Refaat v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 24-229V

NAHED REFAAT, Chief Special Master Corcoran

Petitioner, Filed: November 4, 2025

v.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.

Emily Hanson, U.S. Department of Justice, Washington, DC, for Respondent.

FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM 1

On February 14, 2024, Nahed Refaat filed a Petition for compensation under the

National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq. 2 (the

“Vaccine Act”). Petitioner alleges (under the Vaccine Act Table) that she suffered from

Guillain-Barré syndrome (“GBS”) as a result of an influenza (“flu”) vaccine she received

on February 14, 2022. Pet. at 1.

Respondent’s Rule 4(c) Report (filed on December 20, 2024,) set forth objections

to the Table claim asserted herein. Respondent’s Report, ECF No. 22. Respondent

argues that the medical records support a more likely alternative diagnosis – chronic

1 Because this unpublished Ruling contains a reasoned explanation for the action in this case, I am required

to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act

of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government

Services). This means the Ruling will be available to anyone with access to the internet. In accordance

with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information,

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

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

2

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

of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §

300aa (2018).

inflammatory demyelinating polyneuropathy (“CIDP”) - which means a Table claim is not

viable. 3 Id. at 8-9.

In response to Respondent’s arguments, on September 11, 2025, I ordered

Petitioner to show cause why her Table GBS claim should not be dismissed. ECF No. 24.

I explained that the record as it stands contains several items of evidence supporting a

possible alternate “exclusionary” diagnosis for Petitioner’s GBS – including CIDP. Id. at

3. More so, I noted that (while not the basis of the Order to Show Cause) Petitioner’s

reports of a two-day onset likewise do not support the Table’s requirements for GBS, and

her Table claim would thus fail either way. Id. at 3-4. In reaction, Petitioner filed a status

report stating that she wishes to proceed with a causation-in-fact claim, and understands

her case will be transferred out of SPU. ECF No. 25. Resolution of Petitioner’s Table claim

is now ripe for consideration.

I. Factual Background 4

Petitioner’s medical history is relevant for positive ANA testing in October 2020

and Sjögren’s syndrome. Ex. 5 at 7-9; Ex. 6 at 30-31, 38. Petitioner received the subject

flu vaccine on February 14, 2022, during an annual visit with her primary care provider

(“PCP”). Ex. 2 at 25, 28.

In her witness declaration (authored in February 2024), Petitioner attests that “a

few days after [her] flu vaccine,” she had some body aches. Ex. 11 ¶ 4. Then, “seven to

ten days after” vaccination, she “began to experience symptoms that [she] had never felt

before[,]” including severe pain throughout her body, numbness, significant weakness,

and fatigue. Id. She also described tingling in her feet, which made it difficult to walk or

drive. Id.

On March 7, 2022, Petitioner had a telemedicine visit with her PCP and reported

body aches that began a day or two after her February 14th visit and vaccination. Ex. 7 at

14. She also complained of bilateral lower extremity numbness (that had improved), pain

radiating down the bilateral lower extremities, plus low back pain. Id.

The same day, Petitioner went to the ER complaining of body aches and tingling

in her hands, feet, and knees/legs that began “[a] few days after receiving a flu vaccine 2

weeks ago.” Ex. 6 at 30. Following a neurology consultation on March 8, 2022, and a

3

Respondent also contended that the medical records establish a one-to-two-day onset of her injury, which

is inconsistent with the Table’s 3-42 window for a Table GBS claim. ECF No. 22 at 9-10.

4 A more complete recitation of the facts can be found in the Petition and Respondent’s Rule 4(c) Report.

Although I have reviewed all of the records filed to date, I have limited my discussion in this Ruling to the

records most relevant to the resolution of Petitioner’s Table claim, with a particular focus on diagnosis and

the onset of Petitioner’s alleged injury, where appropriate.

2

normal head CT, the neurologist thought that Petitioner had “symptoms suggestive of

[GBS].” Id. at 40.

While hospitalized, Petitioner had a consultation with a hematologist-oncologist.

Ex. 6 at 42. The treater noted that Petitioner’s white blood cell count was low the previous

week and thus evaluated her for leukopenia. See id. Following an unremarkable brain

MRI, the treater assessed Petitioner with GBS, possible leukopenia “due to GBS vs

autoimmune d/o,” Sjögren’s syndrome, and a low/normal vitamin B12 level. Id. at 45. After

treatment with three doses of IVIG, Petitioner was discharged the next day with

“symptoms suggestive of [GBS].” Id. at 58.

On March 15, 2022, Petitioner had a visit with her PCP and noted ongoing tingling,

weakness, and some chest pain since her hospital discharge. Ex. 2 at 11-12. The PCP

assessed Petitioner with GBS (that had improved with IVIG) and “other neutropenia.” Id.

at 12.

Later that month (on March 23, 2022), Petitioner followed up with her neurologist.

Ex. 3 at 9. The neurologist noted Petitioner’s recent history of “symptoms of [GBS],” that

she was treated with IVIG (during her hospitalization), “and her symptoms of paresthesias

and weakness of the extremities improved somewhat.” Id. Petitioner had “continued

paresthesias in the face and pain in the legs when she exerts herself.” Id. Petitioner’s

“ongoing diagnoses” included GBS and “chronic inflammatory demyelinating polyneuritis

[CIDP].” Id. at 10. Despite both listed diagnoses, the treater’s impression was that

Petitioner’s “symptoms [were] suggestive of [GBS] . . . as a result of influenza

vaccination.” Id. The neurologist prescribed weekly IVIG. Id.

At the direction of her neurologist, Petitioner underwent an EMG of the lower

extremities on May 22, 2022. Ex. 3 at 13. The impression was “demyelinating

polyneuropathy affecting the lower extremities” associated with “acute and chronic motor

axon loss” in the bilateral lower extremities. Id. The neurologist thought “[t]his is consistent

with a diagnosis of CIDP.” Id.

During an October 31, 2022 neurology follow-up visit, Petitioner had ongoing

paresthesias and weakness in her bilateral lower extremities. Ex. 8 at 5. The neurologist

reiterated her earlier impression – that Petitioner had GBS and “[t]his was a result of

influenza vaccination.” Id. at 6. But the neurologist also noted that Petitioner “continue[d]

to remain symptomatic and had CIDP.” Id. Both GBS and CIDP were listed among

Petitioner’s “ongoing diagnoses.” Id. There are no records of any subsequent treatment

pertinent to Petitioner’s GBS diagnosis or the onset of her post-vaccination injury.

3

II. Applicable Legal Standards

Under Section 13(a)(1)(A) of the Act, a petitioner must preponderantly

demonstrate that all requirements for a petition set forth in section 11(c)(1) have been

satisfied. A petitioner may prevail on her claim if the vaccinee for whom she seeks

compensation has “sustained, or endured the significant aggravation of any illness,

disability, injury, or condition” set forth in the Vaccine Injury Table (the Table). Section

11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42 C.F.R. §

100.3, identifies the vaccines covered under the Program, the corresponding injuries, and

the time period in which the particular injuries must occur after vaccination. Section 14(a).

If petitioner establishes that the vaccinee has suffered a “Table Injury,” causation is

presumed.

In order to qualify for a Table presumption of causation for GBS, a petitioner must

establish that she experienced the onset of her symptoms within 3-42 days of the subject

flu vaccination, and that she satisfies the criteria set forth in the Act’s Qualifications and

Aids to Interpretation (“QAIs”). 42 C.F.R. Section 100.3(c)(15). The QAIs require a

showing of (A) bilateral flaccid limb weakness and decreased or absent deep tendon

reflexes in weak limbs; (B) a monophasic illness pattern; (C) an interval between onset

and nadir of weakness between 12 hours and 28 days; (D) subsequent clinical plateau

(which leads to either stabilization at the nadir of symptoms or subsequent improvement

without significant relapse); and (E) the absence of an identified more likely alternative

diagnosis – including (in relevant part) CIDP and vasculitis. Sections 100.3(c)(15)(ii), (vi).

If, however, the vaccinee suffered an injury that either is not listed in the Table or

did not occur within the prescribed time frame, petitioner must prove that the administered

vaccine caused injury to receive Program compensation on behalf of the vaccinee.

Section 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or

[an] off-Table” claim and to prevail, petitioner must prove her claim by preponderant

evidence. Section 13(a)(1)(A). This standard is “one of . . . simple preponderance, or

‘more probable than not’ causation.” Althen v. Sec’y of Health & Human Servs., 418 F.3d

1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v. Sec’y of Health & Human

Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal Circuit has held that to

establish an off-Table injury, petitioners must “prove . . . that the vaccine was not only a

but-for cause of the injury but also a substantial factor in bringing about the injury.”

Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at

1352. The received vaccine, however, need not be the predominant cause of the injury.

Id. at 1351.

The determination that a petitioner is entitled to compensation must not be “based

on the claims of a petitioner alone, unsubstantiated by medical records or by medical

opinion.” Section 13(a)(1). Further, contemporaneous medical records are presumed to

4

be accurate and complete in their recording of all relevant information as to petitioner’s

medical issues. Cucuras v. Sec’y of Health & Human Servs., 993, F.2d 1525, 1528 (Fed.

Cir. 1993). Testimony offered after the events in questions is considered less reliable than

contemporaneous reports because the need for accurate explanation of symptoms is

more immediate. Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523

(1993).

Analysis

As articulated in my Order to Show Cause, Petitioner’s medical records contain at

least two proposed diagnoses: GBS and CIDP – with at least her treating neurologist

opining that her EMG findings were consistent with CIDP as the most accurate diagnosis.

Ex. 3 at 13. Thus, it is not facially evident that Petitioner did suffer from GBS, as alleged.

Indeed, this record suggests that what may have been thought to be GBS initially was

deemed later to be something else.

The presence of CIDP as an identified more likely alternative diagnosis precludes

Petitioner from establishing a Table GBS claim, as her injury is inconsistent with the

Table-defined version of GBS in the QAIs. Section 100.3(c)(15)(vi) (“[e]xclusionary criteria

for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the

following conditions: chronic immune demyelinating polyradiculopathy (CIDP) . . . .”). For

this reason, her Table GBS claim must be dismissed.

Because Petitioner has not demonstrated a GBS diagnosis consistent with the

QAIs, I do not find it necessary to make a determination regarding onset at this time. I will

note, however, there exist notations in the contemporaneous medical records that could

support a one-to-two day onset of her overall injury. 5 See, e.g., Ex. 7 at 14 (reporting that

she “noticed [b]ody-aches [sic] 1-2 days after last visit during which she received the flu

shot, she also noticed numbness in [bilateral] lower ext[remities] off and on which since

improved.”). Although a claimant might seek to argue (on a non-Table basis) that a one-

to-two-day onset was medically acceptable, more often than not such arguments fail. 6

5 On the other hand, there also exists at least one notation placing onset of her body aches and tingling in

her hands, feet, and legs beginning a “few days after receiving a flu vaccine 2 weeks ago.” Ex. 6 at 30. This

notation thus could be interpreted in favor of onset occurring within the Table’s 3-42 day window.

6

See, e.g., Rowan v. Sec’y of Health & Human Servs., No. 17-760V, 2020 WL 2954954, at *16-19 (Fed.

Cl. Spec. Mstr. Apr. 28, 2020) (finding a GBS onset sooner than three days post vaccination was not

scientifically or medically supported by the record, given that GBS is known to be mediated by antibodies

produced via the adaptive immune system, and this process takes longer than 3 days to result in

symptoms); Orton v. Sec’y of Health & Human Servs., No. 13-631V, 2015 WL 1275459, at *3-4 (Fed. Cl.

Spec. Mstr. Feb. 23, 2015) (finding a 1-day onset of GBS following a flu vaccination was not substantiated

by the evidence).

5

Only under special circumstances has such a short onset succeeded. 7 While these prior

determinations do not control this outcome, they demonstrate that what is known

medically/scientifically about the pathogenesis of GBS and weighs against findings of flu

vaccine causality when the onset is too close temporally to the vaccination event.

Despite this, it certainly is not the case in the Program that a claimant can never

establish a vaccine-caused peripheral neuropathy based on a very short onset. And here,

it is conceivable that a non-Table claim could likewise be viable or, alternatively, that

onset was actually later than one-to-two days post vaccination. However, expert support

will be necessary for the resolution of a causation-in-fact claim and a determination

regarding proper diagnosis and onset.

Conclusion

Petitioner cannot proceed on a Table GBS claim in this matter, and therefore any

such claim is hereby DISMISSED. Petitioner’s remaining non-Table claim, however, may

proceed. Because of the factual and medical issues to be decided (requiring amplification

via experts), the claim is unlikely to be expeditiously resolved in SPU. For this reason,

transfer is appropriate. Pursuant to Vaccine Rule 3(d), the above-captioned case is

hereby transferred out of SPU and reassigned randomly to a Special Master by the

Clerk’s Office. Further proceedings will be determined by the assigned Special

Master.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

7

See, e.g., Lehrman v. Sec’y of Health & Human Servs., No. 13-901V, 2018 WL 1788477, at *14-19 (Fed.

Cl. Spec. Mstr. Mar. 19, 2018) (finding entitlement for a petitioner who established a pre-vaccination history

of an upper respiratory infection, which, in combination with the flu vaccination, was found to have resulted

in an upregulation of the petitioner’s immune system that led to a rapid onset of GBS and thus a 1-day

onset was appropriate); Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir.

1999) (finding that a petitioner must prove that the vaccine was a substantial factor – not the only factor –

in causing the illness and that the harm would not have occurred in the absence of the vaccination).

6