Case 1:17-vv-00989-UNJ Document 98 Filed 01/12/24 Page 1 of 33
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`In the United States Court of Federal Claims
`OFFICE OF SPECIAL MASTERS
`No. 17-989V
`Filed: December 18, 2023
`
`
`
`JASON QUIRINO,
`
` Petitioner,
`v.
`
`SECRETARY OF HEALTH AND
`HUMAN SERVICES,
`
` Respondent.
`
`
`
`Andrew Downing, Downing, Allison & Jorgenson, Phoenix, AZ, for petitioner.
`Mitchell Jones, U.S. Department of Justice, Washington, DC, for respondent.
`
`
`
`
`
`Special Master Horner
`
`
`
`
`
`RULING ON ENTITLEMENT1
`
`On July 21, 2017, petitioner filed a petition under the National Childhood Vaccine
`Injury Act, 42 U.S.C. § 300aa-10, et seq. (2018),2 alleging that the Hepatitis B (“Hep B”)
`and Tetanus Diphtheria acellular Pertussis (“Tdap”) vaccines he received on July 28,
`2014, caused him to suffer a “rheumatologic injury.” (ECF No. 1; see also ECF No. 35
`(Amended Petition).) Petitioner later amended his petition to allege that he suffers from
`an “atypical form” of Guillain-Barré Syndrome (“GBS”), “manifesting as an isolated small
`fiber neuropathy.” (ECF No. 53, p. 1.) For the reasons set forth below, I conclude that
`petitioner is entitled to compensation.
`
`
`
`
`
`
`1 Because this document 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 document 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.
`
` Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
`§ 300aa-10-34.
`
`
` 2
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`Case 1:17-vv-00989-UNJ Document 98 Filed 01/12/24 Page 2 of 33
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`I.
`
`Applicable Statutory Scheme
`
`
`
`Under the National Vaccine Injury Compensation Program, compensation
`awards are made to individuals who have suffered injuries after receiving vaccines. In
`general, to gain an award, a petitioner must make a number of factual demonstrations,
`including showing that an individual received a vaccination covered by the statute;
`received it in the United States; suffered a serious, long-standing injury; and has
`received no previous award or settlement on account of the injury. Finally – and the key
`question in most cases under the Program – the petitioner must also establish a causal
`link between the vaccination and the injury. In some cases, the petitioner may simply
`demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
`shown that the vaccine recipient suffered an injury of the type enumerated in the
`“Vaccine Injury Table,” corresponding to the vaccination in question, within an
`applicable time period following the vaccination also specified in the Table. If so, the
`Table Injury is presumed to have been caused by the vaccination, and the petitioner is
`automatically entitled to compensation, unless it is affirmatively shown that the injury
`was caused by some factor other than the vaccination. §§ 300aa-13(a)(1)(A); 300 aa-
`11(c)(1)(C)(i); 300aa-14(a); 300aa-13(a)(1)(B).
`
`In many cases, however, the vaccine recipient may have suffered an injury not of
`the type covered in the Vaccine Injury Table. In such instances, an alternative means
`exists to demonstrate entitlement to a Program award. That is, the petitioner may gain
`an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination
`in question. §§ 300aa-13(a)(1)(B); 300aa-11(c)(1)(C)(ii). In such a situation, of course,
`the presumptions available under the Vaccine Injury Table are inoperative. The burden
`is on the petitioner to introduce evidence demonstrating that the vaccination actually
`caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d
`1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518,
`1525 (Fed. Cir. 1991).
`
`The showing of “causation-in-fact” must satisfy the “preponderance of the
`evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-
`13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that
`standard, the petitioner must show that it is “more probable than not” that the
`vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need
`not show that the vaccination was the sole cause of the injury or condition but must
`demonstrate that the vaccination was at least a “substantial factor” in causing the
`condition, and was a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165
`F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical
`sequence of cause and effect showing that the vaccination was the reason for the
`injury;” the logical sequence must be supported by “reputable medical or scientific
`explanation, i.e., evidence in the form of scientific studies or expert medical testimony.”
`Althen, 418 F.3d at 1278; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
`1148 (Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based
`solely on his or her assertions; rather, the petition must be supported by either medical
`records or by the opinion of a competent physician. § 300aa-13(a)(1).
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`Case 1:17-vv-00989-UNJ Document 98 Filed 01/12/24 Page 3 of 33
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`In what has become the predominant framing of this burden of proof, the Althen
`court described the “causation-in-fact” standard, as follows:
`
`Concisely stated, Althen’s burden is to show by preponderant evidence that
`the vaccination brought about her injury by providing: (1) a medical theory
`causally connecting the vaccination and the injury; (2) a logical sequence
`of cause and effect showing that the vaccination was the reason for the
`injury; and (3) a showing of proximate temporal relationship between
`vaccination and injury. If Althen satisfies this burden, she is entitled to
`recover unless the [government] shows, also by a preponderance of the
`evidence, that the injury was in fact caused by factors unrelated to the
`vaccine.
`
`Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
`need not necessarily supply evidence from medical literature supporting petitioner’s
`causation contention, so long as the petitioner supplies the medical opinion of an
`expert. Id. at 1279-80. That expert’s opinion must be “sound and reliable.” Boatmon v.
`Sec’y of Health & Human Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019) (citing
`Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed.
`Cir. 1994)). The Althen court also indicated, however, that a Program fact-finder may
`rely upon “circumstantial evidence,” which the court found to be consistent with the
`“system created by Congress, in which close calls regarding causation are resolved in
`favor of injured claimants.” 418 F.3d at 1280.
`
`In this case, petitioner has alleged that the Hep B and Tdap vaccines caused him
`
`to suffer an atypical form of GBS, manifesting as an isolated small fiber neuropathy.
`(ECF No. 53, p. 1.) Because this is not an injury listed on the Vaccine Injury Table
`relative to the Hep B and/or Tdap vaccines, petitioner must satisfy the above-described
`Althen test for establishing causation-in-fact.
`
`
`II.
`
`Procedural History
`
`
`
`Petitioner filed his petition on July 17, 2017, alleging that he received the Hep B
`and Tdap vaccinations on July 28, 2014, which caused him to develop a “rheumatologic
`injury.” (ECF No. 1.) This case was originally assigned to Special Master Moran. (ECF
`No. 6.) On October 30, 2017, petitioner filed his vaccination record (Exhibit 1) and
`medical records (Exhibits 2-4). (ECF No. 12.) On November 9, 2017, petitioner filed his
`damages affidavit. (ECF No. 15 (Ex. 5).) Thereafter, the case was reassigned to
`Special Master Sanders. (ECF No. 19-20.)
`
`On January 4, 2018, petitioner filed updated medical records from UCLA Health
`(Exhibit 6) and a statement of completion. (ECF No. 24.) On February 27, 2018,
`respondent filed his Rule 4(c) report, arguing that the evidence presented did not meet
`petitioner’s burden and recommending against compensation. (ECF No. 27.) On
`March 26, 2018, petitioner filed additional medical records (Exhibit 7) and a response to
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`respondent’s Rule 4(c) report. (ECF No. 29-31.) On March 27, 2018, Special Master
`Sanders issued a Rule 5 Order instructing petitioner to file an expert report addressing
`(i) petitioner’s diagnosis, including whether sequela of that condition lasted for more
`than six months following vaccination, and (ii) a causation theory relating petitioner’s
`diagnosis to the vaccines he received. (ECF No. 32.)
`
`On April 9, 2018, petitioner filed an affidavit (Exhibit 8), as well as his first
`amended petition. (ECF Nos. 33-35.) On July 25, 2018, petitioner filed a consented
`motion to substitute Andrew Downing as counsel, in place of Ronald Homer. (ECF No.
`38.) On November 27, 2018, petitioner filed an expert report (Exhibit 10) and curriculum
`vitae (Exhibit 11) of Dr. Laura S. Boylan. (ECF No. 41.) On December 17, 2018,
`petitioner filed his remaining medical records (Exhibit 12) and a statement of
`completion. (ECF No. 44-45.) On June 21, 2019, respondent filed a responsive expert
`report by Dr. Jeffrey Gelfand (Exhibit C), as well as Dr. Gelfand’s curriculum vitae
`(Exhibit D) and accompanying medical literature (Exhibits E-G). (ECF No. 46.)
`Thereafter, this case was reassigned to my docket on August 29, 2019. (ECF No. 48-
`49.)
`
`
`On September 5, 2019, petitioner filed medical literature (Exhibits 13-28) cited in
`Dr. Boylan’s first expert report. (ECF Nos. 50-51.) A status conference was held on
`October 3, 2019, wherein I indicated that, although petitioner pled this case as a
`“rheumatologic injury,” petitioner’s expert subsequently discussed his injury of small
`fiber neuropathy (“SFN”). (ECF No. 52.) Related to the six-month sequela issue raised
`by respondent, I indicated that my preliminary view was that the medical records
`preponderantly evidence six months of numbness and tingling, which are consistent
`with Dr. Boylan’s opinion of SFN. (Id.) Based on my review of the records, I indicated
`that I was preliminarily inclined to find that the onset of petitioner’s alleged SFN
`occurred 36-hours post vaccination. (Id.)
`
`Subsequently, petitioner filed his second amended petition on December 9,
`2019. (ECF No. 53.) On March 3, 2020, petitioner filed a Dr. Boylan’s supplemental
`expert report (Exhibit 29). (ECF No. 57.) On June 8, 2020, respondent filed Dr.
`Gelfand’s supplemental expert report (Exhibit H). (ECF No. 62.) On July 14, 2020,
`petitioner filed a status report indicating that the matter was ready to be set for a hearing
`on entitlement. (ECF No. 63.)
`
`
`A one-day entitlement hearing was held remotely on October 6th, 2022, via
`Zoom. (See ECF Nos. 75-86; see also Transcript of Proceedings (“Tr”), filed at ECF
`No. 90.) On November 14, 2023, petitioner filed additional authority, including a citation
`to an additional case that “specifically address[ed] vaccine-induced small fiber
`neuropathy.” (ECF No. 95 (citing Fiske v. Sec’y of Health & Human Servs., No. 17-
`1378V, 2023 WL 8352761 (Fed. Cl. Spec. Mstr. Nov. 13, 2023)).) This case is now ripe
`for resolution of petitioner’s entitlement to compensation.
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`III.
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`Factual History
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`a. As reflected in the medical records
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`On September 20, 2013, petitioner presented his primary care physician, Dr.
`Jamie Polito. (Ex. 2, pp. 1-4.) Physical examination was notable for normal motor and
`sensory function and normal reflexes. (Id. at 2-3.) He had a history of psoriasis and
`had psoriatic patches observed on the scalp and shins. (Id. at 1.) His psoriasis was
`treated topically without systemic immunosuppression. (Id. at 3-4.) He also had a
`history of rheumatic fever. (Id. at 1.) The primary care evaluation also recorded a
`complaint of low back pain, specifically “sciatica with flares.” (Id.) Petitioner was
`referred to an orthopedic surgeon for further evaluation. (Id.)
`
`On July 11, 2014, petitioner transferred care to a new primary care physician, Dr.
`Judy Kim-Hwang. (Ex. 2, p. 4.) On physical examination, there was no numbness to
`light touch. (Id. at 7.)
`
`On July 28, 2014, he returned to Dr. Kim-Hwang for his annual physical
`examination. (Ex. 2, p. 9.) On review of systems, petitioner reported post nasal drip,
`dry cough, and episodic “sinus type” headaches, without any other neurological
`symptoms. (Id. at 9-10.) His past medical history was notable for psoriasis, irritable
`bowel syndrome, gastroesophageal reflux disease (“GERD”), anxiety, lattice
`degeneration of the retina and lumbar disc herniation. (Id. at 10.) On physical
`examination, strength was normal and there was no sensory loss to light touch. (Id. at
`12-13.) Hemoglobin A1C was normal at 5.0, TSH was normal at 1.5, RPR was non-
`reactive, HIV was non-reactive, and a complete blood count (no differential), creatinine,
`sodium and liver function testing were normal. (Id. at 13-15).
`
`At this annual appointment on July 28, 2014, petitioner received the subject Hep
`B and Tdap vaccinations. (Ex. 1, p. 1; Ex. 2, pp. 15.) On July 29, 2014, petitioner sent a
`message to Dr. Kim-Hwang, stating that he was “having a pretty rough time with [his]
`vaccines.” (Ex. 7, p. 3.) He described how he “started feeling really sick Tuesday
`morning about 18 hours after the injections.” (Id.) At this time, his symptoms included a
`fever, headache, and achiness in his muscles and joints, especially in his neck,
`shoulders, lower back, and legs. (Id.) On July 31, 2014, petitioner sent another
`message to Dr. Kim-Hwang, stating that his fever had subsided, but he had developed
`numbness or tingling in his hands and feet. (Id. at 4.) He further described how he
`began to experience a general feeling of exhaustion late Tuesday night. (Id.) Later that
`same day, Dr. Kim-Hwang documented a telephone note that:
`
` I
`
` spoke to patient this morning regarding his mychart email. He states that
`his fever is gone and he reports no weakness at all, though he has
`lethargy/no energy. Went to work and is at work presently. But since
`Tuesday has felt numbness in his bilateral hands (dorsal/ventral) and
`slightly above the wrist. No facial numbness or difficulty breathing. He has
`been reading about possible “autoimmune reaction/disease” that can
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`develop as a result of hepatitis B vaccination and wanted to discuss that
`with me. I advised him that if at any point his numbness worsened or if
`weakness developed or any respiratory/speech issues, he should go to the
`ER immediately. He will see me tomorrow at 4:40PM for follow-up where I
`will do a complete neurological exam.
`
`(Ex. 6, p. 2.) Later that same day, petitioner returned a call to Dr. Kim-Hwang indicating
`that his fever resolved, but still felt “generalized lethargy / low energy.” (Id.) Petitioner
`also “agreed to see Dr. Cholfin at 9AM on 8/4/2014 for a neurology consultation
`regarding numbness that developed after hepatitis B and tdap vaccination.” (Id.)
`
`
`On August 1, 2014, petitioner presented to Dr. Kim-Hwang for an urgent care
`visit. Dr. Kim-Hwang recorded the following history:
`
`One day after vaccination, patient had developed fevers T 101F at home,
`malaise/myalgias, fatigue and onset of what patient describes as
`numbness/tingling in his LE/UE and now left side of the neck. . . . His
`fevers/myalgias subsided. Denies focal weakness or respiratory problems.
`Pt has been going to work and been able to work. Admittedly, he feels very
`depressed and anxious about this reaction as he read on the internet that
`the hepatitis B vaccine can cause/trigger various autoimmune conditions
`including MS, SLE, and [GBS].
`
`
`He is accompanied by his significant other who also lives with him.
`According to her, he has been very anxious at night losing sleep over this
`and thus she feels his fatigue is largely due to sleep deprivation. He admits
`to a long-standing hx of anxiety.
`
`
`He also notes that he sleeps on his stomach often with his bilateral
`arms crossed. He notices his symptoms most markedly at night but notices
`throughout the day. He describes the numbness as mild dense feeling over
`the tips of his fingertips and his feet, but is not consistent, comes and goes.
`The “tingling” sensation he describes is also a rare tingling he feels at
`various parts of his upper extremities. He does admit that he has known
`herniated disks in lumbar spine that has been recently acting up and he
`admits to having low back pain.
`
`
`He is concerned that he might be developing an autoimmune
`condition and this is causing him significant amount of psychological
`distress/anxiety. He was referred to Dr. Cholfin for evaluation and has an
`appointment with him on Monday. He also notes that last evening he felt a
`dull sensation over his left neck, which is now gone.
`
`
`(Ex. 2, p. 17.) On physical examination, petitioner was afebrile, his blood pressure was
`130/90, and his pulse was 74. (Id. at 18.) Dr. Kim-Hwang recorded normal cranial
`nerves; normal and symmetrical sensation to light touch, temperature, pain, and
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`vibratory sense; normal deep tendon reflexes; full strength; and normal gait. (Id.) Dr.
`Kim-Hwang’s assessment included diagnoses of anxiety and subjective
`numbness/tingling. (Id. at 19.) Dr. Kim-Hwang informed petitioner “that it would be
`atypical (but not impossible) for him to develop symptoms of [GBS] so soon after
`vaccination.” (Id.) It was further noted that petitioner’s symptoms do not correlate with
`SLE and his presentation was not initially concerning for MS. (Id.) Petitioner was
`advised to see a neurologist. (Id.)
`
`On August 4, 2014, petitioner presented to neurologist Dr. Jeremy Cholfin. (Ex.
`2, p. 20.) Dr. Cholfin recorded the following history:
`
`The patient went for a routine physical appointment and received DTaP and
`HepC [sic] vaccines last Monday. The next morning he woke up with fever,
`aches, pains. The next day the fever broke, but he started having some
`unusual sensations in hands/feet, described as a hot feeling, itchy, with mild
`pins and needles. No frank numbness in that he could [sic] normal
`sensations, but more of a subjective sense of numbness. No weakness,
`balance problems, nausea, vomiting. Still has residual hand & feet
`numbness/tingling. Feels worse while in bed. However, he has been
`continuing to work, feels tired during the day, but no significant dysfunction.
`He is worried that it could be anxiety producing the symptoms, as he has a
`history of anxiety.
`
`(Id.) There was no noted history of bowel or bladder symptoms. (Id. at 21.) On
`neurological examination, Dr. Cholfin recorded normal cranial nerve function; normal
`motor function; normal sensation to light touch, pinprick, temperature, and vibration;
`normal cortical sensory function; normal reflexes, including ankle reflexes; and a
`negative Babinski response. (Id. at 23 (“Downgoing toes bilaterally”).) Coordination
`was normal, gait was normal, and the Romberg sign was negative. (Id.)
`
`
`Dr. Cholfin’s assessment was that petitioner had fever followed by “mild residual
`paresthesia[] and subjective numbness of the hands/feet, with a feeling of heat
`sensation in the feet that is bothersome at night.” (Ex. 2, pp. 24-25.) Dr. Cholfin went
`on to write:
`
`
`reaction with subjective
`represents a mild vaccine
`likely
`This
`paresthesia[]/numbness. There is no objective evidence of deficit on exam.
`The patient expresses concern about whether this could represent [GBS] or
`MS. I provided reassurance that at this point there is no sign of either
`disorder. There is no history of MS symptoms, the reflexes are completely
`intact and there are no pathologic findings on exam that would point to either
`disorder.
`
`
`(Id. at 25.) The final diagnosis was dysesthesia, and Dr. Cholfin prescribed a low dose
`of gabapentin at 100 mg at bedtime for symptomatic relief. (Id.)
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`On August 6, 2014, petitioner saw Dr. Kim-Hwang again in primary care. (Ex. 2,
`p. 26.) He indicated that his anxiety was the primary symptom that kept him up at night,
`causing fatigue during the day. (Id.) He further complained about an inability to
`concentrate and feelings of depression due to his belief that “he could’ve potentially
`saved himself from these symptoms by having declined the vaccinations.” (Id.)
`Petitioner reported taking Xanax, “which was somewhat helpful,” but he declined a
`prescription for Ambien “as he had difficult[ies] waking up.” (Id.) It was noted that
`petitioner would “consider an antidepressant in the future;” however, in the interim, he
`requested a “further work-up for his symptoms.” (Id.) Neurological examination was
`again recorded as normal. (Id. at 28.) Vitamin B12 was normal at 459. (Id. at 163-64.)
`ESR was normal at 3 and CRP was <0.3. (Id. at 165-66.) Dr. Kim-Hwang remarked,
`“Though I do not think he has a neurological disease at this present time, I do not have
`a definitive explanation for his symptoms at this present time.” (Id. at 29.)
`
`On August 12, 2014, petitioner presented to neurologist Dr. Cholfin for a follow-
`up. (Ex. 2, p. 30.) Petitioner reported “continued problems with tingling and numbness
`in the fingers and toes bilaterally” since his initial neurology consultation on August 4,
`2014. (Id. at 31.) He further described how the numbness had spread to his lips,
`tongue, and neck, and how it “happened once since last visit, lasted a few hours and
`went away.” (Id.) Petitioner reported feeling “tired with little energy, which is new for
`him.” (Id.) He explained that, although he could still ride his bike and exercise, these
`activities exhausted him more than normal. (Id.) In addition, he reported tiredness and
`weakness in his thighs, arms, and shoulders, as well as “some tremor in the bilateral
`hands.” (Id.) Neurological examination was again normal. (Id. at 32.) At this point, Dr.
`Cholfin concluded that “[t]he localization given the intact reflexes and both upper and
`lower extremity symptoms may relate to either the brain or cervical spine.” (Id. at 34.)
`He ordered brain and cervical spine MRI with and without contrast but indicated that he
`would thereafter order electromyography and nerve conduction studies (EMG/NCS) to
`assess for peripheral nervous system pathology if the MRI results were not revealing.
`(Id.) Dr. Cholfin diagnosed petitioner with dysesthesia and anxiety.3 (Id. at 34-35.)
`
`An MRI of the brain on August 21, 2014, showed “[u]nremarkable contrast
`enhanced MRI of the brain. Small capillary telangiectasias, a benign finding. Incidental
`microadenoma of the pituitary gland. No intracranial abnormality visualized.” (Ex. 2, p.
`230.) There was no evidence of demyelinating disease. (Id.) An MRI of the cervical
`spine on that same day revealed a “[c]ircumferential disc bulge at C3-C4 with no
`associated spinal canal stenosis or neural foraminal stenosis. The remainder of the
`vertebral levels are normal. There is no abnormal enhancement in the spinal canal.”
`(Id. at 229.) There were no abnormal lesions within the cervical cord. (Id.)
`
`On August 25, 2014, petitioner returned to see neurologist Dr. Cholfin. (Ex. 2, p.
`35.) Dr. Cholfin recorded an interval history, which noted that petitioner had been
`sleeping better and feeling “somewhat less anxiety” since his last visit. (Id.) Petitioner
`
`3 Dr. Cholfin remarked that “no matter what the neurologic findings are, [petitioner’s] anxiety is out of
`proportion to the situation and [he] recommended [petitioner] seek medical attention to help manage the
`anxiety symptoms, as these are interfering with his life.” (Ex. 2, p. 34.)
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`described how his shoulders and arm felt “weighted” and how the feeling was
`“noticeable in bed” but lessened during the day. (Id.) He further reported that he was
`still experiencing “tightness/deadening feeling in hands/fingers, feet about the same.”
`(Id.) However, he stated that he was experiencing less “[b]urning dysethesias,” which
`he had not experienced for a week. (Id.) Petitioner described feeling “[m]ore
`jittery/shaky while writing or manipulating fine objects” but having “[b]etter energy over
`the weekend.” (Id.) It was noted that petitioner was running two miles every other day
`for exercise and playing guitar without missing notes. (Id.) However, petitioner was
`also experiencing dry mouth and tongue numbness. (Id.) He reported that he had
`“[t]ried gabapentin 100mg x1,” but he “felt fatigued.” (Id.) Neurological examination was
`normal with the exception of a note that sensation to light touch was “slightly reduced in
`finger tips, vibration slightly reduced at toes bilaterally.” (Id. at 37.) In his assessment,
`Dr. Cholfin “rule[d] out peripheral neuropathy” and advised petitioner that “diagnosis of
`CIDP is unlikely” as “the diagnosis cannot be made in under 8 weeks after onset of
`symptoms.” (Id. at 38.) However, petitioner expressed concern that he could have a
`mild form of CIDP. (Id.)
`
`On September 4, 2014, petitioner returned to Dr. Cholfin for follow-up. (Ex. 2, p.
`39.) Dr. Cholfin documented that, since his last visit, petitioner’s “symptoms have been
`the same.” (Id.) Petitioner again reported taking “gabapentin 100mg twice” and feeling
`“sleepy.” (Id.) He stated that he had not felt like he needed it. (Id. at 39-40.) Petitioner
`reported feeling “significant residual numbness of fingers and feet” and tiredness often,
`although he continued to work and exercise. (Id. at 40.) On laboratory testing,
`petitioner’s antinuclear antigen (“ANA”) was positive at 1:80, rheumatoid factor was
`negative, Sjogren’s antibodies were negative, and SPEP was unremarkable. (Id. at 42.)
`The neurological examination was reported as “Stable.” (Id. at 41.) EMG/NCS on that
`same day revealed “[n]o electrodiagnostic evidence of a peripheral neuropathy, brachial
`or lumbosacral plexopathy, cervical or lumbosacral radiculopathy or irritable myopathy.”
`(Id.) Dr. Cholfin’s assessment was “[v]accine reaction with resulting numbness: stable
`to slightly improved. No evidence of medium to large fiber neuropathy on EMG/NCS.”
`(Id.) He referred petitioner for rheumatological consultation. (Id. at 44.)
`
`
`On September 15, 2014, petitioner presented to rheumatologist Dr. Geraldine
`Navarro. (Ex. 2, p. 44.) Dr. Navarro documented that petitioner “was in his usual state
`of health, until about the 28th of July - had Hep B and Tdap vax, within 24 hrs he
`developed chills, fevers x1 day,” as well as “numbness/tingling in his LE/UE and on the
`L side of his neck.” (Id. at 45.) Dr. Navarro observed that petitioner “has a lot of health
`anxiety” and that he was not sure whether his tingling was “due to anxiety vs a side
`effect of the vaccine.” (Id.) It was further noted that petitioner had “been reading a lot
`on the internet” and was feeling “anxious as has read Hep B vax can lead to neuro
`sequelae.” (Id.) Petitioner described a “heavy sensation in the proximal muscles of his
`LE and UE” that lasted “[f]or awhile.” (Id.) He further described feeling “quite heavy”
`when trying to get up, feeling “a little prickly” in his feet when walking, and experiencing
`a constant “tightness feeling/tingling over his hand and feet.” (Id.) Petitioner recalled
`that “[a]bout 4-5 days later on 8/1/14 he started to feel as though his neck, lips, mouth,
`and tongue if [sic] feels as though he is coming off the anesthetics.” (Id.) He further
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`Case 1:17-vv-00989-UNJ Document 98 Filed 01/12/24 Page 10 of 33
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`recalled taking “gabapentin x 2 pills for the hot sensation.” (Id.) Dr. Navarro explained
`to petitioner that patients “with Sjogrens and SLE can present with neuropathy. His
`Sjogrens Abs were negative. Further recs pending ab wk up. I did explain[] that he has
`[a] h/o autoimmune disease, Psoriasis, and that a + ANA does not mean that he has a
`CTD.” (Id. at 49.) She added that “[a]bout 5% of the normal population can have a +
`ANA w/o any manifestation” but ultimately agreed “that if continued symptoms he many
`benefit from symptomatic tx.” (Id.)
`
`On September 22, 2014, petitioner saw Dr. Navarro for follow-up. (Ex. 2, p. 50.)
`Petitioner’s C3 (complement) was low; the rest of his rheumatological labs were
`negative other than the ANA at 1:80. (Id. at 53-54.) This included negative extractable
`nuclear antigens and antiphospholipid antibody testing. (Id. at 172-78.) Petitioner’s CK
`was normal at 105. (Id. at 181.) Dr. Navarro recommended additional diagnostics and
`ordered an MRI of the spine and pelvis. (Id. at 53-54.) During those repeat diagnostics
`on October 17, 2014, petitioner’s cryoglobulins were negative. (Id. at 188.) Repeat C3
`was slightly low again at 69 (normal 76-165). (Id. at 187.) Petitioner also underwent an
`MRI of the pelvis on October 17, 2014, that revealed “[n]ormal MRI of the sacroiliac
`joints.” (Id. at 231.) The MRI of the lumbar spine on that same day revealed “multilevel
`disc degeneration. At L4-L5 there is a small extra foraminal disc protrusion on the left
`which contacts the exited L4 nerve. There is also mild to moderate left foraminal
`narrowing at L3-L4 and L4-L5. There is no spinal canal stenosis. No abnormal
`enhancement is seen.” (Id. at 232-33.)
`
`On November 24, 2014, petitioner saw Dr. Roland Sakiyama in Internal Medicine
`Urgent Care and was diagnosed with pharyngitis (a sore throat) that was favored to be
`viral. (Ex. 2, pp. 54-58.) Petitioner was also diagnosed with headache secondary to his
`viral upper respiratory infection. (Id. at 57.)
`
`On December 5, 2014, petitioner saw Dr. Cholfin in the neurology clinic. (Ex. 2,
`p. 58.) Dr. Cholfin documented that petitioner was still experiencing “persistent
`numbness of mid forearm to hand;” numbness in the area around his lips, tongue, and
`jaw; and “heat” in his hands and feet in the evening. (Id.) It was also noted that
`petitioner had started taking Lexapro two weeks prior but was no longer taking
`gabapentin. (Id.) Regarding his vaccine reaction with resulting numbness/peripheral
`neuropathy, Dr. Cholfin recorded that petitioner was “stable to slightly improved” and
`that there was “[n]o evidence of medium to large fiber neuropathy on EMG/NCS.” (Id. at
`62.) Dr. Cholfin further recorded that “ANA was mildly positive” and C3 was “mildly
`low.” (Id.) It was noted that Dr. Cholfin suspected immune complex deposition4 as a
`
`4 Respondent contests this assessment in his Rule 4(c) report, arguing that Dr. Cholfin “provides no
`support for this statement.” (ECF No. 27, p. 7, n.3.) An immune complex deposition involves “the binding
`of antibodies to excess antigens, and subsequent deposition of the immune complexes in tissues, where
`they can elicit complement activation and inflammation.” (Id.) Respondent stresses that “[t]his would
`require high levels of circulating antibody as well as high levels of antigenic protein,” and that [t]he small
`quantity of protein in present-day vaccines is unlikely to cause such reactions.” (Id.) Respondent
`stresses that Kurul et al. found “that a large number and frequent doses of vaccines did not lead to
`immune complex deposition in the choroid plexu