Barrett v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 22-258V

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MYRTLE BARRETT, * Chief Special Master Corcoran

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*

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Petitioner, * Filed: September 12, 2024

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v. *

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SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

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Respondent. *

*

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David Proffitt, Proffitt & Cox, LLP, Columbia, SC, for Petitioner.

Naseem Kourosh, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DISMISSING CASE

On March 7, 2022, Myrtle Barrett filed a petition for compensation under the National

Vaccine Injury Compensation Program (the “Program”),1 ECF No. 1 (“Petition”), later amending

her claim (ECF No. 23). Petitioner alleges that she suffered from myasthenia gravis (“MG”)

resulting from Tetanus-diphtheria-acellular pertussis (“Tdap”), and/or pneumococcal

polysaccharide vaccines received on July 21, 2021. She also contended she experienced the Table

claim of a shoulder injury related to vaccine administration (“SIRVA”) in both shoulders resulting

from the administration of both vaccines.

Respondent filed a Motion to Dismiss on December 5, 2023, arguing that Petitioner cannot

show a medically acceptable temporal relationship between her vaccination(s) and the onset of her

MG symptoms as required under prong three of Althen v. Sec’y of Health & Hum. Servs., 418 F.3d

1274 (Fed. Cir. 2005). ECF No. 44 (“Mot. to Dismiss”). Respondent also claims that Petitioner

1

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

100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).

All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

cannot show the onset of pain within 48 hours of a covered vaccination, as required for a SIRVA

claim under the Vaccine Injury Table, 42 U.S.C. §100.3. Petitioner thereafter filed a Motion for a

Ruling on the Record and a Response in Opposition to Respondent’s Motion to Dismiss on March

28, 2024. ECF No. 47 (“Opp.”). Petitioner seeks only to defend her claim that the Tdap vaccine

(possibly in concert with the noncovered version of pneumococcal vaccine she received) caused

her to develop MG, acknowledging that the alleged SIRVA claim is not compensable (and hence

that aspect of the claim has been abandoned).2

Having reviewed the parties’ submissions, I hereby determine (as discussed below) that

Petitioner's symptoms did not develop within a medically acceptable timeframe for causation. For

this reason, Respondent’s Motion to Dismiss is granted.

I. Factual Background

Ms. Barrett’s pre-vaccination medical history includes chronic epigastric pain and diarrhea,

atrial and paroxysmal atrial fibrillation, seizure, restless leg syndrome, migraine, anxiety,

depression, chronic anemia, hypercholesterolemia, renal insufficiency, vitamin B12 deficiency,

hearing impairment, knee arthritis, left breast surgery, hysterectomy, cholecystectomy, and right

and left total knee replacements. Ex. 2 at 4, 32-33, 78; Ex. 7 at 76; Ex. 19 at 10; Ex. 21 at 7-9. On

July 21, 2021, Petitioner (then 85 years old) received a Tdap vaccine, administered intramuscularly

in her right deltoid, and a Pneumovax 23 vaccine (not the version covered by the Program) in her

left deltoid during an annual exam with Huong Phan, M.D., her primary care physician (“PCP”).

Ex. 2 at 75-76, 88-89. There is no medical record evidence of any claimed immediate vaccine

reaction.

Petitioner’s symptoms first arose three months later, on October 28, 2021, when she

checked in to urgent care, complaining of pain in both her arms and neck. Ex. 3 at 2. Petitioner

also reported that over the prior week she had experienced weak spells that caused her legs to give

way. Id. An x-ray of the cervical spine showed mild degenerative changes but was overall

unremarkable. Id. at 5. The impression was cervical spine arthralgia and a pinched nerve, and

Petitioner was advised to take Tylenol and follow up with her PCP. Id. at 4.

On November 1, 2021, Petitioner returned to Dr. Phan, reporting that over the previous few

weeks she had been experiencing neck pain, left shoulder pain, and bilateral leg weakness. Ex. 2

at 103. A musculoskeletal exam showed limited left shoulder range of motion (“ROM”) and

2

As Petitioner admits, the version of the pneumococcal vaccine she received in her left shoulder is not covered by the

Program. And a right shoulder injury due to the covered Tdap vaccine would not be compensable because medical

records show that she did not experience pain and disability in her right shoulder until October 2021 – three months

post-vaccination, and therefore well outside the 48-hour period required for a SIRVA.

2

negative straight leg raise, but no shoulder swelling, good cervical and lumbar spine ROM, and

equal strength and sensation in the upper extremities. Id. at 106. The physical exam was otherwise

normal, and Petitioner was referred to neurology. Id. at 104-05.

A few weeks later, on November 19, 2021, Petitioner saw neurologist Dr. Marck Lencke,

informing him that she had developed swelling and pain after receiving the Tdap vaccine. Ex. 5 at

2. She also reported that she had an episode four weeks prior in which she experienced sudden

weakness in both legs that lasted for approximately ten minutes and resolved spontaneously. Id.

She further reported a few weeks of urinary incontinence. Id. A detailed neurological exam showed

absent Achilles reflexes but was otherwise normal. Id. at 4-6. A cervical spine MRI showed

multilevel arthritic changes as well as multilevel moderate to severe spinal cord narrowing, but no

cord compression or abnormal cord signal. Id. at 10.

There is a six-week records gap before Ms. Barrett again sought medical care. On January

8, 2022, she presented to Dr. Mandev Guram (internal medicine) to establish care. Ex. 4 at 2. Her

physical exam was normal, and Dr. Guram ordered labs. Id. at 5. A few weeks later, on January

26, 2022, Petitioner returned to Dr. Guram, reporting several months of pain in multiple joints,

which she described as aching and intermittent. Id. at 9. Based on the results of the labs, Dr. Guram

diagnosed Petitioner with chronic kidney disease stage 3b. Id. Dr. Guram’s assessment included

unspecified joint and shoulder pain. Id. at 14.

On February 14, 2022, Petitioner complained to Dr. Guram about lower back pain that she

reported had begun two weeks earlier. Ex. 4 at 16. She was referred to physical therapy (“PT”).

Id. at 19. One week later, on February 22, 2022, Petitioner underwent a PT evaluation for lower

extremity weakness and lower back pain and stiffness, that she stated began “in the last year” and

“seemed to have gotten worse after reports of getting a series of vaccinations.” Ex. 14 at 37.

Throughout February and March 2022, Petitioner continued to report lower back pain, leg

pain, right arm pain, and pain in multiple joints. Ex. 14 at 37; Ex. 7 at 35; Ex. 4 at 31. In April

2022, Petitioner requested to be discharged from PT. Ex. 14 at 5-6. On April 7, 2022, Petitioner

reported to Dr. Guram for left shoulder pain. Ex. 4 at 36. She explained that her symptoms had

improved with PT, but had not completely resolved, and Dr. Guram said they could discuss steroid

injections. Ex. 4 at 36, 41.

On April 29, 2022, Petitioner saw ophthalmologist Dr. Robert Edwards, complaining of

double vision after she had fallen two days prior and hit the right side of her head. Ex. 15 at 6. Dr.

Edwards’s assessment was sixth nerve palsy, and he directed Petitioner to report to the emergency

department for an MRI of her head and orbits. Id. at 7. The next day, on April 30, 2022, Petitioner

was discharged home with a diagnosis of double vision due to refractory versus extraocular nerve

weakness. Ex. 8 at 17-18.

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Throughout May 2022, Petitioner continued to report double vision and generalized

weakness, and was prescribed steroids. Ex. 9 at 10. On May 4, 2022, Dr. Powell conducted a

physical exam of Petitioner’s shoulders and diagnosed her with post-traumatic left shoulder pain

with a probable rotator cuff tear. Ex. 7 at 6. On May 7, 2022, Petitioner returned to the emergency

department for left-sided weakness and difficulty swallowing and speaking. Ex. 9 at 36-37. She

also stated that she had been experiencing more profound weakness plus speaking and word-

finding issues since that morning. Id. at 37. On May 20, 2022, Petitioner saw a physician assistant

at Dr. Guram’s office and reported difficulty swallowing, unsteady gait, and slurred speech. Ex. 4

at 43, 46-47.

On May 19, 2022, neurologist Dr. Robert Buechler ordered an MG panel. Ex. 6 at 8. The

results were positive, leading to a formal MG diagnosis. Ex. 11 at 11. Dr. Buechler prescribed

steroids and other medication. Id. Over the next few months, Petitioner’s symptoms improved with

the use of steroids. Ex. 12 at 18. On June 28, 2022, Petitioner reported continuing trouble with her

voice, swallowing, and chewing, and Dr. Buechler increased her steroid dose. Id. at 47. By August

21, 2022, Petitioner had improved significantly, but her voice, swallowing, and chewing issues

persisted and she often felt fatigued. Id. at 76. On October 14, 2022, Petitioner returned to Dr.

Edwards, reporting blurred vision and worsening vision in her right eye. Ex. 15 at 9. Over the next

two years, Petitioner continued to receive treatment for MG, as evidenced by medical records.

II. Expert Opinions

A. Petitioner’s Expert – Dr. David Simpson

Dr. Simpson, a neurologist, prepared a written report on behalf of Petitioner. Simpson

Report, dated Sep. 19, 2023, filed as Ex. 31 (ECF No. 39-1) (“Simpson Rep.”). He proposed that

it is more likely than not that the administration of the Tdap vaccine (in concert with the non-

covered version of the pneumococcal vaccine) was causally related to Petitioner’s MG. Simpson

Rep. at 11.

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

Hospital, where he has worked as an Attending Neurologist since 1984. Simpson CV, filed on

March 7, 2024, as Ex. 58 (ECF No. 45-1) (“Simpson CV”), at 2. 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. Simpson CV at 1. 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

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extensively and has given numerous presentations and lectures on the subject of neurological

disorders, including peripheral neuropathy. Id. at 23-64.

In his report, Dr. Simpson opined that vaccines can lead to neurological illnesses, like MG,

through a variety of biological mechanisms. Simpson Rep. at 8. These mechanisms include

molecular mimicry, neurotoxic effect, and loss of self-tolerance, although he favored molecular

mimicry as the most relevant mechanism in this case. Id. at 8, 11. Dr. Simpson acknowledged that

the specific trigger of MG is unknown but suggested that infections may be responsible. Id. Dr.

Simpson also admitted that no statistical association exists between vaccinations and the onset of

MG symptoms, but argued that this fact was not dispositive, since the rare effects of vaccines are

not often identified in initial prospective, placebo-controlled trials. Id. at 9. He also noted that it

was possible that the simultaneous administration of the non-covered version of the pneumococcal

vaccine provided a booster effect that further enhanced the possibility of an autoimmune reaction

(although his report does not explain how this would have occurred). Id. at 11.

Dr. Simpson then maintained that Petitioner began to experience an onset of MG symptoms

shortly after she received the Tdap vaccine. Simpson Rep. at 10. He noted that Petitioner reported

“weak spells in which her legs gave way” early on in her course of treatment. Id. She also

developed ptosis3 and diplopia4 – symptoms consistent with the neurological manifestations of

MG. Id. at 11. And Petitioner developed initial symptoms within weeks of receiving the vaccine,

which would fall within the medically acceptable timeframe of 42 days post-vaccination. Id. (citing

Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality 535 (K. Stratton et al.,

eds. 2011), filed as Ex. 38 (ECF No. 40-7)). In Dr. Simpson’s view, the sequence of events and

laboratory findings supported a conclusion that the Tdap vaccine triggered Petitioner’s MG. Id.

B. Respondent’s Expert – Dr. Eric Lancaster, Ph.D.

Dr. Eric Lancaster, a neurologist, prepared a written report on behalf of Respondent.

Lancaster Report, dated December 5, 2023, filed as Ex. A (ECF No. 43-1) (“Lancaster Rep.”). He

opined that there was no evidence that the vaccines Petitioner received, alone or in concert, could

have caused Petitioner’s MG – especially in light of the timeframe from vaccination to onset.

Lancaster Rep. at 13.

As shown in his CV, Dr. Lancaster received his undergraduate degree from The John

Hopkins University, and received his Ph.D. in neuroscience plus his medical degree from the

University of Maryland. Lancaster CV, filed on December 5, 2023, as Ex. B (ECF No. 43-13)

3

“Ptosis” is defined as “prolapse or drooping of the upper eyelid.” Ptosis, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=42014 (last visited Sept. 11, 2024).

4

“Diplopia” is defined as “the perception of two images as a single object; also called double vision.” Diplopia,

Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=14354&searchterm=diplopia (last visited Sept. 11, 2024).

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(“Lancaster CV”), at 1. He completed his neurology residency and neuromuscular fellowship at

the University of Pennsylvania. Lancaster CV at 2. Dr. Lancaster is board certified in neurology

from the American Board of Psychiatry and Neurology. Id. He has treated thousands of neurology

patients and has authored over thirty peer-reviewed articles. Id. at 6-8. His recent publications

concern autoimmune neurologic disorders and their mechanisms. Id. at 8. Dr. Lancaster is

presently an Assistant Professor of Neurology at the University of Pennsylvania, and his clinic

focuses on autoimmune neurological diseases Id. at 1-2.

In his report, Dr. Lancaster emphasized the lengthy timeframe from the onset of MG back

to the date of vaccinations in contending that causation could not be established. While Dr.

Lancaster did not dispute the MG diagnosis, he denied that Petitioner experienced any MG-related

symptoms prior to April 2022 – nearly nine months post-vaccination. Lancaster Rep at 9. MG, he

explained, would be characterized by ptosis, diplopia, difficulty chewing and swallowing,

difficulty speaking, and difficulty holding the head upright. Id. at 7. The medical records in this

case, however, did not reveal these kinds of symptoms before Petitioner began experiencing double

vision in April. Id. at 9. Dr. Lancaster noted that he gave more weight to the record than to

Petitioner’s symptoms timeline, which was created after the fact. Id.

Petitioner referenced other symptoms as the start of her MG, but Dr. Lancaster deemed

them to be uncharacteristic of MG. For example, Dr. Lancaster acknowledged that Petitioner

reported pain in her arms and neck in October 2021, but he maintained that pain is not a symptom

of MG. Lancaster Rep. at 9. Dr. Lancaster also opined that the brief periods of leg weakness

reported by Petitioner in November 2021 were not likely MG-related. If it were otherwise, then

they should have been supported by symptoms (ptosis, diplopia, dysphagia) characteristic of MG,

and the bouts of leg weakness should have been longer. Id. Weakness in MG, he maintained, is

generally not focused on the legs, but instead would manifest with respect to the ocular, neck,

bulbar, and breathing muscles. Id.

Dr. Lancaster also expressed doubt that reports of neck, back, and shoulder pain contained

in early 2022 physical therapy notes were reflective of MG symptoms. Lancaster Rep. at 9. In fact,

Petitioner’s neck pain had previously been diagnosed as cervical radiculopathy in October 2021.

Id. at 10. And an MRI in May 2022 revealed the reason for Petitioner’s shoulder and arm pain –

a rotator cuff tear. Id. In Dr. Lancaster’s estimation, these two diagnoses more logically explained

Petitioner’s ongoing pain than MG. Id.

Even if earlier symptoms could be linked to MG, Dr. Lancaster still deemed the timeframe

between vaccination and onset to be unreasonably long. The leg weakness documented in October

2021, for example, would place the onset of MG three months out from the vaccination date.

Lancaster Rep. at 10. But in the few cases where autoimmune diseases may arguably be triggered

by vaccinations, the risk window is typically 5-42 days, so this still falls far outside the acceptable

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timeframe. Id. at 10, 12, referencing T. Safranek et al., Expert Neurology Group, Reassessment of

the Association between Guillain-Barré Syndrome and Receipt of Swine Influenza Vaccine in

1976–1977: Results of a Two-State Study, 133 Am. J. of Epidemiology, 940–51 (1991), filed as

Ex. 35 (ECF No. 40-4); Lawrence B. Schonberger et al., Gullian-Barre syndrome following

vaccination in the National Influenza Immunization Program, United States, 1976-1977, 110 Am.

J. of Epidemiology, 105-23 (1979), filed as Ex. 37 (ECF No. 40-6).5

Besides challenging onset, Dr. Lancaster contested whether vaccination could ever explain

MG’s cause. To that end, he noted some studies that found no reliable evidence that either of the

relevant vaccines cause or aggravate MG. Id. at 11; T.J. Nasca et al., Antibody response to

pneumococcal polysaccharide vaccine in myasthenia gravis: effect of therapeutic plasmapheresis,

5 J. of Clinical Apheresis, 113-39 (1990), filed as Ex. A-6 (ECF No. 43-7); G. Sansone & D. M.

Bonifati, Vaccines and myasthenia gravis: a comprehensive review and retrospective study of

SARS-CoV-2 vaccination in a large cohort of myasthenic patients, 269 J. of Neurology, 3965-81

(2022), filed as Ex. A-9 (ECF No. 43-10). And he questioned the merit of Dr. Simpson’s proposed

causal theories. Lancaster Rep. at 10-11. The mechanistic theory of molecular mimicry,6 for

example, was not applicable, since no showing had been made that the amino acid sequences of

the components of proteins in clinical vaccines have homologic or structural similarity to skeletal

muscle acetylcholine reception (AChR)7. Id. at 11. It was therefore very unlikely that any vaccine

protein could instigate the production of autoantibodies that could drive the pathologic process

resulting in MG. Id.

Dr. Lancaster also challenged Dr. Simpson’s proposition of a “neurotoxic effect,” whereby

vaccines would directly damage the membranes of myelin or axons. Lancaster Rep. at 11. As Dr.

Lancaster explained, MG’s pathogenesis does not involve autoantibodies to axon and/or myelin

antigens. Id. And Dr. Simpson’s theory of vasculitis as resulting in MG was untenable because MG

is a neuromuscular disorder. Id. at 12. Finally, Dr. Lancaster noted that Dr. Simpson’s theory of a

loss of immune self-tolerance is not supported by any data and cannot be considered a proper

causal mechanism. Id.

5

Petitioners filed Safranek (Ex. 35) and Schonberger (Ex. 37) in support of Dr. Simpson’s Report, and Dr. Lancaster

referenced these exhibits in his report.

6

As I have discussed in previous cases, “molecular mimicry” is a scientific concept in which a vaccine’s antigens can

appear similar to self-structures, either due to sequential homology (in the case of amino acid sequences that make up

proteins) common to both, or outright molecular structure “fit.” Bielak v. Sec'y of Health & Hum. Servs., No. 18-761V,

2023 WL 35509, at *12 (Fed. Cl. Spec. Mstr. Jan. 3, 2023).

7

Acetylcholine is a chemical that helps muscles contract and acts as a messenger between nerves and muscles. People

with MG often make an abnormal protein called “AChR,” which interferes with how acetylcholine works.

Acetylcholine Receptor Antibody (Blood), University of Rochester Medical Center Health Encyclopedia,

https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=167&contentid=acetylcholine_receptor_a

ntibody_blood#:~:text=People%20who%20have%20myasthenia%20gravis,double%20vision%20or%20drooping%

20eyelids (last visited Sep. 11, 2024).

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III. Procedural History

As noted above, the case was initiated in March 2022, and later that year, Petitioner added

the claim of a bilateral SIRVA. After Respondent filed his Rule 4(c) Report contesting Petitioner’s

right to compensation (see ECF No. 35), the process of obtaining expert reports began, with the

final report from Dr. Lancaster filed on December 5, 2023. On the same day, Respondent also filed

a Motion to Dismiss. The parties subsequently briefed dismissal, and the matter is now ripe for

resolution.

IV. Parties’ Arguments

A. Respondent’s Motion to Dismiss

On December 5, 2023, Respondent filed a Motion to Dismiss, arguing that Petitioner could

not show a medically acceptable temporal relationship between receipt of the Tdap vaccine and

the onset of her MG. Mot. to Dismiss at 1.

The third Althen prong, he argued, requires “preponderant proof that the onset of symptoms

occurred within a timeframe for which, given the medical understanding of the disorder’s etiology,

it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health and Hum. Servs.,

539 F.3d 1347, 1352 (Fed. Cir. 2008). But Dr. Lancaster’s expert report persuasively established

that Petitioner did not develop symptoms of MG until April 2022, which is “well outside any

plausible window of causation.” Mot. to Dismiss at 2-3; Lancaster Rep. at 13.

Indeed, the earliest Petitioner could have developed MG was October 21, 2021, which was

“still outside any plausible window of causation.” Lancaster Rep. at 13. In most successful non-

Table claims, onset of symptoms for a disease process initiated by vaccination is demonstrated to

have occurred no longer than six to eight weeks after vaccination. Mot. to Dismiss at 3 (citing

Reichert v. Sec’y of Health and Hum. Servs., 2018 WL 4496561, at *15 (Fed. Cl. Spec. Mstr. Aug.

2, 2018)). And Respondent denied awareness of any published Vaccine Program Decision that has

found a timeframe longer than two months to be medically acceptable. Id. For these reasons,

Respondent argues that Petitioner failed to prove prong three of the Althen test, and the claim

should be dismissed. Id. at 4.

B. Petitioner’s Response

Petitioner maintains she can meet all three Althen prongs. Regarding the first, “can cause”

prong, she argues that the Tdap vaccine could cause MG through the biological mechanism of

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molecular mimicry. Opp. at 12. She noted the Program has recognized the validity of the theory

of molecular mimicry, although she did not cite any decisions specific to the Tdap vaccine and

MG. Id. at 13. She also maintained that epidemiological studies that might reveal such a link are

not particularly effective in identifying rare events, and thus are not required to establish any Althen

prong. Id. at 14 (citing Quackenbush-Baker v. Sec’y of Health and Hum. Servs., No. 14-1000V,

2018 WL 1704523, at *16 (Fed. Cl. Spec. Mstr. Mar. 14, 2018)). Dr. Simpson’s opinion – that the

Tdap vaccine, either alone or in combination with the non-covered pneumococcal vaccine, can

cause MG – reflects the medical opinion of a qualified expert, and is sufficient to meet the

preponderant standard for the first Althen prong. Opp. at 15.

Next, Petitioner argues that she has met the burden of Althen prong two by presenting a

logical sequence of cause and effect showing that the Tdap vaccine, either alone or in combination

with the pneumococcal vaccine, was the cause of her MG. Opp. at 15-16. In support, she contended

that she was neurologically asymptomatic prior to receiving the vaccines, but slowly developed

symptoms of MG in the months following receipt of the vaccines. Id. at 16. This sequence, she

claims, is enough to meet the burden of Althen prong 2. Id. at 18.

Finally, Petitioner addresses Respondent’s central argument: whether she has established

a medically acceptable temporal relationship between the date she received the Tdap vaccine and

her onset of MG symptoms. Opp. at 18. While Petitioner acknowledged that her symptoms are

first noted in medical records on October 21, 2021, she represents that she had experienced

comparable symptoms in the days and weeks immediately following the vaccines. See Affidavit

of Myrtle Barrett, dated December 13, 2022, filed as Ex. 22 (ECF No. 26-22) (“Barrett Aff.”);

Opp. at 19. In Petitioner’s affidavit, she testified that “I began having the various symptoms I have

described in the days and weeks immediately after receiving the vaccines on July 21, 2021. Among

other things, my legs became weak and gave way, and I was very tired and fatigued.” Barrett Aff.

at 5. Petitioner also asserts that medical records are not the only reliable evidence, and argues that

representations in her affidavit can be employed to establish a temporal relationship. Opp. at 20.

Thus, the shorter timeframe should be accepted in this case.

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.

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Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).8

There is no Table injury for MG, and as noted above Petitioner no longer advances a SIRVA claim,

leaving only a causation-in-fact claim.

For both Table and Non-Table claims, 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 v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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 Althen prong 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

8

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 104 F. App’x. 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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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 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis

in original)).

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 Kalajdzic v. Sec’y of Health &

Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for

a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing

Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359

(Fed. Cir. 2019); see also 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”), aff’d,

2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the

ultimate burden of establishing their overall 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

11

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 *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 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. den’d 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. den’d (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).

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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 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).

13

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 (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

14

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 & 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 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, 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”).

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E. Resolution of Matter Without Hearing

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 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

The resolution of this case primarily turns on the third Althen prong,9 which requires a

claimant to establish a “proximate temporal relationship” between the date of vaccination and the

onset of the injury alleged. Althen, 418 F.3d at 1281. A proximate temporal relationship exists

when Petitioner offers preponderant proof that the onset of symptoms occurred within a timeframe

(measured from vaccination) in which it is medically acceptable to infer causation. de Bazan, 539

F.3d at 1352.

MG, as the experts agreed, is an autoimmune disorder that affects the neuromuscular

junction, causing normally reliable signals between motor nerves and muscle cells to become less

effective. Simpson Rep. at 8; Lancaster Rep. at 7. It is characterized by fatigable weakness of the

ocular, bulbar, limb, and respiratory muscles. Simpson Rep. at 8. The most common symptoms of

MG, ptosis and diplopia, affect the eye muscles. Lancaster Rep. at 7. People with MG may also

have difficulty chewing, swallowing, and speaking, and limb weakness may also occur. Id.

Here, the record preponderantly supports the conclusion that the onset of Petitioner’s MG

occurred far outside the medically accepted timeframe (assuming MG could have been triggered

by vaccination) agreed upon by both parties’ experts. As Dr. Lancaster persuasively established,

it is unlikely Petitioner’s MG actually manifested before April 2022. He reasonably distinguished

her earlier symptoms as unrelated or as having different explanations. An aberrant autoimmune

process is unlikely to be linked to a vaccine that was administered nine months before the onset of

9

The failure to establish just one of the three prongs of the causation test is sufficient grounds for dismissal. Dobrydnev

v. Sec’y of Health & Hum. Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). Therefore, I need not discuss Petitioner’s

success or failure in establishing the remaining prongs, since I have determined the third prong is unmet.

16

symptoms. This timeframe is simply too long to be considered medically acceptable. Hennessey

v. Sec'y of Dep't of Health & Hum. Servs., 91 Fed. Cl. 126, 142 (2010) (rejecting theory in which

vaccination event long preceded onset, since “it would be virtually impossible to determine that

the vaccine, and not some other environmental condition, was the original triggering event”).

My conclusion is the same even if the earliest possible onset (as established in the record)

– three months post-vaccination – were deemed the first manifestation of Petitioner’s MG. Ex. 3

at 2. While neither expert in this case proposed a timeframe for vaccine-caused MG, both Drs.

Simpson and Lancaster agreed that a general timeframe for an immune-mediated injury from

vaccination would be no more than 42 days, or six weeks. Simpson Rep. at 11; Lancaster Rep. at

10. An onset in the second half of October 2021 – twelve weeks post-vaccination – would

constitute a timeframe double the accepted length.

The record shows that Petitioner received the vaccines on July 21, 2021, and did not report

any side effects or symptoms to a health care provider until three months later, on October 28,

2021. Id. The medical records from October 28, 2021, further indicate that Petitioner told her

physician that her legs gave way approximately one week earlier, on October 21, 2021. Id. The

records from that day do not include any other statements by Petitioner about pain or weakness in

the preceding weeks or months. Days later, on November 1, 2021, Petitioner returned to her

physician and stated that she had been experiencing leg weakness “for the last few weeks,” but did

not elaborate further. Ex. 2 at 103. A few weeks later, on November 19, 2021, Petitioner visited

the doctor again. Ex. 5 at 2. The medical records from this appointment reflect Petitioner’s claim

from her first appointment – that she experienced sudden weakness in her legs four weeks prior.

Id. Accordingly, the records place the onset of symptoms right around October 21, 2021, just

barely three months after Petitioner received the vaccines.

Although the records place the onset of symptoms outside of the medically acceptable

timeframe, and make no mention of an earlier onset, Petitioner alleges that her symptoms actually

developed well within the 42-day window – no later than a few days of receiving the vaccine.

Barrett Aff. at 5. But these witness contentions lack record corroboration – there is no record

evidence of such claims from later instances of Petitioner’s efforts to obtain medical assistance for

her symptoms. And I find the medical records in this case to be far more persuasive than

Petitioner’s statements. When reviewing evidence in a case, a special master “must consider all

relevant and reliable evidence.” See Vaccine Rule 8. But a special master has discretion to weigh

the evidence presented and may give greater weight to medical records. Rickett v. Sec'y of Health

& Hum. Servs., 468 F. App'x 952, *958 (Fed. Cir. 2011). As this court explained in Cucuras v.

Sec'y of Health & Human Servs.:

“The Supreme Court counsels that oral testimony in conflict with contemporaneous

documentary evidence deserves little weight. United States v. United States Gypsum Co.,

333 U.S. 364, 396, 68 S.Ct. 525, 92 L.Ed. 746 (1948) .... Medical records, in general,

warrant consideration as trustworthy evidence. The records contain information supplied

17

to or by health professionals to facilitate diagnosis and treatment of medical conditions.

With proper treatment hanging in the balance, accuracy has an extra premium. These

records are also generally contemporaneous to the medical events.” 993 F.2d 1525, 1528

(Fed.Cir.1993).

In this case, Petitioner’s statements about an earlier onset made over a year after her first

doctor’s appointment following the vaccines, conflict with the medical records. The medical

records mark the onset of Petitioner’s symptoms as October 21, 2021, at the absolute earliest. After

Petitioner received the vaccines on July 21, 2021, she did not see a health care provider in any

capacity until three months later. And then (October 28th) she complained of leg weakness that had

begun one week earlier, around October 21, 2021. Ex. 3 at 2. Had Petitioner begun to experience

leg weakness immediately following receipt of the vaccines, she likely would have disclosed this

to her physician at the first appointment, or at the very least, at any appointment thereafter. But

Petitioner did not make this claim until she filed her affidavit, 14 months later (and it is also not a

given that any earlier symptoms were even related to any of her subsequent complaints – let alone

MG – for the reasons offered by Dr. Lancaster).

The record does not preponderantly support the conclusion that the onset of Petitioner’s

MG symptoms occurred in a medically acceptable timeframe, measured from the date of

vaccination. For this reason, the claim cannot succeed.

CONCLUSION

Claimants must carry their burden of proof. Because Petitioner cannot show by

preponderant evidence that onset of her MG occurred in a medically acceptable timeframe, I deny

entitlement.

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.10

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

10

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.

18