VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-01044
Package ID: USCOURTS-cofc-1_18-vv-01044
Petitioner: Renee Handjis
Filed: 2018-07-17
Decided: 2022-12-05
Vaccine: influenza
Vaccination date: 2015-12-10
Condition: transverse myelitis
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On July 17, 2018, Renee Handjis filed a petition alleging that an influenza vaccine administered on December 10, 2015, caused her to develop transverse myelitis (TM). The case was assigned to Special Master Mindy Michaels Roth. Following discussions about deficiencies in the case, an Order to Show Cause was issued. After reviewing the evidence, Special Master Roth found that Handjis failed to provide preponderant evidence that the flu vaccine caused her TM, leading to the dismissal of her case. The decision noted several deficiencies. First, proof of vaccination was insufficient; the only record was an entry for a "high dose seasonal" flu vaccine on December 10, 2015, which was unlikely for a 49-year-old, as high-dose vaccines are typically for individuals aged 65 and older. No contemporaneous medical records or other persuasive documentation of the vaccination were submitted. Second, Handjis failed to establish a definitive diagnosis of TM. While her local neurologist diagnosed her with TM, objective tests such as MRIs, CSF, and EMG/NCS were normal. Her treating neurologist later expressed uncertainty, stating she had TM "or something very similar to it," and another physician opined her condition was not a "primary neurologic condition." The medical literature submitted by Handjis outlined diagnostic criteria for TM that she did not fulfill. Third, the court found that her alleged injury did not last the required six months. Her symptoms appeared to resolve by March 4, 2016, when she returned to baseline, and subsequent issues in May 2016 were attributed by her physician to "fatigue related phenomenon superimposed on old microscopic thoracic spine injury," not an exacerbation of TM. Symptoms reported in 2017 were described as "completely new" or similar to those experienced prior to the alleged vaccine injury. Fourth, Handjis failed to meet the criteria for an off-Table claim under Althen v. Secretary of Health & Human Services. She did not provide a reputable medical theory connecting the vaccine to TM, a logical sequence of cause and effect, or a proximate temporal relationship. The public decision does not describe the specific onset of symptoms, the exact nature of the neurological deficits, or the specific treatments received beyond physical therapy. Petitioner's counsel was Lawrence Cohan, and respondent's counsel was Darryl Wishard. Special Master Mindy Michaels Roth issued the dismissal decision on December 5, 2022.

Theory of causation field:
Petitioner Renee Handjis alleged that an influenza vaccine administered on December 10, 2015, caused her to develop transverse myelitis (TM). The Special Master dismissed the case, finding insufficient evidence for an off-Table claim. Key deficiencies included: lack of proof of vaccination (only an entry for an unlikely "high dose seasonal" flu vaccine for a 49-year-old); failure to establish a definitive TM diagnosis, as objective tests (MRI, CSF, EMG/NCS) were normal and treating physicians expressed uncertainty; failure to demonstrate injury lasting over six months, with symptoms resolving by March 2016 and later issues attributed to fatigue or other causes; and failure to meet the Althen criteria for causation. Specifically, the petitioner did not provide a reputable medical theory linking the flu vaccine to TM, a logical sequence of cause and effect, or a proximate temporal relationship. The public decision does not name specific medical experts consulted by the petitioner or respondent, nor does it detail the specific mechanism of action proposed for vaccine-induced TM. The case was dismissed by Special Master Mindy Michaels Roth on December 5, 2022, with petitioner's counsel Lawrence Cohan and respondent's counsel Darryl Wishard involved.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-01044-0
Date issued/filed: 2022-12-05
Pages: 21
Docket text: PUBLIC DECISION (Originally filed: 11/7/2022) regarding 46 DECISION of Special Master. Signed by Special Master Mindy Michaels Roth. (msg) Service on parties made.
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Case 1:18-vv-01044-UNJ Document 47 Filed 12/05/22 Page 1 of 21
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1044V
Filed: November 7, 2022
* * * * * * * * * * * * * *
RENEE HANDJIS, * UNPUBLISHED
*
Petitioner, * Dismissal; Influenza (“Flu”)
* Vaccine; Transverse Myelitis
v. * (“TM”); Failure to Prosecute;
* Failure to Follow Court Orders.
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * *
Lawrence Cohan, Esq., Saltz Mongeluzzi & Bendesky, Philadelphia, PA, for petitioner.
Darryl Wishard, Esq., U.S. Dept. of Justice, Washington, DC for respondent.
DISMISSAL DECISION ON ORDER TO SHOW CAUSE1
Roth, Special Master:
On July 17, 2018, petitioner filed a petition for compensation in the National Vaccine
Injury Compensation Program (“the Program”),2 alleging that an influenza (“flu”) vaccination
caused her to develop transverse myelitis (“TM”).
Following a status conference in which the deficiencies in this case were discussed, an
Order to Show Cause was issued detailing those deficiencies and providing petitioner with the
opportunity to respond and cure the deficiencies.
1 Although this Decision has been formally designated “unpublished,” it will nevertheless be posted on the Court of
Federal Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899,
2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). This means the Decision will be available to anyone
with access to the internet. However, the parties may object to the Decision’s inclusion of certain kinds of
confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request
redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance
and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would
constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be
available to the public. Id.
2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat.
3755, codified as amended, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter,
individual section references will be to 42 U.S.C. § 300aa of the Act.

Case 1:18-vv-01044-UNJ Document 47 Filed 12/05/22 Page 2 of 21
After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, I find that petitioner has failed to provide preponderant
evidence that the flu vaccine she allegedly received on December 10, 2015 caused her to suffer
TM. Therefore, this case must be dismissed.
I. Procedural History
On July 17, 2018, petitioner filed a Petition alleging that she received an influenza vaccine
on December 10, 2015 and thereafter suffered from TM caused in fact by the vaccination. Petition
at 1, ECF No. 1.
The matter was assigned to the me on July 18, 2018. Medical records were filed in support
of the petition on the same date. Petitioner’s Exhibits (“Pet. Ex.”) 1-9, ECF Nos. 4-5.
In a status report filed on September 17, 2018, petitioner advised that she was waiting for
additional records that would update her current condition and requested 60 days within which to
file those records. ECF No. 8. A Scheduling Order was issued for the filing of petitioner’s records
by November 16, 2018 and the filing of a status report by respondent by December 31, 2018.
Petitioner filed updated records and a Statement of Completion on November 15, 2018. Pet. Ex.
10-11, ECF No. 9.
After two granted Motions for extension of time, respondent filed his status report on April
26, 2019, listing additional outstanding medical records. ECF Nos. 11-12, 15. Petitioner was
ordered to file the outstanding medical records and a Statement of Completion by June 25, 2019.
ECF No. 16.
Petitioner filed medical records on June 25, 2019, along with a Motion for an extension of
time until July 25, 2019 to complete her filing of records. The Motion was granted. Pet. Ex. 12-
15, ECF Nos. 17-18.
After petitioner filed Motions for issuance of subpoena and an extension of time to file the
medical records which were granted, petitioner filed medical records on August 6, 2019 and
additional records and a Statement of Completion on September 23, 2019. Pet. Ex. 16-17, ECF
Nos. 19-21, 23-24, 26.
Respondent filed a status report on November 22, 2019, requesting to file his Rule 4(c)
Report by January 21, 2020, and the deadline was set. ECF No. 27.
Respondent filed his Rule 4(c) Report on January 21, 2020, recommending against
compensation. Respondent’s Rule 4(c) Report (“Resp. Rpt”) at 1. After summarizing petitioner’s
medical history, treatment, and burden of proof for an off-table claim, respondent highlighted
several issues with petitioner’s claim. Resp. Rpt. at 7-9.
2

Case 1:18-vv-01044-UNJ Document 47 Filed 12/05/22 Page 3 of 21
First, petitioner failed to file any proof of vaccination or a vaccine administration record
but instead relied on an entry in a medical record that documents “influenza high dose seasonal”
with a date of December 10, 2015. Resp. Rpt. at 7; Pet. Ex. 1 at 3. Respondent submitted that the
source of that information was unclear, and it was unlikely that petitioner, who was 49 years old
at the time, would be given a high dose flu vaccine, which is administered to those aged 65 and
older.3 Therefore, she had failed to file a vaccine administration record as required by the Act and
had not established receipt of the alleged vaccination. Id.
Second, petitioner failed to establish that she actually suffered from the alleged injury
claimed. (citations omitted). Respondent submitted that the medical records do not support
petitioner’s allegation that she suffers from TM. Though petitioner’s local neurologist diagnosed
her with TM, none of the tests performed supported that opinion. Her MRIs, CSF, and EMG/NCS
were all normal. Resp. Rpt. at 8; Pet. Ex. 2 at 7, 9, 14, 17, 67, 70, 79; Pet. Ex. 4 at 44. Further, her
treating neurologist later wrote he was “convinced she had an episode of transverse myelitis or
something very similar to it.” Resp. Rpt. at 8; Pet. Ex. 13 at 24. However, an attending physician
at Tulane opined that petitioner’s condition was not a “primary neurologic condition.” Resp. Rpt.
at 8; Pet. Ex. 4 at 50. Therefore, petitioner has not proven that she suffered from TM as alleged.
Resp. Rpt. at 8.
Third, petitioner failed to show that she “suffered the residual effects or complications of
[the alleged] illness, disability, injury or condition for more than 6 months after the administration
of the vaccine. 42 U.S.C.§ 300aa-11(c)(1)(D)(i). Respondent added “even where a petitioner
“experience[s] a difficult reaction in the days immediately following” vaccination, injuries lasting
fewer than six months shall not be compensated under the Vaccine Act.” (citation omitted).
Respondent submits the initial course was self-limited in this case, and the symptoms petitioner
later developed were unrelated. According to the medical records, petitioner received her vaccine
on December 10, 2015, and returned to baseline by March 4, 2016. Resp. Rpt. at 8; Pet. Ex. 13 at
18. Respondent points to a subsequent visit on May 4, 2016 in which the neurologist wrote that he
did not think her symptoms on that date were a true exacerbation of her old TM but rather “a
fatigue related phenomenon superimposed on old microscopic thoracic spine injury.” Resp. Rpt.
at 8-9; Pet. Ex. 13 at 21. Petitioner has therefore failed to satisfy the severity requirement.
Fourth, petitioner failed to provide evidence of a persuasive medical or scientific theory
that establishes that the alleged vaccine can cause the injury claimed and any suggestion that it did
is mere speculation. Further, petitioner failed to show that the onset of the condition was within a
medically appropriate timeframe after the alleged vaccination. In short, petitioner failed to satisfy
the requirements for an off-table claim under Althen. Resp. Rpt. at 9
After two granted Motions for extension of time within which to file the outstanding
medical records, petitioner filed a status report on June 22, 2020, which stated: “Upon review of
3 High-dose flu vaccines are approved only for those aged 65 or older in the United States. See Fluzone High-Dose
Seasonal Influenza Vaccine, https://www.cdc.gov/flu/prevent/qa_fluzonehtm (last visited Jan.17, 2020).
3

Case 1:18-vv-01044-UNJ Document 47 Filed 12/05/22 Page 4 of 21
the medical records and subsequent follow up with petitioner and our expert, petitioner will be
withdrawing his (sic) claim.” The status report further advised that there were no additional
medical records to submit, and petitioner was to sign a consent form allowing the dismissal of her
claim within 20 days. ECF No. 31-33. An Order issued for petitioner to file her Motion for
Dismissal by July 13, 2020.
On July 13, 2020, petitioner filed a Motion for extension of time until August 13, 2020 to
obtain petitioner’s consent to dismiss the petition, which was granted. ECF No. 34. Another
Motion requesting the same relief was filed on August 13, 2020 and granted. ECF No. 35.
On September 2, 2020, petitioner filed a Motion for extension of time for petitioner’s
counsel to move to withdraw as counsel. The Motion stated that respondent consented to the
extension of time, but not counsel’s withdrawal. ECF No. 36.
On September 3, 2020, respondent filed a Motion for an Order to Show Cause compelling
petitioner to file her Motion to Dismiss. ECF No. 37. Petitioner filed a response on September 14,
2020 opposing the Motion and stating that counsel for petitioner cannot be compelled to take any
action that would be detrimental to his client. A status conference was requested and scheduled.
ECF. No. 38.
A status conference was held on September 17, 2020. A detailed Order summarizing the
ongoing issues in this case was issued, requiring petitioner to file a status report by November 2,
2020. ECF No. 39.
In a status report filed on November 2, 2020, petitioner’s counsel quoted emails received
from petitioner and requested that the Court issue an Order to Show Cause. ECF No. 40
An Order to Show Cause was issued on November 3, 2020 requiring petitioner to show
cause as to why her claim should not be dismissed by November 17, 2020. See ECF No. 41. After
filing a Motion for extension of time within which to file a response, which was granted, petitioner
filed an article on “Transverse Myelitis and Vaccines” as Pet. Ex. 18, an exhibit list, and a response
to the Order to Show Cause on December 24, 2020. ECF Nos. 42-45.
The matter is now ripe for adjudication.
II. Factual Summary
A. Medical History Prior to Vaccination
Petitioner has a past medical history of anemia, gallstones4, fatigue, and abdominal pain.
Pet. Ex. 1 at 7.
4 An ultrasound on July 17, 2015 confirmed gallstones. Pet. Ex. 1 at 17.
4

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At a visit to the Family Health Center of Natchez (hereinafter “Family Health”) on August
3, 2015, petitioner reported fatigue, hair loss, cold intolerance, gynecological issues, bloating,
cramping, and a 17-pound weight loss in the past six months. Examination was normal. Pet. Ex. 1
at 7-8.
On September 4, 2015, petitioner underwent a laparoscopic cholecystectomy with
intraoperative cholangiogram for cholelithiasis.5 See generally Pet. Ex. 9, Pet. Ex. 14.
B. Date of Vaccination
In her petition, petitioner asserts having received an influenza vaccination at Family
Medical Health Center of Merit Health on December 10, 2015 and references Pet. Ex. 1 at 4 as
support. Petition at 1. There is no mention of a vaccine in Pet. Ex. 1 at page 4. However, there is
a reference made to a “high dose seasonal” flu vaccine at a December 14, 2015 office visit with a
date of December 10, 2015 in Pet. Ex. 1 at page 3 listed under “Reviewed Vaccines”. Pet. Ex. 1 at
3; Pet. Ex. 13 at 1. The record does not include information of manufacturer, route or site of
administration, lot number, expiration date, date on VIS (vaccine information sheet), VIS given,
or vaccinator. Pet. Ex. 1 at 3. The origin of the information contained in the record is unknown
and there is no record for a December 10, 2015 visit.
Petitioner did not file an affidavit in this case.
C. Medical History After Vaccination
On December 14, 2015, petitioner presented to Family Health with complaints of fatigue,
muscle aches, weakness and tremors in both legs and loss of balance. Pet. Ex. 1 at 4.6 The record
documents her report of waking at 4 am feeling nauseous and weak. She went to the porch for air
and noticed that her legs were very weak “and started to jerk all over.” She grabbed a pole to steady
herself out of fear she was going to faint. Her son helped her inside and noticed that her left pupil
was dilated. She had trouble with her vision. She has been weak since. “She states for the last few
months is (sic) been having more headaches that are more frequent and also more sinus problems,
with rhinorrhea and nasal congestion.” Id. She was well-appearing on examination and ambulating
normally. She had normal muscle strength and tone with no contractures or bony abnormalities.
There was normal movement in all extremities without cyanosis or edema. Id. at 5-6. The
assessment on that day was fatigue, generalized worsening headache, rhinitis, and muscle pain. Id.
at 6. Blood work and a CT scan of the head were ordered. Petitioner was instructed to go to the
emergency room if her symptoms returned. Id. at 6. There was no mention of a flu vaccine.
5 Cholelithiasis is the presence or formation of gallstones. Cholelithiasis, DORLAND’S ILLUSTRATED MEDICAL
DICTIONARY 344 (33rd ed. 2019) [hereinafter “DORLAND’S”].
6 This record is also filed as Pet. Ex. 8.
5

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Petitioner underwent a non-contrast CT of the brain on December 15, 2015 for headaches.
The results were normal/negative. Pet. Ex. 1 at 16.
Records from Natchez Neurology Clinic (hereinafter “Natchez Neurology”) reference a
December 31, 2015 visit, but no record for that date was filed. Later records include complaints of
muscle weakness, visual impairment, increased frequency of urination, numbness of lower and
upper limbs, and ataxic gait. See Pet. Ex. 2 at 52, 57, 62. A December 10, 2015 high-dose flu
vaccine is listed in the record under past vaccines but there is no reference to the flu vaccine during
any visits or in the assessments following examination. Id. at 23, 27, 30, 34, 38, 42, 46, 51, 57, 62.
Petitioner presented for a brain MRI with and without contrast on January 7, 2016, due to
“[b]ilateral lower extremity tremors and numbness, vertigo, weakness, nausea and vomiting.” The
MRI revealed no abnormality. The impression was “[n]egative MRI brain without/with
gadolinium.” Pet. Ex. 1 at 11-12; Pet. Ex. 2 at 3-4, 70-71.
Petitioner presented to Dr. Ricalde at Natchez Neurology on January 8, 2016. She had
numbness in a “quadriparetic fashion” with some reflex asymmetry in the lower extremities,
persistent sensory loss, and weakness. CPK and B12 were normal. MRI of the brain and ANA
testing was negative/normal. An EMG/NCS study was ordered with the expectation that “by now
after the onset December 14th be (sic) able to detect a demyelinating or subtle axonal process.” It
was noted that CSF testing may be necessary to detect neuropathic process. Pet. Ex. 2 at 60. “Since
last seen [petitioner] has had her MRI-we have both reviewed it it shows no CNS demyelinating
illness-it is actually quite pristine nonetheless this is not (sic) completely rule out a demyelinating
illness.” Pet. Ex. 13 at 2. Her vision had improved, but she still had some paresthesia and epicritic
type sensations in the right greater than the left leg and foot. Fingers still had numbness and fatigue.
Blood work was all normal and lupus had been ruled out. Id.
EMG/NCS testing was performed on January 11, 2016. Pet. Ex. 2 at 67. The results were
normal with “no evidence of a neuropathy - axonal or demyelinating and no evidence of a
myelopathy.” Id. CSF testing was performed on January 12, 2016, with normal results: zero white
and red blood cells, glucose of 48, protein of 36, negative Lyme antibodies, negative AchR binding
antibodies, nonreactive VDRL, and zero oligoclonal bands. Id. at 7, 9, 14, 17, 79. An MRI of the
cervical spine performed on January 14, 2016, showed “[m]inimal cervical spondylosis with no
HNP [herniation] or stenosis identified.” Pet. Ex. 1 at 13-14; Pet. Ex. 2 at 5-6, 65-66, 72-73.
Petitioner returned to Dr. Ricalde on January 20, 2016 with continued complaints of
numbness, ataxia, and weakness which precluded her return to work as a nurse because her
employment required only full-time employment. Physical and occupational therapies were
ordered. No contraindication to driving was noted. It was noted that “[t]he MRI of cervical spine
has been reviewed…radiologists report it is unremarkable there is no evidence of intrinsic increase
in cord – there is no neuromyelitis optica and there is no severe transverse myelitis . . . Her
oligoclonal bands are negative – her CSF protein was completely normal . . . there are 0 white
blood cells indicating without doubt – no CNS infectious process.” Pet. Ex. 2 at 49; Pet. Ex. 13 at
9. Dr. Ricalde wrote “the only explanation . . . is a monophasic transverse myelitis.” Id.
6

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Petitioner presented for an eye exam on January 22, 2016. She had no complaints of ocular
symptoms, no headaches, double vision, floaters, light flashes, or blurry or uncomfortable vision.
Pet. Ex. 7 at 10. The impression was good/acceptable contact lens comfort and vision and eye
health, myopia, astigmatism, and presbyopia. Id. at 11.
Petitioner attended six physical therapy sessions between January 29, 2016 and February
25, 2016 for ataxic gait and diagnosis of transverse myelitis. Pet. Ex. 15.
At a February 5, 2016 visit, Dr. Ricalde wrote, “[petitioner] is rapidly/larger rhythmically
improving now this is very encouraging and suggest (sic) a significant healing from the transverse
myelopathy syndrome I anticipate practical full recovery. We will still continue with PT and
continue to justify current leave until symptoms are at the point of patient being able to return to
full duty. And we anticipate this hopefully within the next month.” Pet. Ex. 2 at 44.
Petitioner returned to Dr. Ricalde on February 19, 2016 with continued improvement in
stability and sensation in the lower extremities. She still had some dyspraxia7 of the ring and pinky
fingers on the right hand and her feet were cold on and off. She was exercising, using a treadmill
and bike, doing squats, and walking. Her bowel function was near normal and bladder function
was improving. Pet. Ex. 13 at 15. Her “transverse myelopathy syndrome” was improving and
anticipated to continue improving, with a return to work in two weeks. Id. at 16.
Petitioner returned to Dr. Ricalde on March 5, 2016 reporting ringing in her ear and anxiety,
but no other issues. Pet. Ex. 13 at 18. Dr. Ricalde wrote, “transverse myelopathy syndrome” has
“returned to– baseline there is no indication that at present she cannot return to duty. She is being
cleared to do so.” Id.; Pet. Ex. 2 at 36.
Two months later, on May 4, 2016, petitioner presented to Dr. Ricalde with complaints of
numbness, weakness, and headache. Pet. Ex. 2 at 32; Pet. Ex. 13 at 19. She reported she had been
back to work since March 7 which was hectic due to an office move. She was exhausted but still
walking an hour a day 4-5 times a week. She reported recent heaviness with walking, numbness
in her lateral calves, some occipital soreness, and distal forearm twitching, but she was “overall
better”. Pet. Ex. 13 at 20. Blood work was ordered in case a course of Solu-Medrol with a
prednisone taper was necessary for two weeks. “I do not think this is true exacerbation of the old
transverse myelitis but I think it is a fatigue related phenomenon superimposed on old microscopic
thoracic spine injury.” Pet. Ex. 2 at 32; Pet. Ex. 13 at 21.
On May 19, 2016, petitioner returned to Dr. Ricalde for her blood work results and again
reported fatigue. Pet. Ex. 2 at 28. The record for this date does not contain an assessment or blood
work results. Id.
There are no medical records of any medical visits for the next six months. On November
22, 2016, petitioner presented to Dr. Ricalde with a complaint of “bad tinnits (sic), feel stronger,
fatigue”. She was noted as “doing very well.” Pet. Ex. 13 at 22-24. Dr. Ricalde wrote, “I am
convinced she had an episode of transverse myelitis or something very similar to it – incomplete
7 Dyspraxia is the partial loss of ability to perform coordinated acts. Dyspraxia, DORLAND’S 576.
7

Case 1:18-vv-01044-UNJ Document 47 Filed 12/05/22 Page 8 of 21
a year ago.” Pet. Ex. 2 at 25; Pet. Ex. 13 at 24. She was bothered by tinnitus (ringing in the ears)
and concerned about some difficulty with anomic aphasia/decrease in immediate recall. Id. Her
exam was relatively benign. Id.
There are no records of any medical visits for the next nine months. On August 29, 2017,
petitioner presented as a new patient to Living Well Family Clinic for wellness check. See
generally Pet. Ex. 3. A list of “Chronic Diagnoses” included but was not limited to vitamin
deficiencies, migraine, gastro-esophageal reflux, acute transverse myelitis followed by a
“Comment: Nov 2015-March 2016”, cramps and spasms, urinary incontinence, muscle weakness,
visual disturbances, hearing loss, amnesia, expressive language disorder, fatigue, and tinnitus. Pet.
Ex. 3 at 5. She reported that she did not feel well that day and was disoriented. Id. at 8. She returned
the next day, August 30, 2017 for a woman’s checkup. Id. at 11. She reported a history of
transverse myelitis diagnosed in 2016, “[e]pisodes started 12/2015 with muscle
spasms/weakness/Testing and treatments went on through 12-2015/3-2017.” Id. Her last brain
MRI was over a year ago. She reported that she was having episodes of muscle weakness more
often, decreased hearing, muscle spasms, headaches, and memory/recall problems. She described
spacing out, blanking out, eye blinking, vision changes, blurry, sensitive to light, eyes feeling
weak, and recent episodes of incontinence and expressive aphasia. Id. Her insurance would be
running out the next day, so an urgent visit to neurology based on her symptoms was necessary.
Id. at 13; see also Pet. Ex. 5 at 12-14.
Petitioner presented to Dr. Ricalde on August 30, 2017 reporting headache, alteration in
alertness, severe spasms in her legs, and incontinence starting six weeks ago. Pet. Ex. 13 at 26.
She reported awakening at 4 am two weeks ago with “completely new jerking of the muscles in
the legs with standing and also some stiffness that was associated in the arms and the legs this is
also associated with some blurring of the right eye and perhaps some diplopia.” Id. at 27. The
Assessment and Plan included muscle weakness, numbness of upper and lower limbs, tinnitus,
intermittent paraparesis, incontinence, nystagmus, and unilateral hearing loss. Pet. Ex. 13 at 28-
29; Pet. Ex. 2 at 21. In all capital letters, Dr. Ricalde wrote, “THIS IS ALMOST
CLASSICALLY—SYMPTOMATICALLY AND PHYSIOLOGICALLY MS. I WILL REPEAT
AN MRI BRAIN WITH AT (sic) RIVERPARK. Pet. Ex. 2 at 21; Pet. Ex. 13 at 29.
On September 3, 2017, petitioner presented to the emergency room (“ER”) at Tulane
reporting lower extremity weakness, leg spasms, hand and foot numbness with an 8-month history
of intermittent episodes of “legs locking up”, fatigue, and tingling and numbness in different areas
of her body.8 Pet. Ex. 4 at 13. She reported increased stressors at home and a history of transverse
myelitis and Meniere’s disease. She reported difficulty in finding words, changes in vision and
hearing, dizziness, lightheadedness, a recent episode of bladder incontinence, and hot and cold
flashes. She reported similar symptoms in 2015 when she was diagnosed with transverse myelitis.
Id. at 15. She reported that she drove herself three hours to the Tulane ER because she decided it
was time to get looked at. She awoke with numbness in her hands that morning, was fired from
her job the week before, was a single mom of two children, and feels heavy all over. She reported
her prior transverse myelitis was treated with exercise, not medication. A review of systems for
8 This would place onset of those symptoms in February 2017.
8

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the foregoing complaints was negative. Id. at 30. She reported a daughter with a seizure disorder,
a grandmother with epilepsy, and an uncle with ALS. Id. at 30-31. She was admitted.
An MRI of the brain and spine were negative for structural abnormality or acute process
which could cause her symptoms, and all labs were normal. Pet. Ex. 4 at 13. Neurological
examination revealed “giveway weakness and normal reflexes.”9 She was noted to be focused on
“her previously incorrect diagnosis” and being out of work with the last event for three months.
Id. at 43. She became angry when she was told that the MRIs of the brain, C-spine, T-spine, and
L-spine were normal and could not explain her symptoms. She demanded specific names of
neurological processes that could be consistent with lower extremity weakness and normal MRI
studies. She reported that, while walking with a friend, she was alerted to the fact that she did not
lift her legs well. She became angry, denied having stress in her life, then became tearful about her
home situation and that there were no government funds to deal with situations like hers. When
therapy was recommended, she said it takes too long. Pet. Ex. 4 at 44, 50. The neurologist wrote,
“This is not a primary neurological condition…” Id. at 50. Petitioner declared she did not want
any further interaction with the Tulane Neurology Team and would seek care elsewhere. She
reportedly walked out of the hospital on her own at discharge without any difficulty. Id. at 44.
Petitioner returned to Living Well Family Clinic on November 10, 2017 to discuss her test
results from Tulane. She reported driving herself to Tulane when she “woke up about 2 months
ago with complete numbness to bilateral hands and legs/Couldn’t walk/Headaches were still going
on/severe spasms to legs moreso (sic) than arms.” She planned to see a neurologist in New Orleans
on November 22, 2017. She reported a history of transverse myelitis diagnosed in 2016. She
wanted to discuss Lexapro which she had started taking two months ago and noticed a difference.
She reported headaches and fatigue, ringing in her ears, problems urinating, chronic joint and
muscle pain, spasms, numbness and tingling in her toes and fingers, and heaviness in her legs when
walking. She had memory loss and intermittent aphasia with anxiety and depression. Pet. Ex. 5 at
6. Examination was normal and she was administered a vitamin B12 injection. Pet. Ex. 5 at 7.
Petitioner presented to the LSU Healthcare Network for evaluation of possible MS on
November 22, 2017. She reported on “12/2015 she had an episode; she had a flushot (sic) with
unusual reaction followed by extreme fatigue. She then had severe nausea, impaired balance and
weakness of the legs. Prior to this she could walk several miles after this she could not walk
upstairs.” Pet. Ex. 6 at 1.10 All testing was normal. She required prolonged rehabilitation and
continued to have hearing loss. On “8/2017 she started noticing increased fatigue, decreased
hearing.” She couldn’t see out of her right eye and “things were blurry . . . her vision fluctuated
and now has returned to baseline. She feels pressure behind her eyes with headache in the back of
her head. It took about 6 weeks for her eye to improve. She went to Tulane because she woke up
with complete numbness on the hands and weakness on the legs.” Id. She noted increased urinary
urgency and has leg spasms sometimes 10 times a day. Id. Examination and testing were
9 There is no formal definition for “giveway” or “giveaway” weakness; it is often used by physicians to describe
patients who are not fully cooperating during examination but may also be attributed to pain. See Davis v. Sec'y of
Health & Human Servs., No. 14-978V, 2022 WL 1654743 n.73 (Fed. Cl. Spec. Mstr. Apr. 27, 2022).
10 This record is also filed as Pet. Ex. 10 and Pet. Ex. 12.
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normal/negative. The record documents a “[p]uzzling case. Bilateral lower extremity weakness
with preserved reflexes developing after flu shot with normal MRI’s of brain and spine. Improved
since initial attack but still with persistent weakness.” Id. at 3. In a discussion with petitioner, it
was explained that the diagnosis was unclear but very unlikely to be MS. It was unlikely she would
have subsequent events. “Discussed transverse myelitis. Reassured her that she does not have
ALS.” Id.
Petitioner returned to Dr. Lovera at LSU Healthcare Network on February 1, 2018 for
impaired balance and weakness of her bilateral lower extremities. She complained of low back
pain radiating into her left leg. On examination, her deep tendon reflexes were “hyper-reflexic” at
the knees and symmetrical at the ankles. Strength was normal except for slight weakness of the
left great toe extension. NCS testing performed on the lower extremities was normal. EMG testing
of the bilateral lower extremities revealed significant chronic denervation involving the left L5
myotome. Pet. Ex. 6 at 4; Pet. Ex. 12 at 9. The impression was significant chronic L5
radiculopathy. Id.
Petitioner presented for an eye examination on April 18, 2018 complaining of blurry vision.
She reported no disorders or current medical treatment except for a pinched nerve followed by a
neurologist. Pet. Ex. 7 at 4. Following a comprehensive eye exam, petitioner was noted to have
corneal neovascularization of the left eye and suspected bilateral glaucoma. Id. at 5. A May 3,
2018 visit confirmed primary open angle glaucoma. Id. at 1.
Petitioner returned for eye examination on June 12, 2018. She reported that her left eye
always seemed hazy. Pet. Ex. 11 at 20. She returned on November 9, 2018 for a recheck secondary
to glaucoma and was noted to be responding to topical medication. Id. at 29-31.
Petitioner’s last medical record filed was for a follow-up eye examination on May 16, 2019.
Pet. Ex. 16.
D. Transverse Myelitis
Transverse myelitis (“TM”) is a rare clinical syndrome in which an immune-mediated
process causes neural injury to the spinal cord, resulting in varying degrees of weakness, sensory
alterations, and autonomic dysfunction. Pet. Ex. 18 at 1.11
The Transverse Myelitis Consortium Working Group’s proposed diagnostic criteria for TM
includes bilateral sensory, motor, or autonomic dysfunction attributable to the spinal cord, a clearly
defined sensory level, and peaking of symptoms within 4 hours and 21 days. Pet. Ex. 18 at 1.
The pathogenesis of TM is believed to be autoimmune in nature and involves a breakdown
of the blood-brain barrier resulting in cerebrospinal fluid (“CSF”) pleocytosis within a focal area
11 N. Agmon-Levin et al., Transverse myelitis and vaccines: a multi-analysis, 18 LUPUS 1198 (2009), filed as “Pet.
Ex. 18.”
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of the spinal cord. Pet. Ex. 18 at 1. Thus, where TM exists, there is observed evidence of an
inflamed spinal cord, pleocytosis in the CSF, and elevated IgG index or gadolinium enhancement
by MRI. Id. at 1-2.
TM may present as a multi-focal central nervous system disease such as multiple sclerosis,
as a result of direct injury to the spine such as radiation or spinal cord infarct, as a part of a systemic
issue such as malignancy, as an autoimmune disease such as lupus, or as an isolated entity. Pet.
Ex. 18 at 1.
The cause of most autoimmune processes is multi-factorial, including genetic,
immunological, hormonal, and environmental factors. Infectious illnesses play a key role, and up
to 40% of TM cases are associated with a preceding infectious illness, mostly within a month of
TM onset, and often with preceding infections of respiratory, gastrointestinal, or flu-like illness.
Pet. Ex. 18 at 2. In most cases, TM begins after the infection resolves and no infectious agent has
been isolated in the nervous system. Id. “Thus, TM appears not to be a direct infectious process,
but rather an autoimmune response triggered by the infectious antigens.” Id. Several cases of TM
have been reported after vaccination and in children within one month of symptom onset. Id.
Transverse myelopathy, as opposed to transverse myelitis, refers to various functional
disturbances or pathologic changes that extend across the spinal cord.12 Myelopathy is a general
term that refers to dysfunction of the spinal cord caused by one of many diseases, including
transverse myelitis. See Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1342
(Fed. Cir. 2010).
III. Standard for Adjudication
The Vaccine Act provides petitioners with two avenues to receive compensation for their
injuries resulting from vaccines or their administration. First, a petitioner may demonstrate that he
or she suffered a “Table” injury — i.e., an injury listed on the Vaccine Injury Table that occurred
within the timeframe provided within the Table. 42 U.S.C. § 300aa-11(c)(1)(C)(i). “In such a case,
causation is presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed.
Cir. 2006); see 42 U.S.C. § 300aa-13(a)(1)(B). Alternatively, where the claimed injury is not listed
in the Vaccine Table or does not fit squarely within the Table parameters, a petitioner may bring
an “off-Table” claim. 42 U.S.C. § 300aa-11(c)(1)(C)(ii). An “off-Table” claim requires that the
petitioner “prove by a preponderance of the evidence that the vaccine at issue caused the injury.”
Capizzano, 440 F.3d at 1320; see 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(II). Initially, a petitioner must
provide evidence that he or she suffered, or continues to suffer, from a definitive injury.
Broekelschen., 618 F.3d at 1346 (Fed. Cir. 2010). A petitioner need not show that the vaccination
was the sole cause or even the predominant cause of the alleged injury; showing that the
vaccination was a “substantial factor” and a “but for” cause of the injury is sufficient for recovery.
See Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006); Shyface v.
12 Transverse myelopathy, DORLAND’S 1203.
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Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Additionally, the Vaccine
Act requires petitioners to show by preponderant evidence that the “residual effects or
complications” of the alleged vaccine-related injury lasted longer than six months. 42 U.S.C.
§ 300aa-11(c)(1)(D)(i).
IV. Analysis
Because petitioner does not allege an injury listed on the Vaccine Injury Table, her claim
is classified as “off-table.” As noted above, to prevail on an “off-table” claim, petitioner must show
by preponderant evidence that she suffered an injury, and that the alleged injury was caused by the
vaccination at issue. Capizzano, 440 F.3d at 1320. There are four key areas at issue in this case
that affect entitlement: (1) the lack of proof of vaccination, (2) the lack of a definitive diagnosis,
(3) petitioner’s ability to demonstrate her injuries and/or related sequalae lasted the requisite six
months, and (4) her failure to satisfy the Althen requirements.
A. Proof of Vaccination
The only references to a flu vaccine on December 10, 2015 is a medical record entry of
“influenza, high dose seasonal” with a date of “12/10/15.” See Pet. Ex. 2 at 23, 27, 30, 34, 38, 42,
46, 51, 57, 62. There was no record filed of any medical visit on December 10, 2015 or vaccine
record.
The first reference to “influenza, high dose seasonal” vaccine on “12/10/15” is contained
in a record of petitioner’s visit to her primary care physician on December 14, 2015, when she
complained of weakness. The amount, route, site, lot number, manufacturer, expiration date, date
on VIS, VIS given, or administrator of the vaccine was not included. Pet. Ex. 1 at 3. All other
references to a December 10, 2015 flu vaccine was provided by petitioner when reporting her
history to providers.
In her response to the Order to Show Cause, petitioner submitted that she attempted to
obtain proof of vaccination “through every means possible, but it was found that such a form does
not exist.” She did not recall signing any document for the vaccine, only being told she was due
for the flu vaccine and verbally consenting to receiving it on that date. Petitioner’s Response to
the Order to Show Cause (hereinafter “Pet. Response”) at 10-11. Petitioner did not file an affidavit
in this case and did not provide any details of what her attempts to obtain proof of vaccination
included.
Petitioner’s claim that she received a high dose flu vaccine creates further questions
regarding her alleged vaccination. Petitioner was 49 years old on December 10, 2015, and the high
dose flu vaccine is only approved/licensed in the United States for those ages 65 and older.13
Therefore, it is unlikely that she would have been given a high dose flu vaccine.
13 Centers for Disease Control, supra note 3.
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As set forth in the Vaccine Act, petitioners are required to file an affidavit and “vaccination
records associated with the vaccine allegedly causing injury,” 42 U.S.C. §300aa-11(c)(1)-(2) or
“an identification of any records of the type described in paragraph (1) or (2) which are unavailable
to the petitioner and the reasons for their unavailability.” 42 U.S.C §300aa-11(c)(3).
Here, petitioner did not provide a vaccination record or an affidavit detailing her receipt of
the alleged vaccination or her efforts to secure documentation to prove receipt of the flu
vaccination. She relied on a single entry in the medical record, four days after her alleged receipt
of the vaccination, which does not include any information associated with the vaccine or the
source of the information for the record and which appears repetitively thereafter as part of an
electronic medical record. Pet. Ex. 1 at 3. Further, the record documents a high dose flu vaccine
with no explanation as to why it would be given to a 49-year-old.
There is no corroborating evidence submitted in this case from any physician, nurse, or
other medical professional that an influenza vaccination was administered to petitioner on
December 10, 2015.
Due to the absence of contemporaneous medical records or any persuasive documentation,
petitioner has failed to meet the preponderance of the evidence standard required to show
administration of a vaccine on December 10, 2015. See Lamberti v. Sec'y of Dep't of Health &
Human Servs., No. 99-507V, 2007 WL 1772058 at *7 (Fed. Cl. May 31, 2007); Groht v. Sec'y of
the Dep't of Health & Human Servs., No. 00-287V, 2006 WL 3342222 at *2 (Fed. Cl. Spec. Mstr.
Oct. 30, 2006); §300aa–11(b)(1)(A).
B. Defined and Recognized Injury
An initial step of an off-table claim is to “determine what injury, if any, was supported by
the evidence presented in the record.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d
1343, 1353 (Fed. Cir. 2011). The Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury,” and “[i]n the absence of a showing of the
very existence of any specific injury[,] . . . the question of causation is not reached.” Id.;
Broekelschen, 618 F.3d at 1346 (explaining that a vaccine-related injury “has to be more than just
a symptom or manifestation of an unknown injury.”); Stillwell v. Sec’y of Health & Human Servs.,
118 Fed. Cl. 47, 56 (2014) (“[I]f the special master finds, as a preliminary matter, that petitioner
has failed to substantiate the alleged injury, the special master need not apply the Althen test for
causality.”). Thus, petitioner has the burden to demonstrate the medically recognized injury from
which she suffers. Broekelschen, 618 F.3d at 1348; see also Lasnetski v. Sec’y of Health and
Human Servs., 128 Fed. Cl. 242 (2016), aff’d, 696 F. App’x 497 (Fed. Cir. 2017).
When determining whether petitioner has adequately proven a demonstrable injury, special
masters analyze petitioner’s complete medical records as filed into the record. 42 U.S.C. § 300aa-
11(c)(2). Medical records created contemporaneously with the events they describe are generally
considered to be trustworthy. Cucuras v. Sec’y of Health and Human Servs., 993 F.2d 1525, 1528
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(Fed. Cir. 1993); but see Kirby v. Sec’y of Health & Human Servs., 993 F.3d 1378, 1382-83 (Fed.
Cir. 2021) (clarifying that Cucuras does not stand for proposition that medical records are
presumptively accurate and complete). Subsequent statements made by third parties that contradict
contemporaneous medical records are less persuasive to special masters than the medical records.
Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006).
Petitioner argues she has established that she suffered and continues to suffer from TM
through her treating physicians. Pet. Response at 11-12; Pet. Ex. 2 at 25, 49; Pet. Ex. 5 at 7.
Petitioner offers citations to her medical records including, “The only explanation for the above is
monophasic transverse myelitis”, “patient with complicated history suggestive of transverse
myelitis…” “Hx of Transverse Myelitis…”, “Pt is a 51 yo female with previous dx of transverse
myelitis…”. Pet. Response at 11-12 (citing Pet. Ex. 2 at 49; Pet. Ex. 10 at 6; Pet. Ex. 6 at 614; Pet.
Ex. 4 at 15).
Petitioner’s references in support of her TM diagnosis are taken out of context or are
incomplete statements. When read in their entirety, the medical records upon which petitioner
relies include: “I’m convinced she had an episode of transverse myelitis or something very similar
to it-incomplete a year ago.” Pet. Ex. 2 at 25 (emphasis added). Another record states:
…there is no neuromyelitis optic and there is no severe transverse myelitis, however, the
only explanation for the above is a monophasic transverse myelitis. Her oligoclonal bands
are negative-her CSF protein was completely normal the CSF was appropriately obtained
without contamination and there are 0 white blood cells indicating without doubt-no CNS
infectious process.
Pet. Ex. 2 at 49. Reference is made to billing codes, which are used for purposes of payments for
services, and included acute transverse myelopathy, muscle weakness, blurry vision, expressive
aphasia, numbness, and Vitamin D12 deficiency. Pet. Ex. 5 at 7 (emphasis added). In another
record, a section titled “Counseling” documents that “petitioner’s diagnosis remains unclear but is
unlikely MS”, that it was “less likely she would have subsequent events”, and “[d]iscussed
transverse myelitis. Reassured her that she does not have ALS.” Pet. Ex. 10 at 6. In the
“Assessment” section of the same record, an entry contains, “Puzzling case. Bilateral lower
extremity weakness with preserved reflexes developing after flu shot with normal MRI’s of the
brain and spine. Improved since initial attack but still with persistent weakness.” Id. It is unknown
from this record what was discussed regarding TM or whether petitioner was reassured that she
did not have TM, like she was reassured she did not have ALS. Finally, petitioner relies on the
content of the Tulane ER record which mentions TM, but that mention was part of the history
petitioner provided upon presentation. Pet. Ex. 4 at 15.
The literature petitioner filed in support of her claim is more persuasive in showing that
she did not have TM. None of the diagnostic criteria for a finding of TM proposed by the
14 There is no page 6 of this record and no reference to TM on the other pages.
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Transverse Myelitis Consortium Working Group and discussed in the literature filed—bilateral
sensory, motor, or autonomic dysfunction attributable to the spinal cord, clearly defined sensory
level, and peaking of symptoms within 4 hours to 21 days—exists in this case. See Pet. Ex. 18.
In weighing evidence, special masters are expected to consider the views of treating
doctors. Capizzano, 440 F.3d at 1326. Treating doctors’ views about the appropriate diagnosis are
often persuasive because the doctors have direct experience with the patient they are diagnosing.
See McCulloch v. Sec’y of Health & Human Servs., No. 09-293V, 2015 WL 3640610, at *20 (Fed.
Cl. Spec. Mstr. May 22, 2015). However, as respondent accurately highlighted, though petitioner’s
local neurologist Dr. Ricalde diagnosed petitioner with transverse myelitis, he did so without any
supporting objective testing: petitioner’s MRIs, CSF, and EMG/NCS testing were all normal.
Resp. Rpt. at 8; Pet. Ex. 2 at 7, 9, 14, 17, 67, 70, 79; Pet. Ex. 4 at 44. Dr. Ricalde later questioned
the diagnosis of TM, adding that petitioner had TM “or something very similar to it.” Pet. Ex. 13
at 24. He also began referring to her condition as myelopathy rather than myelitis. Further,
petitioner presented with no sensory deficits, full strength of all limbs, and symptoms that did not
peak within 4 to 21 days. Rather, according to petitioner’s reports to her physicians, her symptoms
progressed in the weeks that followed, with increasing weakness that required a walker and then a
wheelchair. Finally, she was not treated with any treatment typically used for illnesses thought to
be autoimmune in origin, but rather was prescribed only physical therapy.
Further, after testing and examination, the neurologist at Tulane concluded that petitioner
did not have a “primary neurologic condition.” Pet. Ex. 4 at 50.
Petitioner has failed to meet her burden of showing a defined and recognized injury.
Petitioner has undoubtedly suffered from a host of symptoms as documented over the years,
including but not limited to weakness, numbness, dizziness, aphasia, memory deficits, and visual
problems. See Pet. Ex. 1 at 3-4; Pet. Ex. 5 at 3; Pet. Ex. 7; Pet. Ex. 10 at 6. However, she has not
been provided with a definitive diagnosis, has not been treated for an immune mediated disease,
and does not fulfill the criteria for TM.
C. Six-Month Requirement
The Vaccine Act requires petitioners to show by preponderant evidence that the “residual
effects or complications” of the alleged vaccine-related injury lasted for more than six months. 42
U.S.C. § 300aa-11(c)(1)(D)(i). In Cloer v. Sec’y of Health and Human Servs., the Federal Circuit
explained that the six-month requirement is “a condition precedent for filing a petition for
compensation” in the vaccine program and serves as a restriction on eligibility for compensation
in the Program. 654 F.3d 1322, 1335 (Fed. Cir. 2011). Congress intended this duration requirement
“to limit the availability of the compensation system to those individuals who are seriously injured
from taking a vaccine.” Id. (quoting H.R. Rep. No.100-391(I), at 699 (1987), reprinted in 1987
U.S.C.C.A.N. 2313-1, -373.
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Petitioner argues that the six-month requirement is met because she experienced onset of
symptoms on December 14, 2015, four days after her alleged receipt of the flu vaccine on
December 14, 2015, and these symptoms continued through November 22, 2017 as evidenced by
her medical records. Pet. Response at 12. She further submits that as of November 22, 2017, her
symptoms were still attributed to her December 10, 2015 flu vaccine. Id. at 6.
Petitioner’s medical records do not, in fact, support her claim that the six-month
requirement is satisfied. Petitioner claims to have received her flu vaccine on December 10, 2015
and presented with weakness on December 14, 2015. Pet. Ex. 1 at 4. When she saw Dr. Ricalde
on March 5, 2016, petitioner complained of ringing in her ears and anxiety; she reported no other
issues. Pet. Ex. 13 at 18. At that time, Dr. Ricalde wrote that she had “returned to-baseline…”, she
could return to work and was cleared to do so. Pet Ex. 2 at 36; Pet. Ex. 13 at 18. Petitioner did
return to work full time and when she presented two months later on May 4, 2016, reporting
numbness, weakness, and headache, Dr. Ricalde specifically referred to her symptoms as a “fatigue
related phenomenon”, not an exacerbation of her prior condition. Pet. Ex. 2 at 32; Pet. Ex. 13 at
21. Petitioner returned to Dr. Ricalde on May 19, 2016, but there was no record filed of an
assessment on that date. Pet. Ex. 2 at 28-31.
Thereafter, petitioner did not seek care for six months, until she returned to Dr. Ricalde on
November 22, 2016, with a new complaint of “bad tinnits (sic), feel stronger, fatigue” but was
noted to be “doing very well.” Pet. Ex. 13 at 22, 24. Her exam was benign. Pet. Ex. 2 at 25; Pet.
Ex. 13 at 24.
Petitioner had no further treatment for nine months, until she presented as a new patient to
Living Well Family Clinic for a wellness check on August 29, 2017 and a woman’s check up on
August 30, 2017. By her own reported history, she claimed to have suffered from transverse
myelitis diagnosed in 2016, “episodes started 12/2015 with muscle spasms/weakness/Testing and
treatments went on through 12-2015/3-2017.” Pet. Ex. 3 at 11. At that time, she reported having
episodes of muscle weakness more often, decreased hearing, muscle spasms, headaches, and
memory/recall problems. She described spacing out, blanks out, eye blinking, vision changes,
blurry, sensitive to light, eyes feeling weak, and recent episodes of incontinence, and expressive
aphasia. Id. She was sent directly to her neurologist since her insurance would lapse the following
day. Id. at 13; see also Pet. Ex. 5 at 10-14.
Upon presenting to Dr. Ricalde on August 30, 2017, she reported that her symptoms started
six weeks ago. Pet. Ex. 2 at 20; Pet. Ex. 13 at 26 (emphasis added). She reported “completely new
jerking of the muscles in the legs with standing,” some stiffness in her arms and the legs, some
blurring of the right eye and perhaps some diplopia about two weeks ago. Pet. Ex. 13 at 27. Dr.
Ricalde’s assessment was “almost classically – symptomatically and physiologically MS.”15 Pet.
Ex. 2 at 21; Pet. Ex. 13 at 29.
On September 3, 2017, petitioner presented to Tulane reporting lower extremity weakness,
leg spasms, hand and foot numbness, and an 8-month history of intermittent episodes of “legs
15 This entry appeared in all capital letters in the record.
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locking up”, fatigue, tingling, and numbness in different areas of her body.16 She reported a history
of TM and Meniere’s disease and that her current symptoms were similar to those she had 2015
when she was diagnosed with TM. Pet. Ex. 4 at 13, 15. MRIs of the brain and spine were normal
as were her labs, and a neurological examination revealed “giveway weakness and normal
reflexes.” The neurologist wrote, “This is not a primary neurological condition…” Pet. Ex. 4 at
50.
When she presented to LSU Healthcare Network on November 22, 2017 to be evaluated
for MS, petitioner reported on “12/2015 she had an episode; she had a flushot (sic) with unusual
reaction followed by extreme fatigue. She then had severe nausea, impaired balance and weakness
on the legs.” Pet. Ex. 6 at 1. She reported that she started noticing increased fatigue, decreased
hearing, and vision issues in August 2017, and “went to Tulane when she woke up with complete
numbness to the hands and weakness on the legs.” She noted increased urinary urgency and leg
spasms. Id. Examination and testing were normal/negative. The record notes a “[p]uzzling case.
Bilateral lower extremity weakness with preserved reflexes developing after flu shot with normal
MRI’s of brain and spine. Improved since initial attack but still with persistent weakness.” Id. at
3. In a discussion with petitioner, it was explained that the diagnosis was unclear, but it was
unlikely to be MS and unlikely she would have subsequent events. “Discussed transverse myelitis.
Reassured her that she does not have ALS.” Id.
Thereafter, in 2018, she continued to complain of impaired balance and weakness of her
bilateral lower extremities and low back pain radiating into her left leg. The impression after
EMG/NCS was significant chronic L5 radiculopathy. Pet. Ex. 6 at 4; Pet. Ex. 12 at 9.
Petitioner’s own reports of her history repetitively show that her complaints of bilateral
weakness in her lower extremities had resolved by the beginning of March 2016, when Dr. Ricalde
noted that she had returned to baseline. Further, Dr. Ricalde did not believe that the symptoms she
experienced in May 2016 were an exacerbation of her prior condition. It was not until 2017 that
she presented again reporting an onset of symptoms eight months prior, which were similar to
those she experienced after her flu shot in 2015.
Based on the records in their entirety, I find that petitioner has failed to establish that the
residual effects of her alleged vaccine-related injury lasted for more than six months as required
under the Vaccine Act. In fact, the record supports that her alleged injury resolved in less than
three months. However, even if petitioner’s symptoms were deemed to have continued in excess
of six months, there is still no definitive diagnosis of what those symptoms represented, no
objective testing to support a diagnosis of TM or other definable neurologic disease, no treatment
to suggest that they were thought to be an immune mediated condition, and no indication that what
she suffered was related to the December 10, 2015 flu vaccine she allegedly received.
16 Eight months from this date would be January 2017.
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D. Althen Criteria
Petitioner has failed to provide proof of vaccination and a definitive diagnosis or injury
that has lasted longer than the requisite six months. Typically, “[i]n the absence of a showing of
the very existence of any specific injury of which petitioner complains, the question of causation
is not reached.” Lombardi, 656 F.3d at 1353. However, even if petitioner had been able to provide
proof of vaccination and shown a definable injury that lasted at least six months, she would be
unable to sustain her burden of proving causation under the three-pronged test established in Althen
v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Althen requires that
petitioner establish by preponderant evidence that the vaccination she received caused 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 a proximate temporal relationship between vaccination and injury.” Id. Together, these
prongs must show “that the vaccine was ‘not only a but-for cause of the injury but also a substantial
factor in bringing about the injury.’” Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1379 (Fed. Cir. 2012) (quoting Shyface, 165 F.3d at 1352-53). In this case, petitioner fails on all
three prongs.
1. Reputable Medical Theory
The first Althen prong requires petitioner to provide a “reputable medical theory”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford v. Sec’y of
Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006) (citation omitted). To satisfy
this prong, petitioner’s “theory of causation must be supported by a ‘reputable medical or scientific
explanation.’” Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009) (quoting Althen, 418 F.3d at 1278). This theory need only be “legally probable,
not medically or scientifically certain.” Id. at 1380 (emphasis omitted) (quoting Knudsen, 35 F.3d
at 548). Nevertheless, “petitioners [must] proffer trustworthy testimony from experts who can find
support for their theories in medical literature.” LaLonde, 746 F.3d at 1341.
On Prong I, petitioner submits that numerous case studies have provided a medical theory
causally connecting the flu vaccine and TM, with a majority of cases manifesting within several
days of vaccination. She relied on the article she submitted, which provides, “’The pathogenesis
of transverse myelitis is mostly of an autoimmune nature, triggered by various environmental
factors, including vaccination . . . The association of different vaccines with a single autoimmune
phenomena allude to the idea that a common denominator of these vaccines, such as an adjuvant,
might trigger this syndrome.”’ Pet. Response at 7 (quoting Pet. Ex. 18). Therefore, her weakness,
numbness, and fatigue four days after the flu vaccine were manifestations of TM. Id.
Absent a persuasive medical or scientific theory establishing that, in this case, the flu
vaccine can cause TM as alleged by petitioner, any suggestion that the vaccine did cause such an
injury is mere speculation. Nothing in petitioner’s medical records suggest that the flu vaccine was
the actual cause of petitioner’s condition. Therefore, on the existing record, petitioner has failed to
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establish by preponderant evidence that she suffered from a vaccine-related injury. See 42
U.S.C.§300aa-12(a)(1).
Under the Act, petitioner may not be given a Program award based solely on the petitioner’s
claims alone. Rather, the petition must be supported by either medical records or by the opinion
of a competent physician. § 13(a)(1). In this case, because the medical record is insufficient to
support petitioner’s claim, a medical opinion must be offered in support. However, petitioner has
offered no such opinion that supports a finding of entitlement. While petitioner filed medical
literature on post-vaccination TM, the literature outlines diagnostic criteria for TM including
bilateral sensory, motor, or autonomic dysfunction attributable to the spinal cord, a clearly defined
sensory level, and peaking of symptoms within 4 hours and 21 days, none of which petitioner
satisfies. See Pet. Ex. 18 at 1.
Because TM is not a table injury associated with flu vaccine, petitioner must provide the
evidence necessary to support her claim that her alleged TM or any other neurological disease was
associated with the flu vaccine she received. Petitioner has not filed an expert in this case. Further,
even if I were to accept Dr. Ricalde’s diagnosis of TM, there is no evidence filed in this case that
supports a finding that flu vaccine can cause TM. Petitioner has failed to satisfy Prong I.
2. Logical Sequence of Cause and Effect
The second Althen prong requires proof of “[a] logical sequence of cause and effect.”
Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). In other words, even if the
vaccination can cause the injury alleged, petitioner must show “that it did so in [this] particular
case.” Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation
omitted). “A reputable medical or scientific explanation must support this logical sequence of
cause and effect,” id. at 961 (citation omitted), and “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,” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1385
(Fed. Cir. 2015) (quoting Andreu, 569 F.3d at 1375).
Petitioner relies on Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326
(Fed. Cir. 2006), arguing that where a petitioner has satisfied Prongs I and III as she has, it is
logical to conclude that there “is a logical sequence of cause and effect linking the influenza
vaccine to [petitioner’s] transverse myelitis.”, and she has therefore satisfied Prong II. Pet.
Response at 9.
As petitioner cannot satisfy Prong I, her argument as to Prong II is not persuasive. Further,
petitioner fails on this prong because the medical records show that while Dr. Ricalde initially
referred to petitioner as having TM despite all objective testing being normal or negative, he later
referred to her as having myelopathy or something like TM. Even if Dr. Ricalde’s initial diagnosis
of TM is accepted, he did not treat her for TM. He also found that she had returned to baseline by
the end of March 2016, attributing her new symptoms in May 2016 to stress and fatigue. In 2017,
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Dr. Ricalde referred to her symptoms as possible MS. Petitioner’s other treating physicians
questioned her diagnosis, referring to her presentation and complaints as “puzzling” and not a
primary neurologic disease. The failure of any objective testing confirming any neurological
disease begs the question, what, if anything, did the flu vaccine in this case cause? While
petitioner’s treating physicians may have documented her receipt of flu vaccine in December of
2015, they did so based on her reported history, and none implicated the flu vaccine in her
presenting complaints.
The literature submitted by petitioner discusses the Transverse Myelitis Working Group’s
criteria for a diagnosis of TM, which petitioner does not fulfill. Petitioner has failed to satisfy
Prong II.
3. Proximate Temporal Relationship
To satisfy the third Althen prong, petitioner must establish a “proximate temporal
relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This
“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 & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir.
2008). Typically, “a petitioner’s failure to satisfy the proximate temporal relationship prong is due
to the fact that onset was too late after the administration of a vaccine for the vaccine to be the
cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case, the
temporal relationship is not such that it is medically acceptable to conclude that the vaccination
and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Human Servs., 685
F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was administered,
logically, the vaccine could not have caused the illness.”).
Petitioner argues that, like her case, the majority of TM cases manifest within several days
of vaccine with symptoms of fatigue, weakness, and leg tremors, which she had. Therefore, she
has met her burden under Prong III because her medical records and medical literature support her
four-day onset following vaccination. Pet. Response at 8; see Pet. Ex. 18.
The literature filed by petitioner discussing TM provides for the onset of symptoms within
a month. See Pet. Ex. 18. If one were to accept that petitioner received a high dose flu vaccine on
December 10, 2015 and presented on December 14, 2015 with symptoms that were ultimately
diagnosed as TM and supported by objective testing, then petitioner would have satisfied Prong
III. However, there is no proof of vaccine, and no definable injury to access a reasonable medical
timeframe for onset. Therefore, petitioner fails to satisfy Prong III.
V. Conclusion
The analysis in this case resulted from the filing of an Order to Show Cause, providing
petitioner with the opportunity to cure the many deficiencies in her case. After review of the
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medical records, medical literature, and submissions of counsel, it is clear that petitioner has failed
to provide sufficient evidence to demonstrate: (1) that she received a high dose flu vaccine on
December 10, 2015; (2) that she suffered TM following the high dose or any influenza vaccination;
(3) that the injuries alleged to have occurred lasted in excess of the requisite six months; and (4)
that the influenza vaccine can and/or did cause her to suffer TM injury within an appropriate
timeframe in order to satisfy the Althen criteria. There is no doubt that petitioner has suffered
greatly. However, despite my sympathy for petitioner, my decision must reflect a thorough
analysis of the evidence presented and the application of the law based upon probative weight and
persuasiveness. The dismissal of petitioner’s case is not a sanction or penalty, but rather the result
of a lack of evidence sufficient to support a finding of entitlement.
For these reasons, I find that petitioner has not established entitlement to compensation,
and accordingly, her petition must be dismissed. In the absence of a timely filed motion for review
pursuant to Vaccine Rule 23, the Clerk is directed to enter judgment consistent with this decision.17
IT IS SO ORDERED.
s/ Mindy Michaels Roth
Mindy Michaels Roth
Special Master
17 Pursuant to Vaccine Rule 11 (a), if a motion for review is not filed within 30 days after the filing of the special
master’s decision, the clerk will enter judgment immediately.
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