VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01414
Package ID: USCOURTS-cofc-1_21-vv-01414
Petitioner: Isabel Zamora
Filed: 2021-06-01
Decided: 2025-06-26
Vaccine: influenza
Vaccination date: 2019-10-08
Condition: chronic fatigue syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Isabel Zamora filed a petition on June 1, 2021, alleging that an influenza vaccination administered on October 8, 2019, caused her to develop chronic fatigue syndrome. Ms. Zamora, born in 1962, received the Flulaval influenza vaccine. She reported experiencing headaches and fatigue soon after the vaccination. Her symptoms reportedly intensified, leading her to stop working in March 2020 and again on June 6, 2020, due to severe headaches, fatigue, and numbness in her fingers. A diagnosis of chronic fatigue syndrome was made on September 26, 2020, by a physician assistant. Ms. Zamora was represented by attorneys Andrew Downing and later Courtney Jorgensen of Siri & Glimstad, LLP. The respondent, the Secretary of Health and Human Services, was represented by Naseem Kourosh of the U.S. Department of Justice. 

To support her claim, Ms. Zamora presented expert testimony from neurologist Dr. Mitchell Miglis. Dr. Miglis opined that the influenza vaccine caused Ms. Zamora's chronic fatigue syndrome, suggesting a possible mechanism of molecular mimicry, with an onset between October and December 2019. The respondent presented expert testimony from rheumatologist Dr. Roland Staud, who opined that Ms. Zamora's chronic fatigue syndrome predated the vaccination and that there is no scientifically proven connection between influenza vaccination and chronic fatigue syndrome. 

Special Master Christian J. Moran reviewed the evidence and arguments. He found that Ms. Zamora failed to establish that the influenza vaccine can cause chronic fatigue syndrome, which is a requirement under the first prong of the Althen standard for off-Table injuries. The Special Master noted the lack of scientific evidence supporting a causal link and the limitations of epidemiological studies and case reports. He also found issues with the temporal relationship, as both experts placed the onset of symptoms before the vaccination. Dr. Miglis placed the onset between October and December 2019, while Dr. Staud placed it even earlier. The Special Master concluded that Ms. Zamora had not met her burden of proof for Althen prong one. 

Ms. Zamora appealed the Special Master's decision to the Court of Federal Claims. Senior Judge Loren A. Smith reviewed the case and affirmed the Special Master's decision. The Court found that Special Master Moran did not apply a heightened standard of proof and that Ms. Zamora failed to meet her burden of proof under the Althen standard. The Court agreed that the evidence did not support a causal link between the influenza vaccine and chronic fatigue syndrome, and that the temporal relationship was not established. The petition was denied, and no compensation was awarded.

Theory of causation field:
Petitioner Isabel Zamora alleged that an October 8, 2019, Flulaval influenza vaccination caused her to develop chronic fatigue syndrome (CFS). Petitioner's expert, neurologist Dr. Mitchell Miglis, opined that the vaccine caused CFS through molecular mimicry, with onset between October and December 2019. Respondent's expert, rheumatologist Dr. Roland Staud, opined that CFS predated the vaccination and that no scientific link exists between influenza vaccines and CFS. Special Master Christian J. Moran denied entitlement, finding petitioner failed to establish Althen prong one (medical theory connecting vaccine and injury) due to insufficient evidence that the flu vaccine can cause CFS, and noting that both experts placed symptom onset before the vaccination. The Court of Federal Claims affirmed, agreeing that petitioner failed to meet her burden of proof under the Althen standard and that the Special Master did not apply an incorrect standard. Petitioner counsel: Courtney Jorgensen (Siri & Glimstad, LLP). Respondent counsel: Naseem Kourosh (U.S. Department of Justice). Special Master: Christian J. Moran. Judge: Loren A. Smith. Decision Date: March 19, 2025 (Special Master), June 26, 2025 (Court). Outcome: Denied. Award: None.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-01414-0
Date issued/filed: 2025-04-14
Pages: 19
Docket text: PUBLIC DECISION (Originally filed: 03/19/2025) regarding 85 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 1 of 19
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * *
ISABEL ZAMORA, * No. 21-1414V
*
Petitioner, *
* Special Master Christian J. Moran
v. *
* Filed: March 19, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
Courtney Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for petitioner;
Naseem Kourosh, United States Dep’t of Justice, for respondent.
DECISION DENYING ENTITLEMENT TO COMPENSATION1
Isabel Zamora alleges that an influenza (“flu”) caused her to develop chronic
fatigue syndrome. To support her claim, Ms. Zamora presented the opinion of a
neurologist, Mitchell Miglis. The Secretary opposes Ms. Zamora’s claim and relies
upon a contrary opinion from a rheumatologist, Roland Staud. After the experts
disclosed all their opinions, the parties advocated through memoranda.
A review of the evidence and arguments shows that Ms. Zamora has not met
her burden to show the flu vaccine caused her chronic fatigue syndrome. A basic
1 Because this decision contains a reasoned explanation for the action taken in this case, it
must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 2 of 19
challenge is that the etiology of chronic fatigue syndrome is unknown. Ms.
Zamora has not persuasively established that the flu vaccine can cause chronic
fatigue syndrome. Without this showing, Ms. Zamora cannot be awarded
compensation.
I. Facts2
A. Before Vaccination
Ms. Zamora was born in 1962 in Mexico. Exhibit 10 (affidavit regarding
damages) ¶ 1. She averred that before the allegedly causal vaccination, she had
“very controlled pre-diabetes.” Id. ¶ 3; Exhibit 48 (affidavit) ¶ 4. However, via
her attorney, she also represented that she was not receiving much medical
treatment. Pet’r’s Status Rep., filed Oct. 17, 2022.
In the years leading up to the allegedly causal vaccination, Ms. Zamora
earned income, which was reported to the Social Security Administration. Exhibit
56. Ms. Zamora’s primary job was working on an assembly-line. Exhibit 10 ¶ 5.3
Although Ms. Zamora earned some wages, she remained eligible for Medicaid,
which largely paid her medical expenses. Id. ¶ 4.
On at least two occasions before the allegedly causal vaccination, Ms.
Zamora received other doses of the flu vaccine. See Exhibit 4 at 82 (Jan. 26, 2018)
and Id. at 63-64 (Oct. 12, 2017). In November 2018, Ms. Zamora went to Mexico
for plastic surgery. Exhibit 4 at 94.
B. Vaccination and Afterwards
On October 8, 2019, Ms. Zamora went to the place where she received her
primary medical care, Salud Para La Gente, where she saw a nurse practitioner,
RoseMarie Sandoval. Ms. Zamora received a dose of the flu vaccine. Exhibit 4 at
99. The specific type of flu vaccine was Flulaval. Id. at 28. Flulaval contains an
inactivated form of the flu virus. Court Exhibit 1001 (Flulaval package insert) at 5.
2 Because the outcome of Ms. Zamora's case largely depends upon evidence not related to
her personally, events in her life are presented summarily. For a more detailed account, see
Pet’r’s Br., filed June 19, 2024, at 1-26; Resp’t’s Br., filed Aug. 19, 2024, at 1-18, and the
exhibits cited therein.
3 In her affidavit, Ms. Zamora estimated her annual earnings were in an amount that
exceeded the earnings reported to the Social Security Administration.
2

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 3 of 19
Through an affidavit created during this litigation, Ms. Zamora averred that
soon after the vaccination, she began to experience headaches. Exhibit 1 ¶ 1. Ms.
Zamora further avers that she also developed fatigue. Id.
Within approximately two weeks of the vaccination, Ms. Zamora sought
care at Salud Para La Gente for a lacerated finger. Exhibit 4 at 102 (Oct. 11, 2019
– initial visit) and at 104 (Oct. 18, 2019 – suture removal). Although a complaint
about fatigue was not memorialized in the records created on these two dates, Ms.
Zamora averred that she was experiencing fatigue, weakness, or confusion.
Exhibit 14 ¶ 10. Likewise, Ms. Zamora attested that when she had a routine
screening for breast cancer on October 31, 2019, she was feeling exhausted. Id. ¶
11.
Ms. Zamora averred that when she woke up on November 4, 2019,
“everything was different. The headache was very intense in the back, but [she]
had the sensation of being in another dimension as if it were disconnected.”
Exhibit 1 ¶ 2. Ms. Zamora also asserted that she was “dizzy, confused and scared
because [she] did not understand what was happening.” Id.
Ms. Zamora averred that during a trip to Mexico from November 16, 2019 to
December 9, 2019 to visit her mother, she felt “very sad” because she didn’t know
what was going on with her health. Exhibit 14 ¶ 18. In December 2019, Ms.
Zamora scheduled an appointment with her doctor for January 2020. Exhibit 1 ¶ 3.
This appointment at Salud Para La Gente took place on January 2, 2020,
when nurse practitioner Sandoval saw her. Exhibit 4 at 113. Ms. Zamora’s chief
complaint included “headache, dizziness, and blurry vision on and off x 1 month.”
Id. NP Sandoval assessed Ms. Zamora as suffering from adjustment disorder with
anxiety. Id. at 114-15. NP Sandoval recommended that Ms. Zamora seek therapy.
Id.
By February 2020, Ms. Zamora was working. Exhibit 1 (affidavit) ¶ 3; see
also Exhibit 56 (Social Security Administration records). Ms. Zamora averred that
working was difficult because she had no control over her headaches and fatigue.
Exhibit 1 ¶ 3. In February 2020, Ms. Zamora worked between 40 and 50 hours per
week. Exhibit 16 at 11-15.
Although not recounted in Ms. Zamora’s affidavit, the coronavirus pandemic
was severely affecting this country by February or March 2020. Ms. Zamora avers
that on “March 18, 2020 I decided to not go to work. I took refuge in my house
and only woke up to do the necessary things.” Exhibit 1 ¶ 4. This account is
3

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 4 of 19
corroborated in her employer’s pay records. Exhibit 16 at 8 (showing that for the
week beginning March 15, 2020, she worked 0.00 hours). Ms. Zamora attested
about the next steps with respect to her employment: “In April 2020, I applied for
unemployment online. I argued that my work was a place with many risks of
contagion, since we were too many people working very closely. They denied me
unemployment and said that I had just quit my job.” Id. ¶ 5. The employment
records do not say anything about whether Ms. Zamora quit her job, whether she
sought unemployment benefits, or whether she was sick. See Exhibit 16.
Ms. Zamora did not see any medical doctors during this time. In her
affidavit, she explained that “I believed in the diagnosis of the doctor who said it
was stress so I never thought it could be a disability.” Id.
Ms. Zamora returned to work in May 2020. Exhibit 1 ¶ 6. (Apparently, Ms.
Zamora changed employers because the employment records she filed do not
contain any information about her returning to work at the company where she
worked before the pandemic. See Exhibit 16.) She stated: “My headaches
increased.… I only worked until June 6, because my headaches were getting more
and more intense, my legs and arms had no energy, my tongue did not have the
normal movement. I could talk but I had difficulty moving it and my fingers were
numb.” Id. Records from the California Unemployment Office confirm that she
applied for benefits in June 2020. Exhibit 15 at 2.4 Ms. Zamora received benefits
for about one year. Id. at 3.
Approximately eight months after the flu vaccination, Ms. Zamora had a
telemedicine appointment with a physician assistant at Salud Para La Gente, Alicia
Potes. Exhibit 4 at 117. Ms. Zamora reported three weeks of bilateral hand
cramping. She also complained about “some issues going back to the fall, Oct.
2019. She says her symptoms started after getting the flu vaccine. She was feeling
confused and having headaches.” Id. On exam, Ms. Zamora had normal cognitive
function, but she had a depressed mood and flat affect. Id. at 118. PA Potes
assessed Ms. Zamora has having a headache syndrome, depression and pain and
she suspected that Ms. Zamora’s “occurred symptoms are related to depression.”
PA Potes referred Ms. Zamora to neurology. Id. at 119.
Over the next three months, Ms. Zamora sought a variety of medical
providers for a variety of complaints. However, these details do not affect whether
4 The completeness of the unemployment records is uncertain as these records do not
reflect an application for benefits in April 2020.
4

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 5 of 19
Ms. Zamora has established whether the flu vaccine caused her to suffer chronic
fatigue syndrome.
A more relevant record was created on September 26, 2020. On that date, a
physician assistant (Caitlin Casey) diagnosed Ms. Zamora as suffering from
chronic fatigue syndrome. Exhibit 4 at 141. Ms. Casey supported Ms. Zamora’s
request for disability benefits with an opinion regarding chronic fatigue syndrome.
Exhibit 15 at 4. Ms. Zamora’s expert, Dr. Miglis, agreed with the diagnosis of
chronic fatigue syndrome. Exhibit 19 at 12. So, too, the Secretary’s expert, Dr.
Staud, agreed that Ms. Zamora suffered from chronic fatigue syndrome. Exhibit A
at 12. However, as discussed below in section V.A.2, Dr. Staud places the onset of
Ms. Zamora’s chronic fatigue syndrome before (not after) her flu vaccination.
Chronic Fatigue Syndrome
Chronic fatigue syndrome is “a serious, chronic, complex, and systemic
disease that frequently and dramatically limits the activities of affected patients."
Institute of Medicine Report at 5 / pdf 28.5 Sometimes, “chronic fatigue
syndrome” is joined with another condition, known as “myalgic
encephalomyelitis,” which is often abbreviated “ME.” Id. at 27-28. / pdf 50. For
the sake of simplicity and consistent with the parties’ terminology, this decision
labels Ms. Zamora’s condition as “chronic fatigue syndrome.” People with
“chronic fatigue syndrome” have three symptoms: (1) a substantial reduction in the
ability to engage in activities, which is accompanied by fatigue, (2) post-exertional
malaise, and (3) unrefreshing sleep. Id. at 6 /pdf 29. They also have either
cognitive impairment or orthostatic intolerance. Id.
Doctors have limited knowledge about what causes chronic fatigue
syndrome. Dr. Staud stated that “The disease has an ‘unknown etiology.’” Exhibit
A at 9. Dr. Miglis did not profess to have any more knowledge. He wrote: “The
cause of ME/CFS remains unknown, however multiple lines of evidence have
demonstrated impairment in energy metabolism pathways, autonomic nervous
system function, immune dysfunction, and neuro-inflammation.” Exhibit 19 at 3.
Dr. Miglis presented various articles that found unusual immunologic results
in people with chronic fatigue syndrome. Immunologic substances studied
5 Institute of Medicine, Beyond Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
(2015); filed as Exhibit 21.
5

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 6 of 19
included: antibodies to EBNA (Loebel),6 low amounts of natural killer cells
(Strayer),7 autoantibodies to nuclear envelope antigens (Konstantinov),8 various
cytokines (Montoya),9 and autoantibodies to muscarinic cholinergic receptors
(Tanaka, Chu).10 Other articles have noted that some infections precede the onset
of chronic fatigue syndrome. See Bateman,11 White,12 and Magnus.13
However, Ms. Zamora is not argued to have suffered from an infection
before she developed chronic fatigue syndrome. Her medical records on this point
are relatively muted.
After Ms. Zamora was diagnosed with chronic fatigue syndrome, she
received medical treatment from many doctors. But, these more recent medical
records do not help determine whether a flu vaccine can cause chronic fatigue
syndrome. For more information about the course of Ms. Zamora’s health, see
Pet’r’s Br. at 12-26; Resp’t’s Br. at 10-17 and the medical records cited therein.
6 Madlen Loebel et al., Serological profiling of the EBV immune response in Chronic
Fatigue Syndrome using a peptide microarray, 12 PLOS ONE 1 (2017); filed as Exhibit 26.
7 David R. Strayer, Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and
Relationship to Symptom Severity, 6 J. CLIN. & CELLULAR IMMUNOL. 4 (2015); filed as Exhibit
28.
8 K. Konstantinov et al., Autoantibodies to nuclear envelope antigens in chronic fatigue
syndrome, 98 J. CLIN. INVEST. 1888 (1996); filed as Exhibit 31.
9 Jose G. Montoya et al., Cytokine signature associated with disease severity in chronic
fatigue syndrome patients, 114 PROC. NATL. ACAD. SCI. USA E7150 (2017); filed as Exhibit 34.
10 Susumu Tanaka et al., Autoantibodies against muscarinic cholinergic receptor in
chronic fatigue syndrome, 12 INT. J. MOL. MED. 225 (2003); filed as Exhibit 32.
Lily Chu et al., Onset Patterns and Course of Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome, 7 FRONT. PEDIATR. 1 (2019); filed as Exhibit 39.
11 Lucinda Bateman et al., Myalgic Encephalomyelitis/Chronic Fatigue Syndrome:
Essentials of Diagnosis and Management, 96 MAYO CLIN. PROC. 2861 (2021); filed as Exhibit
22.
12 P. D. White et al., Incidence, risk and prognosis of acute and chronic fatigue syndromes
and psychiatric disorders after glandular fever, 173 BR. J. PSYCHIATRY 475 (1998); filed as
Exhibit 23.
13 P. Magnus et al., Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is
associated with pandemic influenza infection, but not with an adjuvanted pandemic influenza
vaccine, 33 VACCINE 6173 (2015); filed as Exhibit 27. Magnus is discussed in more detail
below.
6

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 7 of 19
II. Procedural History14
Ms. Zamora started her claim by filing a petition on June 1, 2021. She was
represented by Attorney Andrew Downing, who frequently represented petitioners
in the Vaccine Program. Ms. Zamora periodically submitted medical records.
The Secretary reviewed this material and advised that Ms. Zamora was not
entitled to compensation. The Secretary proposed that Ms. Zamora’s chronic
fatigue syndrome developed before the vaccination. Resp’t’s Rep., filed May 6,
2022, at 18. Because the parties appeared to be seeking reports from experts, a set
of instructions for experts was issued. See Order, issued Aug. 9, 2022.
Ms. Zamora supported her claim with a first report from Dr. Miglis. Exhibit
19, filed Feb. 6, 2023. Dr. Miglis recounted Ms. Zamora’s medical records. Id. at
5-11. He stated that she suffered from chronic fatigue syndrome. Id. at 12. The
onset of this problem was “as early as October 2019, and as late as December
2019.” Id.
Dr. Miglis provided background information about chronic fatigue
syndrome. Id. at 2-5. As to how a flu vaccine can cause chronic fatigue syndrome,
he wrote: “The mechanism of influenza vaccine-induced ME/CFS has not been
described. However, given that ME/CFS has been described after influenza
infection, a presumed theory is one of molecular mimicry."
In turn, the Secretary opposed Ms. Zamora’s claim by presenting a first
report from Dr. Staud. Exhibit A, filed June 6, 2023. Among the opinions that Dr.
Staud presented was a view that Ms. Zamora developed chronic fatigue syndrome
before the vaccination. Id. at 12. Dr. Staud also challenged the assertion that a flu
vaccine can cause chronic fatigue syndrome.
Ms. Zamora attempted to address Dr. Staud’s opinion by filing a second
report from Dr. Miglis. Exhibit 38, filed Aug. 15, 2023. Dr. Miglis essentially
maintained the opinions that he had expressed previously. For example, Dr. Miglis
continued to assert that Ms. Zamora’s chronic fatigue syndrome started after (not
before) her vaccination. Id. at 1.
With the disclosure of opinions from experts completed, the parties were
directed to file briefs. Order, issued April 4, 2024. As part of this process, Ms.
Zamora was asked whether she wanted to pursue a claim that the vaccination
14 The course of Ms. Zamora's litigation has been straightforward.
7

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 8 of 19
significantly aggravated (as opposed to caused) her chronic fatigue syndrome. Via
an affidavit, Ms. Zamora confirmed that she was pursuing an initial onset claim
only. Exhibit 48.
As instructed, the parties advocated through memoranda. Ms. Zamora filed
her initial brief on June 19, 2024, and her reply on September 17, 2024. In
between, the Secretary filed his brief on August 19, 2024.
After the briefing ended, Mr. Downing stopped representing Ms. Zamora.
He was replaced as counsel of record by Attorney Courtney Jorgensen. Attorney
Jorgensen formerly was a partner of Mr. Downing. Thus, the appearance of a new
attorney for Ms. Zamora does not necessarily require a delay in adjudication.
Resolving Ms. Zamora’s case based upon the evidence and arguments
presented so far is appropriate. Ms. Zamora has had a full and fair opportunity to
present evidence. Her expert, Dr. Miglis, submitted the most recent substantive
report and she submitted the last brief.15 In other words, Ms. Zamora has had the
final word. As discussed below, the flaws and gaps in Dr. Miglis’s opinion cannot
be solved with oral testimony. Thus, the case can be adjudicated now.
III. Standards for Adjudication
A petitioner is required to establish her case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
15 The parties each filed a “Statement From Testifying Expert” with their briefs, providing
a short explanation of newly filed medical literature. These do not constitute substantive reports.
8

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 9 of 19
Cir. 1993) (disagreeing with dissenting judge’s contention that the special master
confused preponderance of the evidence with medical certainty).
In a case in which the vaccine-injury combination is not listed on the
Vaccine Table, such as this one, petitioners are not afforded a presumption of
causation. Rather, they must establish with preponderant evidence that the vaccine
was the cause-in-fact of their injury. Petitioners bear a burden “to show by
preponderant evidence that the vaccination brought about [the vaccinee’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.” Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005).
IV. Analysis – Althen Prong One
As to whether the flu vaccine can cause chronic fatigue syndrome, the
evidence falls into two broad categories. The first category consists of evidence
that is generally applicable to any theory, such as epidemiological studies and case
reports. The second category consists of evidence more specific to the theory that
Dr. Miglis is offering, molecular mimicry.
A. Epidemiological Studies and Case Reports
These types of evidence are joined together because they may present
evidence that the flu vaccine causes chronic fatigue syndrome without necessarily
investigating the method by which the flu vaccine causes chronic fatigue
syndrome.
1. Epidemiologic Studies
The study receiving the most attention from the parties is an article by Per
Magnus.16 Magnus and colleagues accessed computerized medical records for
about essentially the entire population of Norway, which exceeds more than four
million people. Magnus at 6174. The researchers determined how many
Norwegians suffered from chronic fatigue syndrome and the percentage who had
either been infected with an influenza virus or had received a vaccination against
16 Filed as Exhibit A-16 and Exhibit 27; supra note 13.
9

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 10 of 19
H1N1. Id.17 The researchers found that people who suffered an H1N1 infection
had a “two-fold increased risk” of chronic fatigue syndrome. Id. at 6173. In
contrast, for vaccination, the researchers found “no increased risk” of chronic
fatigue syndrome. Id. The Magnus study, therefore, tends to undermine the claim
that flu vaccines can cause chronic fatigue syndrome, although this single study is
not dispositive.18
In response to the Magnus study, Dr. Miglis and Ms. Zamora make two
points. They contend that epidemiological studies are limited. Exhibit 19 (Dr.
Miglis’s report) at 4; see also Pet’r’s Br. at 52-53 and Pet’r’s Reply at 15-17. As
support, they pointed out that Magnus and colleagues recognized that: “there is still
a lack of large, well-characterized cohort studies with [chronic fatigue syndrome]
as an end point.” Magnus at 6176. This point is accurate in the sense that
additional studies might be informative. However, special masters must decide
cases based upon the evidence before them.
Although Ms. Zamora downplays the results in Magnus about the influenza
vaccination, she emphasizes the results regarding influenza infection. She
maintains that if an infection is associated with an adverse consequence, then the
vaccination against this infectious organism should be presumed to be capable of
causing the same adverse consequence. Pet’r’s Br. at 39. In response, the
Secretary argued that this assertion was unsupported, “offered without any
scientific testimony or literature.” Resp’t’s Br. at 34. In reply, Ms. Zamora did not
identify any support from her expert, Dr. Miglis. Instead, Ms. Zamora cited a case
decided by another special master. Pet’r’s Reply at 11, quoting Ahlum v. Sec’y of
Health & Human Servs., No. 12-763V, 2018 WL 4323623, at *44 (Fed. Cl. Spec.
Mstr. Aug. 16, 2018).
The attempted analogy between flu infection and flu vaccination has not
been persuasively established. A basic difference is that special masters have
consistently found that inactivated flu vaccines do not replicate in a person’s body.
See Greenslade v. Sec’y of Health & Hum. Servs., No. 14-1140V, 2024 WL
3527665, at *24 (Fed. Cl. Spec. Mstr. June 28, 2024) (summarizing expert
17 The specific brands of flu vaccine were Pandemrix and Celvapan. Magnus at 6174.
Ms. Zamora received a different type of flu vaccine. However, neither party developed any
arguments regarding the difference in flu vaccines.
18 It appears that one special master (the undersigned) discussed Magnus previously. See
McCabe v. Sec’y of Health & Hum. Servs., No. 13-570V, 2018 WL 3029175, at *28 (Fed. Cl.
Spec. Mstr. May 17, 2018).
10

Case 1:21-vv-01414-LAS Document 86 Filed 04/14/25 Page 11 of 19
opinion); Martin v. Sec’y of Health & Hum. Servs., No. 17-250V, 2020 WL
4815840, at *28 (Fed. Cl. Spec. Mstr. July 17, 2020); see also Miller v. Sec’y of
Health & Hum. Servs., 172 Fed. Cl. 762, 782 (2024) (ruling special master did not
err in rejecting theory based upon an assertion that a flu vaccine can replicate);
D’Tiole v. Sec’y of Health & Hum. Servs., No. 15-085V, 2016 WL 7664475, at *1
n.4 (Fed. Cl. Spec. Mstr. Nov. 28, 2016) (discussing a live attenuated flu vaccine),
mot. for rev. denied, 132 Fed. Cl. 421 (2017), aff’d, 726 Fed. App’x 809 (Fed. Cir.
2018). By way of contrast, the measles-mumps-rubella vaccine contains
attenuated viruses, which do replicate in a person’s body. Therefore, Ms. Zamora’s
reliance on Ahlum, which involved an MMR vaccine, is misplaced.
Although most attention was on Magnus, the parties also addressed some
other articles that discussed whether vaccines can cause chronic fatigue syndrome.
Appel19 and Ortega-Hernandez20 were both written more than 15 years ago. As
such, the assessments are somewhat dated. Moreover, these articles are not
original studies. Rather, they cite to other works. For example, Appel summarized
findings from a Canadian Working group. Appel at 51.21 Ultimately, both articles
tend to exonerate the flu vaccine as a potential cause of chronic fatigue syndrome.
Ortega-Hernandez at 603, Table 2 (stating that the influenza virus is not a risk for
chronic fatigue syndrome); Appel (stating “there is no study that found induction
of CFS by vaccination”). This lack of association is surprising because Yehuda
Shoenfeld, who has often testified in the Vaccine Program that vaccines caused an
injury, was a co-author on both articles.
Finally, in a report filed in conjunction with Ms. Zamora’s brief, Dr. Miglis
cited an article published in June 2024. Exhibit 58, citing Arron.22 This group of
authors recognized that cases of chronic fatigue syndrome have occurred after
vaccination, but the only study they cited, which evaluated the human papilloma
19 S. Appel, Joab Chapman, & Yehuda Shoenfeld, Infection and Vaccination in Chronic
Fatigue Syndrome: Myth or Reality?, 40 AUTOIMMUNITY 48 (2007); filed as Exhibit A-22.
20 Oscar Danielo Ortega-Hernandez & Yehuda Shoenfeld, Infection, Vaccination, and
Autoantibodies in Chronic Fatigue Syndrome, Cause or Coincidence?, 1173 ANN. N.Y. ACAD,
SCI. 600 (2009); filed as Exhibit 40.
21 The paper from the Canadian working group is not an exhibit in this case, but it has
been filed as an exhibit in other cases. See Doe 54 v. Sec’y of Health & Hum. Servs., No. 99-
454V, 2009 WL 5196160, at *21 (Fed. Cl. Spec. Mstr. May 28, 2009).
22 Hayley E. Arron, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: the biology
of a neglected disease, 15 FRONT. IMMUNOL. 1 (2024); filed as Exhibit 57.
11

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virus vaccine, did not find an increased risk of chronic fatigue syndrome. Arron at
7.
2. Case Reports
The Arron article is not the only article that reports that people received a
vaccination before developing chronic fatigue syndrome. For other examples, see
Ortega-Hernandez at 602; Appel at 51.
The parties dispute the value of case reports. Ms. Zamora contends that case
reports have more value than epidemiologic studies. Pet’r’s Br. at 43-44. She does
so, however, without citing any legal authority. In contrast, the Secretary
maintains that case reports have limited utility. Resp’t’s Br. at 35. n.3. Despite the
Secretary’s citation to many cases that minimize the value of medical case reports,
Ms. Zamora did not address this argument by identifying cases that support her
position. See Pet’r’s Reply at 12.
In general, case reports provide little, if any, information helpful to
determining causation because they present only a temporal sequence of events in
which the vaccination preceded an adverse health event. See K.O. v. Sec’y of
Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *11-12 (Fed. Cl. Spec.
Mstr. July 7, 2016) (discussing appellate precedent on case reports). In accordance
with this precedent, the undersigned declines to afford the various case reports
much weight. Thus, neither the epidemiologic studies nor the case reports carry
Ms. Zamora’s burden to establish that the flu vaccine can cause chronic fatigue
syndrome.
B. Molecular Mimicry
The presence of epidemiological evidence pointing away from vaccines as a
cause for chronic fatigue syndrome does not necessarily mean Ms. Zamora is not
entitled to compensation automatically, as epidemiology is not dispositive by itself.
Therefore, the specific theory that Ms. Zamora’s proposes, molecular mimicry, is
evaluated. Because molecular mimicry is often invoked, appellate authorities have
reviewed this theory. Accordingly, this appellate precedent is reviewed before the
specific evidence Ms. Zamora’s case is analyzed.
1. Appellate Precedent regarding Molecular Mimicry
Because special masters are often called upon to evaluate the persuasiveness
of the theory of molecular mimicry, the Court of Federal Claims and the Court of
Appeals for the Federal Circuit have considered molecular mimicry in their
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appellate role of reviewing opinions.23 In December 2019, the undersigned
identified the leading precedents as W.C. v. Sec’y of Health & Hum. Servs., 704
F.3d 1352 (Fed. Cir. 2013), and Caves v. Sec’y of Dep’t. of Health & Hum. Servs.,
100 Fed. Cl. 119 (2011), aff’d sub nom., 463 F. App’x 932 (Fed. Cir. 2012). Tullio
v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019 WL 7580149, at *12-14 (Fed.
Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl. 448 (2020).
While Tullio describes those cases in more detail, their essence appears to be that
although molecular mimicry is accepted in some contexts, special masters may
properly require some empirical evidence to show that a particular vaccine can
cause a particular disease.
In the next approximately five years, appellate authorities reviewing
decisions involving molecular mimicry have generally endorsed the approach of
looking for some evidence that persuasively shows that a portion of a vaccine
resembles a portion of human tissue, which contributes to causing the disease, and
that the immune system will respond to the relevant amino acid sequence.24
Chronologically, the list of more recent appellate cases begins with the opinion in
Tullio, which denied the motion for review. 149 Fed. Cl. 448, 467-68 (2020).
Another example in which the Court of Federal Claims held that the special
master did not elevate the petitioner’s burden of proof in the context of evaluating
the theory of molecular mimicry is Morgan v. Sec’y of Health & Hum. Servs., 148
Fed. Cl. 454, 476-77 (2020), aff’d in non-precedential opinion, 850 F. App’x 775
(Fed. Cir. 2021). In Morgan, the Chief Special Master found that petitioner had not
presented persuasive evidence about a relevant antibody. Id. at 477. The Chief
Special Master also noted that the articles about the relevant disease do not list the
wild flu virus as potentially causing the disease. Id. When examining this
analysis, the Court of Federal Claims concluded: “the Chief Special Master did not
raise the burden of causation in this case; petitioner simply failed to meet it.” Id.
The Federal Circuit also evaluated the Chief Special Master’s approach in
Morgan. The Federal Circuit concluded: “We discern no error in the special
master’s causation analysis.” 850 F. App’x 775, 784 (Fed. Cir. 2021).
23 The briefs would have been improved if they had discussed any appellate cases about
molecular mimicry.
24 The term “homology” is used when discussing molecular mimicry. “Homology” is
defined as “the quality of being homologous; the morphological identity of corresponding parts;
structural similarity due to descent from a common form.” Dorland’s at 868.
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Most other recent appellate cases follow this path. See, e.g., Stricker v.
Sec’y of Health & Hum. Servs., 170 Fed. Cl. 701, 720-21 (2024); Duncan v. Sec’y
of Health & Hum. Servs., 153 Fed. Cl. 642, 661 (2021) (finding the special master
did not err in rejecting a bare assertion of molecular mimicry and stating “there is
an important difference between the general theory of molecular mimicry and the
more specific theory that the vaccine at issue is capable of triggering an
autoimmune response that culminates in the petitioner's injury”); Caredio v. Sec’y
of Health & Hum. Servs., No. 17-79V, 2021 WL 6058835, at *11 (Fed. Cl. Dec. 3,
2021) (indicating that a special master did not err in requiring more than homology
and citing Tullio); Yalacki v. Sec’y of Health & Hum. Servs., 146 Fed. Cl. 80, 91-
92 (2019) (ruling that special master did not err in looking for reliable evidence to
support molecular mimicry as a theory); but see Patton v. Sec’y of Health & Hum.
Servs., 157 Fed. Cl. 159, 169 (2021) (finding that a special master erred in
requiring petitioner submit a study to establish medical theory causally connecting
flu vaccine to brachial neuritis).
The Court of Federal Claims explained why petitioners must present some
evidence to show the persuasiveness of molecular mimicry as a theory in their
cases. Dennington v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640 (2023),
appeal withdrawn, No. 2024-1214 (Fed. Cir. Mar. 25, 2024). There, Ms.
Dennington alleged that a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine
caused her to develop GBS. Id. at 644. She supported her claim with two reports
from a neurologist, Carlo Tornatore, who put forward molecular mimicry. Id. at
647-49. The Chief Special Master denied entitlement. Id. at 656.
The Court of Federal Claims denied a motion for review because the Chief
Special Master did not commit any error in evaluating Ms. Dennington’s prong one
evidence. The Court emphasized the lack of evidence supporting Dr. Tornatore’s
opinion:
• “While Petitioner and Dr. Tornatore put forth the well-established
medical theory of molecular mimicry as the mechanism through
which the Tdap vaccine could cause GBS, nowhere in Dr. Tornatore’s
expert reports, nor in Petitioner’s briefs, do they specifically tie the
Tdap vaccine to GBS through molecular mimicry.” Id. at 653.
• “Dr. Tornatore never actually explains how molecular mimicry might
occur from the Tdap vaccine specifically, nor does he elaborate on
how molecular mimicry could cause the specific autoimmune system
reaction that could cause GBS.” Id.
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• “There is nothing in Dr. Tornatore’s report that explains or even
alludes to what antigens or structures in the Tdap vaccine could share
homology with possible host antigens and how these antigens could
react in the manner GBS is believed to progress.” Id. at 654.
• “The literature upon which he relies make no mention of any causal
connection between GBS and the Tdap vaccine.” Id.
Based upon these observations, the Court criticized the lack of specificity in
Dr. Tornatore’s opinions:
In fact, because Dr. Tornatore does not offer any specific
explanation as to the distinct connection between Tdap,
molecular mimicry, and GBS, one could take Dr.
Tornatore’s causation theory and substitute any table
vaccine (e.g., the measles vaccine) and any autoimmune
disorder (e.g., autoimmune encephalitis) and Dr.
Tornatore’s expert report’s discussion of molecular
mimicry would require absolutely no changes. That is
how general her molecular mimicry theory is—it does
not matter which vaccine and which autoimmune
disorder are plugged in. But Althen prong one requires
more.
Id.
In accordance with precedents such as W.C., Caves, Tullio, Yalacki, Stricker,
Duncan, and Dennington, the undersigned will look to see whether any evidence
supports the theory that the flu vaccine can cause chronic fatigue syndrome.
2. Ms. Zamora's evidence
Doctor Miglis’s opinion regarding molecular mimicry is thin. Part of the
trouble is medical officials know very little about that causes of chronic fatigue
syndrome. For example, whether chronic fatigue syndrome is autoimmune in
origin is unclear as multiple different pathologic processes have been proposed.
As discussed, some studies have detected abnormal antibodies in people
with chronic fatigue syndrome. However, whether these antibodies cause chronic
fatigue syndrome has not been established with preponderant evidence. Moreover,
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even if the antibodies were causative, Dr. Miglis does not connect the flu vaccine
to the development of the (assumed) causative antibodies.
In supporting Dr. Miglis’s opinion, Ms. Zamora relies, in part, on an
attempted analogy to the influenza virus. See Pet’r’s Br. at 43; Pet’r’s Reply at 11-
12. However, this argument is unpersuasive for the reason explained above---the
flu virus, unlike Flulaval, replicates.
In short, Ms. Zamora has not persuasively established that molecular
mimicry explains how the flu vaccine can cause chronic fatigue syndrome.
Accordingly, she has failed to meet her burden of proof with respect to Althen
prong one.
V. Additional Comments / Questions
Although Ms. Zamora's failure with respect to Althen prong one is
dispositive, the additional elements merit a short discussion.
A. Althen Prong Three
One portion of a petitioner’s burden is to show with preponderant evidence,
“a proximate temporal relationship between vaccination and injury.” Althen, 418
F.3d at 1278. The timing prong actually contains two parts. A petitioner must
show the “timeframe for which it is medically acceptable to infer causation” and
the onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum.
Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other
grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir.
2013).
1. Expected Interval
The expected interval depends, at least in part, upon the theory being
offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 421, 443
(2013); see also Resp’t’s Br. at 46. Here, the theory is molecular mimicry.
To assist with the submission of useful reports from experts, instructions for
these reports were issued on Aug. 9, 2022. One portion was devoted to having the
experts discuss the appropriate interval between a vaccination and the onset of
chronic fatigue syndrome. ¶ 7.a.
Doctor Miglis’s first report stated that the appropriate interval was “several
weeks to several months.” Exhibit 19 at 12. No explanation was given beyond his
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own words. More clarification was sought. Order for Briefs, filed Aug. 4, 2024, at
7.
The briefs add very little, unfortunately. Ms. Zamora quotes portions of Dr.
Miglis’s two reports. Pet’r’s Br. at 51. She proposes neither a minimum number of
weeks nor a maximum number of months. The Secretary challenged Ms. Zamora’s
evidence on this point. Resp’t’s Br. at 46 (“petitioner’s vague and varied assertions
of an onset timeframe are conclusory and unsupported, and do not amount to a
preponderant showing of a medically appropriate timeframe for post-flu-
vaccination onset of ME/CFS”). In reply, Ms. Zamora analogizes the time for the
flu vaccine to potentially cause chronic fatigue syndrome to the time listed in the
Vaccine Table for the flu vaccine to cause Guillain-Barré syndrome. Pet’r’s Reply
at 5. But, this appears to be more of an argument from an attorney, rather than an
argument based upon evidence from Dr. Miglis.
In sum, although no definitive finding is reached, Ms. Zamora’s evidence
and argument regarding the appropriate interval appears to lack persuasiveness.
Dr. Miglis’s reports seem to be too vague to be creditable. See Hennessey v. Sec’y
of Health & Hum. Servs., 91 Fed. Cl. 126, 142 (2010) (the expert’s “overly broad”
opinion on timing effectively “renders Althen’s third prong a nullity”).
2. Onset
The second aspect of the third prong of Althen is when the condition
developed. Here, too, there are questions about Ms. Zamora’s evidence.
Before problematic areas are set out, two foundational points need to be
established. First, determining when chronic fatigue syndrome begins can be
difficult. See Pet’r’s Reply at 7; Yalacki, 146 Fed. Cl. at 93-94; McCabe, 2018 WL
3029175, at *37. Second, the parties agree that chronic fatigue syndrome is an
appropriate diagnosis for Ms. Zamora. Thus, there is no dispute about diagnosis.
However, a diagnosis of chronic fatigue syndrome on September 26, 2020
does not mean that Ms. Zamora’s chronic fatigue syndrome began on that date.
See Rocha v. Sec’y of Health & Hum. Servs., No. 16-241V, 2024 WL 752787, at
*33 (Fed. Cl. Spec. Mstr. Feb. 1, 2024) (stating “As a matter of logic, a doctor's
detection of a disease does not establish the date the disease began” and citing
appellate cases affirming findings regarding date of onset). Indeed, both experts
maintained that Ms. Zamora began suffering from chronic fatigue syndrome
months and months earlier. Dr. Miglis places onset somewhere between October
and December 2018. Exhibit 19 at 13 cited in Pet’r’s Br. at 51. By contrast, Dr.
17

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Staud places onset before vaccination. Exhibit A at 10-12 cited in Resp’t’s Br. at
41.
In resisting the argument that she suffered from (undiagnosed) chronic
fatigue syndrome before vaccination, Ms. Zamora cites medical records describing
her employment. Pet’r’s Reply at 3, citing Exhibit 4 at 60 (September 6, 2017) and
Exhibit 4 at 68 (Jan. 26, 2018). This is a fair critique of the Secretary’s position.
Yet, the evidence shows that Ms. Zamora continued to work throughout 2019 and
into 2020. This level of activity appears inconsistent with an assertion that Ms.
Zamora was suffering chronic fatigue in October, November, or December 2019.
See McCabe, 2018 WL 3029175, at *58 (questioning onset of chronic fatigue
syndrome when petitioner went to work two days after the alleged onset);
D’Angiolini v. Sec’y of Health & Hum. Servs., No. 99-578V, 2014 WL 1678145,
at *36 (Fed. Cl. Spec. Mstr. Mar. 27, 2014) (noting that petitioner’s extensive
exercise called into question whether petitioner was suffering from chronic fatigue
syndrome), mot. for rev. denied, 122 Fed. Cl. 86 (2005), aff’d without op., 645
Fed. App’x 1002 (Fed. Cir. 2016).
Based upon the existing record, the undersigned declines to make any
finding regarding onset. Ms. Zamora’s lack of success on prong one is dispositive.
However, if the undersigned were required to determine how the evidence
preponderates, the undersigned would be inclined to hold a hearing to receive oral
testimony. See Vaccine Rule 8(a).
B. Althen Prong Two
An analysis of the second Althen prong likewise is not required. As
explained above, Ms. Zamora has not established with persuasive evidence a
theory by which the flu vaccine can cause chronic fatigue syndrome. As such,
prong two does not factor into the outcome. Stricker, 170 Fed. Cl. at 721-22.
Furthermore, whether the sequence of events between the flu vaccine and
the onset of chronic fatigue syndrome is logical depends in part on when her
chronic fatigue syndrome began. See Capizzano v. Sec’y of Health & Hum.
Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (stating evidence can be related to
more than one prong). As set forth in section V.A.2, several questions prohibit an
easy determination about onset. These questions also contribute to a reluctance to
analyze prong two in detail.
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VI. Conclusion
Ms. Zamora’s chronic fatigue syndrome has taken a toll on her, and this
disruption in her health entitles her to sympathy. However, special masters are
required to resolve claims based upon the evidence presented. Ms. Zamora has not
presented evidence of sufficient quality or quantity to establish that the flu vaccine
can cause chronic fatigue syndrome. As such, she is not entitled to compensation.
The Clerk’s Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about filing a motion for
review, including the deadline, can be found in the Vaccine Rules, which are
available on the website for the Court of Federal Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
19

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_21-vv-01414-1
Date issued/filed: 2025-06-26
Pages: 7
Docket text: REPORTED opinion and order reissuing 92 of sealed opinion and order denying 87 Petitioner's Motion for Review. Signed by Senior Judge Loren A. Smith. (ajd) Service on parties made.
--------------------------------------------------------------------------------
Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 1 of 7
In the United States Court of Federal Claims
No. 21-1414V
(Filed Under Seal: May 28, 2025)1
Filed: June 26, 2025
)
ISABEL ZAMORA, )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
OPINION & ORDER
Courtney Christine Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for petitioner.
Naseem Kourosh, Vaccine/Torts Branch, Civil Division, United States Department of
Justice, Washington, D.C., for respondent.
SMITH, Senior Judge
Petitioner, Ms. Isabel Zamora, who suffers from chronic fatigue syndrome that
she links to an October 8, 2019, influenza vaccination, appeals Special Master Christian
J. Moran’s decision denying compensation under the National Vaccine Injury
Compensation Program. See generally Motion for Review, ECF No. 87. To her,
Special Master Moran’s factual determinations were arbitrary and capricious under
prongs one and three of Althen v. Sec’y of Dep’t of Health & Hum. Servs.’ liability
evaluation. 418 F.3d 1274, 1278 (Fed. Cir. 2005). On prong one, causation, she
contends that Special Master Moran applied a heightened and incorrect standard—of
definitive scientific certainty—to her vaccine injury causation theory, instead of the
correct preponderance of the evidence standard. See Memorandum in Support of
Petitioner’s Motion for Review at 5–6, ECF No. 88 [hereinafter Pet.’s Mem.]. For
prong three, medically acceptable timeframe, she asserts that Special Master Moran
incorrectly determined that Ms. Zamora’s proffered expert evidence failed to establish a
creditable connection between her injury and the vaccination. Id. at 15–17.
1 This opinion was issued under seal on May 28, 2025. The parties were given an opportunity to propose
redactions before public release, but no such proposals were made.

Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 2 of 7
Neither argument has merit. Special Master Moran did not apply any heightened
standard to Ms. Zamora. Rather, she simply failed to prove her case and is, in essence,
now hoping the Court will “second guess the Special Masters fact-intensive
conclusions,” despite having previously had ample opportunity to use any fact, expert,
and law to establish her case. Hodges v. Sec’y of Dep’t of Health & Hum. Servs., 9
F.3d 958, 961 (Fed. Cir. 1993). That being so, the Court affirms the below decision.
Ms. Zamora’s Motion for Review, ECF No. 87, is denied.
I
On October 8, 2019, Ms. Zamora, a resident of the State of California, received
the at-issue Flulaval influenza vaccination from her primary medical care physicians at
Salud Para Le Gente. See Special Master’s Decision at 2, ECF No. 85 [hereinafter
Decision]. Flulaval vaccinations contain an inactive form of the influenza virus. Id.
Soon after the vaccination, Ms. Zamora began experiencing headaches and fatigue. Id.
at 3. Then on November 4, 2019, “everything was different”: Ms. Zamora woke up to
a very intense headache causing her to have a “sensation [of] being in another
dimension,” making her feel “dizzy, confused and scared.” Id. (internal quotation
marks and citation omitted).
After a trip to visit her mother in Mexico between November 16, 2019, to
December 9, 2019, Ms. Zamora scheduled an appointment with her primary care
physician on January 2, 2020, to discuss her symptoms. Id. At this appointment with
nurse practitioner RoseMarie Sandoval, Ms. Zamora complained of headaches dizziness
and blurry vision. Id. Nurse practitioner Sandoval diagnosed Ms. Zamora with
adjustment disorder intermixed with anxiety and recommended that Ms. Zamora seek
therapy. Id. But Ms. Zamora’s headaches and fatigue did not recede—thus making
work difficult—and by March 2020, during the coronavirus pandemic, she did not go to
work at all. Id. at 3–4. In April 2020, she applied for unemployment based on the risks
of contracting the coronavirus at her workplace, but was denied. Id. at 4. Soon after,
she quit her job. Id. These records do not mention an illness, and she was not
evaluated by any medical physicians during this period. Id.
In May 2020, Ms. Zamora returned to work. Id. But she quit her job again on
June 6, 2020, because her “headaches were getting more and more intense.” Id.
(internal quotation marks and citation omitted). Moreover, her “legs and arms had no
energy, [her] tongue did not have the normal movement[, and she] could talk but . . .
had difficulty moving it and [her] fingers were numb.” Id. (internal quotation marks and
citation omitted). In June 2020, Ms. Zamora reapplied for benefits and the State of
California’s Unemployment Office approved her application; she received those
benefits for “about one year.” Id.
In June 2020, “[a]pproximately eight months after” her influenza vaccination,
Ms. Zamora elected to see medical professionals again at Salud Para La Gente. Id.
Physician assistant, Alicia Potes, evaluated Ms. Zamora. Id. To physician assistant
Potes, Ms. Zamora reported bilateral hand cramping—and, for the first time, linked her
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Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 3 of 7
symptoms, of generalized headaches and fatigue, as starting after her October 2019
influenza vaccination. Id. At the examination, however, Ms. Zamora had normal
cognitive function, despite being depressed with a flat affect. Id. Physician assistant
Potes diagnosed Ms. Zamora with “headache syndrome, depression and pain,” and
referred Ms. Zamora to a neurologist. Id.
Over the following three months in 2020, Ms. Zamora saw a variety of medical
professionals. Id. Relevant here is Ms. Zamora’s appointment on September 26, 2020,
with physician assistant Caitlin Casey, who diagnosed Ms. Zamora with chronic fatigue
syndrome and supported Ms. Zamora’s application of disability benefits based on this
diagnosis. Id. at 5. On June 1, 2021, and relying on this diagnosis, Ms. Zamora
petitioned for compensation under the National Vaccine Injury Compensation Program.2
See generally Petition, ECF No. 1.
II
On March 19, 2025, Special Master Moran issued his decision denying
compensation to Ms. Zamora for her claim that her chronic fatigue syndrome was
caused by her October 8, 2019, influenza vaccination. See generally Decision. In so
holding, along with the petitioner’s medical records, Special Master Moran reviewed
both Ms. Zamora’s expert, Dr. Mitchell Miglis, and respondent’s expert, Dr. Roland
Staud, reports. Id. at 1, 7–8. Ms. Zamora filed both an initial and rebuttal report
written by Dr. Miglis, whereas the respondent filed one report written by Dr. Staud. Id.
at 7–8.
Dr. Miglis’s Initial Report. Dr. Miglis is a neurologist. Id. at 1. For his initial
report, he reviewed Ms. Zamora’s medical reports, and determined that she suffers from
chronic fatigue syndrome, which originated in early October 2019, or as late as
December 2019, and was likely caused by her October 8, 2019, influenza vaccination.
Id. at 7. While uncertain about how influenza vaccinations can induce chronic fatigue
syndrome, he presumes the origin is one of “molecular mimicry.” Id. (internal
quotation marks omitted).
Dr. Staud’s Expert Report. Dr. Staud is a rheumatologist. Id. at 1. For his
report, Dr. Staud challenged Dr. Miglis’s contention that the influenza vaccination
caused Ms. Zamora’s chronic fatigue syndrome. Id. at 7. Instead, Dr. Staud points to
the onset of symptoms associated with the syndrome prior to the vaccination itself. Id.
Moreover, Dr. Staud also asserts that there is no scientifically proven connection
between influenza vaccination and chronic fatigue syndrome. Id.
Dr. Miglis’s Rebuttal Report. In his rebuttal report, Dr. Miglis “essentially
maintained the opinions that he had expressed previously.” Id. This report was the last
expert disclosure. Id. at 8.
2 Later in the litigation, the Ms. Zamora was given the opportunity to change her claimed injury to a claim
that the influenza vaccination “significantly aggravated (as opposed to caused) her chronic fatigue syndrome,” but
she chose not to pursue this nudge by the Office of Special Masters. See Decision at 7–8.
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Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 4 of 7
III
On April 16, 2025, Ms. Zamora moved for review of Special Master Moran’s
decision. See generally Motion for Review, ECF No. 87. That same day, she filed her
Memorandum in Support of her Motion to Review. See generally Pet.’s Mot. On May
13, 2025, respondent filed its response in opposition to Ms. Zamora’s Motion for
Review. See generally Respondent’s Response in Opposition to the Motion for
Review, ECF No. 90 [hereinafter Resp’t’s Mot.]. The Court elects to issue its decision
on the papers.
IV
Under the Vaccine Act, this Court reviews a Special Master’s decision upon the
timely request of either party. 42 U.S.C. § 300aa-12(e)(1)–(2). In reviewing such a
request, this Court may:
(A) uphold the findings of fact and conclusions of law . . . ,
(B) set aside any findings of fact or conclusion of law . . . found to be
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law . . . , or
(C) remand the petition to the special master for further action in
accordance with the court’s direction.
Id. § 300aa-12(e)(2)(A)–(C). “Fact findings are reviewed . . . 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.” Munn v. Sec’y of
Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The Court,
however, cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder v. Sec’y of Health & Hum. Servs.,
88 Fed. Cl. 706, 718 (2009). Instead, if a special master’s decision is “based on
evidence in the record that [is] not wholly implausible, [the Court is] compelled to
uphold that finding as not being arbitrary or capricious,” Cedillo v. Sec’y of Health &
Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010), because the Court will neither
relitigate the factual record nor “assess whether the special master correctly evaluated
the evidence, or examine the probative value of the evidence or the credibility of the
witnesses,” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir.
2011). In turn, “if the special master has considered the relevant evidence of record,
drawn plausible inferences and articulated a rational basis for the decision,” the Court
will rarely find reversible error.
Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (internal
quotation marks omitted).
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Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 5 of 7
V
Ms. Zamora makes two arguments in favor of reversing Special Master Moran’s
decision under prongs one and three of Althen v. HHS’s liability evaluation. See
generally Pet.’s Mem. Both are meritless.
Prong One: Causation. For prong one’s causation analysis, Ms. Zamora asserts
that Special Master Moran applied a heightened and incorrect standard—of definitive
scientific certainty—to her vaccine injury causation theory, instead of the correct
preponderance of the evidence standard established by Althen. See Pet.’s Mem. at 5–6.
This assertion is simply wrong for two key reasons.
First, Ms. Zamora’s own evidence concludes the influenza vaccination does not
cause chronic fatigue syndrome; or, worse, the studies that her expert, Dr. Miglis, relied
upon to support Ms. Zamora’s claim did not evaluate influenza vaccination risks but
rather human papilloma virus vaccination risks—and even that study “did not find an
increased risk of chronic fatigue syndrome.” Decision at 9–12. The Court will not
reopen a closed record when the record clearly does not support—indeed, completely
undermines—a petitioner’s cause-of-action in the original forum, for the Court is
always compelled to uphold a special master’s decision when it is “based on evidence
in the record that [is] not wholly implausible.” Cedillo, 617 F.3d at 1338. When a
petitioner’s own evidence does not support the claimed injury, it is obviously not
implausible to hold that compensation for that injury is unwarranted.
Second, Ms. Zamora’s reliance upon previous caselaw where the Office of
Special Masters found that an influenza infection could cause chronic fatigue syndrome
is equally unavailing because an influenza infection and an inactive influenza virus
vaccination, such as the at-issue Flulaval dose, are not the same thing. See Pet.’s Mem.
at 6–8. As Special Master Moran found and all the caselaw identified by Ms. Zamora
confirms, influenza infections replicate and Flulaval’s inactive virus does not. Decision
at 10–11. Nor does Ms. Zamora provide any evidence to dispute the scientific and legal
consensus—in fact, once again, the evidence provided by the parties “tend[s] to
exonerate the [in]flu[enza] vaccine as a potential cause of chronic fatigue syndrome.”
Id. at 11. Accordingly, by evaluating the very evidence provided by Ms. Zamora and
others, Special Master Moran was holding Ms. Zamora to the minimum standard of
causation; or as Special Master Moran correctly held: a “special master may properly
require some empirical evidence to show that a particular vaccine can cause a particular
disease.” Id. at 13. In no way is that standard one of heightened scientific certainty. It
is hornbook vaccine causation analysis. E.g., Grant v. Sec’y of Dep’t of Health & Hum.
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (“Causation in fact requires proof of a
logical sequence of cause and effect showing that the vaccination was the reason for the
injury. A reputable medical or scientific explanation must support this logical
sequence of cause and effect.” (emphasis added)).
Prong three: Medically Acceptable Timeframe. For prong three’s medically
acceptable timeframe analysis, Ms. Zamora argues that Special Master Moran
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Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 6 of 7
incorrectly determined that Ms. Zamora’s proffered expert evidence failed to establish a
credible connection between her injury and the vaccination under Althen. See Pet.’s
Mem. at 15–17. This position is incorrect and a mischaracterization of Special Master
Moran’s decision.
Both petitioner and respondent’s experts agree that “Ms. Zamora began suffering
chronic fatigue syndrome months” prior to her influenza vaccination. Decision at 17.
Indeed, Ms. Zamora’s expert, Dr. Miglis, “places onset somewhere between October
and December 2018”—a full year before her October 8, 2019, at-issue vaccination. Id.
at 2, 17. Special Master Moran therefore correctly determined that the parties agree on
the symptom onset window, and that window came long before Ms. Zamora’s Flulaval
dose.
Still, while a judicial conclusion where the parties agree is rarely arbitrary and
capricious, Ms. Zamora maintains that her expert believes “that [an] acceptable window
includes October of 2019,” so Special Master Moran should have accepted that date
over the 2018 onset window. Pet.’s Mem. at 17. Even assuming this position is
correct, “a proximate temporal association alone does not suffice to show a causal link
between the vaccination and the injury.” Grant, 956 F.2d at 1148. Rather,
contemporaneous evidence of her condition is the gold standard to establish a medically
acceptable timeframe for vaccine claims. E.g., Moberly ex rel. Moberly v. Sec'y of
Health & Hum. Servs., 592 F.3d 1315, 1323 (Fed. Cir. 2010). For instance, in Moberly,
the United States Court of Appeals for the Federal Circuit upheld a denial of causation
under Althen prong three because no contemporaneous treating physician diagnosed a
link between the claimant’s symptoms and the vaccination itself. Id.
The same is true here. Ms. Zamora’s physicians thought that she suffered from
depression or a flat affect, not fatigue syndrome. Decision at 4–5. In fact, not a single
physician diagnosed her with fatigue syndrome until almost a year after the at-issue
influenza vaccination. Id. at 4. And even Dr. Casey’s September 2020 diagnosis of
chronic fatigue syndrome was in support of a disability application, not in search of
whether a previous vaccination caused the current illness. Id. at 5. Like the Federal
Circuit in Moberly, the Court finds this evidence to be too “speculative” to support Dr.
Miglis’s possible 2019 onset window. Moberly ex rel. Moberly, 592 F.3d at 1323.
Special Masters are not required to take a petitioner’s inconsistent opinions at face
value. Nonetheless, because the parties agree on a pre-vaccination onset of symptoms
anyway, the Court does “not find that determination to be arbitrary or capricious.” Id.
at 1324.
VI
Litigants are reminded that appeals are not generally for lifting the curtain on a
closed record; cases are to be proven at their proper juncture. Ms. Zamora’s chance
was at the Office of Special Masters, and Special Master Moran correctly held her to all
applicable standards. The decision below, ECF No. 85, is AFFIRMED. The Motion
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Case 1:21-vv-01414-LAS Document 98 Filed 06/26/25 Page 7 of 7
for Review, ECF No. 87, is DENIED. The Clerk of Court is directed to enter judgment
accordingly.
IT IS SO ORDERED.
Loren A. Smith
s/
Loren A. Smith,
Senior Judge
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================================================================================
DOCUMENT 3: USCOURTS-cofc-1_21-vv-01414-2
Date issued/filed: 2025-06-26
Pages: 7
Docket text: d by Senior Judge Loren A. Smith. (aoc) Service on parties made. **RE-DOCKETED FOR POSTING TO THE COURT'S WEBSITE.** JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 98 Reported Opinion and Order reissuing 92 of sealed opinion and order denying 87 Petitioner's Motion for Review. Signe
--------------------------------------------------------------------------------
Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 1 of 7
In the United States Court of Federal Claims
No. 21-1414V
(Filed Under Seal: May 28, 2025)1
Filed: June 26, 2025
)
ISABEL ZAMORA, )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
OPINION & ORDER
Courtney Christine Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for petitioner.
Naseem Kourosh, Vaccine/Torts Branch, Civil Division, United States Department of
Justice, Washington, D.C., for respondent.
SMITH, Senior Judge
Petitioner, Ms. Isabel Zamora, who suffers from chronic fatigue syndrome that
she links to an October 8, 2019, influenza vaccination, appeals Special Master Christian
J. Moran’s decision denying compensation under the National Vaccine Injury
Compensation Program. See generally Motion for Review, ECF No. 87. To her,
Special Master Moran’s factual determinations were arbitrary and capricious under
prongs one and three of Althen v. Sec’y of Dep’t of Health & Hum. Servs.’ liability
evaluation. 418 F.3d 1274, 1278 (Fed. Cir. 2005). On prong one, causation, she
contends that Special Master Moran applied a heightened and incorrect standard—of
definitive scientific certainty—to her vaccine injury causation theory, instead of the
correct preponderance of the evidence standard. See Memorandum in Support of
Petitioner’s Motion for Review at 5–6, ECF No. 88 [hereinafter Pet.’s Mem.]. For
prong three, medically acceptable timeframe, she asserts that Special Master Moran
incorrectly determined that Ms. Zamora’s proffered expert evidence failed to establish a
creditable connection between her injury and the vaccination. Id. at 15–17.
1 This opinion was issued under seal on May 28, 2025. The parties were given an opportunity to propose
redactions before public release, but no such proposals were made.

Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 2 of 7
Neither argument has merit. Special Master Moran did not apply any heightened
standard to Ms. Zamora. Rather, she simply failed to prove her case and is, in essence,
now hoping the Court will “second guess the Special Masters fact-intensive
conclusions,” despite having previously had ample opportunity to use any fact, expert,
and law to establish her case. Hodges v. Sec’y of Dep’t of Health & Hum. Servs., 9
F.3d 958, 961 (Fed. Cir. 1993). That being so, the Court affirms the below decision.
Ms. Zamora’s Motion for Review, ECF No. 87, is denied.
I
On October 8, 2019, Ms. Zamora, a resident of the State of California, received
the at-issue Flulaval influenza vaccination from her primary medical care physicians at
Salud Para Le Gente. See Special Master’s Decision at 2, ECF No. 85 [hereinafter
Decision]. Flulaval vaccinations contain an inactive form of the influenza virus. Id.
Soon after the vaccination, Ms. Zamora began experiencing headaches and fatigue. Id.
at 3. Then on November 4, 2019, “everything was different”: Ms. Zamora woke up to
a very intense headache causing her to have a “sensation [of] being in another
dimension,” making her feel “dizzy, confused and scared.” Id. (internal quotation
marks and citation omitted).
After a trip to visit her mother in Mexico between November 16, 2019, to
December 9, 2019, Ms. Zamora scheduled an appointment with her primary care
physician on January 2, 2020, to discuss her symptoms. Id. At this appointment with
nurse practitioner RoseMarie Sandoval, Ms. Zamora complained of headaches dizziness
and blurry vision. Id. Nurse practitioner Sandoval diagnosed Ms. Zamora with
adjustment disorder intermixed with anxiety and recommended that Ms. Zamora seek
therapy. Id. But Ms. Zamora’s headaches and fatigue did not recede—thus making
work difficult—and by March 2020, during the coronavirus pandemic, she did not go to
work at all. Id. at 3–4. In April 2020, she applied for unemployment based on the risks
of contracting the coronavirus at her workplace, but was denied. Id. at 4. Soon after,
she quit her job. Id. These records do not mention an illness, and she was not
evaluated by any medical physicians during this period. Id.
In May 2020, Ms. Zamora returned to work. Id. But she quit her job again on
June 6, 2020, because her “headaches were getting more and more intense.” Id.
(internal quotation marks and citation omitted). Moreover, her “legs and arms had no
energy, [her] tongue did not have the normal movement[, and she] could talk but . . .
had difficulty moving it and [her] fingers were numb.” Id. (internal quotation marks and
citation omitted). In June 2020, Ms. Zamora reapplied for benefits and the State of
California’s Unemployment Office approved her application; she received those
benefits for “about one year.” Id.
In June 2020, “[a]pproximately eight months after” her influenza vaccination,
Ms. Zamora elected to see medical professionals again at Salud Para La Gente. Id.
Physician assistant, Alicia Potes, evaluated Ms. Zamora. Id. To physician assistant
Potes, Ms. Zamora reported bilateral hand cramping—and, for the first time, linked her
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Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 3 of 7
symptoms, of generalized headaches and fatigue, as starting after her October 2019
influenza vaccination. Id. At the examination, however, Ms. Zamora had normal
cognitive function, despite being depressed with a flat affect. Id. Physician assistant
Potes diagnosed Ms. Zamora with “headache syndrome, depression and pain,” and
referred Ms. Zamora to a neurologist. Id.
Over the following three months in 2020, Ms. Zamora saw a variety of medical
professionals. Id. Relevant here is Ms. Zamora’s appointment on September 26, 2020,
with physician assistant Caitlin Casey, who diagnosed Ms. Zamora with chronic fatigue
syndrome and supported Ms. Zamora’s application of disability benefits based on this
diagnosis. Id. at 5. On June 1, 2021, and relying on this diagnosis, Ms. Zamora
petitioned for compensation under the National Vaccine Injury Compensation Program.2
See generally Petition, ECF No. 1.
II
On March 19, 2025, Special Master Moran issued his decision denying
compensation to Ms. Zamora for her claim that her chronic fatigue syndrome was
caused by her October 8, 2019, influenza vaccination. See generally Decision. In so
holding, along with the petitioner’s medical records, Special Master Moran reviewed
both Ms. Zamora’s expert, Dr. Mitchell Miglis, and respondent’s expert, Dr. Roland
Staud, reports. Id. at 1, 7–8. Ms. Zamora filed both an initial and rebuttal report
written by Dr. Miglis, whereas the respondent filed one report written by Dr. Staud. Id.
at 7–8.
Dr. Miglis’s Initial Report. Dr. Miglis is a neurologist. Id. at 1. For his initial
report, he reviewed Ms. Zamora’s medical reports, and determined that she suffers from
chronic fatigue syndrome, which originated in early October 2019, or as late as
December 2019, and was likely caused by her October 8, 2019, influenza vaccination.
Id. at 7. While uncertain about how influenza vaccinations can induce chronic fatigue
syndrome, he presumes the origin is one of “molecular mimicry.” Id. (internal
quotation marks omitted).
Dr. Staud’s Expert Report. Dr. Staud is a rheumatologist. Id. at 1. For his
report, Dr. Staud challenged Dr. Miglis’s contention that the influenza vaccination
caused Ms. Zamora’s chronic fatigue syndrome. Id. at 7. Instead, Dr. Staud points to
the onset of symptoms associated with the syndrome prior to the vaccination itself. Id.
Moreover, Dr. Staud also asserts that there is no scientifically proven connection
between influenza vaccination and chronic fatigue syndrome. Id.
Dr. Miglis’s Rebuttal Report. In his rebuttal report, Dr. Miglis “essentially
maintained the opinions that he had expressed previously.” Id. This report was the last
expert disclosure. Id. at 8.
2 Later in the litigation, the Ms. Zamora was given the opportunity to change her claimed injury to a claim
that the influenza vaccination “significantly aggravated (as opposed to caused) her chronic fatigue syndrome,” but
she chose not to pursue this nudge by the Office of Special Masters. See Decision at 7–8.
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Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 4 of 7
III
On April 16, 2025, Ms. Zamora moved for review of Special Master Moran’s
decision. See generally Motion for Review, ECF No. 87. That same day, she filed her
Memorandum in Support of her Motion to Review. See generally Pet.’s Mot. On May
13, 2025, respondent filed its response in opposition to Ms. Zamora’s Motion for
Review. See generally Respondent’s Response in Opposition to the Motion for
Review, ECF No. 90 [hereinafter Resp’t’s Mot.]. The Court elects to issue its decision
on the papers.
IV
Under the Vaccine Act, this Court reviews a Special Master’s decision upon the
timely request of either party. 42 U.S.C. § 300aa-12(e)(1)–(2). In reviewing such a
request, this Court may:
(A) uphold the findings of fact and conclusions of law . . . ,
(B) set aside any findings of fact or conclusion of law . . . found to be
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law . . . , or
(C) remand the petition to the special master for further action in
accordance with the court’s direction.
Id. § 300aa-12(e)(2)(A)–(C). “Fact findings are reviewed . . . 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.” Munn v. Sec’y of
Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The Court,
however, cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder v. Sec’y of Health & Hum. Servs.,
88 Fed. Cl. 706, 718 (2009). Instead, if a special master’s decision is “based on
evidence in the record that [is] not wholly implausible, [the Court is] compelled to
uphold that finding as not being arbitrary or capricious,” Cedillo v. Sec’y of Health &
Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010), because the Court will neither
relitigate the factual record nor “assess whether the special master correctly evaluated
the evidence, or examine the probative value of the evidence or the credibility of the
witnesses,” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir.
2011). In turn, “if the special master has considered the relevant evidence of record,
drawn plausible inferences and articulated a rational basis for the decision,” the Court
will rarely find reversible error.
Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (internal
quotation marks omitted).
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Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 5 of 7
V
Ms. Zamora makes two arguments in favor of reversing Special Master Moran’s
decision under prongs one and three of Althen v. HHS’s liability evaluation. See
generally Pet.’s Mem. Both are meritless.
Prong One: Causation. For prong one’s causation analysis, Ms. Zamora asserts
that Special Master Moran applied a heightened and incorrect standard—of definitive
scientific certainty—to her vaccine injury causation theory, instead of the correct
preponderance of the evidence standard established by Althen. See Pet.’s Mem. at 5–6.
This assertion is simply wrong for two key reasons.
First, Ms. Zamora’s own evidence concludes the influenza vaccination does not
cause chronic fatigue syndrome; or, worse, the studies that her expert, Dr. Miglis, relied
upon to support Ms. Zamora’s claim did not evaluate influenza vaccination risks but
rather human papilloma virus vaccination risks—and even that study “did not find an
increased risk of chronic fatigue syndrome.” Decision at 9–12. The Court will not
reopen a closed record when the record clearly does not support—indeed, completely
undermines—a petitioner’s cause-of-action in the original forum, for the Court is
always compelled to uphold a special master’s decision when it is “based on evidence
in the record that [is] not wholly implausible.” Cedillo, 617 F.3d at 1338. When a
petitioner’s own evidence does not support the claimed injury, it is obviously not
implausible to hold that compensation for that injury is unwarranted.
Second, Ms. Zamora’s reliance upon previous caselaw where the Office of
Special Masters found that an influenza infection could cause chronic fatigue syndrome
is equally unavailing because an influenza infection and an inactive influenza virus
vaccination, such as the at-issue Flulaval dose, are not the same thing. See Pet.’s Mem.
at 6–8. As Special Master Moran found and all the caselaw identified by Ms. Zamora
confirms, influenza infections replicate and Flulaval’s inactive virus does not. Decision
at 10–11. Nor does Ms. Zamora provide any evidence to dispute the scientific and legal
consensus—in fact, once again, the evidence provided by the parties “tend[s] to
exonerate the [in]flu[enza] vaccine as a potential cause of chronic fatigue syndrome.”
Id. at 11. Accordingly, by evaluating the very evidence provided by Ms. Zamora and
others, Special Master Moran was holding Ms. Zamora to the minimum standard of
causation; or as Special Master Moran correctly held: a “special master may properly
require some empirical evidence to show that a particular vaccine can cause a particular
disease.” Id. at 13. In no way is that standard one of heightened scientific certainty. It
is hornbook vaccine causation analysis. E.g., Grant v. Sec’y of Dep’t of Health & Hum.
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (“Causation in fact requires proof of a
logical sequence of cause and effect showing that the vaccination was the reason for the
injury. A reputable medical or scientific explanation must support this logical
sequence of cause and effect.” (emphasis added)).
Prong three: Medically Acceptable Timeframe. For prong three’s medically
acceptable timeframe analysis, Ms. Zamora argues that Special Master Moran
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Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 6 of 7
incorrectly determined that Ms. Zamora’s proffered expert evidence failed to establish a
credible connection between her injury and the vaccination under Althen. See Pet.’s
Mem. at 15–17. This position is incorrect and a mischaracterization of Special Master
Moran’s decision.
Both petitioner and respondent’s experts agree that “Ms. Zamora began suffering
chronic fatigue syndrome months” prior to her influenza vaccination. Decision at 17.
Indeed, Ms. Zamora’s expert, Dr. Miglis, “places onset somewhere between October
and December 2018”—a full year before her October 8, 2019, at-issue vaccination. Id.
at 2, 17. Special Master Moran therefore correctly determined that the parties agree on
the symptom onset window, and that window came long before Ms. Zamora’s Flulaval
dose.
Still, while a judicial conclusion where the parties agree is rarely arbitrary and
capricious, Ms. Zamora maintains that her expert believes “that [an] acceptable window
includes October of 2019,” so Special Master Moran should have accepted that date
over the 2018 onset window. Pet.’s Mem. at 17. Even assuming this position is
correct, “a proximate temporal association alone does not suffice to show a causal link
between the vaccination and the injury.” Grant, 956 F.2d at 1148. Rather,
contemporaneous evidence of her condition is the gold standard to establish a medically
acceptable timeframe for vaccine claims. E.g., Moberly ex rel. Moberly v. Sec'y of
Health & Hum. Servs., 592 F.3d 1315, 1323 (Fed. Cir. 2010). For instance, in Moberly,
the United States Court of Appeals for the Federal Circuit upheld a denial of causation
under Althen prong three because no contemporaneous treating physician diagnosed a
link between the claimant’s symptoms and the vaccination itself. Id.
The same is true here. Ms. Zamora’s physicians thought that she suffered from
depression or a flat affect, not fatigue syndrome. Decision at 4–5. In fact, not a single
physician diagnosed her with fatigue syndrome until almost a year after the at-issue
influenza vaccination. Id. at 4. And even Dr. Casey’s September 2020 diagnosis of
chronic fatigue syndrome was in support of a disability application, not in search of
whether a previous vaccination caused the current illness. Id. at 5. Like the Federal
Circuit in Moberly, the Court finds this evidence to be too “speculative” to support Dr.
Miglis’s possible 2019 onset window. Moberly ex rel. Moberly, 592 F.3d at 1323.
Special Masters are not required to take a petitioner’s inconsistent opinions at face
value. Nonetheless, because the parties agree on a pre-vaccination onset of symptoms
anyway, the Court does “not find that determination to be arbitrary or capricious.” Id.
at 1324.
VI
Litigants are reminded that appeals are not generally for lifting the curtain on a
closed record; cases are to be proven at their proper juncture. Ms. Zamora’s chance
was at the Office of Special Masters, and Special Master Moran correctly held her to all
applicable standards. The decision below, ECF No. 85, is AFFIRMED. The Motion
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Case 1:21-vv-01414-LAS Document 102 Filed 06/26/25 Page 7 of 7
for Review, ECF No. 87, is DENIED. The Clerk of Court is directed to enter judgment
accordingly.
IT IS SO ORDERED.
Loren A. Smith
s/
Loren A. Smith,
Senior Judge
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