooner than eleven days post-vaccination. Id. As a result, Dr. Simpson concluded that “the
occurrence and evolution of objective neurologic signs did not occur until the second week following
vaccination.” Id. at 7.
However, Dr. Simpson argued, even if onset had occurred within 72 hours of vaccination,
such a timeframe would still be medically acceptable. In support, he referenced a single item of
literature. Simpson Rep. at 7; Y. Park et al., Clinical Features of Post-Vaccination Guillain-Barré
Syndrome (GBS) in Korea, J. Korean Med. Sci. 2017 Jul;32(7):1154–1159, (“Park”).7 Dr. Simpson
deemed a two-day onset to be acceptable, noting that Park’s authors observed an onset of
neurological symptoms occurring within three weeks in 47 of 48 of the analyzed GBS cases, and
occurred within two days in a bit more than half. Simpson Rep. at 7.
III. Procedural History
This case was filed a little over four years ago. After its activation from “pre-assignment
review,” it was initially assigned to the SPU. But despite the parties’ efforts, settlement proved
impossible, largely if not wholly because of the onset issues discussed above. Accordingly, in
September 2023, the matter was reassigned to my personal docket (see ECF No. 35), and I ordered
the parties to formally brief the longstanding onset issue. See Petitioner’s Brief, dated Dec. 14, 2023
(ECF No. 39) (“Br.”); Respondent’s Response, dated Jan. 19, 2024 (ECF No. 40) (“Opp.”). That
process has been completed, and the matter is now ripe for resolution.
7 Petitioner has not filed Park, but as noted below in my analysis, I am familiar with the article and have discussed it in
other cases in which the flu vaccine is alleged to have caused GBS.
7

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IV. Parties’ Arguments
A. Petitioner
Petitioner defends her GBS onset as consistent with the Table’s timeframe as well as the
third prong set by the Federal Circuit in Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005). First, she argues her onset was not likely as close to vaccination as many
records suggest, pointing to her witness statements plus those of her husband and daughter.8 She
explains that the medical records do not provide any clarification as to the precise timing of
Petitioner’s onset of GBS-related symptoms, and that the only medical record that provides a specific
time frame for onset was documented at an appointment with Dr. Yang on May 3, 2019. Br. at 3;
Ex. 14. However, Petitioner maintains that Dr. Yang mistakenly believed that Petitioner received
the flu vaccine on October 28, 2018 (as opposed to October 27, 2018), and that the note that
Petitioner began experiencing problems “since the second day” post-vaccination technically “falls
in line with [her] contention that she did not have any problems until at least three days after her
vaccination.” Br. at 4. Moreover, Petitioner contends that Dr. Yang also documented,
contradictorily, Petitioner’s symptoms as beginning one day following her flu vaccine. Id.; Ex. 14
at 87. Therefore, Petitioner argues that a “self-contradictory medical record entered months after
Petitioner received her flu vaccine” should not be given greater weight than direct testimony of
Petitioner and her family, coupled with other, more contemporaneous medical records. Br. at 4.
Additionally, Petitioner maintains that she has submitted an expert report from Dr. Simpson
who opined that Petitioner “did not exhibit any symptoms specifically consistent with GBS until
more than three days after her vaccination.” Id.; Simpson Rep. at 7. Dr. Simpson relies on multiple
studies supporting a connection between vaccination and the development of demyelinating
neuropathy, thus satisfying the first Althen prong. Similarly, Dr. Simpson noted no logical alternative
causes, and stated that symptoms onset beginning within several days to two weeks post-vaccination
and followed by progressive neurological sensory and motor deficits is consistent with an
AIDP/GBS diagnosis. Id. Finally, to support a proximate temporal relationship, Petitioner argues
that “the earliest that any record suggests that Petitioner could have experienced any complications
. . . was two days after her flu vaccination” and that such a time frame is consistent with the Park
Study which Dr. Simpson relies on. Id. Thus, Petitioner maintains that she has sufficiently shown
that her symptoms meet the Table requirements, or in the alternative, that she has provided record
proof to satisfy an off-Table claim. Br. at 10.
8 See Affidavit of Kim Flowers, dated Jan. 15, 2021, filed as Ex. A (ECF No. 26-1); Affidavit of Paul Flowers, dated
Jan. 15, 2021, filed as Ex. B (ECF No. 26-2); Affidavit of Miranda Flowers, dated Jan. 15, 2021, filed as Ex. C (ECF
No. 26-3).
8

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B. Respondent
Respondent maintains that Petitioner has not established a viable Table claim. Opp. at 8.
Respondent notes that in the first two weeks immediately following Petitioner’s receipt of the flu
vaccine, she consistently reported experiencing symptoms “since” vaccination. Id.; Ex. 2 at 11, 12;
Ex. 3 at 4, 5; Ex. 4 at 50, 53, 103, 132, 173, 175. He further argues that Petitioner’s use of the terms
“since” and “shortly after” are clear indications that her GBS-related symptoms likely began less
than three days post-vaccination. Opp. at 10. Indeed, Respondent points to several other medical
records that suggest Petitioner began experience neurologic symptoms as early as “upon returning
home” from receiving the vaccine at issue. Id.; Ex. 10 at 534, 554. Respondent maintains that such
records bulwark the notion that Petitioner’s symptoms began outside of the Table timeframe. Opp.
at 11.
Respondent also argues that Petitioner has not established a viable off-Table, causation-in-
fact claim. Opp. at 11. He criticizes Petitioner’s expert report from Dr. Simpson, noting that the
single item of literature he references to support a temporal association—the Park study—has been
found unreliable in its attempt to establish an off-Table Flu/GBS claim, where onset occurred less
than 72 hours post-vaccination. Id. at 13; Block v. Sec’y of Health & Hum. Servs., No. 19-969V,
2021 WL 5709764, at *4 (Fed. Cl. Spec. Msrt. Oct. 29, 2021). Moreover, because Dr. Simpson lacks
immunological expertise, his report is not compelling on foundational matters of “can cause”
causation relating to what onset is medically acceptable. Opp. at 14 (citing Block, 2021 WL 5709764,
at *5 (finding that Dr. Simpson did not possess adequate immunological expertise to credibly support
a shorter onset timeframe)). Similarly, Respondent maintains that Petitioner failed to offer a treating
physician willing to opine a shorter-than-usual vaccine caused onset—noting that nothing about
Petitioner’s case suggests otherwise. Opp. at 17.
V. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he
suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to
one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative,
(2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections
13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also
Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y
of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).9 In this case, Petitioner asserts a
Table claim, along with a causation claim in the alternative. Br. at 2, 5.
9 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.
Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning
legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d
9

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Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof.
Section 13(1)(a). 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, 592 F.3d at 1322
n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or
speculation is insufficient under a preponderance standard). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular,
a 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 his assertions; rather, the petition must be supported by either
medical records or by the opinion of a competent physician. Section 13(a)(1).
In attempting 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, 418 F.3d 1274 , 1278: “(1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of proximate temporal relationship between vaccination and injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
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 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or 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 essentially thorny scientific and medical questions, and thus
scientific evidence offered to establish Althen prong one is viewed “not through the lens of the
laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed
on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed. Cl. at 245.
104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL 504728,
at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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In discussing the evidentiary standard applicable to the first Althen prong, the Federal Circuit
has consistently rejected the contention that it can be satisfied merely by establishing the proposed
causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum. Servs.,
941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d
1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a
‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof” (citing
Moberly, 592 F.3d at 1322)); Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4
(Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), appeal
docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). Otherwise, petitioners always have the ultimate
burden of establishing their Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health
& Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States,
133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of
proving causation-in-fact under the Vaccine Act” by a preponderance standard).
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; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and
views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at
1367; 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 1280). Medical records are generally viewed as particularly trustworthy
evidence, since 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).
Medical records and statements of a treating physician, however, 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. Section 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 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 Dept. of Health & Hum. Servs., No. 06-522V, 2011 WL 1935813, at
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*17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed. Cl. 344, 356 (2011), aff’d
without opinion, 475 F. Appx. 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 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe 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 align 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. denied after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503
F. Appx. 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 rev. denied (Fed. Cl. Dec. 3, 2013), aff’d,
773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required to
consider “all [ ] relevant medical and scientific evidence contained in the record,” including “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,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). 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) (determining
that 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).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions
explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick
people attempt to honestly report their health problems to those professionals; and (iii) medical
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professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992),
aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail
to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should be
afforded substantial weight. 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. United
States 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, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health &
Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) 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 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).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). 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
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(4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health &
Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a
determination regarding whether to afford greater weight to contemporaneous medical records or
other evidence, such as testimony at hearing, there must be evidence that this decision was the result
of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present expert
testimony in support of his 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). Under
Daubert, the 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).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. 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 the persuasiveness
and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742–
45. 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 in order to rebut a petitioner’s case. Where
both sides offer expert testimony, a special master's decision may be “based on the credibility of the
experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec'y of Health
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& Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However,
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.
146 (1997)); see also Isaac v. Sec'y of Health & Hum. Servs., No. 08–601V, 2012 WL 3609993, at
*17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540
F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). 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. Moberly, 592 F.3d 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”).
D. Consideration of Medical Literature
Both parties filed numerous items of medical and scientific literature in this case, but not all
such items factor into the outcome of this decision. While I have reviewed all the medical literature
submitted in this case, I discuss only those articles that are most relevant to my determination and/or
are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical
record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5
(Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013)
(“[f]inding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).
E. Standards for Ruling on the Record
I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where (in the exercise
of their discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided case
on the papers in lieu of hearing and that decision was upheld). I am simply not required to hold a
hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Hum.
Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his discretion
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in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Hum. Servs.,
No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
ANALYSIS
Petitioner cannot establish entitlement under any possible version of the claim—Table or
not.
The Table elements for a flu-GBS claim cannot be met (and to the extent there was any
ambiguity as to this question in my prior Order to Show Cause, I hereby dispel it). The medical
records preponderantly establish that Petitioner’s onset most likely occurred less than three days
after vaccination—thus sooner than the 3-42 day timeframe provided for by the Vaccine Injury
Table. 42 C.F.R. § 100.3; Ex. 4 at 103; Ex. 10 at 534, 554; Ex. 14 at 11, 87. And this is not a case
where a claimant confuses some initial vaccine reaction-associated malaise with what later proved
to be onset of GBS, such that I could distinguish the two and focus on the “real” onset of neurologic
symptoms. Rather, Petitioner consistently claimed to have begun experiencing neurologic symptoms
within a day or two of vaccination—even as soon as the very same day. Ex. 10 at 534, 554. It makes
no difference that those symptoms progressed over time, with Petitioner experiencing worsening
that later encouraged her to seek emergency care less than two weeks post-vaccination—for (as
noted in the Table) GBS nadir from onset typically progresses up to 28 days after symptoms first
manifest. 42 C.F.R. § 100.3(c)(15)(i).
Dr. Simpson’s onset arguments are unpersuasive. First, although it is true that certain timing
references in the contemporaneous records are nonspecific and vague, that does not mean a one to
two-day onset lacks overall preponderant support, based on all of the evidence. And vagueness in
identifying an onset date does not preclude my finding. Program claimants often use imprecise
terminology in describing to treaters when symptoms began. But more often than not, terms like
“since” or “shortly after” are reasonably understood by the special masters to mean very close in
time—immediately, or at most within a day or two. (Indeed, in the context of claims that a vaccine
caused a “shoulder related to vaccine administration, or “SIRVA,” a patient’s reports of pain
conveyed with similarly nonspecific language are consistently interpreted to mean within 48 hours
of vaccination). See, e.g., O’Leary v. Sec’y of Health & Hum. Servs., No. 18-584V, 2021 WL
3046617, at *10 (Fed. Cl. Spec. Mstr. June 24, 2021); accord Williams v. Sec’y of Health & Hum.
Servs., No. 17-1046V, 2020 WL 3579763, at *5 (Fed. Cl. Spec. Mstr. Apr. 1, 2020) (holding that
“based on the record as a whole, I find the notations characterizing onset as ‘since,’ ‘after receiving,’
‘following’, and ‘very soon after’ injection are best understood as indicating onset was effectively
immediate, or within 48 hours of vaccination”). Since the Program does not reject vague onset
references outright, they deserve evidentiary weight—and here, coupled with other record evidence
more precise on onset timing, they support the conclusion that Petitioner’s onset began less than
three days of vaccination, and perhaps as early as the same day.
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Second, Dr. Simpson’s onset arguments confuse when Petitioner’s GBS could be diagnosed,
or when it worsened to the point of nadir, with when onset actually began. It is a foundational matter
of Vaccine Program law that onset occurs at first manifestation of a symptom, regardless of whether
the disease it foretells could be diagnosed at that time—and thus whether the onset symptoms would
be clearly understood to reflect the start of the illness. § 300aa-16(a)(2); Carson v. Sec’y of Health
& Hum. Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013). In addition, there is a distinction between the
start of an acute and monophasic illness like GBS, and when it reaches nadir (as the Table reflects).
Here, the evidence preponderantly establishes that not only was Petitioner experiencing sufficiently-
alarming neurologic symptoms to seek treatment for them eleven days post-vaccination, but that at
that time and consistently thereafter she reported they had begun no later than a day after
vaccination. Ex. 4 at 87. This record thus plainly preponderates in favor of a one to two-day post-
vaccination onset—meaning the Table timeframe cannot be evidentiarily be satisfied.
Other fact arguments about onset timing are not well-supported by the record. Petitioner may
be correct, for example, that Dr. Yang’s records from May 2019 may well be internally inconsistent
on onset, or presume a wrong vaccination date. Yet, as discussed above, not only are there ample
records much closer in time to vaccination suggestive of an early onset, but some that even pinpoint
it as the same day. See, e.g., Ex. 10 at 534, 554. It remains the case that overall, preponderant
evidence is not favorable to Petitioner’s onset contention.
This leaves a potential non-Table, causation-in-fact claim that would have to meet the three
prongs set by the Federal Circuit in Althen. But the claim (again) fails on the third, timeframe prong,
because a one to two-day onset (or even sooner) has not been shown to be medically acceptable.
Petitioners asserting a non-Table flu vaccine-GBS claim are not formally limited by the
Table’s timeframe element, and thus can attempt to demonstrate that an onset sooner than three days
post-vaccination is medically acceptable. Nevertheless, that timeframe best captures the most likely
period in which vaccine-caused GBS would begin, based on the most persuasive and reliable science
currently available. See Rowan v. Sec'y of Health & Hum. Servs., No. 17-760V, 2020 WL 2954954,
at *14–16 (Fed. Cl. Spec. Mstr. Apr. 28, 2020) (discussing the relationship between Table
requirements and non-Table claims in context of flu-GBS claims). Special masters should not simply
extend the Table’s defined timeframe period (which reflects careful and reasoned analysis of medical
and scientific evidence) on the say-so of an expert—since to do so would eliminate the distinction
between Table and non-Table claims entirely. Velasquez v. Sec’y of Health & Hum. Servs., No. 19-
1703V, 2024 WL 829599, at n.13 (Fed. Cl. Spec. Mstr. Jan. 31, 2024).10
10 The same reasoning applies in the opposite direction for this kind of claim. I would not likely find (under Althen prong
one) the flu vaccine cannot cause GBS in a non-Table context, even if Respondent sought mightily to so establish—and
even if he offered persuasive evidence in support—since to do so would be to wholly contradict the Table version of
such a claim.
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Instead, petitioners seeking to prove a shorter timeframe is medically acceptable need to
explain what about the specific facts of their case suggests a faster onset would occur. This has been
done, and Petitioner references some instances of it. Br. at 10 (citations omitted). But this occurs
only where other factors establish that some synergistic combination of causes involving the vaccine
and the claimant’s own preexisting health likely caused a faster immune stimulation process. See,
e.g., Orton v. Sec'y of Health & Hum. Servs., No. 13-631V, 2015 WL 1275459 (Fed. Spec. Mstr. Cl.
Feb. 23, 2015) (dismissing claim where inadequate evidence established the medical acceptability
of a one-day onset of GBS); Rowan, 2020 WL 2954954, at *19 (dismissing claim because it did not
demonstrate 30-36 hour onset in elderly petitioner). And here, as Respondent establishes, the kind
of special factors evidenced from the medical record that would render a short onset more acceptable
are absent. Opp. at 15–16.
Dr. Simpson’s opinion does not establish unusual circumstances relevant to the Petitioner
that would explain how vaccination could have so quickly caused her to begin experiencing
neurologic symptoms. He references Park in support—but I have in other cases (also involving Dr.
Simpson) noted that this article only reveals that a different country’s vaccine compensation program
paid damages in a few cases involving short onset, with no discussion of whether such an onset
actually had scientific or medical support. See, e.g., Block, 2021 WL 2182730, at *5, 8–9 (dismissing
flu-GBS Table claim due to onset occurring outside the defined 3-42 day timeframe, and discussing
Korean vaccine injury program referenced in Park).11 This is hardly robust proof that a short onset
is medically acceptable—at all, let alone in this case.
In addition (and although the claim is properly dismissed on the basis of the third Althen
prong), the second, “did cause” prong is also unsatisfied. There is no evidence of any suspicious
vaccine reaction that could suggest an aberrant immune response had begun. No testing or clinical
11 I specifically noted in Block the following:
In support of his opinion, Dr. Simpson cited to Y. Park et al., Clinical Features of Post-Vaccination Guillain-
Barré Syndrome (GBS) in Korea, J. Korean Med. Sci. 2017 Jul;32(7):1154-1159, filed as Exhibit 22 (ECF
No. 21-9) (“Park”). Simpson Rep. at 7. Park reviews post-vaccination GBS cases submitted for compensation
to the Korean Advisory Committee on Vaccination Injury Compensation between 2002 and 2014 as part of
the National Immunization Program in South Korea. Park at 1154-55. Park's authors note that of the 48 flu-
GBS cases approved for compensation in South Korea during that period, more than half of the cases (25)
involved onset of neurological symptoms within two days of vaccination. Id. at 1155-56 and Fig. 1.
* * *
Park does not, however, discuss whether that timeframe was deemed medically acceptable, or what set of
criteria was applied in awarding injury compensation in these Korean cases, although it does assert that the
GBS diagnoses were mostly confirmed with commonly-applied diagnostic criteria deemed acceptable by the
world-wide medical/scientific community. Park at 1155.
Block, 2021 WL 2182730, at *5. Thus, I rejected Park as reliably supporting the contention that a less than three-day,
post-vaccination onset was medically acceptable. Id. at *8.
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observations are evident that would be consistent with vaccine causation, other than the temporal
relationship. At most, there is some record evidence that treaters took note of the pre-onset
vaccination (perhaps based on Petitioner’s prompting), but without opining to a causal relationship.
And I am not obligated to accept their opinions at face value merely because they treated Petitioner
contemporaneously, but may weigh them against not only contrary evidence, but their own internal
reliability. Snyder v. Sec'y of Health & Hum. Servs., No. 01-162V, 2009 WL 2569773 at n.67 (Fed.
Cl. Spec. Mstr. Aug. 11, 2009) (“[h]owever, 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”).
Ultimately, Petitioner’s treaters did not coalesce around vaccination as the reason for her GBS.
CONCLUSION
A Program entitlement award is only appropriate for claims supported by preponderant
evidence. Here, Petitioner has not made such a showing. Petitioner is therefore not entitled to
compensation.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.12
IT IS SO ORDERD.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
12 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
19

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DOCUMENT 2: USCOURTS-cofc-1_20-vv-00285-1
Date issued/filed: 2024-11-08
Pages: 17
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) of 47 Judge Vaccine Order/Opinion. Signed by Judge Thompson M. Dietz. (sbp) Service on parties made.
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Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 1 of 17
In the United States Court of Federal Claims
No. 20-285
(Filed Under Seal: October 24, 2024)
(Reissued: November 8, 2024)1
**************************************
KIMBERLY F. FLOWERS, *
*
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND HUMAN *
SERVICES, *
*
Respondent. *
**************************************
Jeremy S. McKenzie, McKenzie & Hart, LLC, Savannah, GA, counsel for Petitioner.
Alec Saxe, U.S. Department of Justice, Civil Division, Washington, DC, counsel for Respondent.
OPINION AND ORDER
DIETZ, Judge.
Petitioner Kimberly F. Flowers (“Flowers”) seeks review of Chief Special Master
(“CSM”) Brian Corcoran’s decision denying her compensation under the National Childhood
Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 et seq. (“the Act”). Flowers alleges that she
suffered from Guillain-Barré Syndrome (“GBS”) following an influenza (“flu”) vaccine. She
filed a petition for compensation. The CSM dismissed her petition, concluding that the onset of
her GBS occurred too soon following her vaccination to qualify either as a Vaccine Injury Table
(“Table”) claim or a non-Table claim. Because Flowers has not demonstrated that the CSM’s
decision was arbitrary or capricious, the Court DENIES her motion for review and SUSTAINS
the CSM’s decision.
1 Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims, the Court issued this
Opinion and Order under seal on October 24, 2024, and provided the parties fourteen days to propose redactions.
See [ECF 47]. The parties did not propose any redactions. Accordingly, the Court reissues this Opinion and Order
without redactions.

Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 2 of 17
I. BACKGROUND2
Flowers identifies as a fifty-year-old female. [ECF 1-3] at 9. Prior to receiving the flu
vaccine at issue, she suffered from numerous health issues, including “obesity, irritable bowel
syndrome, hypertension, type 2 diabetes, bipolar disorder, and immune thrombocytopenic
purpura—an autoimmune blood platelet deficiency disease for which she received specific
treatment.” Flowers, 2024 WL 2828211, at *1. Further, “[i]n January 2016, she was diagnosed
with a lung neuroendocrine tumor,” which later “proved to be nonaggressive.” Id. One month
before her vaccination, Flowers received “neurologic treatment for chronic daily headaches” that
she had experienced since 2014. Id. “She also then reported left anterolateral thigh numbness and
tingling.” Id. Flowers’ neurologist, Dr. Yi Tsai, concluded that her headaches were “likely
caused by cervical spondylosis” and “proposed that the thigh numbness was attributable to a
condition involving sensory nerve compression.” Id.
On October 26, 2018, Flowers visited the Kaiser Permanente TownPark Advanced Care
Center (“TP-ACC”) to check on a blister. [ECF 1-3] at 5. Flowers received the flu vaccine while
at the TP-ACC that day. Id. at 10, 14. “There is no immediate contemporary record evidence of
any vaccine reaction.” Flowers, 2024 WL 2828211, at *2.
Eleven days later, on November 6, 2018, Flowers returned to the TP-ACC complaining
of “chest pain, shortness of breath, fever, ‘tingling all over body,’ [and] cough for the past 3
days.” [ECF 1-4] at 13. Flowers stated that she “had the flu shot last Friday and [symptoms]
began shortly afterward.” Id. After examining Flowers, her treaters assessed that she suffered an
“adverse [e]ffect of flu [v]accine.” Id. at 12. She was prescribed medications for her symptoms,
discharged, and told to “[f]ollow-up with [her] Primary Care Physician.” Id.
On November 8, 2018, Flowers again returned to the TP-ACC complaining that, “since
[her] flu vaccine . . . [she] has been ill with cough, fatigue, severe joint pain, and [nausea and
vomiting]” and that her “[p]ain is severe now and [she] barely can walk.” [ECF 1-5] at 5.
Following an exam, her treaters found her positive for “fatigue,” “myalgias,” and “global
weakness,” and stated that “[s]he is able to ambulate w[ith] assistance.” Id. at 8-9. They
discharged her with a diagnosis of musculoskeletal pain and pruritus. Id. at 15.
The next day, November 9, 2018, Flowers went by ambulance to the emergency room
(“ER”) at Emory St. Joseph’s Hospital (“Emory/St. Joseph’s”). Flowers, 2024 WL 2828211, at
*2. According to the ambulance patient care report, Flowers complained of “weakness/general
pain, and general numbness.” [ECF 1-17] at 6. Flowers stated that “she received the flu vaccine
on 10/27 and had been [complaining of] generalized body pain, generalized numbness, and
generalized weakness.”3 Id. She also stated that “she had been unable to walk for the last 2 days
due to progressing weakness.” Id.
2 The background is derived from the CSM’s decision, see Flowers v. Sec’y of Health & Hum. Servs., 2024 WL
2828211 (Fed. Cl. May 8, 2024), and the record evidence. Citations to the record evidence are based on the filing
numbers and page numbers generated by the CM/ECF system.
3 Several medical records incorrectly state that Flowers received the flu vaccine on October 27, 2018. However, it is
undisputed that Flowers received the flu vaccine on October 26, 2018. When quoting the medical records in this
opinion, the Court recites the vaccination date contained in the medical records, even if it is the incorrect date.
2

Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 3 of 17
The ER physician’s record lists Flowers’ chief complaint as “[w]eakness.” [ECF 9-7] at
51. It explains that Flowers “had a flu shot on 10/27 and she reports she has been having trouble
since that time.” Id. It indicates that Flowers “had some numbing and tingling around her teeth
initially, but that has progressed to her whole body and affects mostly her lower extremities.” Id.
The record notes Flowers’ history of diabetes and bipolar disorder. Id. It further explains that
Flowers was brought to the ER for evaluation and treatment because “there was concern of
[GBS] or some other side effect” due to “her continued symptomology.” Id. After examination,
the ER physician assessed her as “hyperreflexic in the lower extremities, in the knees and ankle”
with “[s]ymmetric reflexes in the upper extremities” and “[d]ecreased 2 point discrimination in
the lower extremities from the foot to the thigh and decreased motor strength.” Id. at 52. She was
admitted to the hospital on November 9, 2018. Id. at 53. The ER physician’s diagnostic
impression noted, among other conditions such as diabetes, a “[p]ossible side effect adverse
reaction to influenza vaccination” and expressed a “need to rule out [GBS] or other neurologic
disorder.” Id. The ER admission report stated: “pt from home reporting since had flu shot has
been having general weakness to her extremities [especially] to [both] legs, [nausea and
vomiting], and pain.” Id. at 54. It also notes Flowers’ history of diabetes. Id.
Flowers’ “History and Physical” report dated November 9, 2018, lists her chief complaint
as “[g]eneralized pins and needles and weakness affecting mostly lower extremities x3 days.”4
[ECF 9-7] at 91. It states that Flowers, “with [a] history of bipolar disorder, diabetes mellitus,
went to [TP-]ACC a couple of times in the last two days and had some workup done over there .
. . but [s]he was not found to have anything abnormal on the workup and was discharged.” Id. It
further explains that Flowers “claims that she has been getting weak gradually especially over
the last three days” and that “[s]he was able to walk around three days ago, but gradually she has
been losing her strength to the point that today, her husband had to carry her to the bathroom.”
Id. It states that Flowers “claims that she feels pins and needles and increased pain all over her
body mostly over the lower extremities below the hips and is currently not able to stand.” Id. It
notes that Flowers “had her flu vaccine on 10/27/2018, and that was followed with a course of
upper respiratory symptoms especially cold symptoms that resolved gradually on its own.” Id. at
92. The concluding impression states: “Gradual weakness of her lower extremities in last three
days. This appears to be some kind of demyelinating/inflammatory process. Because of history
of recent influenza vaccine, there is a possibility that it could be [GBS] although this needs to be
worked up.” Id. at 94. In addition to correcting an insulin dosage for her diabetes, the treatment
plan included a neurology consultation.5 Id.
4 The Emory/St. Joseph’s discharge documentation dated November 14, 2018, shows that Flowers was “[a]dmitted
to ESJH on 11/9/2018 for [complaints of] paresthesis and [lower extremity] weakness x 3 days.” [ECF 9-7] at 88. It
states that “[p]rior to admission [Flowers] lost balance and fell on her husband . . . [and that] [s]he was evaluated by
Neurology and started on [Intravenous Immunoglobulin (“IVIG”] for possible GBS.” Id. IVIG “is a blood product
used to treat patients with antibody deficiencies, including neurological disorders.” Flowers, 2024 WL 2828211, at
*14 n.3 (citing Clinical Use of Intravenous Immunoglobulin, NCBI (2005)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480 (last visited on October 21, 2024)).
5 A subsequent medical record from her stay at Emory/St. Joseph’s dated November 10, 2018, shows that Flowers
“present[ed] due to acute onset of bilateral paresthesias/weakness in ascending manner after flu vaccination on
10/27, as well as associated diarrhea for 5-6 days afterwards” with a “likely etiology of weakness/paresthesias
related to GBS.” [ECF 9-7] at 174. A record from November 13, 2018, reflects that Flowers “presented with
progressive neurologic decline over 2 weeks post flu shot” with admission [work up] for GBS.” Id. at 133.
3

Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 4 of 17
Flowers underwent a neurology consultation with Dr. Ramesh Kumar on November 9,
2018. [ECF 9-7] at 104. The consultation record states that Flowers “received ‘Flu’ vaccine end
of Oct[ober] 2018 [and that] since then she has been having facial numbness, bilateral foot
sensory symptoms with worsening symptoms in last few days.” Id. It further explains that
Flowers “has been weak with both [lower extremities], unable to walk as per [her] husband . . .
and has generalized pain all over the body.” Id. After examination, Dr. Kumar assessed Flowers
with “[p]ain/sensory symptoms/leg weakness/gait disorder [status post] Flu vaccine in [October
2018] of unclear etiology,” adding that her symptoms were “[n]ot typical for GBS or [Miller
Fisher Syndrome] variant.” Id. at 106. He noted that the reflex symptoms were “likely from
chronic [diabetes mellitus peripheral neuropathy].” Id. As a precautionary measure, Dr. Kumar
ordered IVIG treatment. Id.
Flowers commenced the IVIG treatment on November 10, 2018, and it was stopped on
November 12, 2018, after failing to improve her bilateral lower extremity weakness. [ECF 9-7]
at 88. During treatment, Flowers experienced a seizure due to a “suspected airway edema.” Id.
She was intubated and her MRI “was consistent with FLAIR abnormalities in parietoccipital
region concerning for PRES syndrome.”6 Id. On November 13, 2018, Flowers was transferred to
the Intensive Care Unit at Emory University Hospital Midtown (“Emory/Midtown”) for
monitoring and management. Id. at 89. She remained at Emory/Midtown until December 6,
2018, when she was discharged to the Shepherd Center, an in-patient rehabilitation center. [ECF
25-5] at 32, 40. Her discharge summary lists her discharge diagnosis as GBS and her chronic
diagnoses as diabetes and bipolar disorder. Id. at 32. It states that Flowers was seen on October
27, 2018, “for cold [symptoms] and given flu shot” and that “[u]pon returning home, she began
to experience gradual weakening and pins and needles sensation to lower extremities, and
inability to stand.” Id. at 32. Her “History and Physical” report also states that she received the
flu shot and that “[u]pon returning home, she began to experience gradual weakening to [her
bilateral lower extremities] that worsened to the point that her husband had to carry her to the
restroom.” Id. at 52. Flowers was treated at the Shepherd Center from December 6, 2018, until
February 16, 2019. [ECF 9-11] at 287. Upon discharge, Flowers “ha[d] made improvements in
activity tolerance, endurance, self-care and functional mobility” and was able to perform all
activities of daily living with supervision. Id. at 290. She could ambulate with assistance,
primarily using a motorized wheelchair. Id. Her discharge diagnosis listed many conditions,
including GBS and diabetes mellitus. Id. at 287.
In May 2019, Flowers saw neurologist Dr. Cui Yang for a follow-up neurology
consultation. [ECF 9-2] at 79-80. The record from her visit noted that she “came in for recent[ly]
diagnosed [GBS].” Id. at 80. In the history section, it explained that Flowers “got her flu shot on
10/27/2018, [and] since the second day, she developed gradual weakness, pins and needles
sensation in all ext[remities]. At the point, she was not able to stand.” Id. It further explained
that, since her discharge from the Shepherd Center, Flowers has been in a wheelchair and
6 “PRES” is an acronym for “posterior reversible encephalopathy syndrome.” Flowers, 2024 WL 2828211, at *3. It
is “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.” Id. at *14, n.5.
(citing Reversible Posterior Leukoencephalopathy Syndrome, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=111286 (last visited May 8, 2024)).
4

Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 5 of 17
receiving physical therapy and that she “still has had severe needle like pain.” Id. at 81.
However, on the date of her consultation, Dr. Yang recorded that Flowers showed greater
strength in all extremities and normal reflexes. Id. at 84-85. In her assessment, Dr. Yang stated
that Flowers “could have Flu shot related GBS, but normally it happen[s] days or weeks after
getting a vaccination [and] her symptoms started one day after her flu shot.” Id. at 88. Dr. Yang
posited that this “doesn’t fit the typical GBS” because, “[f]or GBS, [the] patient would have the
absence of [Deep Tendon Reflexes (‘DTR[s]’)], which she might have [had] when she was in
hospital . . . however, her DRTs were normal today.” Id. She further explained that
“[n]ormally[,] if [a] patient has GBS, the absence of DTRs will last months to years or never
recover[].” Id. Following her assessment, Dr. Yang recommended an NCS/EMG study to look
for “any evidence of GBS (demyelinating features), [l]arge fiber [d]iabetic neuropathy or
cervical/lumbar radiculopathy.”7 Id. at 88.
The results from Flowers’ NCS/EMG study, which was performed in mid-June of 2019,
were abnormal. [ECF 9-2] at 124. Dr. Yang found “[the] findings [to be] nonspecific for etiology
but . . . consistent with an axon loss polyneuropathy predominately affecting the distal motor
fibers of the lower extremity, as may be seen in diabetes mellitus.” Id. at 124-25. She noted that
“[t]his study doesn’t show any typical demyelinating features.” Id. at 125. Dr. Yang therefore
proposed the following treatment plan: “diabetes control/rule out other treatable
causes/symptomatic treatment” with pain management, physical therapy, and a neurology clinic
follow-up. Id.
Flowers’ treatment records from 2020 largely reflect concerns about diabetes-related
symptoms. See [ECF 17-2] at 57 (visit to primary care physician in February 2020 complaining
of elevated sugars); id. at 117-18 (telemedicine appointment in April 2020 for diabetes care
management); id. at 153-54 (visit to primary care physician in July 2020 for diabetes mellitus).
However, in August 2020, Flowers returned to the neurologist for a “follow up of [her history] of
GBS and neuropathy related to [diabetes mellitus].” Id. at 202. Flowers reported “numbness in
all four extremities,” ongoing neuropathic pain, and difficulty ambulating. Id. at 202-03. Her
difficulties were confirmed on exam. Id. at 209. The examination also revealed slightly
decreased strength in lower extremities, along with normal reflexes and normal response to
sensory touch. Id. at 208-09.
On March 13, 2020, Flowers filed the instant petition, seeking compensation under the
Act “for injuries, including [GBS], resulting from adverse effects of a quadrivalent influenza
vaccination received on October 26, 2018.” Pet. [ECF 1] at 1.8 On May 7, 2020, the CSM
assigned the case to the Special Processing Unit (“SPU”), [ECF 11], because he thought that
Flowers might easily be able to establish a Table claim. Flowers, 2024 WL 2828211, at *1.9
7 “NCS/EMG” is an acronym for Nerve Conduction Study/Electromyography. Electromyography (EMG) and Nerve
Conduction Study, WEBMD (Mar. 14, 2024), https://www.webmd.com/brain/emg-and-nerve-conduction-study (last
visited October 21, 2024).
8 All page numbers in the petition for compensation and the parties’ briefings refer to the page numbers generated by
the CM/ECF system.
9 On November 2, 2020, while the case was assigned to the SPU, the government filed its report under Vaccine Rule
4(c), arguing that Flowers was not entitled to compensation under the Act because she failed to demonstrate that she
5

Case 1:20-vv-00285-TMD Document 49 Filed 11/08/24 Page 6 of 17
However, on September 6, 2023, after it became apparent that there were several disputed fact
issues, the CSM reassigned the case to his regular docket. Id.; see also Order [ECF 35].
On September 18, 2023, the CSM ordered Flowers to show cause why her case should
not be dismissed on the grounds “that the evidence preponderates in favor of an onset occurring
earlier than three days post-vaccination.” Order [ECF 37] at 1. The CSM also advised Flowers to
consider whether, alternatively, she could “establish that a non-Table claim of GBS after the flu
vaccine could be viable even if onset were within two days or so of vaccination.” Id. at 2. Based
on Flowers’ response to the show cause order and the government’s response to Flowers’
filing,10 the CSM found that “[t]he record preponderates in favor of the conclusion that
[Flowers’] GBS onset occurred too soon post-vaccination to meet the Table timeframe—and
given that record, such a short onset would also not be medically-acceptable even under a non-
Table causation-in-fact analysis.” Flowers, 2024 WL 2828211, at *1. Therefore, on May 8, 2024,
the CSM denied Flowers’ petition for entitlement. Entitlement Decision [ECF 41]. Flowers
sought review of the CSM’s decision on June 5, 2024. Pet.’s Mot. [ECF 43]. The government
responded on July 5, 2024. Gov.’s Resp. [ECF 45]. The Court held oral argument on October 11,
2024. [ECF 46].
II. STANDARD OF REVIEW
This Court has jurisdiction under the Act to review a special master’s decision. 42 U.S.C.
§ 300aa-12(e)(2). In reviewing a special master’s decision, this Court may:
(A) uphold the findings of fact and conclusions of law of the special
master and sustain the special master’s decision, (B) set aside any
findings of fact or conclusions of law of the special master found to
be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and
conclusions of law, or (C) remand the petition to the special master
for further action in accordance with the court’s direction.
42 U.S.C. §§ 300aa-12(e)(2)(A)-(C).
This Court reviews a special master’s findings of fact under the “arbitrary and
capricious” standard, legal questions under the “not in accordance with law” standard, and
discretionary rulings under the “abuse of discretion” standard. Turner v. Sec’y of Health & Hum.
Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001). With respect to the arbitrary and capricious
either suffered a Table injury or that the vaccination caused her GBS. Gov.’s Rule 4(c) Report [ECF 20] at 10-12.
Thereafter, the SPU ordered the parties to brief the question of when Flowers’ neurologic symptoms began. Order
[ECF 23] at 1. After the parties submitted their briefs, see Pet.’s Br. [ECF 26]; Gov.’s Br. [ECF 28], the SPU
informed them that even if Flowers established that the onset of her GBS occurred within three to 42 days following
vaccination, the issue of whether her GBS was caused by other factors remained. Order [ECF 29] at 1. Therefore,
the SPU ordered the parties to indicate whether they could informally resolve the petition. Id. On July 7, 2022, the
parties filed a joint status report indicating that the government wished to continue to defend its position. Joint Status
Report [ECF 34] at 1.
10 See Pet.’s Br. [ECF 39]; Gov.’s Br. [ECF 40].
6

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standard, “no uniform definition . . . has emerged,” but it is “a highly deferential standard of
review” such that “[i]f the special master has considered the relevant evidence of record, drawn
plausible inferences and articulated a rational basis for the decision, reversible error will be
extremely difficult to demonstrate.” Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,
1527-28 (Fed. Cir. 1991); accord Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.
Auto Ins. Co., 463 U.S. 29, 43 (1983) (a decision is arbitrary and capricious only if it is “so
implausible that it could not be ascribed to a difference of view”). The arbitrary and capricious
standard of review is difficult for an appellant to satisfy with respect to any issue, but particularly
with respect to an issue that turns on the weighing of evidence by the trier of fact. Lampe v. Sec’y
of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). “[I]t is not . . . the role of this
court to reweigh the factual evidence, [] to assess whether the special master correctly evaluated
the evidence[, or to] . . . examine the probative value of the evidence or the credibility of the
witnesses.” Lampe, 219 F.3d at 1360 (quoting Munn v. Sec’y of Health & Hum. Servs., 970 F.2d
863, 871 (Fed. Cir. 1992)). “These are all matters within the purview of the fact finder.” Id.
The “not in accordance with law” standard, on the other hand, is applied without
deference to legal determinations, such as “[w]hether the special master applied the appropriate
standard of causation . . . .” Deribeaux v. Sec’y of Health & Hum. Servs., 717 F.3d 1363, 1366
(Fed. Cir. 2013). Lastly, the abuse of discretion standard applies to the special master’s
evidentiary rulings, such as determinations regarding the qualification of experts and the
admissibility of their testimony. Piscopo v. Sec’y of Health & Hum. Servs., 66 Fed. Cl. 49, 53
(2005) (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)). “The [abuse of
discretion standard] will rarely come into play except where the special master excludes
evidence.” Munn, 970 F.2d at 870 n.10; accord Caves v. Sec’y of Health & Hum. Servs., 100
Fed. Cl. 119, 131 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012).
The Federal Circuit has made clear that special masters, as the finders of fact, have the
responsibility to weigh the persuasiveness and reliability of evidence presented to them, and if
appropriate, the credibility of testimony. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d
1315, 1325 (Fed. Cir. 2010); see Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316
(Fed. Cir. 1999) (“[T]he rules of evidence require that the trial judge determine whether the
testimony has a reliable basis in the knowledge and experience of [the relevant] discipline.”)
(internal quotation marks omitted). The special master has broad discretion in determining the
credibility of witnesses and weighing the evidence, and these credibility determinations are
“virtually unreviewable” by the reviewing court. Bradley v. Sec’y of Health & Hum. Servs., 991
F.2d 1570, 1575 (Fed. Cir. 1993). In other words, the reviewing court does not reweigh the
evidence, assess whether the special master correctly evaluated the evidence, or examine the
probative value of the evidence or the credibility of the witnesses because all of these matters are
within the purview of the factfinder. Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d
1339, 1349 (Fed. Cir. 2010) (citing Munn, 970 F.2d at 871); accord Loyd, Next Friend of C.L. v.
Sec’y of Health & Hum. Servs., 2023 WL 1878572, at *2 (Fed. Cir. Feb. 10, 2023).
III. LEGAL STANDARDS
The Act was established to compensate individuals for a vaccine-related injury or death
after a showing that the vaccine caused that injury or death. 42 U.S.C. § 300aa-11(a)(5)(B)(10).
7

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Under the Act, a petitioner may establish causation in two ways. Munn, 970 F.2d at 865. First, a
petitioner may demonstrate causation through a statutorily prescribed presumption by showing
that the alleged injury meets the criteria listed on the Table. 42 U.S.C. § 300aa-14. According to
the Table, a petitioner is considered to have suffered from GBS due to a seasonal influenza
vaccine if onset occurs “not less than 3 days and not more than 42 days” after vaccination. 42
C.F.R. § 100.3(a). “[I]f a petitioner can establish that she received a listed vaccine and
experienced such symptoms or injuries within the specified timeframes, she has met her prima
facie burden to prove that the vaccine caused her injuries.” de Bazan v. Sec’y of Health & Hum.
Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008). A petitioner must satisfy the requirements by a
preponderance of evidence. 42 U.S.C. § 300aa-13(a)(1). However, neither the special master nor
the Court may find that a petitioner satisfies the requirements based solely on the petitioner’s
claims, unsubstantiated by medical records or medical opinion. Id.
Alternatively, if a petitioner suffered an injury listed on the Table but not within the
specified time period, or if a petitioner suffered an “off-Table injury,” he must prove “causation-
in-fact” by a preponderance of the evidence.11 See 42 U.S.C. § 300aa-11(c)(1)(C)(ii); see also
Broekelschen, 618 F.3d at 1341-42. “Causation-in-fact in the Vaccine Act context is the same as
‘legal cause’ in the general torts context.” de Bazan, 539 F.3d at 1351. Thus, “the vaccine is a
cause-in[-]fact when it is ‘a substantial factor in bringing about the harm.’” Id. (quoting
Restatement (Second) of Torts § 431(a)). In Althen, the Federal Circuit articulated a three-part
test for showing causation-in-fact:
[A petitioner must] show by preponderant evidence that the
vaccination brought about [petitioner’s] 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.
418 F.3d at 1278. Before applying the Althen test, however, the court must determine whether a
petitioner has shown by preponderant evidence a “medically recognized injury” that is “more
than just a symptom or manifestation of an unknown injury.” Lombardi v. Sec’y of Health &
Hum. Servs., 656 F.3d 1343, 1352-53 (Fed. Cir. 2011) (citing Broekelschen, 618 F.3d at 1349)
(explaining that “if the existence and nature of the injury itself is in dispute,” then “identification
of a petitioner’s injury is a prerequisite to an Althen analysis of causation”).
“Once the petitioner has established a prima facie case for entitlement to compensation
and thus met her burden to prove causation-in-fact, the burden shifts to the government to prove
‘[by] a preponderance of the evidence that the [petitioner’s injury] is due to factors unrelated to
the administration of the vaccine described in the petition.’” de Bazan, 539 F.3d at 1352 (quoting
42 U.S.C. § 300aa-13(a)(1)(B)). Under the Act, “factors unrelated to the administration of the
vaccine” may include “infection, toxins, trauma (including birth trauma and related anoxia), or
11 “This court has interpreted the ‘preponderance of the evidence’ standard referred to in the Vaccine Act as one of
proof by a simple preponderance, of ‘more probable than not’ causation.” Althen v. Sec’y of Health & Hum. Servs.,
418 F.3d 1274, 1279 (Fed. Cir. 2005) (citing Hellebrand v. Sec’y of Health & Hum. Servs., 999 F.2d 1565, 1572-73
(Fed. Cir. 1993)).
8

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metabolic disturbances which have no known relation to the vaccine involved, but which in the
particular case are shown to have been the agent or agents principally responsible for causing the
petitioner’s illness, disability, injury, condition, or death.” 42 U.S.C.A. § 300aa-13(a)(2).
Significantly, a petitioner need only demonstrate that the vaccine was a substantial factor in
bringing about the alleged harm. de Bazan, 539 F.3d at 1354. However, the government must
demonstrate that an unrelated factor “was the sole substantial factor in bringing about the
injury.” Id. In addition, the government’s proof of alternative actual causation-in-fact must
satisfy the same standard as the petitioner’s proof of actual causation-in-fact in non-Table cases.
Deribeaux, 717 F.3d at 1368 (citing Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549
(Fed. Cir. 1994)). If the Court finds that the government failed to prove alternative actual
causation-in-fact, the petitioner is entitled to compensation. de Bazan, 539 F.3d at 1352. If the
Court finds the parties’ evidence to be in equipoise, the petitioner is entitled to compensation.
Heinzelman v. Sec’y of Health & Hum. Servs., 2008 WL 5479123, at *19 (Fed. Cl. Dec. 11,
2008) (citing Knudsen, 35 F.3d at 550).
IV. ANALYSIS
In this case, the CSM denied Flowers’ petition, finding that her “GBS onset occurred too
soon post-vaccination to meet the Table timeframe—and given that record, such a short onset
would also not be medically-acceptable even under a non-Table, causation-in-fact analysis.”
Flowers, 2024 WL 2828211, at *1. Flowers objects to both conclusions, arguing that the CSM’s
determinations arbitrarily ignore contradictory medical records, evidence, and expert testimony.
[ECF 43] at 6, 14. For the reasons stated below, the Court finds that the CSM considered the
relevant evidence, drew plausible inferences, and articulated a rational basis for his conclusions,
and that, therefore, Flowers has not shown that the CSM’s decision was arbitrary or capricious.
A. The CSM’s Determination That Flowers’ GBS Was Not a Table Injury
First, Flowers objects to the CSM’s determination that the onset of her GBS symptoms
did not occur within the timeframe set by the Table. [ECF 43] at 6. Flowers argues that the CSM
“ignored the [TP-ACC] record of November 6, 2018[,] in which [Flowers] reported the onset of
GBS-related symptoms ‘for the past 3 days,’” and that this record is “the most contemporaneous
medical record that provides a definite time period in which [Flowers’] GBS-related symptoms
began.” Id. at 8. In her view, the November 6, 2018, record definitively establishes that her GBS
qualifies as a Table injury. Id. Flowers also contends that the CSM placed undue reliance on
statements in her later medical records and that he should not credit caselaw interpreting
temporal indicators such as “since,” “shortly after,” or “following,” as meaning “within 48 hours
of vaccination.” Id. at 8-9 (internal quotation marks omitted). Flowers states that “other decisions
of this court do not place such vague temporal references as to the timing of onset on such high a
pedestal, particularly in the face of other conflicting evidence.” Id. at 9. Also, Flowers argues
that, in addition to the November 6, 2018, record, her own declaration and those of her family
members establish that the onset of her GBS symptoms occurred more than one week after she
received the vaccination “and override any vague, nonspecific onset statements.” Id. at 10.
Flowers further argues that her unrefuted expert witness, Dr. David Simpson, corroborates her
contention that onset did not occur “until more than three days after her vaccination.” Id. at 12.
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The Court finds that the CSM’s determination that Flowers’ GBS was not a Table injury
was rationally based on the record evidence. Beginning in the “Fact History” section of his
opinion,12 the CSM notes that on multiple occasions, Flowers reported experiencing symptoms
close in time to the vaccination. The CSM states that “on November 6, 2018, Ms. Flowers
returned to the TP-ACC with several complaints, including cough, shortness of breath, and
paresthesias she characterized as ‘tingling all over her body.’” Flowers, 2024 WL 2828211, at
*2. According to the CSM, “[s]he specifically reported . . . that these symptoms had begun
‘shortly after’ receiving the flu vaccine . . . .” Id. In support of these statements, the CSM cites to
the notes taken by a physician and a nurse at TP-ACC. Id.; [ECF 1-4] at 12-13 (11/6/2018 notes
by Dr. Shakira N. Thomas stating: “She thinks her symptoms may be due to recent flu shot. . . .
Poss symptoms are due to the recent flu shot”; 11/6/2018 notes by RN Erin M. Burkhalter
stating: “States had flu shot last Friday and sx’s began shortly afterward.”) (emphasis added).
The CSM also states that Flowers made similar statements regarding the onset of her symptoms
when she returned to the TP-ACC on November 8, 2018. Flowers, 2024 WL 2828211, at *2. In
this instance, the CSM cites to notes from Flowers’ visit to the TP-ACC on that date. Id. (citing
[ECF 1-5] at 5) (“States since had flu vaccine on 27th has been ill with cough, fatigue, severe
joint pain, and N/V”) (emphasis added).13
Next, the CSM avers that Flowers made similar statements regarding symptom onset
when she was transported to the ER on November 9, 2018, and during the early period of her
hospitalization, even though the symptoms became acute shortly before her ER visit. Flowers,
2024 WL 2828211, at *2. In support of these findings, the CSM again cites to notes made by her
treating physicians and nurses. Id.; [ECF 9-7] at 51, 54, 91, 133, 174 (notes by Dr. Alan Aidan
Farabaugh stating: “[Flowers] had a flu shot on 10/27 and she reports she has been having
trouble since that time”; notes by Nurse Charles Lwanga stating: “pt from home reporting since
had flu shot has been having general weakness to her extremities esp to b/legs. NV, and pain. hx
DM”; notes by Dr. Satya Deo Singh stating: “Patient claims that she has been getting weak
gradually especially over the last three days”; notes by Doctor Helen M. Ward stating:
“[Flowers] presented with progressive neurologic decline over 2 weeks post flu shot and acute
URI/diarrhea symptoms”; notes by Dr. Shawnay N. Mazell stating: “[Flowers] presents due to
acute onset of bilateral paresthesias/weakness in ascending manner after flu vaccination on
10/27, . . . .”) (emphasis added).
The CSM also cites to the notes made by neurologist, Dr. Kumar, regarding his
November 9, 2018, consultation with Flowers, noting that Flowers “again provid[ed] a
comparable history (including onset of symptoms right after vaccination) to what she had offered
other treaters.” Flowers, 2024 WL 2828211, at *3 (citing [ECF 9-7] at 104) (11/9/2018 notes by
Dr. Kumar). In his notes, Dr. Kumar stated: “Member received ‘Flu’ vaccine end of oct 2018.
since then she has been having facial numbness, bilateral foot sensory symptoms with worsening
symptoms in last few days.” [ECF 9-7] at 104 (emphasis added). Further, the CSM states:
12 In assessing whether the CSM’s determination regarding the onset of Flowers’ GBS symptoms was arbitrary or
capricious, the Court reviews both the “Fact History” and “Analysis” sections of his opinion.
13 It is unclear from the record who authored these notes.
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Petitioner’s initial neurologic work-up [after her November 13,
2018, transfer to Emory/Midtown] memorializes her report that the
same day as vaccination, she had experienced “gradual weakening
to [bilateral lower extremities] that worsened to the point that her
husband had to carry her to the restroom,” later progressing [to] the
point where she sought emergency care earlier that month.
Flowers, 2024 WL 2828211, at *3 (alteration added) (emphasis in original). In support of these
findings, the CSM cites to the notes taken by two of Flowers’ treaters. Id. (first citing [ECF 25-5]
at 52; then citing [ECF 9-2] at 81) (11/14/2018 notes by Ronald K. Fuller14 and 5/3/2019 notes
by Dr. Yang, respectively). In his notes regarding Flowers’ November 13, 2018, visit to
Emory/Midtown, Mr. Fuller stated:
50 year old female with PMH BiPolar Disorder, DM who presented
to Kaiser ACC on 10/27 for c/o cold sx and was discharged home
on hydrocodone cough syprup and was also administered the flu
shot. Upon returning home, she began to experience gradual
weakening to BLE that worsened to the point that her husband had
to carry her to the restroom. She c/o pins and needles sensation to
lower extremities and was unable to stand up. Her husband called
911 because of the worsening of her sx and she was transported to
SJH ED. After evaluation by the ED MD, neurology was called and
pt was admitted on 11/9 for further evaluation.
[ECF 25-5] at 52 (emphasis added). In her notes regarding Flowers’ May 3, 2019, visit to Kaiser
Permanente/Townpark Medical Center (“KP/TMC”), Dr. Yang stated: “50 year old female with
PMH BiPolar Disorder, DM was seen at Kaiser clinic on 10/27 for cold sx and given flu shot.
Upon returning home, she began to experience gradual weakening and pins and needles
sensation to lower extremities, and inability to stand.” [ECF 9-2] at 81 (emphasis added).
Regarding Flowers’ May 2019 visit with Dr. Yang at KP/TMC, the CSM remarks: “The
history of present illness section from the record of this visit identified the second day from
vaccination as when [Flowers] first began to experience weakness and paresthesias in her
extremities.” Flowers, 2024 WL 2828211, at *4 (internal quotation marks omitted) (citing [ECF
9-2] at 80) (5/3/2019 notes by Dr. Yang regarding Flowers’ 5/3/2019 visit to KP/TMC stating:
“She got her flu shot on 10/27/2[0]18, since the second day, she developed gradual weakness,
pins and needles sensation in all exts.”) (emphasis added). The CSM then states: “In her
assessment, Dr. Yang allowed for the possibility of GBS attributable to the flu vaccine, but also
noted that ‘normally [GBS] happened days or weeks after getting a vaccination, but her
symptoms started one day after her flu shot,’ which ‘doesn’t fit the typical GBS.’” Flowers, 2024
WL 2828211, at *4 (emphasis in original) (quoting [ECF 9-2] at 88) (5/3/2019 notes by Dr.
Yang).
In the “Analysis” section of his opinion, the CSM explains why “[t]he medical records
preponderantly establish that [Flowers’] onset most likely occurred less than three days after
14 Mr. Fuller’s title is not clear from the record.
11

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vaccination—thus sooner than the 3-42 day timeframe provided for by the Vaccine Injury
Table.” Flowers, 2024 WL 2828211, at *11 (emphasis in original). Here, the CSM again cites to
Dr. Kumar’s notes following his neurology consultation with Flowers and her husband on
November 9, 2018. Id. (citing [ECF 9-7] at 104). In addition, the CSM cites to two medical
records from Emory/Midtown. Flowers, 2024 WL 2828211, at *11. The first document, the
notes from a December 6, 2018, assessment by Brian J. Sestrich,15 states: “50 year old female
with PMH BiPolar Disorder, DM was seen at Kaiser clinic on 10/27 for cold sx and given flu
shot. Upon returning home, she began to experience gradual weakening and pins and needles
sensation to lower extremities, and inability to stand.” [ECF 25-5] at 32 (emphasis added). The
second document, which the CSM previously referenced in his “Fact” section, is Mr. Fuller’s
notes from Flowers’ November 13, 2018, visit to Emory/Midtown. See id. at 52. Further, the
CSM cites to two medical records from Kaiser Permanente. Flowers, 2024 WL 2828211, at *11.
The first document, the notes from a February 26, 2019, assessment by Dr. Kristen M. Foster,
states: “Kimberly F Flowers is a pleasant patient who presents with complaint of last fall went to
TP and had flu shot. Notes developed GB soon after. Was at St. Joseph to Memory Midtown. No
fc. Slowly regaining strength.” [ECF 9-2] at 12 (emphasis added). The second document, which
the CSM also previously referenced in his “Fact” section, is Dr. Yang’s notes from her May 3,
2019, assessment of Flowers. See [ECF 9-2] at 88. Based on the medical records, the CSM
determined that Flowers “consistently claimed to have begun experiencing neurologic symptoms
within a day or two of vaccination—even as soon as the very same day.” Flowers, 2024 WL
2828211, at *11 (emphasis in original).
In addition to citing to multiple sources within Flowers’ medical records in support of his
conclusion that her GBS symptoms began less than three days after vaccination, the CSM
explains why he was not persuaded by the arguments of her expert medical witness, Dr.
Simpson. Flowers, 2024 WL 2828211, at *11. First, although the CSM concedes that certain
references in the contemporaneous record regarding the onset of Flowers’ GBS are “nonspecific
and vague,” he maintains that his determination regarding onset is supported by “all of the
evidence.” Id. (emphasis in original). According to the CSM, terms such as “since” and “shortly
after” have been interpreted by other special masters as meaning “very close in time—
immediately, or at most within a day or two.” Id. (emphasis in original). Additionally, the CSM
contends that, in the context of assessing a petitioner’s claim that a vaccine caused a shoulder
injury, similar language has been interpreted as meaning within the first 48 hours following
vaccination. Id. Therefore, he reasons that, because the Vaccine Program does not outright
dismiss or reject such vague language in the context of onset timing, it—coupled with other
evidence—not only deserves consideration, but in this case supports a finding that onset of
Flowers’ GBS occurred “less than three days of vaccination, and perhaps as early as the same
day.” Id.
Next, the CSM criticizes Dr. Simpson for failing to distinguish between when Flower’s
GBS could be diagnosed and when onset occurred. Flowers, 2024 WL 2828211, at *12. Citing
the Act, the CSM contends that “onset occurs at first manifestation of a symptom, regardless of
whether the disease it fortells could be diagnosed at that time—and thus whether the onset
symptoms would be clearly understood to reflect the start of the illness.” Id. (emphasis in
original). The CSM also avers that “there is a distinction between the start of an acute and
15 Mr. Sestrich’s title is not clear from the record.
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monophasic illness like GBS, and when it reaches nadir (as the Table reflects).” Id. In other
words, the CSM contends that, while GBS may first appear in an individual at an earlier date, the
key for purposes of the Act is to determine when onset or the first manifestation of symptoms
occurs. Id. The CSM therefore finds that “[h]ere, the evidence preponderantly establishes that not
only was [Flowers] experiencing sufficiently-alarming neurologic symptoms to seek treatment
for them eleven days post-vaccination, but that at that time and consistently thereafter she
reported they had begun no later than a day after vaccination.” Id. (emphasis in original).16
Finally, the CSM concedes that Dr. Yang’s May 2019 records may be internally
inconsistent as to the date of onset, or identify the wrong vaccination date. Flowers, 2024 WL
2828211, at *12. Nevertheless, the CSM states that “there [are] ample records much closer in
time to vaccination suggestive of an early onset, [including] some that even pinpoint it as the
same day.” Id. Flowers, 2024 WL 2828211, at *12. Thus, despite the issues raised by Flowers
relating to the inconsistent medical records, the CSM concludes: “It remains the case that overall,
preponderant evidence is not favorable to [Flowers’] onset contention.” Id.
In her motion for review, Flowers challenges the CSM’s onset timing conclusion on
multiple grounds, but none have merit. First, Flowers challenges the CSM’s interpretation of the
terms “since,” “shortly after,” or “following” within her medical records. It is not, however, this
Court’s role to reassess or reweigh the evidence. See Cedillo v. Sec’y of Health & Hum. Servs.,
617 F.3d 1328, 1338 (Fed. Cir. 2010) (“We do not sit to reweigh the evidence. [If] the Special
Master’s conclusion [is] based on evidence in the record that [is] not wholly implausible, we are
compelled to uphold that finding as not being arbitrary or capricious.”) (internal quotation marks
omitted) (alteration in original). As detailed above, the CSM’s finding that Flowers’ GBS
symptoms first appeared within three days of vaccination was rationally based on statements in
her medical records.17 Significantly, the CSM credits Flowers’ own account of when her
16 The CSM cites to Flowers’ Discharge Summary dated November 14, 2018, to support this statement. See Flowers,
2024 WL 2828211, at *12 (citing [ECF 9-7] at 88). The Discharge Summary states that Flowers was “[a]dmitted to
ESJH on 11/9/2018 for c/o par[]esthesias and LE weakness x 3 days. Prior to admission she lost balance and fell on
her husband.” [ECF 9-7] at 88. While this document provides support for the portion of the CSM’s statement that
Flowers experienced sufficiently-alarming neurologic symptoms to seek treatment eleven days post-vaccination, it
does not provide support for the portion stating that “at that time and consistently thereafter she reported they had
begun no later than a day after vaccination.” See Flowers, 2024 WL 2828211, at *12 (emphasis in original). The
Court views this omission as harmless error because, throughout the CSM’s decision, he cites to the record evidence
to support his finding that Flowers had reported that her symptoms began less than three days after vaccination.
17 “Medical records, in general, warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of Dep’t of Health
& Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). That is because “[t]he records contain information supplied to
or by health professionals to facilitate diagnosis and treatment of medical conditions[ at a time when, with] proper
treatment hanging in the balance, accuracy has an extra premium.” Id. Further, [t]hese records are also generally
contemporaneous to the medical events.” Id.; accord Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1383
(Fed. Cir. 2015) (noting the importance of contemporaneous medical records in vaccine cases); see also Canuto v.
Sec’y of Health & Hum. Servs., 660 F. App’x 955, 958 (Fed. Cir. 2016) (noting that “[b]ecause of their impartial
nature, medical records strongly ‘warrant consideration as trustworthy evidence’”); Simanski v. Dep’t of Health &
Hum. Servs., 601 F. App’x 982, 987-88 (Fed. Cir. 2015) (“And to the extent that the finding relied on medical
records from treating physicians, we note that we have held such records can be ‘quite probative’ or ‘favored’ when
considering issues relating to claims under the Vaccine Act.”); Zatuchni v. Sec’y of Health & Hum. Servs., 69 Fed.
Cl. 612, 624 (2006) (stating that the petitioner’s documentary evidence was “especially thorough and compelling,
13

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symptoms began—as memorialized in the notes made by the doctors, nurses, and other providers
who treated her starting on November 6, 2018, when she visited the TP-ACC to complain of her
post-vaccination symptoms and ending on May 3, 2019, when she followed up with Dr. Yang for
a neurology consultation. That other special masters have interpreted these terms differently in
other cases does not establish that the CSM’s interpretation in this instance was irrational—a fact
Flowers appears to concede when she states that “[d]ecisions in this Court have previously held
that nonspecific reports regarding the timing of onset do not always require a determination that
onset occurred within 2 days of a vaccination.” [ECF 43] at 9 (emphasis added). In each case, it
is up to the special master to determine when onset occurred based on the preponderance of the
evidence. Thus, the presence of nonspecific terms in Flowers’ medical records does not mandate
that the CSM or this Court reach any particular conclusion regarding onset. In this case, the
CSM’s conclusion regarding onset timing hinged on his overall assessment of and assignment of
weight to the record evidence, not on the application of a rule governing nonspecific or vague
onset references in the medical records.
Next, Flowers challenges the CSM’s crediting certain medical records over Flowers’ own
testimony and that of her immediate family members. This argument, too, is without merit. Here,
Flowers argues that her testimony and that of “her husband and daughter are ‘consistent, clear,
cogent, and compelling’ as to the fact that [her] GBS symptoms did not arise until well after
three days following her flu vaccination,” and that “[s]uch testimony should be particularly
controlling since it is wholly consistent with the November 6, 2018 medical record reporting that
Petitioner’s GBS symptoms developed at least a week after her flu vaccine.” [ECF 43] at 12.
Flowers states: “Such testimony is not refuted by facially inaccurate, vague and/or self-
contradictory statements regarding onset made by her healthcare providers in her subsequent
medical records, but is instead corroborated by the November 6, 2018[,] medical record.” Id.
Once more, Flowers asks the Court to reweigh the evidence that was before the CSM, which is
not something this Court can or will do. Also, simply because the CSM relied upon
contemporaneous medical records that were arguably vague as to when Flowers first began to
experience GBS symptoms does not mean that these records were inaccurate or self-
contradictory. In sum, the CSM’s conclusions are not rendered irrational because he placed more
evidentiary weight on certain medical records than on Flowers’ own testimony or that of her
family.18 See Giles v. Sec’y of the Dep’t of Health & Hum. Servs., 37 Fed. Cl. 525, 541 (1997)
(noting that “the special master was fully within his discretion to believe the contemporaneous
medical records over recollection testimony offered by the petitioners”), aff’d sub nom. Giles v.
Sec’y of Health & Hum. Servs., 168 F.3d 1316 (Fed. Cir. 1998).
consisting of the medical records of the many physicians who examined [her], or who reviewed the history of [her]
symptoms and provided their medical opinion”).
18 In his decision, the CSM referenced the affidavits of Flowers and her family members only one time—in a
footnote when summarizing Flowers’ arguments. Nevertheless, the CSM is not required to discuss every piece of
evidence or testimony in the record, so long as the decision makes clear that he fully considered Flowers’
arguments. See Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 728 (2009). The Court “generally
presume[s] that a special master considered the relevant record evidence even though he does not explicitly
reference such evidence in his decision.” Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir.
2016). Here, it is clear from the decision that the CSM fully considered Flowers’ position regarding the onset of her
GBS symptoms, and, while the CSM only referenced the affidavits one time in a footnote, the Court presumes that
the CSM considered the affidavits in reaching his conclusions.
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Lastly, Flowers contends that the CSM failed to consider and give “controlling weight” to
Dr. Simpson’s testimony regarding onset. [ECF 43] at 13. Regarding onset, Flowers further
argues that the CSM’s reliance on Dr. Yang’s notes from her May 3, 2019, visit was arbitrary
because the records were created more than six months after Flowers received her vaccine and
because Dr. Yang mistakenly stated that Flowers “received her shot on October 28, 2018 (versus
October 2[6], 2018).” Id. However, according to the CSM, he discounted Dr. Simpson’s
testimony regarding the onset of Flowers’ symptoms in part because he was not persuaded by his
arguments and in part because he found that the Korean study Dr. Simpson relied upon lacked
scientific or medical support. Just because Dr. Simpson’s testimony was not directly refuted by a
government expert witness does not mean that the CSM must accept it. Furthermore, as
explained above, the CSM conceded that Dr. Yang’s May 2019 records identify the wrong
vaccination date. Flowers, 2024 WL 2828211, at *12. Despite this deficiency, he concluded that
there are “ample records much closer in time to vaccination” that demonstrate that Flowers
experienced an early onset of the GBS symptoms—a conclusion that is supported by the record
evidence.19 Id. In sum, the CSM provided a rational explanation for his rejection of Dr.
Simpson’s testimony, as well as his interpretation of and reliance on the medical records. While
Flowers may not agree with the CSM’s assignment of weight to the record evidence, such
disagreement does not demonstrate that the CSM acted arbitrarily or capriciously. See Stricker v.
Sec’y of Health & Hum. Servs., 170 Fed. Cl. 701, 716 (2024) (noting that “mere disagreement is
not an adequate basis for rejecting a special master’s reasoned conclusion”).
B. The CSM’s Determination That Flowers’ GBS Was Not a Non-Table Injury
Flowers also objects to the CSM’s determination that her GBS did not qualify as a non-
Table injury. [ECF 43] at 14. According to Flowers, because the government does not contest the
fact that the flu vaccine can cause GBS, the first Althen prong (providing a medical theory
causally connecting the vaccination and the injury) has been satisfied.20 Id. at 16. Flowers also
contends that the second Althen prong (providing a logical sequence of cause and effect showing
that the vaccination was the reason for the injury) has been satisfied because her expert, Dr.
Simpson, testified that her GBS was likely caused by her flu vaccine. Id. at 18. Lastly, Flowers
argues that the third Althen prong (providing a showing of a proximate temporal relationship
between vaccination and injury) has been satisfied because she has established a proximate
temporal relationship between her vaccination and GBS. Id. at 19. Regarding the third prong,
Flowers contends that there exists preponderant proof that the onset of her symptoms occurred
within the medically accepted timeframe such that causation-in-fact may be inferred. Id. In
support of her argument, Flowers points to the 2017 Korean National Immunization Program
study that Dr. Simpson relied upon, as well as “other cases decided by this Court in which GBS
developed less than three days after vaccination.” Id.
The Court finds that the CSM’s determination that Flowers’ GBS was not a non-Table
injury was not arbitrary or capricious. The CSM concluded that Flowers failed to satisfy the third
19 The CSM correctly noted in his decision that Flowers was vaccinated on October 26, 2018.
20 The CSM does not discuss the first Althen prong in his decision.
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Althen prong “because a one to two-day onset (or even sooner) has not been shown to be
medically acceptable.” Flowers, 2024 WL 2828211, at *12.21 The CSM begins his analysis by
stating that the Table’s timeframe “best captures the most likely period in which vaccine-caused
GBS would begin, based on the most persuasive and reliable science currently available.” Id.
(emphasis in original). In his view, special masters should not extend this timeframe simply
because an expert opines otherwise, noting that “to do so would eliminate the distinction
between Table and non-Table claims entirely.” Id. Rather, the CSM contends that when
petitioners seek to establish that a shorter timeframe is medically acceptable, they must explain
why “the specific facts of their case suggest a faster onset would occur.” Id. (emphasis in
original). According to the CSM, “this occurs only where other factors establish that some
synergistic combination of causes involving the vaccine and the claimant’s own preexisting
health likely caused a faster immune stimulation process.” Id. In this case, the CSM concludes
that “the kind of special factors evidenced from the medical record that would render a short
onset more acceptable are absent.” Id. Additionally, the CSM notes that Dr. Simpson does not
identify any special factors unique to Flowers that would support a finding that she suffered an
earlier than usual onset of GBS and that the Korean study he cited “only reveals that a different
country’s vaccine compensation program paid damages in a few cases involving short onset,
with no discussion of whether such an onset actually had scientific or medical support.” Id. at
*13 (emphasis in original).22
Flowers’ challenge to the CSM’s review of her GBS as a non-Table injury fares no better
than her challenge to his review of her GBS as a Table injury. Regarding the CSM’s analysis
under the third Althen prong, Flowers argues that “there is no credible evidence that [her] GBS-
related symptoms occurred less than three days after her flu vaccine,” and that even if her
symptoms did begin two days after vaccination, the Korean study cited by Dr. Simpson found
that 54.2% of the individuals studied experienced symptoms within two days of receiving the
vaccination. [ECF 43] at 19. In support of her position, Flowers cites three “other cases decided
by this Court in which GBS developed less than three days after vaccination.” Id. (citing Block v.
Sec’y of Health & Hum. Servs., 2021 WL 2182730 (Fed. Cl. Apr. 26, 2021); Garcia v. Sec’y of
Health & Hum. Servs., 2008 WL 5068934 (Fed. Cl. Nov. 12, 2008), adh’d to on recons., 2010
WL 2507793 (Fed. Cl. May 19, 2010); Lehrman v. Sec’y of Health & Hum. Servs., 2018 WL
1788477 (Fed. Cl. Mar. 19, 2018)). First, none of the cases cited by Flowers are persuasive, as
21 Although unnecessary to his conclusion that Flowers fails to establish that her GBS was an off-Table injury, the
CSM also concludes that Flowers fails to satisfy the second Althen prong. Flowers, 2024 WL 2828211, at *13. To
satisfy the second prong, Flowers was required to establish a logical sequence of cause and effect from vaccine to
injury that is supported by the record evidence. Lozano v. Sec’y of Health & Hum. Servs., 958 F.3d 1363, 1371 (Fed.
Cir. 2020). In the CSM’s view, although certain individuals who treated Flowers noted that she was vaccinated
before her symptoms appeared, they did not opine on a causal relationship. Id. He also notes that the record does not
contain any testing or clinical observations that would support a finding of causation. Id. Furthermore, the CSM
states that “[u]ltimately, [Flowers’] treaters did not coalesce around vaccination as the reason for her GBS.” Id.
These findings are supported by the record evidence. See [ECF 9-7] at 106 (Dr. Kumar noting that Flowers’
symptoms are not typical for GBS variant); [ECF 9-2] at 88 (Dr. Yang noting the same); [ECF 9-2] at 124 (test
results showing findings as typically seen with diabetes mellitus).
22 The CSM further notes that he came to the same conclusion in a previous vaccine petition where Dr. Simpson was
similarly offered as an expert witness and cited the Korean study in support of his theory of causation. Flowers,
2024 WL 2828211, at *13.
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they are not binding on this Court and are based on distinguishable facts.23 While these cases
demonstrate that it is possible for a petitioner to demonstrate that a shorter onset timeframe is
medically acceptable—a point that the CSM acknowledges in his decision—they do not mandate
a particular outcome based on the facts and record evidence in the instant case. Further, under the
third prong, Flowers is “required to establish the timeframe for which it is medically acceptable
to infer causation.” Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011).
Here, as noted by the CSM, Flowers has not explained how or provided any evidence
demonstrating that in this case, in an exception to the generally accepted timeframe for the onset
of symptoms, the flu vaccine caused her to experience GBS symptoms less than three days after
vaccination. The Court will not assess whether the CSM correctly evaluated Dr. Simpson’s
opinion or the Korean study in this regard. See Munn, 970 F.2d at 871. Based on this record, the
CSM rationally concluded that Flowers did not satisfy the third Althen prong because she failed
to establish the medical acceptability of her early onset. See Martinez v. Sec’y of Health & Hum.
Servs., 165 Fed. Cl. 76, 88 (2023) (noting that “cases in which onset occurs too early fail Althen
prong three because, as with late onset cases, the temporal relationship is not such that it is
medically acceptable to conclude that the vaccination and the injury are causally linked”)
(internal quotation marks omitted).
V. CONCLUSION
Flowers has not demonstrated that the CSM’s decision was arbitrary or capricious.
Therefore, Flowers’ motion for review of the CSM’s decision [ECF 43] is DENIED, and the
CSM’s entitlement decision of May 8, 2024, is SUSTAINED. The Clerk of the Court is
DIRECTED to enter judgment accordingly.
IT IS SO ORDERED.
s/ Thompson M. Dietz
THOMPSON M. DIETZ, Judge
23 For example, in Garcia, the vaccine at issue was not the flu vaccine, but rather a vaccination for tetanus. Garcia,
2008 WL 5068934, at *1. There, the special master found that the petitioner’s “diarrheal illness pre-primed
[p]etitioner's immune response, such that when Petitioner received the tetanus vaccine, his immune system was
highly reactive” and that “the tetanus vaccine, once administered, [] triggered an over-reactive autoimmune
response that led Petitioner's immune system to attack his own nervous system, resulting in symptomatology best
described as the syndrome known as Guillain–Barré Syndrome.” Id. at 10. In Lehrman, although the Special Master
concluded “that the petitioner had an abrupt onset of atypical GBS within 24 hours of his flu vaccine,” Lehrman,
2018 WL 1788477, at *14, he did so based on an extensive evidentiary record, which included the petitioner’s own
testimony, petitioner’s medical records, the reports of petitioner’s two expert neurologists, and the reports of
respondent’s expert neurologist, and medical literature, id. at *1. Furthermore, the petitioner in Lehrman “suffered
from a [upper respiratory infection] shortly before receiving his flu vaccination” which “caused an aberrant response
or acted in a synergistic manner.” Id. at 19. Lastly, in Block, the CSM did not—as Flowers suggests—hold that the
petitioner’s GBS developed within three days of her vaccination. Rather, the CSM held that, based on Dr. Simpson’s
expert testimony plus his reliance on the Park study, that the petitioner had “offered barely enough evidence on the
third Althen prong . . . to allow the claim to go forward for now.” Block, 2021 WL 2182730, at *9 (emphasis in
original). The CSM added: “Respondent will be given the opportunity now to file an expert report or other evidence
rebutting the contention that a one-day onset is medically acceptable—and if he does so, the balance will likely tip
against Petitioner.” Id. In fact, both parties submitted additional materials after this decision issued and the CSM
ultimately found that the petitioner was unable to establish causation-in-fact under Althen and dismissed her non-
Table claim. Block v. Sec’y of Health & Hum. Servs., 2021 WL 5709764, at *6 (Fed. Cl. Oct. 29, 2021).
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