# Skinner-Smith v. Secretary of Health and Human Services

> United States Court of Federal Claims · September 9, 2022

URL: https://www.frixlaw.com/law-library/cases/8129311

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** September 9, 2022
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Daniel T. Horner
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/8129311

## How later opinions describe it (automated extraction)

- explaining that the Federal Circuit “found that a treating physician who was familiar with the patient both before and after the alleged vaccine injury is likely to be in a better position than an expert retained after the fact” to opine with respect to vaccine causation

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: August 15, 2022
PUBLISHED

Special Master Horner
ALICIA SKINNER-SMITH,

Petitioner, Tetanus Diphtheria and
v. acellular Pertussis (“Tdap”)
vaccine; cause in fact; cellulitis;
SECRETARY OF HEALTH AND chronic fatigue syndrome (CFS)
HUMAN SERVICES,

Respondent.

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Terrence Kevin Mangan, Jr., U.S. Department of Justice, Washington, DC, for
respondent.

RULING ON ENTITLEMENT 1

On December 17, 2014, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that the tetanus,
diphtheria, acellular pertussis (“Tdap”) vaccine that petitioner received on February 6,
2012, caused her to suffer an abscess, pain, and related injuries that became chronic.
(ECF No. 1.) By the time of the hearing held in this case in May of 2021, petitioner had
clarified that the chronic injury she alleges is Chronic Fatigue Syndrome (“CFS”). (ECF
No. 132.) For the reasons set forth below, I conclude that petitioner is entitled to
compensation for her more limited cellulitis injury but is not entitled to compensation for
her broader CFS.

1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will

be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), 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 the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.

§ 300aa-10-34.

1
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. § 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).

2
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 their claim, so
long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The
court also indicated that, in finding causation, 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.” Id. at 1280.

In this case, none of the injuries alleged by petitioner are injuries identified by the
Vaccine Injury Table. Accordingly, petitioner must satisfy the above-described Althen
test for establishing causation in fact.

II. Procedural History

As noted above, petitioner filed her petition on December 17, 2014. (ECF No. 1.)
Since the filing of that petition, this case has had a long history under four different
special masters as two threshold issues were successively litigated before expert
presentations and an entitlement hearing were eventually reached.

Based on the allegations in the petition (abscess and related pain), this case was
initially assigned to the Special Processing Unit (“SPU”) under then Chief Special
Master Vowell. (ECF No. 5.) “The Special Processing Unit is designed to expedite the
processing of claims that have historically been resolved without extensive litigation.”
(Id. at 1.) Petitioner’s initial Statement of Completion was filed soon thereafter on
December 24, 2014. (ECF No. 7.) However, the parties engaged in litigation regarding
a threshold question of the administration site of petitioner’s vaccine, a point made
significant by petitioner’s allegation of an (abscess) injury local to the area of injection. 3

3 More accurately, the medical records indicate petitioner suffered “cellulitis,” which is “an acute, diffuse,

spreading, edematous, suppurative inflammation of the deep subcutaneous tissues and sometimes
muscle, sometimes with abscess formation. It is usually caused by infection of a wound, burn, or other
cutaneous lesion by bacteria . . . .” Cellulitis, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=8514 (last accessed July 28, 2022). An “abscess”
is “a localized collection of pus within tissues, organs, or confined spaces.” Abscess, DORLAND’S MEDICAL
DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=185 (last accessed July 28,

3
During this period, the case was reassigned to Special Master Dorsey when she
became Chief Special Master. (ECF No. 31.)

After a year and a half of litigation, Chief Special Master Dorsey issued a “Ruling
on Facts” on April 26, 2016, that addressed the parties’ dispute regarding the injection
site of petitioner’s February 6, 2012, Tdap vaccination. She concluded that petitioner
received her vaccination in her left dorsal gluteal muscle. 4 (ECF No. 45; see also
Skinner-Smith v. Sec'y of Health & Human Servs., No. 14-1212V, 2016 WL 3180635
(Fed. Cl. Spec. Mstr. Apr. 27, 2016).) This is consistent with the fact finding urged by
petitioner. (ECF No. 13-2.) Respondent was ordered to file his Rule 4(c) Report, which
he did on July 5, 2016. (ECF No. 45, p. 4; ECF No. 48.) Respondent recommended
against compensation on a number of grounds. (ECF No. 48.)

Following the filing of respondent’s report, the case was reassigned out of the
SPU and to Special Master Millman. (ECF No. 50.) She initially ordered petitioner to
file an expert report. Petitioner continued to develop the record for over a year, from
August of 2016 through October of 2017, but did not file an expert report during this
period. 5 However, during a status conference held October 19, 2017, Special Master
Millman specifically ordered petitioner to file materials relating to the medical review
panel referenced in the petition. 6 (ECF No. 73.) Petitioner filed such materials marked
as Exhibit 14 and 15. (ECF No. 74.) The fact of petitioner’s prior medical review panel
filing then constituted the focus of the case for the next year.

Special Master Millman issued an Order to Show Cause why the case should not
be dismissed on the basis that Exhibit 14 showed petitioner to have had a medical
malpractice suit pending at the time she filed this petition. (ECF No. 75.) Following
motion practice on the issue, Special Master Millman issued a decision dismissing this
case on June 25, 2018. (ECF No. 89; see also Skinner-Smith v. Sec'y of Health &
Human Servs., No. 14-1212V, 2018 WL 3991343 (Fed. Cl. Spec. Mstr. June 25, 2018),
review granted, decision rev'd, 141 Fed. Cl. 348 (2018).) She concluded that

2022). Petitioner’s initial diagnosis was “cellulitis/left gluteal abscess.” (Ex. 1, p. 441.) However,
subsequent records suggested no evidence of an abscess underlying petitioner’s cellulitis. (Id. at 680,
705.)
4
This finding of fact is not binding on me; however, I agree with the outcome and analysis in this fact
finding and will not address the issue further. Godfrey v. Sec’y of Health & Human Servs., 2015 WL
10710961, at *9 (Fed. Cl. Spec. Mstr. Oct. 27, 2015) (noting that “[g]enerally, special masters may
change or revisit any ruling until judgment enters, even if the case has been transferred.”); see also
Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir.
1999) (special masters are not bound by their own or other special masters’ decisions).

5 Petitioner did file a letter by one of petitioner’s treating physicians, Dr. Ferrier (ECF No. 55; Ex. 8).

However, the special master required petitioner to file a further, more detailed, report explaining the basis
for the opinion stated in the letter. (ECF No. 56.) Petitioner never filed a further report from Dr. Ferrier
and ultimately argued that such a report was unnecessary. (ECF No. 63.)
6
In her petition, petitioner acknowledged the prior filing of a “medical review panel proceeding,” but
represented that no civil action had been filed. (Id. at 1-2.)

4
petitioner’s filing of a complaint with the Louisiana medical review panel constituted
initiation of a civil action under Section 11 of the Vaccine Act. (Id. at 5.)

Petitioner then pursued a successful motion for review of that dismissal decision.
On December 18, 2018, the Court of Federal Claims issued an Opinion and Order
granting petitioner’s motion for review and remanding the case for further proceedings
before the special master with instructions to reinstate the petition. (ECF No. 103; see
also Skinner-Smith v. Sec'y of Health & Human Servs., 141 Fed. Cl. 348 (2018).) Once
the case was remanded, petitioner returned to pursuing an expert to support her claim.
(ECF No. 106.)

Due to Special Master Millman’s subsequent retirement, the case was
reassigned to the undersigned’s docket on June 7, 2019. (ECF No. 110.) After several
motions for extension of time, petitioner filed her initial expert report by Dr. Charles Lapp
on August 16, 2019. (ECF No. 113; Ex. 16.) Petitioner filed a further report by Dr.
Lapp, inclusive of a physical examination, on November 15, 2019. (ECF No. 115; Ex.
21.) Respondent filed expert reports by Drs. Oddis and He on January 3, 2020. (ECF
Nos. 115-19; Exs. C-D.) Petitioner filed a responsive supplemental report by Dr. Lapp
on April 6, 2020. (ECF No. 121; Ex. 22.)

Thereafter, on May 11, 2020, a two-day entitlement hearing was scheduled to
commence May 20, 2021. (ECF No. 124.) The pre-hearing record closed on April 26,
2021 (ECF No. 126); however, petitioner filed for leave to file medical literature out of
time (ECF No. 136). Respondent filed a competing motion to strike the proposed filings.
(ECF No. 137.) On May 13, 2021, petitioner’s motion for leave to file out of time was
granted and respondent’s motion to strike denied. (ECF No. 140.) Respondent was
permitted an opportunity to address any issues that might arise during the hearing
relative to the late-filed literature with post-hearing filings. (Id.)

The hearing was held as scheduled on May 20-21, 2021 and was held via
Webex video conference due to the ongoing Covid-19 pandemic. (See Transcript of
Proceedings (“Tr.”), May 20-21, 2021, at ECF Nos. 148-49.) During the hearing,
petitioner, Dr. Lapp, Dr. Oddis, and Dr. He testified. Following the hearing, petitioner
was ordered to file two articles (by Rook and Mu respectively) referenced by Dr. Lapp
during the hearing, a graphic used during his testimony, and updated medical records.
(ECF No. 143.) Respondent was instructed to file a status report 30 days thereafter
indicating whether he would request an opportunity for further filings or otherwise
confirming the record to be complete. (Id.) On July 6, 2021, respondent confirmed the
record is complete. (ECF No. 150.)

Accordingly, this case is now ripe for resolution. In total, petitioner has filed
medical records marked as Exhibits 1-6, 11-13, 31-32, and 37-38, affidavits marked as
Exhibits 7 and 10, medical review panel Exhibits 14-15, a treating physician letter
marked as Exhibit 8, expert reports by Dr. Lapp marked as Exhibits 16, 21-22 (his
curriculum vitae as Exhibit 20), and medical literature marked as Exhibits 17-29, 23-30.

5
Respondent has filed reports, curricula vitae, and supporting medical literature by Drs.
Oddis and He marked as Exhibits C (with tabs 1-3) and D (with tabs 1-2). 7

III. Factual History

a. As Reflected by the Medical Records

i. Pre-Vaccination Records

Prior to the vaccination at issue, petitioner had a history of rosacea, vitamin D
deficiency, degenerative cervical disc disease with radiculopathy, anemia, and recurrent
throat infections. (Ex. 1, p. 109, 418, 451, 574.) Additionally, petitioner had a right
rotator cuff repair on October 22, 2009, and a right shoulder arthroscopic lysis of
adhesions, arthroscopic revision, subacromial decompression, and bursectomy on
January 15, 2010. (Ex. 1, p. 430.)

On March 8, 2010, petitioner presented to Dr. Deryk Jones, the orthopedist who
performed petitioner’s rotator cuff repair surgery. (Ex. 1, p. 577.) On examination,
petitioner demonstrated a slight decrease in internal rotation on the involved side with
excellent strength and good range of motion overall. Patient appeared to be doing
“quite well overall.” (Id.)

On September 30, 2010, petitioner presented to Dr. Herbert Van Horn
complaining of “a 6-month history of recurrent throat infections, but also [] nasal
congestion symptoms and sinusitis.” (Ex. 1, p. 574.) She also complained of an “ear
ringing sensation.” (Id.) Dr. Van Horn noted in the HPI that petitioner “occasionally
takes Vicodin for her right shoulder pain as she is recovering from rotator cuff and torn
labrum surgery performed in January of this year.” (Id.) He noted that petitioner’s
family members had a history of throat and tonsillar problems. (Id.) No evidence for
recent strep cultures were found in the computer database. (Id.) Dr. Van Horn
concluded that petitioner was “not acutely ill and [did] not require antibiotics[.]” (Id. at
575.) He discussed concerns with petitioner about concomitant use of Vicodin and
Zyrtec because of sedation possibilities and encouraged petitioner to use the Vicodin
sparingly. (Id.)

On October 20, 2010, petitioner presented to Dr. Jones for a follow-up on her
right shoulder pain and pathology. (Ex. 1, p. 572.) Petitioner was “currently reporting
no significant limitations at this time.” (Id.) On examination petitioner demonstrated
mild weakness with stress of the rotator cuff musculature at the right side. (Id.)

On March 29, 2011, petitioner presented with pain and numbness in her legs that
had worsened within the past two weeks. (Ex. 1, p. 465.) Spinal MRI on April 20, 2011,
showed bulging at L3-L4 and L4-L5 and straightening of the lumbar lordosis. (Ex. 1, pp.

7 Respondent’s Exhibits A-B relate to a subpoena issued by respondent relative to litigating the site of

injection. (ECF Nos. 41, 43.)

6
477-79.) On March 31, 2011, results from petitioner’s ultrasound showed no evidence
of a lower extremity deep venous thrombosis. (Ex. 1, p. 581.)

On April 20, 2011, petitioner underwent erect weight-bearing (“stand up”) MRI of
the lumbar spine without contrast. (Ex. 1, p. 477-79.) The MRI showed (1) bulging of
the L3-L4 and L4-L5 intervertebral discs without nerve root effacement associated
therewith the patient in the passive neutral posture; (2) straightening of the lumbar
lordosis with the patient in the passive neutral posture consistent with a pattern of
muscle spasm; and (3) fibroid uterus with dominant submucosal leiomyoma measuring
approximately 2.2 cm in diameter. (Id. at 478-79.)

On May 23, 2011, petitioner established new patient care with Ochsner spine
services with complaints of lower leg pain, burning, numbness, coldness, and tingling.
She described her back pain as “mechanical in nature, worse with activity, especially
walking” and described her lower extremity pain as “burning, aching pain in her bilateral
calves and feet” which “ha[d] been going on for several years” and “relieved with
Vicodin.” (Ex. 1, p. 570.) Petitioner reported that her symptoms began years prior and
had worsened more recently. (Ex. 1, p. 461.) She further indicated that she was able to
perform her daily routine with these symptoms and was able to work despite her
condition. (Ex. 1, p. 464.) Petitioner was diagnosed with degenerative disc disease,
lumbago, and lateral lower extremity radiculopathy. (Ex. 1, pp. 570-71.)

On July 5, 2011, petitioner called her PCP Dr. Ferrier to schedule an
appointment. (Ex. 1, p. 546.) Petitioner reported “pain in her lower legs for years – she
would like to be tested for diabetes.” (Id.) She further reported problems with night
sweats and recurrent yeast infections. (Id.) On July 11, 2011, petitioner presented with
a deep nodule in her right calf, which was a lipoma that was late excised. (Ex. 1, p.
460.) Petitioner had been prescribed Vicodin over an extended period of time, first for
her shoulder pain and later for her bilateral leg pain. (E.g., Ex. 1, pp. 574-57, 465.)

On January 5, 2012, petitioner saw Dr. Deryk G. Jones regarding her right
shoulder pain and was diagnosed with right shoulder rotator cuff inflammation with
possible biceps tendinopathy and recurrent weakness of the anterior subscapularis
tendon. (Ex. 1, p. 443.)

On January 16, 2012, petitioner saw her primary care provide (“PCP”), Dr. Janine
M. Ferrier, with complaints of sore throat and bilateral ear pain that began three weeks
prior. (Ex. 1, p. 442.) Petitioner also complained of postnasal drip, hoarseness,
shortness of breath, cough, fatigue, and intermittent fever. (Id.) Physical exam findings
for mouth and throat were “[n]o tonsillar enlargement. Positive pharyngeal erythema
and pustule on the right.” (Id.) Petitioner was diagnosed with acute pharyngitis and was
prescribed clindamycin (antibiotic) and Diflucan (antifungal). (Id.)

7
ii. Vaccination and Initial Treatment

On February 6, 2012, petitioner burned her hand and went to the Ochsner
Medical Center Emergency Room for treatment. (Ex. 1, p. 684.) At the emergency
room, petitioner received a Tdap vaccine in her left dorsal gluteal muscle. See Skinner-
Smith v. Sec’y of Health & Human Servs., No. 14-1212V, 2016 WL 3180635 (Fed. Cl.
Spec. Mstr. Apr. 27, 2016). Petitioner was discharged on the same day. (Ex. 1, p.
688.)

A couple of days following her vaccination on February 9, 2012, petitioner saw
Dr. Ferrier for a follow up. (Ex. 1, p. 441.) Petitioner complained of left hip pain and
lower back pain after receiving the Tdap vaccination and that the area around the
injection was red, inflamed, and painful. (Id.) Upon examination, Dr. Ferrier noted that
petitioner’s left hand burn was dorsal between the first and second finger and that
petitioner was “positive induration of left gluteus with erythema.” (Id.) Petitioner was
assessed with cellulitis/left gluteal abscess and was referred to general surgery as well
as prescribed Bactrim. (Id.)

A handwritten note dated February 13, 2012, indicates that petitioner presented
to Dr. Michael C. Townsend for a consultation for her buttock abscess. (Ex. 1, p. 439-
40.) He diagnosed petitioner with cellulitis of the buttocks and abscess. (Id.) The
remainder of Dr. Townsend’s notes are illegible. The next day, February 14, 2012,
petitioner returned to Dr. Townsend. (Ex. 1, p. 451.) Dr. Townsend noted that
petitioner had a “localizing area of induration without frank purulence” on her left
buttocks, but that her cellulitis was resolved. (Id.) His impression also included that
petitioner had a localizing, minimally tender mass, and at that point, petitioner should
continue with antibiotics. (Id.)

On February 24, 2012, petitioner called Dr. Ferrier’s office regarding her tetanus
shot reaction. (Ex. 1, p. 542.) The note indicates that

[Petitioner] had a reaction and was put on antibiotics and pain med.
[Petitioner] was referred to Dr. Townsend to lance or remove. Dr did not do
either. [Petitioner] still in pain (pain in legs/groin area), has swelling.
[Petitioner] wanting pain med. to get her thru. [Petitioner] will be calling the
other dr. [Petitioner] would like to see Dr. Ferrier soon[.]

(Id.)

Thereafter, on February 24, 2012, petitioner returned to the emergency room
with complaints of fever. (Ex. 1, p. 692.) The records noted that petitioner’s chief
complaint was “since [tetanus] shot on 2/6 has had problems with fever, leg swelling
and [fatigue].” (Id.) Petitioner reported that her fever began suddenly about 17 days
ago, chills and sweating, night sweats, body aches, joint swelling, itching, rash, and dry
skin. (Id.) Petitioner indicated that she has received a Tdap vaccination prior without
any reaction. (Id. at 693.) On physical examination, Dr. McNulty observed “no soft

8
tissue or body tenderness, no joint swelling or tenderness.” (Id. at 662.) He “[did] not
see any swelling of the thighs lower legs or feet[,] no erythema of the thighs or legs.”
(Id.) Dr. McNulty noted petitioner’s neck was “supple, no adenopathy noted.” (Id.)
Petitioner’s blood and urine cultures were collected, and the results were normal.
Petitioner was also transported for an x-ray, but discharged on the same day. (Ex. 1, pp.
693-96.)

Petitioner went back to the emergency room three days later, on February 27,
2012 with complaints of joint pain, stating that her symptoms began on February 6,
2012 after receiving Tdap immunization. (Ex. 1, p. 698.) Petitioner reported that on the
evening of her vaccination, she felt malaise and some aching fever, and by the next day
she had some swelling at the injection site and groin area. On physical exam, petitioner
had some enlarged inguinal lymph nodes and some darkening and hyperpigmentation
of her skin around her inguinal area and neck. (Id. at 705.) Additionally, it was noted
that she did not have any kind of obvious rash or redness at the injection site on her left
buttock, but there was mild tenderness and a “little knot there.” (Id.) Dr. Patricia C.
Porada’s assessment was that petitioner likely had a reaction to the Tdap vaccination,
possibly a delayed serum sickness type or hypersensitive type reaction. (Id. at 706.)
Petitioner was discharged on the same day with a primary diagnosis of fever of
unknown origin. (Id. at 703.) Dr. Porada added that a reaction can last up to 21 days
and noted that “there are other potential causes for [petitioner’s] persistent symptoms,
but these all seem to be related to the tetanus shot as these symptoms all developed
after her tetanus injection. (Id. at 706.)

On February 29, 2012, petitioner saw Dr. Ferrier for a “followup of emergency
room visit for cellulitis.” (Ex. 1, p. 436.) It was noted that petitioner completed her
antibiotics and her cellulitis was improved, but that she still had fatigue, fever, myalgias,
joint pain, swelling, headaches, back pain, and spams down the back of her legs. (Id.)
Petitioner was assessed with myalgia and fatigue and additional testing was ordered.

iii. Post Initial Treatment Records

On March 2, 2012, petitioner returned to Dr. Ferrier’s office for a follow-up visit.
(Ex. 1, p. 538.) Petitioner was referred to rheumatology “ASAP for rheumatoid arthritis,
positive CCP antibodies.” (Id.) Petitioner was informed of her results, including low
vitamin D.

On March 7, 2012, petitioner had an allergy evaluation with Dr. Jamie R. Lurie.
(Ex. 3, p. 1.) Petitioner indicated that she had a burn on her hand which led to her to
ER, where she received a tetanus shot. Petitioner reported that about 30 minutes to an
hour after the shot, petitioner had nausea, fatigue, and aching at the site of the injection,
and the next day, she had joint pain, swelling, fever, and “her nerves were firing.” (Id.)
Petitioner reported that she returned to her PCP, who referred petitioner to general
surgery for possible infection from the shot, but there was nothing to drain. Additionally,
on February 24, almost three weeks following her vaccination, petitioner went to the ER
with fatigue, fever, chills, joint pain, and rash and swelling at the vaccination site. At this

9
visit with Dr. Lurie, petitioner reported that her symptoms improved, but she was still
suffering from pain in her hip where the vaccine was administered, night sweats,
fatigue, loss of appetite, middle low back pain. (Id.) Dr. Lurie stated that petitioner had
serum sickness as a reaction to Tdap vaccine with typical symptoms of fatigue, rash,
fever, joint pain, and swelling at the site. Dr. Lurie also posited that petitioner may have
had an immunologic reaction to her vaccination and referred petitioner to a
rheumatologist. (Id. at 3.)

On April 17, 2012, petitioner saw Dr. Reginald D. Sanders for musculoskeletal
pain at the referral of Dr. Lurie. (Ex. 4.) Petitioner denied any prior musculoskeletal
pains and that she developed generalized stiffness and pain in her left buttock after
receiving a tetanus shot. (Id. at 1.) Moreover, petitioner reported that she “has not
gotten back to normal since the shot,” and she has pain in the left side of her body as
well as joint pain. Petitioner was assessed with polyarthralgia. (Id.) It was noted that
petitioner did not appear to have systemic inflammatory rheumatic disease and that
petitioner declined further laboratory studies.

On April 30, 2012, petitioner presented to her PCP Dr. Ferrier complaining of a
sore throat, sinus congestion, and cough. (Ex. 1, p. 426.) She indicated that her
symptoms “started weeks ago” and “have improved.” (Id.) Petitioner was assessed
with an upper respiratory tract infection. (Id.)
On May 30, 2012, petitioner presented to Dr. Jack Jacob for an annual
gynecological examination. (Ex. 2, pp. 10-14.) Petitioner complained of “mark reaction
to pert. and Tet. shot.” (Id. at 10.) In petitioner’s past medical / surgical history, Dr.
Jacob noted “tentative [rheumatoid arthritis] after receiving PTAP [sic] (2/6/12).” (Id.)
Dr. Jacob further noted that petitioner was self-reliant in her usual daily activities. (Id. at
11.) Petitioner’s assessment was otherwise normal. (Id. at 13.)
On June 6, 2012, petitioner presented to another rheumatologist, Dr. Tamika
Webb-Detiege, complaining of arthralgias and positive CCP. (Ex. 1, p. 418.) Petitioner
recalled that hours after her tetanus vaccination she developed “severe joint pain,
fatigue, sweating, swelling of the hands, swelling and pain in the legs and hips
especially on the left, or rash that started to peel on her face and hands, fever, night
sweats and an overall feeling of malaise.” (Id.) She further noted enlarged lymph
nodes in her groin, blisters on her tongue, hoarseness in her voice, peeling around her
nails, tinnitus, and blurred vision.” (Id.) Petitioner reported to Dr. Webb-Dietiege that
her symptoms had since improved, though she continued to have achiness, involving
mainly her left leg, fatigue, and night sweats. (Id.) Her pain improved with the use of
Vicodin and ibuprofen, twice daily. (Id.) Petitioner also noted family history of
rheumatoid arthritis. (Id. at 419.) Petitioner was assessed with arthralgias where
“symptoms began after tetanus shot which was associated with cellulitis of buttocks,”
positive CCP, fatigue, night sweats, and dry mouth. (Id. at 422.)
Petitioner returned to Dr. Webb-Detiege on June 27, 2012, with a chief complaint
of arthralgias and positive CCP. (Ex. 1, p. 412.) Petitioner reported “120 minutes of
morning stiffness,” though she reported feeling better, with less joint pain and less
mental confusion. (Id.) She described pain in “muscle below knees and above feet.”

10
(Id.) Petitioner reported difficult sleeping “since this started.” (Id.) Her arthritis joint
survey in the cervical spine showed no widening of the atlanto-odontoid relationship in
flexion, though the osseous elements of the cervical spine were degenerated at C5-6
with large osteophyte and slight interspace narrowing. (Id. at 415.) She showed no
arthritis in her knees, hands and wrist, or feet. (Id.) Petitioner was assessed with
arthralgias, positive CCP, fatigue, night sweats, dry mouth (“negative SSA and SSB”).
(Id.)

On August 8, 2012, petitioner was seen at the emergency department for joint
pain. (Ex. 1, p. 5.) Petitioner’s radiology results revealed no evidence of synovitis. (Id.
at 6.) Petitioner saw her PCP on August 23, 2012 for leg pain, sore throat, sinusitis,
and back pain. (Id. at 17.) Petitioner reported that her sore throat started about a week
ago and that she noticed redness of her lower legs and aching sensation after
undergoing a nuclear tag test. (Id. at 22.) Petitioner also reported intermittent pain in
her left buttock, leg, and foot since receiving a tetanus vaccination. (Id.) Petitioner was
assessed with acute pharyngitis, back pain, arthralgias, and vitamin D deficiency. (Id. at
23.)

On September 21, 2012, petitioner had an ultrasound and venous examination
with Dr. George E. Barnes. (Ex. 6.) It was noted that petitioner began having pain in
her left lower extremity on February 6, 2012, that had been increasing dramatically and
progressively. Dr. Barnes indicated that petitioner associated her symptoms with her
tetanus vaccination. (Id. at 1.) Additionally, in a handwritten note, petitioner also wrote
that she believed “DTAP compromised my health […] most of others [symptoms]
including high blood pressure level, elevated anti-CPP level, rheumatoid arthritis, weight
loss, hair loss, depleted vitamin D-level, impaired vision, sleep apnea, extreme leg pain
at site location (lower left buttock); swollen/inflamed lymph node, in groin region etc.”
(Id. at 3.) Petitioner also answered that petitioner experienced varicose veins after
trauma and had pain, swelling, spider veins, skin discoloration, and night cramps as
associated with her varicose veins. (Id. at 4.) Dr. Barnes noted that petitioner had a
history of venous varicosities, but only recently experiencing symptoms. (Id.) The
ultrasound showed evidence of venous incompetence associated with history of several
months of left lower extremity pain syndrome. (Id.) She was assessed with left leg pain
and was recommended for surgery and for a complete duplex scan study. (Id. at 7.)

On September 30, 2012, petitioner returned to Dr. Ferrier for a blood pressure
check and complained of swelling in her legs and swollen nodes in her groin. (Ex. 1, p.
46.) Additionally, petitioner reported continued left leg pain. (Id.) Petitioner then saw
Dr. Ferrier again on October 2, 2012 to address her arthralgias, myalgias, and positive
anti-CCP results. (Id. at 53.) Here, petitioner reported that her symptoms began after
receiving her tetanus shot and that serum sickness was suspected. (Id.) Under review
of systems, petitioner was positive for fatigue, red appearance of hands with cold
exposure, polyuria, dry mouth, dyspnea on exertion, and jaw pain. (Id.) Dr. Ferrier
noted that petitioner’s symptoms relating to arthralgias began after tetanus shot, “which
was associated with cellulitis of buttocks.” (Id. at 55.)

11
On October 2, 2012, petitioner returned to Dr. Webb-Detiege for a follow-up
regarding her arthralgias, myalgias, and positive anti-CCP. (Ex. 1, p. 52.) She reported
“feeling better with the joint pain.” (Id.) She complained of pain in her left leg, in the
groin and down the leg, as well as a “blotchy appearance.” (Id. at 52-53.) She reported
swelling in her right and left legs, in the thighs. (Id.) Petitioner continued to report night
sweats. (Id. at 53.) She presented with a facial rash. (Id.) Petitioner now reported
family history of rheumatoid arthritis in her grandmother, mother, and maternal aunts.
(Id.) Dr. Webb-Detiege assessed petitioner with arthralgias, positive CCP, fatigue, night
sweats, dry mouth, in addition to venous insufficiency of the legs. (Id. at 55.)

Petitioner saw Dr. Ferrier on January 11, 2013 for an immune system evaluation
with complaints of sinus problem, including chills, congestion, coughing, ear pain,
headaches, neck pain, and sore throat. (Ex. 1, p. 105.) Petitioner summarized that
within two weeks of her tetanus shot in February 2012, she experienced severe
arthralgias, hair loss, rash, fever blisters, nails splitting, and elevated labs. Since then,
she has had recurrent throat and sinus infections, fatigue, insomnia, memory loss, night
sweats, jaw tightness, sinusitis, ear infection, and pharyngitis. However, petitioner has
seen a rheumatologist and extensive workup has all been normal. (Id.) Petitioner also
reported that she has had 5-6 antibiotics treatment since February. (Id.) Petitioner was
assessed with chronic sinus infection and arthralgia. (Id. at 107.)

Petitioner had a consultation with Dr. Jeffrey Coco on February 7, 2013. (Ex. 3,
p. 11.) Under reason for visit, it was listed that petitioner had Tdap vaccination and had
stiffness, pain, sweating, heart racing, and nausea the night of her shot and within 48
hours, she saw her PCP. Also, the record indicated that petitioner saw Dr. Lurie after
experiencing leg swelling, sores in mouth, hair loss, vision changes, and was placed on
antibiotics and referred for surgical intervention. Moreover, petitioner was transitioned
to narcotics to treat her joint pain. (Id.) Again, petitioner was listed as having serum
sickness and it was noted that Dr. Coco discussed the Vaccine Program with petitioner
at this visit. Petitioner was told to avoid all further vaccines. (Id. at 12.)

Petitioner frequently visited her PCP for various reasons throughout the year,
including upper respiratory infection, allergy test, conjunctivitis, sore throat, leg pain,
anemia, and venous insufficiency. (Ex. 1, pp. 127,131, 133, 152, 160, 168.) Petitioner
avoided receiving any further vaccinations, indicating that she was hesitant due to
adverse reaction from tetanus shot. (Ex. 1, p. 131.)

On July 15, 2013, petitioner was examined by Dr. Olusegun O. Osinbowale for
venous insufficiency consultation. (Ex. 1, p. 168.) Petitioner reported that since
receiving the tetanus shot, petitioner had been experiencing hot/cold sensation in both
legs, night sweats, arthralgias, swollen ankles, and leg erythema. (Id.) Dr. Osinbowale
assessed petitioner with venous insufficiency, unspecified myalgia and myositis, and
skin sensation disturbance, adding that there was discussion of the possibility of
petitioner having primary venous insufficiency rather than secondary to her other
complaints. (Id. at 171.)

12
On September 3, 2013, petitioner presented to hematologist / oncologist Dr. Fu
for an initial anemia consultation. (Ex. 1, p. 202.) Petitioner’s medical history listed
anemia, degenerative disc disease, vitamin D deficiency, arthralgias, recurrent upper
respiratory infections, and urticaria (hives). (Id.) She reported “fatigue easily. I am sick
only after the tetanus shot in Feb 2012.” (Id. at 204.) Petitioner further reported skin
rash, shortness of breath, muscle pain, acute join pain, sweating, swelling lymph node,
leg swelling, muscle spasms, hair loss, dry mouth, and “[l]eft leg burning sensation after
tetanus shot in feb 2012.” (Id.) On physical examination, Dr. Fu observed no
noticeable or palpable swelling, redness, or rash around the throat or on the face and
no swollen or erythematous joints. (Id. at 207.) Dr. Fu concluded that “[t]he fact that
[petitioner] has isolated cytopenia (anemia) with normal WBC and platelet count
suggest[s] that that the possibility of bone marrow failure such as MDS, myelofibrosis,
bone marrow infiltration, etc is low, although pure red cell anaplasia can not be
excluded.” (Id. at 208.) Of note, Dr. Fu observed that petitioner had “mild elevation of
plt count,” which, in the setting of nonspecific symptoms such as myalgia, arthralgia,
skin rash, finger tingling numbness, is “likely due to chronic inflammation.” (Id.)
However, Dr. Fu wanted to rule out lymph proliferative disorder, MPD, B12 deficiency,
and monogammapathy. (Id.) Dr. Fu planned run a routine anemia work up, including a
blood smear review—and to consider a bone marrow biopsy if the blood work was
unrevealing. (Id.)

On September 11, 2013, petitioner returned to her gynecologist Dr. Jacob, for a
follow-up examination. (Ex. 2, pp. 18-21.) Petitioner’s history included “chronic
inflammation to the tetanus inj[ection], with many organ damage.” (Id. at 18.) Dr. Jacob
reported again that petitioner was self-reliant in her usual daily activities. (Id. at 19.)
She described feeling poorly, with reports of malaise and anxiety. (Id.) Petitioner
further reported muscle aches and pain localized in one or more joints, as well as
dizziness and dyspnea. (Id.)

On January 13, 2014, petitioner presented to internist Dr. Green, complaining of
a sore throat, upper respiratory infection, and nasal congestion. (Ex. 1, pp. 298-99.)
She reported to Dr. Green that she suffered from recurrent lymph node infections. (Id.
at 298.) Petitioner likewise reported that she was experiencing generalized arthralgias,
which she attributed to her tetanus injection on February 6, 2012. (Id.) On physical
examination, Dr. Green observed that petitioner’s “pharynx was infected but without
exudate” and her sinuses were tender to palpation. (Id. at 299.) She was assessed
with chronic joint paint, lymphadenitis, acute pharyngitis, and chronic rhinitis.” (Id.) Dr.
Green prescribed antibiotics.

On March 31, 2014, petitioner had an electrodiagnostic study of her left upper
and lower extremities, which revealed a delay of left median sensory distal latency that
is compatible with mild left carpal tunnel syndrome, but was otherwise normal. (Ex. 5.)
Petitioner’s clinical summary included that she received a tetanus injection with
subsequent fever, stiffness, and pain all over, which has persisted since vaccination.
(Id. at 1.)

13
On May 28, 2014, petitioner presented to her PCP, Dr. Ferrier, in follow-up to her
emergency room visit for facial swelling. (Ex. 1, pp. 409-10.) Petitioner reported that
she had facial swelling primarily on the right side, with her right eye swollen shut. (Id. at
409.) She reported to Dr. Ferrier a sensation of heaviness on the right side of her face.
(Id.) Petitioner additionally reported fatigue, persistent night sweats, persistent and
intermittent swelling, initially in her extremities, now extending up to her face, associated
with a tingling sensation. (Id.) She further reported skin discoloration associated with
flareups. (Id.) Dr. Ferrier assessed petitioner with improving facial swelling and
recommended Zyrtec and Ranitidine. (Id. at 410.)

On August 4, 2014, petitioner sought treatment from her PCP, Dr. Ferrier, for
diffuse pain, complaining of burning sensation in her hands and feet. (Ex. 12, p. 3-4.)
Petitioner then returned on September 4, 2014 with complained of right leg pain at the
site of lipoma excision. (Id. at 11.) Additionally, petitioner saw Dr. Osinbowale on
September 8, 2014 for a follow up appointment regarding her venous insufficiency. (Ex.
12, p. 16.) Petitioner reported chronic intermittent neuropathic pain radiating from the
left gluteal region to the calf, burning sensations, cold sensations, and tingling and
intermittent numbness in her extremities. (Id.) Dr. Osinbowale indicated that
petitioner’s symptoms were unlikely vascular in origin. (Id. at 18.)

On November 10, 2014, petitioner presented to Dr. Nelson, complaining of eye
pain in both eyes, “stabbing pain for couple of months,” left more than right. (Ex. 12, pp.
37-38.) She commented that her peripheral vision decreased since she was last seen
(5/28/2014), on the right and left eye lateral side, though not a blind spot, but a delayed
focus. (Id. at 37.) Petitioner complained of swollen eyelids in the morning, with the right
eye feeling heavy. (Id.) Dr. Nelson assessed petitioner with bilateral eye pain and
visual disturbance. (Id. at 37-38.) Specifically, petitioner explained that she will “walk
by husband” and not know that he is in the room. (Id. at 38.) She described “problem[s]
w tetanus injection in 2012 which has led to a host of problems and she did research
which said visual problems could happen too.” (Id. (internal citation omitted).)
Petitioner’s eye exam was within normal limits, but Dr. Nelson ordered a visual field test
to rule out scotoma. (Id.)

Petitioner had an ophthalmology evaluation with Dr. Andrew W. Lawton for
problems with her peripheral vision on December 1, 2014. (Ex. 11.) Petitioner reported
that she noticed problems with her vision since she received the Tdap vaccination in
2012, specifically saying that she was “poisoned, adverse reaction.” (Id. at 5.)
Petitioner also added that she had other problems since her vaccination aside from her
vision issues, including chronic inflammation. (Id.) With regards to her vision, petitioner
reported that “she does see things to her sides. She will walk by her husband and not
see.” However, petitioner’s peripheral vision testing was normal. (Id.) Petitioner was
assessed with Keratoconjunctivitis sicca and subjective visual disturbance of both eyes.
(Id. at 5-6.)

Petitioner returned to see Dr. Ferrier on January 27, 2015, for abdominal pain,
with complaints of loss of appetite, nausea, vomiting, and diarrhea. (Ex. 12, p. 59.)

14
Petitioner reported that “her symptoms are cyclical after getting a tetanus several years
ago.” (Id.) Petitioner was assessed with paresthesia with regards to her back pain,
shoulder pain, sore throat, seizures, and fatigue. (Id. at 60-61.) Overall, petitioner
visited Dr. Ferrier frequently for various concerns including sore throat, ear pain, cough,
upper respiratory infection, back pain, and swelling. (Id. at 72, 81, 86, 107.)

On February 25, 2015, petitioner visited Dr. Jones for a right shoulder evaluation.
(Ex. 11, p. 7.) According to her history of present illness, petitioner had a rotator cuff
repair in 2009, a vaccine injury in 2011, and global neurological symptoms. (Id. at 10.)
Petitioner’s shoulder pain was described as chronic, starting more than one year ago
with a history of trauma. (Id.) On physical exam, petitioner tested positive in various
tests on her right and not on her left. (Id. at 11-12.) Petitioner was ordered to continue
pain management with Dr. Ferrier. (Id. at 14.) Petitioner’s MRI found a partial tear of
the supraspinatus tendon. (Id. at 24.) On March 11, 2015, petitioner had a follow up
with Dr. Jones following her MRI studies. (Id. at 29.) Dr. Jones recorded that petitioner
was unable to get MRA due to potential allergy to dye and petitioner was unable to
obtain steroid injection due to concerns of potential reaction. (Id.) Following this visit,
petitioner decided to proceed with surgery and physical therapy. (Id. at 34-35.)

Petitioner had a neurology consultation on April 16, 2015, with Dr. Frank S. Oser.
(Ex. 11, p. 36.) Petitioner had complaints of numbness in her feet and spasms
extending from the feet and lower legs into the low back area, where onset was after
receiving her tetanus shot. (Id. at 38.) Petitioner stated that “there was some sort of an
immune reaction that took place, and associated with multiple allergic reactions, as well
as diffuse arthralgias and myalgias among other things.” (Id.) Dr. Oser indicated that
petitioner was positive for all questions asked during review of systems except for
syncope, hearing loss, and incontinence. (Id. at 39.) She was diagnosed with
numbness, pain in limb, lumbago, memory loss, and anemia. (Id. at 36.) Dr. Oser
concluded that petitioner needs daily treatment of hydrocodone to address her back and
leg pain, foot numbness, and other joint pains. (Id. at 40.) However, he indicated that
petitioner’s neurological exam was benign despite an abnormal mental status.
Petitioner was referred for formal neuropsychological testing. (Id.) Petitioner’s EMG,
conducted on May 29, 2015, showed no evidence of radiculopathy, large fiber
neuropathy, or small fiber neuropathy. (Id. at 65.)

Petitioner had an ophthalmology appointment on August 3, 2016, at Ochsner
South Shore Region. (Ex. 13.) Her visit summary listed her current problems including
anemia, arthralgia, joint pain, venous insufficiency, shoulder pain, biceps tendinitis on
right, and more. (Id. at 1.) Since petitioner’s last visit on June 23, 2016, petitioner
indicated that her visual disturbance increased and she would get random tingling
around the eyes. (Id. at 12.) Petitioner also complained of headaches, flashes of light,
frequent floaters, and more. Petitioner was diagnosed with visual disturbance and
referred to seek outside neurology care. (Id. at 13.)

On August 16, 2016, petitioner saw Dr. Tere Vives for a neuro-ophthalmology
consultation. (Ex. 13, p. 14.) Petitioner completed a questionnaire and listed under the

15
chief complaint that “TDAP vaccine injury (02/06/2012) caused acute visual
disturbances without resolve.” Additionally, it was noted that petitioner’s visual
problems persisted since receiving the Tdap vaccination. (Id.) Additionally, petitioner
indicated that she experienced trauma, migraine, allergies, ear infection, attention deficit
disorder since her “TDAP vaccine injury.” (Id.) Dr. Vives diagnosed a reaction to her
tetanus shot and orbital pain. (Id. at 25.) Petitioner was prescribed gabapentin
(Neurontin) and vitamin B12 and an MRI was ordered. (Id. at 26-27.) However,
petitioner reported to Dr. Patterson on August 24, 2016, that she had an allergic
reaction to the gabapentin. 8 (Ex. 12, p. 144.) The MRI studies were conducted on
August 30, 2016, and were interpreted as unremarkable. (Ex. 13, pp. 32-36.) On
September 6, 2016, Dr. Vives referred petitioner to neurologist Jesus Lovera. (Id. at 34.)

On October 18, 2016, petitioner had a neurology consultation with Dr. Jesus F.
Lovera. (Ex. 13, p. 37.) At this visit, petitioner reported that she was healthy and
started having problems in Feb 2012. Petitioner indicated that she felt sharp pain at the
injection site that radiated down the side of her leg and thereafter, her injection site
became red and she was treated for cellulitis. (Id.) Petitioner indicated that she
continued to experience ongoing symptoms, including spasms, heaviness sensation on
the legs, impaired concentration and focus, decreased appetite, dizziness, blurred
vision, and paresthesia. (Id.) Dr. Vives told Dr. Lovera that petitioner did not have optic
neuritis but that there’s a concern for an ongoing neuroimmunological problem. (Id.)
Petitioner’s brain MRI was unremarkable, but her lumbar spine radiograph showed
lumbar spondylosis and partially visualized uterine fibroids. (Id. at 38-39.) Dr. Lovera
assessed petitioner with weakness of both lower extremities and tetanus vaccine side
effects. (Id. at 40.) Dr. Lovera wrote that petitioner “had a reaction to tetanus
vaccination four years ago. She has a plethora of symptoms that have persisted since
the reaction.” (Id.)

On November 7, 2016, petitioner underwent MRI of the thoracic spine without
contrast. (Ex. 15, p. 9-10.) Petitioner’s history reported that she suffered midback and
neck pain, more prominent on the left with burning paresthesia and bilateral lower
extremity weakness. (Id. at 9.) Petitioner was assessed with mild, early changes from
thoracic spondylosis causing no canal or foraminal stenosis. (Id.) In his impression, Dr.
Harlin noted that petitioner continued to move on repeat imaging sequences, degrading
some of the images and limiting the evaluation of cord signal, especially. (Id. at 10.)
On most of the gradient axial images, there appeared to be abnormal cord signal, but
Dr. Harlin indicated that it was not correlated with T2 sequences or STIR sagittal, which
confirms that it is most likely motion artifact. (Id.) Judging by the sagittal T2 and STIR
images, Dr. Harlin noted no obvious cord signal abnormalities, but very small, focal cord
signal abnormalities which could have been obscured by the artifact. (Id.) Dr. Harlin
observed changes from cervical spondylosis were causing mild central canal stenoses
at C4-C5, C5-C6, and C6-C7. (Id.) He also observed “multilevel bilateral foraminal
stenoses.” (Id.)

8 Petitioner reported that the gabapentin was prescribed for optic neuritis; however, that diagnosis does

not appear in Dr. Vives’s record. Dr. Vives confirmed as part of her referral to neurology that petitioner
did not have optic neuritis. (Ex. 13, p. 37.)

16
Petitioner had a chronic pain consult on April 21, 2017, with Dr. Gassan M.
Chaiban. (Ex. 11, p. 63.) Petitioner was reported to have a “long-standing history of
neuropathic pain dating back to a tetanus injection in 2010 9 which resulted in cellulitis
and an immunologic response which corresponded with the onset of the patient’s pain.”
(Id.) Dr. Chaiban noted that petitioner has been evaluated by multiple specialists but
without any clear diagnosis. (Id.) Dr. Chaiban ordered flexion extension x-rays to be
conducted and depending on the results, Dr. Chaiban wanted to enroll petitioner in
physical therapy. Additionally, Dr. Chaiban directed petitioner to follow up with
psychiatry, neurosurgical, and surgical evaluations. (Id. at 68-69.)

On June 20, 2017, petitioner sough a neurosurgical evaluation for nerve injury
with complaints of “generalized body pain and dysesthesia after tetanus injection.” (Ex.
11, p. 78.) It was recorded that petitioner began having severe left leg pain and
dysesthesia “after a supposed needle injury to the sciatic nerve.” (Id.) The impression
was that petitioner had “post-tetanus injection polyradiculoneuropathy,” and was
referred to Dr. Daniel G. Larriviere for further evaluation. (Id. at 82.) Petitioner saw Dr.
Larriviere on June 30, 2017. (Id. at 87.) Petitioner reported similarly as to prior visits,
the symptoms she experienced immediately following her Tdap vaccination as well as
the following days. In addition, petitioner reported that “[d]uring the ensuing years since
her injection, she experiences constant pain, burning, tingling, and formication
throughout her entire body, including her scalp.” (Id.) Dr. Larriviere noted that her
exam was normal and prior workup was unremarkable, and that petitioner did not have
polyneuropathy. An EMG was then ordered to confirm any evidence for neuropathy.
(Id. at 91.)

On July 12, 2017, petitioner returned to Dr. Lovera for her “ongoing autoimmune
condition.” (Ex. 15, pp. 6-11.) Petitioner reported that her condition was getting worse.
“She feels hot all the time, every time she ingests something no matter what she gets a
bad feeling of burning in her back and spreads through all of her body.” (Id. at 6.)
Likewise, “she also complains of pain over her upper and lower extremities. She
endorses fatigue, malaise. She drops things and fell twice during last couple of months.”
(Id.) Petitioner indicated that her short-term memory was impaired. (Id.) Petitioner
endorsed blurry, double vision, worse in the morning and evening. (Ex. 15, p. 6.)
Petitioner recalled a trip to the hospital due to hypertension “in the 170’s” with
numbness and paresthesia on the face and head. (Id.) She presented to the ER and
was treated for her blood pressure. (Id.) Petitioner reported that she is “normally not
hypertensive.” (Id.) Additionally, petitioner complained of hyperpigmentation on her
skin, worsening since the last visit—“[s]he has seen dermatology and they attributed
this to the tetanus shot.” (Id.) Dr. Lovera assessed petitioner with dysphagia and
“tetanus vaccine side effect.” (Ex. 15, p. 11.) Reviewing petitioner’s November 11,
2016 spinal MRI, Dr. Lovera noted that there were no cord lesions on her cervical and
thoracic spine MRIs. (Id.) Dr. Lovera planned to continue reviewing petitioner for

9 This particular record had a disclaimer, indicating that the note was generated using voice-recognition

software and therefore there may be typographical errors. (Ex. 11, p. 63.) Of note, petitioner’s tetanus
shot was in 2012.

17
symptomatic management, though he was “[n]ot sure that immunosuppressant agents
would be helpful.” (Id.) He noted that he spent 50% of the time counseling petitioner
and he “agree[d] her symptoms are possibly related to her tetanus shot.” (Id.)

On August 18, 2017, petitioner presented to her PCP Dr. Ferrier for a follow-up
after presenting to the emergency department for paresthesia. (Ex. 12, p. 209.) She
presented to Dr. Ferrier complaining of tingling sensations involving the left side of her
body. (Id.) She noticed the “peak in pain” around the middle of the month. (Id.)
Petitioner further reported fatigue, diffuse myalgia, bruising, joint pain, hoarseness,
memory loss, and perspiration along her torso. (Id.) She described pain shooting down
her spine, spreading to her extremities. (Id.) Likewise, she reported feeling
lightheaded, with pain behind her eyes. (Ex. 12, p. 209.) Her symptoms were
improving, however. (Id.) Dr. Ferrier assessed petitioner with paresthesia and ordered
her to continue taking vitamin supplements and monitor her blood pressure. (Id. at 10.)

On November 1, 2017, petitioner returned to Dr. Ferrier for a follow-up visit
regarding her hypertension. (Ex. 37, p. 14.) Petitioner was not tolerating
antihypertensives. (Id.) She complained of spasms in her left leg, making walking
difficult. (Id.) She told Dr. Ferrier that her left knee was warm, with ecchymoses. (Id.)
Petitioner further complained of an aching sensation in the bottom of her foot; swelling
in her left hip, worse with weight bearing; decreased grip strength; and night sweats.
(Id.) Petitioner’s diagnoses included essential hypertension and polyneuropathy. (Id. at
15.)

On November 6, 2017, petitioner presented to Dr. Jones complaining of left knee
pain. (Ex. 38, p. 1.) Petitioner complained of joint pain, back pain, joint swelling,
muscle cramps, and muscle weakness; she denied night sweats and denied numbness
or paresthesia. (Id.) On physical examination, petitioner’s left knee, right hip, left and
right shoulder tests were normal, though petitioner demonstrated a deformity in her left
knee. (Id. at 2-4.) She had 4/5 strength in her left quadriceps and hamstring. (Id. at 4.)
Petitioner was assessed with left knee pain (unspecified chronicity), arthralgia
(unspecified joint), chronic right shoulder pain, and fibromyalgia. (Id. at 5.)

On February 6, 2018, petitioner returned to Dr. Ferrier for a follow-up for her
hypertension and chronic pain. (Ex. 37, p. 38.) She denied any chest pain or shortness
of breath, but complained of headache, blurred vision, excessive fatigue and nausea.
(Id.) Petitioner reported her ambulatory blood pressures were good, though her blood
pressures were higher in the right arm. (Id.) Dr. Ferrier ordered her to return for follow-
up in 3 months. (Id. at 39.)

On March 19, 2018, petitioner returned to Dr. Webb-Detiege with a chief
complaint of joint pain. (Ex. 38, p. 7.) Dr. Webb-Detiege noted that petitioner had
“chronic fatigue, immunologic issues and pain since tetanus shot in 2012.” (Id.)
Petitioner described night sweats, feeling like “her nerves are on fire and [] can hear her
heart race.” (Id.) She complained of 24-hour stiffness and difficulty staying on task.
(Id.) Petitioner was negative for symptoms of lupus; but positive for fatigue, fever, dry
mouth, dry eyes, cough, chest pain, headaches, adenopathy and easy

18
bruising/bleeding. (Id. at 7-8.) On physical examination, petitioner had pain on
palpation for 12/18 tender points for fibromyalgia. (Id. at 8.) She also demonstrated
zero swollen and zero tender joints. (Id.) Petitioner was assessed with arthralgias
(“symptoms began after tetanus shot which was associated with cellulitis of buttocks”),
myalgias, positive CCP, fatigue, night sweats, dry mouth, venous insufficiency of the
legs, and optic neuritis. 10 (Id. at 10.) Dr. Webb-Detiege ordered repeat ANA, labs, and
an arthritis survey. (Id.)

On July 17, 2018, petitioner returned to Dr. Ferrier again for a follow-up of her
hypertension. (Ex. 37, p. 87.) She denied chest pain, blurred vision, excessive fatigue,
nausea or vomiting but complained of shortness of breath and morning headaches.
(Id.) Petitioner reported that she was involved in a motor vehicle accident in April and
developed hand swelling immediately after the accident. (Id.) She also reported left
shoulder popping. (Id.) Dr. Ferrier indicated that petitioner’s blood pressure was well
controlled and ordered her to follow-up with an orthopedist and continue pain
medication for fibromyalgia. (Id. at 88.)

On August 14, 2018, petitioner presented to Dr. Ferrier complaining of right
shoulder and arm pain, pain in the right side of her neck, right wrist weakness, hand
swelling and difficulty stretching her fingers. (Ex. 37, p. 103.) She further complained of
numbness in her right upper extremity. (Id.) According to petitioner her symptoms
began 10 days prior. (Id.) Dr. Ferrier recommended salon pas for the right wrist pain.
(Id. at 104.)

On October 15, 2018, petitioner presented to Dr. Jones with bilateral shoulder
pain, right greater than left. (Ex. 38, p. 11.) She described a fall that caused a
“shocking” pain in her shoulder one month prior. (Id.) Petitioner continued to have
aching and burning in her right arm and shoulder. (Id.) She observed swelling into her
arm, causing difficulty with ADLs. (Id.) Dr. Jones noted petitioner “had a vaccine injury
in 2011 and has had global neurological symptoms.” (Id.) Dr. Jones reviewed
petitioner’s bilateral shoulder x-ray showed mild degenerative joint disease. (Id.) She
was assessed with right shoulder pain (unspecific chronicity), left shoulder pain
(unspecific chronicity), rotator cuff syndrome in the right shoulder, fibromyalgia, biceps
tendinitis in the right shoulder, and arthralgia (unspecific joint). (Id. at 15.) Dr. Jones
ordered an MRA of petitioner’s right shoulder. (Id. at 15-16.) The next day, petitioner
presented to Dr. Sisco-Wise, in the same office, who ordered an EMG to evaluate
petitioner for possible peripheral nerve compression. (Id. at 17.)

On November 19, 2018, petitioner presented to Dr. Ferrier for a follow-up on her
hypertension. (Ex. 37, p. 143.) She continued to experience joint pain but noted that
physical therapy and water therapy were helping. (Id.) She described neck pain, worse
on the right; numbness, tingling, and burning sensations in her right arm; and right-hand
pain. (Id.) Dr. Ferrier assessed petitioner with cervicalgia and prescribed hydrocodone
and ordered cervical spine MRI. (Id. at 144.)
10 Dr. Webb-Detiege noted that petitioner’s records indicated that Dr. Lovera ruled out optic neuritis, but

petitioner wished to see Dr. Webb-Detiege “because of her concern of an ongoing neuroimmunological
problem.” (Ex. 38, p. 10.)

19
On January 22, 2019, petitioner presented to Dr. Chaiban for a follow-up on her
chronic pain. (Ex. 38, p. 21.) Petitioner’s EMG/NCV showed mild carpal tunnel
syndrome. (Id.) Petitioner was continuing occupational therapy, and improving, but it
was discontinued secondary for a concern of cervical radiculopathy. (Id.) Dr. Chaiban
noted petitioner’s long-standing history of neuropathic pain dating back to her tetanus
injection, having been seen by multiple specialists, including rheumatology,
hematology/oncology, neurology, cardiology and “there has not been a clear diagnosis
at this time.” (Id.) He noted that in the past petitioner “had a positive rheumatoid factor
and she has thrombocytosis, there is a question of orthostatic hypotension versus
venous insufficiency and this has been undergoing workup.” (Id.) She continued to
describe “burning tingling sensations” in her bilateral lower extremities, abdomen, and
face, with occasional facial droop. (Id.) Dr. Chaiban referred petitioner for an
allergy/immunology consult and suggested a sural nerve biopsy or cervical burst
stimulation at St. Jude. (Id. at 28.)

On March 27, 2019, petitioner presented to PA-C Erin Diebold with a
subcutaneous mass on her medial right elbow. (Ex. 38, p. 29.) Onset of her symptoms
began approximately one year prior, with gradual worsening. (Id.) She developed
progressive weakness and numbness in her fourth and fifth digits and thumb. (Id.) PA-
C Diebold noted petitioner previously had two masses removed which were diagnosed
as lipomas. (Id.)

On April 1, 2019, petitioner presented to Dr. Smith for a consultation regarding
her lipoma. (Ex. 38, p. 32.) Dr. Smith noted in the HPI that petitioner had been
diagnosed with fibromyalgia and peripheral neuropathy “as a reaction to a vaccine in
2012.” 11 (Id.) Dr. Smith further noted that petitioner had not been seen by neurology or
rheumatology in over a year. (Id.) Dr. Smith assessed petitioner with right brachial
artery aneurysm but ordered repeat imaging because petitioner’s “[r]epresentative
images are not convincing.” (Id.)

On June 3, 2019, petitioner presented to Dr. Trinh with a chief complaint of right
arm lymphadenopathy. (Ex. 38, p. 34.) Upon reviewing petitioner’s labs, right arm
ultrasound, right arm vascular ultrasound, and MRI of her humerus, Dr. Trinh assessed
petitioner with chronic pain syndrome, right-hand and wrist arthritis, right epitrochlear
lymphadenopathy, positive CCP, and multiple antibiotic allergies. (Id. at 35.) Dr. Trinh
ordered follow-up laps, MRI of her right hand, wrist, and forearm, and follow-up visits
with Drs. Webb and Townsend. (Id.)

On June 5, 2019, petitioner presented to Dr. Ferrier for a follow-up of her
hypertension. (Ex. 37, p. 215.) She reported decreased sensation in her left leg and a
throbbing sensation in her right arm. (Id.) She further reported diffuse body aches,
fatigue, nausea and vomiting following her blood draw. (Id.)

11 By this time petitioner had already had a telephone interview with Dr. Lapp, though the resulting report

does not specifically confirm a diagnosis of fibromyalgia. (Ex. 16.) Petitioner was later evaluated by Dr.
Lapp in person in November of 2019. (Ex. 21.)

20
On June 13, 2019, petitioner returned to Dr. Webb-Detiege for a follow-up. (Ex.
38, p 37.) She reported “24-hour stiffness during flare[s]” and described taking 4 hours
to get ready in the morning. (Id.) She described flares for the past five days to two
weeks. (Id.) Petitioner further reported losing sensation in her hands. (Id.) In addition
to her prior diagnoses, Dr. Webb-Detiege assessed petitioner with hypertension
(“worsens with flare of symptoms”). (Id. at 40.)

On June 26, 2019, petitioner presented to Dr. W. Edward Davis III for an allergy
consultation. (Ex. 38, p. 41.) Dr. Davis noted that petitioner was last seen in Allergy by
Dr. Hassett on January 11, 2013. (Id.) He noted that petitioner “attributes multiple
symptoms to her [tetanus shot] reaction, most of which have been neurologic and
muscular.” (Id.) In a detailed survey, petitioner indicated, in part, that her symptoms
occur sometimes two to three times a week, based on dietary intake, and in response to
“outdoor elements and/or contact with various chemicals or products…flare ups are
random and can appear regardless of precautions and avoiding known allergies.” (Id. at
42.) She further indicated that “food allergies only became relevant after TDAP vaccine
injury.” (Id. at 43.) Dr. Davis assessed petitioner with chronic rhinitis (“consider
allergic”), chronic cough with shortness of breath (“consider allergic component”),
history of adverse reaction to tetanus injection, and fibromyalgia. (Id. at 44.) He
ordered neuro-ophthalmology and neurology follow-ups. (Id.)

On August 7, 2019, petitioner returned to Dr. Trinh for a follow-up on her right
arm lymphadenopathy. (Ex. 38, p. 45.) She indicated that she was still awaiting MRI
and reported continued right arm pain and worse swelling since the prior visit. (Id.) Dr.
Trinh noted that an extensive infectious work-up was negative, including bartonella,
toxo, syphilis, HIV, and EBV. (Id. at 46.) She further noted “[s]uspect underlying
autoimmune process cause of right epitrochlear [lymphadenopathy].” (Id.)

On August 8, 2019, petitioner presented to Dr. Robin Davis for a neurology
consult. (Ex. 38, p. 48.) Dr. Davis discussed with petitioner that some of her weakness
may be accounted for by the carpal tunnel noted her EMG. (Id.) Petitioner was
“insistent that she has ulnar Neuropathy not median neuropathy despite the converse
being observed on her EMG.” (Id.) Dr. Davis remarked that her exam was notable only
for multiple functional signs and she complained of 10/10 pain whenever she is touched.
(Id.) Of note, Dr. Davis discussed with petitioner her (1) right carpal tunnel syndrome
(2) chronic pain syndrome and (3) excessive daytime sleepiness. (Id.) Upon review of
petitioner’s EMG, Dr. Davis confirmed her bilateral carpal tunnel syndrome “however the
patient refutes this.” (Id. at 48-49.) Petitioner also insisted that she suffered from
polyneuropathy, though her EMG in 2018 and 2018 showed only evidence of carpal
tunnel syndrome. (Id. at 49.) Dr. Davis noted that she did not receive records from
Ochsner neurology, however. (Id.) Dr. Davis was unable to identify the primary
neurologic cause for petitioner’s chronic pain but noted that she agreed with petitioner’s
PCP who recommended refraining from adding new medications. (Id. at 48.) Dr. Davis
also referred petitioner to Sleep Disorders for her excessive daytime sleepiness. (Id.)

On August 21, 2019, petitioner presented to Dr. Townsend with tender nodule on
her right medial arm. (Ex. 38, p. 52.) Dr. Townsend assessed petitioner with tender

21
lymphadenopathy and recommended an excisional biopsy. (Id. at 54.) On September
11, 2019, petitioner presented for a follow-up after her reactive lymph node was
removed. (Id. at 56.)

On September 12, 2019, petitioner returned to Dr. Ferrier for another follow-up
for hypertension. (Ex. 37, p. 249.) Additionally, she reported that she was not sleeping
at night. (Id.) Petitioner complained of persistent right hand and wrist pain. (Id.) Her
MRI showed findings which could be consistent with ulnar abutment syndrome. (Id.)

On September 16, 2019, petitioner returned to Dr. Webb-Detiege. (Ex. 38, p.
57.) Petitioner noted “she is having a flare since Saturday.” (Id.) She complained of
fatigue, fever, trouble swallowing and dry mouth, dry eyes, shortness of breath, chest
pain, headaches, adenopathy, and easy bruising. (Id. at 57-58.) Dr. Webb-Detiege
assessed petitioner with undifferentiated connective tissue disease (UCTD) “manifested
by myalgias and arthralgias, reactive lymph node at right elbow, ANA, CPP, and
fatigue.” (Id. at 60.) Dr. Webb-Detiege ordered labs and messaged petitioner’s eye
doctor for clearance for Plaquenil for her UCTD. (Id.)

On October 7, 2019, petitioner presented to a new physician, Dr. Ronald French
Jr., complaining of pain and swelling in her hands. (Ex. 38, p. 63.) Dr. French Jr. noted
that petitioner had been seen by several different doctors for this issue. (Id.) He noted
that petitioner’s recent MRI showed inflammatory changes of the right wrist. (Id.) Dr.
French Jr. assessed petitioner with inflammatory arthritis of the right hand and wrist,
ulnar impaction syndrome in the right wrist, and right carpal tunnel syndrome. (Id. at
65.) Petitioner was given a corticosteroid injection in her right wrist and a wrist brace.
(Id.) Dr. French Jr. recommended possible surgery for ulnar shortening osteotomy.
(Id.) Petitioner returned to Dr. French Jr. on January 23, 2020, after undergoing ulnar
shortening osteotomy and carpal tunnel release. (See Ex. 38, pp. 71-73 (s/p two
weeks).) On March 9, 2020, petitioner returned to Dr. French Jr. for a post-op follow-up
and was “doing well, pain is minimal, definitely improving.” (Id. at 77.)

On March 23, 2020, petitioner returned to Dr. Ferrier for a follow-up visit. (Ex.
37, p. 301-02.) Petitioner complained of right forearm pain following surgery, but also
reported that sensation was returning to her fingertips in her right hand. (Id. at 301.)
Dr. Ferrier assessed petitioner with mildly elevated blood pressure but noted
improvement; and planned to continue pain control for her fibromyalgia and
polyneuropathy. (Id. at 302.)

On May 6, 2020, petitioner had a telemedicine visit with Dr. Ferrier, complaining
of stress. (Ex. 37, p. 318.) Petitioner further complained of dry skin, hair loss, mouth
sores, fatigue, insomnia, back pain, right shoulder weakness, swollen lymph nodes, ear
pain, and jaw stiffness. (Id. at 318-19.) Dr. Ferrier prescribed Ambien for petitioner’s
insomnia. (Id. at 320.)

On June 24, 2020, petitioner presented to for a follow-up with Dr. Ferrier,
complaining of bilateral leg and knee pain and additional lipoma. (Ex. 37, p. 333.) Dr.
Ferrier assessed petitioner with knee pain, unspecified chronicity, lipoma, and

22
hypertension, secondary to pain, but improving. (Id. at 334.) Subsequent ultrasound
did not reveal lipoma. (Id. at 372.) Petitioner continued to report left leg pain, stinging
pain and bilateral ankle and foot swelling, hair loss, lack of sleep (secondary to pain),
headaches (due to lack of sleep), back pain, and perspiration down her back. (Id.) In
December 2020, petitioner additionally complained of being forgetful and dropping
things due to pain exacerbation. (Id. at 394.)

On March 1, 2021, petitioner returned to Dr. French Jr. with residual numbness
and tingling in her right ring and small finger. (Ex. 38, p. 81.) Petitioner indicated that
she wished to restart physical therapy on both hands. (Id.) Dr. French Jr. indicated that
he was “[n]ot sure why she is having the numbness,” so he ordered a nerve conduction
study of both arms. (Id. at 83.) A subsequent nerve conduction study of both hands
showed mild carpal tunnel syndrome bilaterally, no evidence of cubital tunnel or ulnar
nerve compression. (Id. at 84.) Dr. French Jr. administered another corticosteroid
injection and continued petitioner on anti-inflammatory medication. (Id. at 86.) Dr.
French Jr. referred petitioner to Dr. Alvah Tyson Wickboldt Jr. for her neck pain. (Ex.
38, pp. 95-99.) Dr. Wickboldt reviewed petitioner’s prior EMG and MRIs, but “given the
length of time she has been dealing with symptoms” he explained that resolution was
unlikely. (Id. at 99.) He referred petitioner for cognitive behavioral therapy. (Id.)

As of May 2021, petitioner presented to Dr. Ferrier complaining of leg pain. (Ex.
38, p. 102.) She described a heaviness sensation in her leg and shooting pain up her
right leg to her groin. (Id.) Dr. Ferrier assessed petitioner with right leg pain (awaiting
ultrasound), hypertension (elevated, likely secondary to pain), and right hip pain. (Id. at
102-03.)

b. As Reflected by Testimony/Affidavits

Petitioner averred that she received the Tdap vaccination in her left buttocks in
the emergency room on February 6, 2012. (Ex. 7.) Petitioner stated that the nurse
administering the vaccination suggested the buttock and petitioner did not protest
although she thought it was strange. (Id. at 2.) According to petitioner it was “chaotic”
at the emergency room that day and the nurse appeared to petitioner to be “rushed,
distracted, and not competent.” (Id.) Additionally, petitioner affirmed on July 2, 2017
that she has scarring with atrophy and a persistently bothersome bump at the
vaccination site. (Ex. 10.) Petitioner also indicated that the injection site was painful
upon touch with burning and itching. (Id.)

Petitioner testified that prior to vaccination she was social and active, comparing
herself to the “Energizer bunny.” (Tr. 9-10.) In contrast, she described her post-
vaccination life as follows:

I'm feeling horrible. I am not well, and I am afraid that I'm not going to get
better because I'm not getting better. And I just can't do anything normal like
I would be able to be very active and be more in control of being organized
and not fatigued. Anything I try to do makes me tired. Especially when I try
to do things, I get stressed, because I can't complete the task because I'm

23
tired all the time. And I've even tried to stay in the bed longer to rest, even
to sleep, but still when I awaken, it's like I've never slept. And I've told Dr.
Ferrier, all my physicians, numerous, numerous, I'm just tired, I'm just tired.
So when I try to do a normal day's activity, which that no longer exists for
me -- I don't have any normalcy; I live day to day, because I have a lot of, I
guess you would say, symptoms that's just recurring. And the pain is
unbearable. Like right now I'm getting tired waiting, because I want to sleep,
and I'm trying to stay focused, so I can participate. And I got a little sleep
last night, but still when I awake, the hoarseness is there. I can tell when I'm
really bad because it's like I hit a wall, oomph. And even if I try to push past
it, my mind is saying I can do it, but my body's saying, we're not doing that.
Literally you're not doing that.

(Tr. 7-8.)

On cross-examination, respondent’s counsel explored details of petitioner’s
medical history and petitioner provided testimony regarding her subjective experience of
the symptoms discussed in the medical records. This related in large part to
understanding her sleep patterns and how she experienced what was reported as
insomnia and night sweats by her physicians. (Tr. 15-20.) Petitioner also indicated that
the leg pain she experienced pre-vaccination was not severe, only “normal” achiness,
and that she only ever took Vicodin for her shoulder problem. (Tr. 20-21.) Petitioner
disagreed with the medical record of May 23, 2011 (Ex. 1, p. 570) characterizing her
pain problems as “longstanding.” (Tr. 21-29.) Petitioner characterized her back and leg
pain as residual effects of her shoulder problem that were ultimately resolved by her
later 2012 surgery. (Id.) Petitioner also disagreed with a characterization in the medical
records (Ex. 1, p. 574) from September of 2010 of her having “recurrent” throat
infections, preferring to characterize them as either periodic or “off and on.” (Tr. 30-32.)
Petitioner confirmed she had an upper respiratory infection in January of 2012 (Tr. 32-
33) and reviewed the record of her January 16, 2012, encounter with Dr. Ferrier (Ex. 1,
p. 442). Petitioner acknowledged having the symptoms reported in the record, including
cough, fatigue, and intermittent fever. (Tr. 34-35.)

IV. Expert Opinions

a. Petitioner’s Experts

i. Janine M. Ferrer, M.D.

On November 2, 2016, Dr. Ferrier, petitioner’s primary care physician, wrote a
letter addressing petitioner’s claim. (Ex. 8.) Dr. Ferrier stated that petitioner received a
Tdap vaccine in her left hip in 2012 and experienced pain and redness around her
injection site. (Id.) Thereafter, petitioner experienced intermittent fatigue, fever,
myalgias, joint pains, intermittent swelling, and headaches. Additionally, Dr. Ferrier
wrote that petitioner also had other symptoms including decreased appetite, nausea,
spasms, and burning sensation in her left lower extremity. Dr. Ferrier stated that

24
“[m]any of the symptoms [petitioner] has experienced may be attributable to her
vaccination, including injection site pain and redness, fever, headaches nausea, chills,
and bodyaches [sic].” (Id.) Dr. Ferrier indicated that petitioner continued to experience
symptoms intermittently.

ii. Charles Lapp, M.D.

Dr. Lapp currently is the medical director of the Hunter-Hopkins Center in North
Carolina. (Ex. 20.) He received his medical degree from Albany Medical College in
1974 and completed his residency in internal medicine and pediatrics at North Carolina
Memorial Hospital. (Id.) He has experience in diagnosis and management of CFS and
Fibromyalgia since 1985. (Ex. 16.) Dr. Lapp has published various articles covering
many topics and recently took part in an article about CFS and Myalgic
Encephalomyelitis. (Ex. 20, p. 3.)

Petitioner was evaluated by Dr. Lapp on November 12, 2019 following a phone
consultation on February 29, 2019. 12 (Ex. 21.) As part of her history of present illness,
Dr. Lapp noted that petitioner experienced nausea, fatigue, and injection site pain within
30 to 60 minutes following receipt of the Tdap vaccination to her left buttock on
February 6, 2012. Additionally, the following day, petitioner experienced widespread
arthralgias, pain in the left hip and back, discomfort in the left leg, and swelling in her
hands and legs. From there, petitioner was diagnosed with cellulitis of the left buttock,
diagnosed with serum sickness following a rheumatology consult, and developed more
symptoms including malaise, insomnia, memory loss, headaches, body pain, recurrent
sore throat, cervical and inguinal lymphadenopathy. (Id. at 1.) Dr. Lapp noted that
petitioner’s symptoms persisted and that she “is almost never free of severe pain, which
12 Although the opinions of treating physicians are not binding (see § 13(b)(1)), the Federal Circuit has
recognized that “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.’” Capizzano v.
Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen v. Sec'y of Health
and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)). Accordingly, such opinions are often
considered “quite probative.” Id. This logic has also been applied in the context of diagnosis. See, e.g.,
D'Angiolini v. Sec'y of Health & Human Servs., No. 99-578V, 2014 WL 1678145, at *24 (Fed. Cl. Spec.
Mstr. Mar. 27, 2014) (finding a treating physician’s opinion regarding diagnosis “worth a great deal” and
“almost definitive evidence on that point”), mot. for rev. denied, 122 Fed. Cl. 86 (2015), aff'd, 645 F. Appx.
1002 (Mem.) (Fed. Cir. 2016). However, the extra weight often assigned treating physician opinions is
premised on the notion that, in addition to being qualified to offer a medical opinion, the treating
physicians were eyewitnesses with personal knowledge of the unfolding of a petitioner’s condition. Nuttall
v. Sec’y of Health & Human Servs., 122 Fed. Cl. 821, 832-33 (2015) (explaining that the Federal Circuit
“found that a treating physician who was familiar with the patient both before and after the alleged vaccine
injury is likely to be in a better position than an expert retained after the fact” to opine with respect to
vaccine causation), aff’d 640 Fed. Appx. 996 (Mem.) (Fed. Cir. 2016). Here, Dr. Lapp’s evaluation does
not fit that context. He had one phone consultation and one in-person evaluation with petitioner, both of
which occurred years after the alleged onset of her condition. Moreover, the evaluation was for purposes
of developing Dr. Lapp’s opinion in this case and did not occur in the ordinary medical treatment context.
For these reasons, while recognizing that Dr. Lapp’s ability to conduct an in-person exam and interview
contributed to the basis for his opinion and likely added to what he was able to observe in making to his
assessment, his opinion does not qualify for any added enhancement as a treating physician in the
context of the record for this case.

25
comes from all over, from muscles, bones, and joints.” (Id.) At this evaluation,
petitioner reported moderate to severe symptoms at rest, but severe symptoms with
activity. (Id. at 2.) Dr. Lapp also listed Tdap and all vaccines as part of petitioner’s
allergies. (Id. at 3.)

Under a review of systems, Dr. Lapp noted that petitioner experiences many
symptoms including flu-like feelings, recurrent sore throat, blurred vision, recurrent sinus
congestion and drainage, frequent queasiness, and more. (Ex. 21, p. 3.) Upon
examination, Dr. Lapp noted petitioner was positive for joint tenderness and limited
range of motion at the right wrist. (Id. at 4.) He also noted some elevated levels from
her laboratory. (Id.) Dr. Lapp assessed petitioner with fibromyalgia, CFS, sleep
disorder, as well as dysphagia, irritable bowel syndrome, amenia, vitamin D deficiency,
and several other conditions. (Id. at 4-5.)

Dr. Lapp reports that immune challenges, like immunizations, can cause CFS.
(Ex. 16, p. 3.) He explains that a shift in the immune response towards a TH2 profile
results in a fatiguing illness after vaccination; and moreover, overproduction of pro-
inflammatory cytokines can cause alterations in the cardiovascular and cognitive
systems. Dr. Lapp indicates that an immune imbalance toward a TH2 immune state is
observed in patients with CFS. He states that, “it is well known by researchers in this
field, that CFS is frequently triggered by infections and various immune challenges,
including vaccinations.” (Id.) Therefore, Dr. Lapp opines that petitioner has CFS and
Systemic Exertion Intolerance Disease, and that petitioner’s condition was triggered by
her receipt of the Tdap vaccination on February 6, 2012. (Id.)

In a supplemental report, Dr. Lapp provides a response to the reports from Drs.
Oddis and He. (Ex. 22.) Dr. Lapp points out that routine laboratory and diagnostics are
typically normal in CFS and fibromyalgia patients. He responds that a one-time
shoulder pain, backaches, and leg pain cannot explain the physical and cognitive
symptoms that petitioner experienced all over her body since her vaccination. Again,
Dr. Lapp emphasizes that petitioner’s rheumatologist concluded that petitioner had a
reaction to her vaccination. (Id. at 1.) He disagrees that petitioner’s condition was
caused by an infection or cellulitis. Dr. Lapp indicates that “[f]ever and swelling
occurred at the injection site within one hour of the injection, which is too rapid for
infection; and within one day the patient experienced diffuse joint pain, a clear sign of
immune reaction.” (Id.) Dr. Lapp again asserts that petitioner developed fever,
swelling, arthralgias, and other symptoms that meet the criteria for Fibromyalgia and
CFS. (Id. at 2.)

During the hearing, Dr. Lapp testified in accordance with his prior reports. (Tr. at
41-171; 176-244.) He further explained the immunology underlying his theory and
addressed specific medical record entries that he opines support his interpretation that
petitioner experienced onset of her CFS within two weeks of her Tdap vaccine. He also
discussed the relevant diagnostic criteria for CFS in detail and explained that he
believes petitioner’s treating physicians misinterpreted manifestations of petitioner’s
CFS as serum sickness.

26
b. Respondent’s Experts

i. You-Wen He, M.D., Ph.D.

Dr. He currently teaches as a professor of immunology at Duke University
Medical Center and oversees four clinical trials for cancer immunology. (Ex. C.) Dr. He
also serves as a reviewer for several journals. He received his medical degree from
The Fourth Military Medical University in Xian, China in 1986 and his doctorate in
microbiology and immunology from the University of Miami School of Medicine in 1996.
(Ex. C, Tab 1.) He has ongoing research focusing on T cell receptor-activated
autophagy and immune-modulating antibody for lung cancer treatment. (Id. at 6.)

Upon review of the medical records, Dr. He concludes that petitioner had chronic
conditions that did not result in any definitive diagnosis. (Ex. C.) Dr. He opines that
CFS is poorly understood and may be related to several possible causes including
infection, immune dysfunction, endocrine-metabolic dysfunction, and neuropsychiatric
factors. (Id. at 3 (citing Stephen J. Gluckman et al., Clinical features and diagnosis of
myalgic encephalomyelitis/chronic fatigue syndrome, 11(4) UPTODATE 1 (2019) (Ex. C,
Tab 2.)).) Although Dr. Lapp cited to a case report relating vaccination and CFS, Dr. He
states that there is insufficient support for causation between vaccination and CFS. In
his opinion, it is more likely that petitioner’s chronic condition was infection-induced
since petitioner had cellulitis after her receipt of her February 6, 2012. (Id. at 3.)

During the hearing, Dr. He testified in accordance with this report. (Tr. at 282-
309.) He also provided specific criticisms of the immunology Dr. Lapp presented during
the hearing.

ii. Chester V. Oddis, M.D.

Dr. Oddis received his medical degree at Pennsylvania State University, College
of Medicine in 1980. (Ex. D, Tab 1.) He currently holds a teaching position as a
professor of medicine in the division of rheumatology and clinical immunology at the
School of Medicine at the University of Pittsburg. (Ex. D.) He is board certified in
internal medicine and rheumatology. Dr. Oddis specialized his research in myositis and
interstitial lung disease. (Id.)

Regarding petitioner’s history, Dr. Oddis notes that petitioner was never
diagnosed with either CFS or Fibromyalgia and that all her laboratory and diagnostic
studies were normal. (Ex. D, p. 3.) Additionally, Dr. Oddis points out that petitioner had
musculoskeletal problems and was treating her chronic pain following right shoulder
surgery prior to receiving the Tdap vaccination in February 2012. (Id. at 3-4.) Dr. Oddis
notes that when petitioner complained of diffuse pain, petitioner’s rheumatologist and
immunologist diagnosed petitioner with “arthralgia,” or joint pain without evidence of
inflammation. (Id. at 5.)

27
Dr. Oddis opines that petitioner had chronic pain syndrome prior to vaccination
and that petitioner does not meet the criteria for the diagnosis of CFS. (Id. at 4-5.) He
indicates that petitioner has some features, but many of her symptoms were non-
specific and therefore disagrees with Dr. Lapp’s diagnosis. Dr. Oddis also notes that
the basis of Dr. Lapp’s report “sets up the potential for an extremely biased report where
a physician can suggest many of the clinical features/diagnostic criteria to a patient and
then report them.” (Id. at 5.) Aside from contesting petitioner’s diagnosis, Dr. Oddis
also opines that petitioner had “self-limited and non-specific symptoms after the Tdap
vaccination,” that never manifested into any treatable condition.

On Dr. Lapp’s theory regarding CFS and vaccination, Dr. Oddis disputes the
association and notes that “CFS is often triggered and perpetuated by an ongoing
microbial infection and that was also not the case with [petitioner].” (Id. at 6.)

During the hearing, Dr. Oddis likewise testified in accordance with his report. (Tr.
at 245-281.)

V. Discussion

a. Diagnosis

When faced with disagreement among qualified experts regarding the
identification and nature of a disputed injury, the Federal Circuit has concluded that it is
“appropriate for the special master to first determine what injury, if any, [is] supported by
the evidence presented in the record before applying the Althen test to determine
causation.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1351-53
(Fed. Cir. 2011). Importantly, however,“[t]he function of a special master is not to
‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record as a
whole and the totality of the case, whether it has been shown by a preponderance of the
evidence that a vaccine caused the [petitioner]’s injury.’” Andreu v. Sec’y of Health &
Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (quoting Knudsen v. Sec’y of
Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)).

Nonetheless, petitioner must “specify [her] vaccine-related injury and shoulder
the burden of proof on causation.” Broekelschen v. Sec'y of Health & Human Servs.,
618 F.3d 1339, 1346 (Fed. Cir. 2010). “Although the Vaccine Act does not require
absolute precision, it does require the petitioner to establish an injury – the Act
specifically creates a claim for compensation for ‘vaccine-related injury or death.’”
Stillwell v. Sec'y of Health & Human Servs., 118 Fed. Cl. 47, 56 (2014) (quoting
42.U.S.C. § 300aa-11(c)). And, in any event, a petitioner must prove by a
preponderance of the evidence the factual circumstances surrounding her claim. §
300aa–13(a)(1)(A).

In this case, petitioner has a complex overall medical history. Initially, petitioner
pleaded only that she suffered an abscess and unspecified “related injuries,” the
symptoms of which she alleged had become chronic. (ECF No. 1, p. 1.) Following her

28
expert’s assessment, she narrowed the “related injuries” to a diagnosis of CFS in her
prehearing brief. (ECF No. 132.) However, Drs. Lapp and Oddis raise questions about
a number of specific conditions. On petitioner’s behalf, Dr. Lapp opines that petitioner
does have CFS and comorbid fibromyalgia; however, he denies that she suffered any
serum sickness as documented in the medical records. (Tr. 148.) Respondent’s
expert, Dr. Oddis, disagrees that petitioner has either CFS or fibromyalgia and further
opines that petitioner suffered a pre-existing chronic pain syndrome. (Tr. 255-56.) Dr.
Oddis does not have any opinion regarding the serum sickness diagnosis contained in
the medical records. (Id. at 280-81.) There are also references in the medical records
to possible rheumatoid arthritis. (Ex. 1, pp. 419, 422, 538; Ex. 2, p. 10.) Finally, both
experts agree that petitioner likely suffered the cellulitis documented in the medical
records. (Tr. 182, 290-91.)

i. Cellulitis

Petitioner’s medical records reflect that on February 9, 2012, she presented to
Dr. Ferrier for symptoms that included pain, redness, and inflammation at the site of her
Tdap injection. 13 (Ex. 1, 441.) On examination, she had “positive induration of left
gluteus with erythema.” (Id.) The assessment was cellulitis/left gluteal abscess. (Id.)
Both Dr. Lapp and Dr. Oddis agree that a temporary cellulitis was present. (Tr. 182; Tr.
279-80.) Accordingly, there is preponderant evidence petitioner suffered cellulitis.

ii. Serum sickness

When petitioner presented for care at the emergency department on February
27, 2012, she described symptoms beyond those associated with her previously
diagnosed cellulitis and this was felt to be “most likely a reaction to the tetanus shot and
possibly a delayed serum sickness type hypersensitivity reaction . . . .” (Ex. 1, p. 706
(emphasis added).) On March 7, 2012, petitioner had a follow up with an allergist, Dr.
Lurie. (Ex. 3, pp. 1-3.) Dr. Lurie characterized petitioner as a patient with “serum
sickness non IgE immunologic reaction to DTap vaccine.” (Id. at 3.) This was based on
her symptoms being “typical” of such a reaction and it was assumed they would resolve
within weeks. (Id.) By June of that year, later records characterize serum sickness as
having been previously “suspected.” (Ex. 1, p. 412 (“serum sickness was suspected”);
Ex. 1, p. 418 (Dr. Lurie felt symptoms “may be related to serum sickness”); Ex. 1, p. 52
(repeating in October 2012 that “serum sickness was suspected”).)

On November 2, 2016, petitioner’s primary care doctor, Dr. Ferrier, wrote a letter
indicating that following her Tdap vaccination, petitioner experienced, inter alia,
“intermittent fatigue, fever, and myalgias.” (Ex. 8.) She opined that “[m]any of the
symptoms she has experienced may be attributable to her vaccination, including
injection site pain and redness, fever, headache, nausea, chills and body aches. She
continues to experience symptoms intermittently.” (Id.) However, Dr. Ferrier did not

13 The previously assigned special master also confirmed that petitioner’s Tdap vaccine was injected in a

corresponding location and I have adopted that finding as my own. (See n. 4, supra.)

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specifically invoke serum sickness in her letter. Nor was Dr. Ferrier among those
physicians who included an impression of serum sickness in petitioner’s post-
vaccination treatment records.

Taking the medical records as a whole, it does not appear that serum sickness
was ever definitively diagnosed. Dr. Lapp also opines that petitioner did not ever have
serum sickness. He bases this on two factors: the symptoms attributed to serum
sickness are better explained by his subsequent diagnosis of CFS and the symptoms
did not resolve on the appropriate time course for a serum sickness reaction. (Tr. 151,
230.) On respondent’s behalf, Dr. Oddis declined to offer an opinion as to whether
petitioner suffered a serum sickness. He indicated that it may be “reasonable,” but
noted that it is generally a difficult diagnosis to substantiate. (Tr. 280-81.) Dr. He
declined to offer any opinion as to diagnosis. (Tr. 292.)

On this record, there is not preponderant evidence that petitioner suffered a
serum sickness reaction.

iii. Chronic pain syndrome / lower extremity pain

Dr. Oddis opined that prior to vaccination (and continuing afterward), petitioner
suffered from “chronic pain syndrome.” (Ex. D, p. 4.) Dr. Lapp agreed on petitioner’s
behalf that chronic pain syndrome is a valid diagnostic entity generally, and further
indicated that “I think technically you could say she does have a chronic pain syndrome
because she has lumbago, low back pain, and she has a pain that radiates down the
leg which has not been explained despite numerous studies to try to explain it.” (Tr.
241.)

Importantly, however, Dr. Oddis is unpersuasive to the extent he would suggest
that a chronic pain syndrome in itself constitutes an explanation for the entirety of
petitioner’s presentation. Dr. Oddis opines that petitioner’s pre-vaccination
musculoskeletal complaints and her post-vaccination presentation represent “a
continuum.” (Tr. 259.) He ultimately summarized his opinion as follows: “I would just
reiterate that if somebody is on narcotics for one to two years, that implies pain, and that
pain is chronic. And that pain was well characterized in the medical record and it
predated vaccination.” (Tr. 263.) To support this view, Dr. Oddis cited the following:
Ex. 1, p. 432 (medical record regarding chronic shoulder pain); Id. at 465 (medical
record regarding leg pain); Id. at 477 (medical record regarding bulging lumbar discs);
Id. at 570 (medical record regarding lower back pain of a mechanical nature); and Id. at
546 (petitioner requesting diabetes screening for lower leg pain) (Tr. 257-58; Ex. D, p.
3-4).

Absent from Dr. Oddis’s opinion is any discussion of diagnostic standards for a
chronic pain syndrome or any broader explanation of when the label is appropriately
applied. Instead, he discusses seemingly disparate musculoskeletal symptoms with at
least suspected diagnoses and labels them as a syndrome based on petitioner’s
treatment with narcotic medication. During the hearing, Dr. Oddis was asked what

30
basis he had for including petitioner’s shoulder pain in his assessment of chronic pain
syndrome when it appeared to have a clear mechanical cause treated by surgery. (Tr.
259-60.) He responded that he only included that as an example of a musculoskeletal
complaint prior to vaccination and that he is “perfectly agreeable to taking that out of the
chronic pain picture I have painted thereafter.” (Tr. 260.) Accordingly, on later
questioning, Dr. Oddis was asked:

Q: We talked a little bit earlier about the idea of the chronic pain syndrome
before vaccination and what went into that. Hypothetically, if I concluded
that I could find an explanation for every complaint the Petitioner had before
the vaccination, how would that change your opinion, if at all?

A: It wouldn’t change my opinion. I just saw it as a continuum.

(Tr. 277.) To the extent Dr. Oddis views the course of petitioner’s symptom
presentation differently than Dr. Lapp – and disagrees that the vaccination at issue
represented any inflection point – that raises a potential question under Althen prong
two, as discussed below. However, it is not credible to further suggest that petitioner’s
medical history should be entirely explained by a pain syndrome and viewed as a
continuum of that syndrome without any regard to the etiology of petitioner’s specific
musculoskeletal complaints.

During the hearing, Dr. Lapp explained that under the Fukuda criteria, which he
relies upon in part and which is discussed further below, diagnosis of CFS must exclude
conditions that could plausibly explain the relevant symptoms, particularly the fatigue.
(Tr. 52; The CDC (Fukuda 1994) Definition for Chronic Fatigue Syndrome, CFids-
Me.org, https://www.cfids-me.org/cdcdefine.html (last updated Mar. 30, 2008) (Ex. 27).)
Specifically, the Fukuda criteria explain what types of conditions exclude a diagnosis of
CFS. (Fukuda Definition, supra, at Ex. 27.) These include active medical conditions
that may explain chronic fatigue, diagnosable illnesses that may not have completely
resolved during treatment (if they explain fatigue), major depressive disorders,
substance abuse, and severe obesity. (Id.) The criteria indicate that “[a]ny unexplained
abnormality detected on examination or other testing that strongly suggests an
exclusionary condition must be resolved before attempting further classification.” (Id. at
2.) However, the criteria specify that the following does not exclude a diagnosis of CFS:
“[a]ny isolated and unexplained physical examination finding, or laboratory or imaging
test abnormality that is insufficient to strongly suggest the existence of an exclusionary
condition.” (Id.) Here, Dr. Oddis’s testimony is inadequate to establish either that the
proposed pain syndrome is a condition that can entirely explain petitioner’s relevant
symptoms, especially including fatigue, or that the findings he cites “strongly suggest”
an exclusionary condition. Rather, Dr. Oddis acknowledged during cross examination
that a patient with CFS and fibromyalgia can have other medical problems. (Tr. 275.)

Dr. Oddis’s willingness to apply a pain “syndrome” label to petitioner’s medical
history based mainly on her longer-term treatment with narcotics is also inconsistent
with his skepticism regarding other aspects of petitioner’s medical history. For example,

31
Dr. Oddis was critical of Dr. Lapp’s CFS diagnosis in large part because it was not also
diagnosed by the treating specialists. (Tr. 254-55.) Yet, his chronic pain syndrome
diagnosis is similarly absent from the earlier, contemporaneous medical records. 14
Additionally, to the extent his opinion hinges on longer term treatment with narcotics, he
was willing to express skepticism of petitioner’s physicians for overprescribing
antibiotics and suggested it was relevant to assessing her history longitudinally. (Tr.
275-76.) Yet, his pain syndrome assessment appears to take the advisability of
petitioner’s narcotics prescriptions at face value. Doing so is not necessarily incorrect;
however, Dr. Oddis appears to apply his skepticism selectively.

Thus, while petitioner experienced pre-vaccination lower extremity pain that was
not definitively explained, there is not preponderant evidence that this condition,
whether labeled as a chronic pain syndrome or not, excludes the diagnosis of CFS
proposed by Dr. Lapp.

iv. Rheumatoid arthritis

Petitioner tested positive for anti-CCP antibodies, a precursor to rheumatoid
arthritis, and rheumatoid arthritis was considered by her treating physicians. (See, e.g.,
Ex. 1, p. 538.) During the hearing, however, both Dr. Lapp and Dr. Oddis agreed that
petitioner did not have clinical Rheumatoid arthritis during the period at issue. Dr. Lapp
opined that rheumatoid arthritis may have developed later based on certain x-ray
findings, but that a later diagnosis of rheumatoid arthritis is not incompatible with his
opinion regarding CFS. (Tr. 232-33.) Dr. Oddis opined that petitioner’s antibody results
do not necessarily result in clinical symptoms of rheumatoid arthritis and confirmed that
he does not believe petitioner had rheumatoid arthritis clinically. (Tr. 278-79.)
Accordingly, there is not preponderant evidence that rheumatoid arthritis explains any of
petitioner’s symptoms. 15

14 It appears that a “chronic pain syndrome” was referenced in petitioner’s medical records beginning in

2019. (Ex. 38, p. 34.) On June 3, 2019, petitioner presented for evaluation of a right arm
lymphadenopathy. Dr. Trinh characterized her history as including a “history of chronic pain syndrome.”
(Id.) In that same record, however, Dr. Trinh indicated that petitioner had developed CFS subsequent to
her February 2012 Tdap vaccination. (Id.) Accordingly, Dr. Trinh’s notation does not contradict Dr. Lapp’s
opinion. Additionally, in August of 2019, petitioner presented to neurologist Robin Davis, M.D., with
regard to “numerous complaints.” (Ex. 38, p. 48.) Dr. Davis was unable to identify a primary neurologic
cause and assessed a chronic pain syndrome. (Id.) Importantly, however, Dr. Davis indicated that she
did not have access to petitioner’s prior medical records and considered herself uninformed of petitioner’s
prior history. (Id.) Accordingly, it would not be accurate to interpret Dr. Davis as offering any opinion as to
petitioner’s overall course.

15 The updated medical records filed after the hearing show that petitioner was diagnosed with

undifferentiated connective tissue disease on September 16, 2019, based in part on the CCP finding. (Ex.
38, p. 60.) In making that diagnosis, Dr. Webb-Detiege appears to suggest that it could account for both
myalgia and fatigue. (Id.) This could warrant further expert opinion with respect to whether it should in
itself call the proposed CFS diagnosis into question. However, because I have in any event concluded
pursuant to Althen that petitioner’s CFS was not vaccine-caused, it is not necessary to resolve that
question.

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v. Fibromyalgia

Petitioner testified that she was diagnosed with fibromyalgia by Dr. Ferrier
subsequent to her 2012 Tdap vaccination. (Tr. 36.) However, fibromyalgia is not listed
as a diagnosis in her earlier medical records and Dr. Ferrier did not otherwise mention
fibromyalgia in her letter to the court. (Ex. 8.) The updated medical records petitioner
filed after the hearing seem to suggest Dr. Ferrier added fibromyalgia to petitioner’s
problem list in December of 2019 based on Dr. Lapp’s assessment. (Ex. 37, p. 276.)
Petitioner was assessed as having fibromyalgia by Dr. Jones on November 6, 2017.
(Ex. 38, pp 1-6.) However, the basis for that assessment is unclear as Dr. Jones noted
no tenderness on physical exam. Subsequently, in March of 2018, Dr. Webb-Detiege
conducted a tender point exam that documented tenderness at 12 of 18 points;
however, she did not specifically diagnose fibromyalgia. (Ex. 38, pp. 7-10.) Later, on
September 16, 2019, Dr. Webb-Detiege documented only 8 of 18 tender points. (Id. at
58.) Dr. Lapp opines that petitioner does have fibromyalgia based on his own
evaluation while Dr. Oddis opines that she did not based on the medical records. (Tr.
133-34, 255-56.)

Fibromyalgia is commonly comorbid to CFS, but it is not necessary to the
diagnosis. (Gluckman et al., supra, Ex. C, Tab 2, pp. 7-8.) In this case, Dr. Lapp
confirms that the fibromyalgia he opines is present is merely a comorbidity of
petitioner’s CFS. (Tr. 136.) He also confirmed during the hearing that, although he
does opine that fibromyalgia could in general be vaccine-caused, he is not aware of
literature to support that assertion and has not included fibromyalgia in his causal
opinion. (Tr. 208-09, 232.) Accordingly, petitioner’s claim does not turn on whether any
of her symptoms can be properly characterized as fibromyalgia and that specific
question need not be resolved.

vi. Chronic fatigue syndrome (CFS)

Finally, the most extensively litigated diagnosis in this case is CFS. Petitioner
was not diagnosed with CFS by any of her treating physicians prior to her evaluation by
Dr. Lapp in 2019, roughly seven years post-vaccination. Accordingly, the question of
whether she can be diagnosed with CFS turns on the persuasiveness of the experts.

CFS, also sometimes referred to as myalgic encephalomyelitis, is a condition
characterized by severe debilitating fatigue that lasts for more than six months. (L.D.
Devanur & J.R. Kerr, Chronic fatigue syndrome, J. CLIN. VIROLOGY 1, 2 (2006) (Ex. 17).)
It is diagnosed clinically and also involves muscular, infections, and neuropsychiatric
symptoms, and sleep disturbances. (Id.) The name CFS persists because it remains a
syndrome without a definitely established etiology. However, the alternative term
myalgic encephalomyelitis is meant to connote that it is a condition of widespread
inflammation and multisystemic neuropathology. (B.M. Carruthers et al., Myalgic
encephalomyelitis: international consensus criteria, 270 J. INTERN. MED. 1 (2011) (Ex.
24).)

33
During the hearing, Dr. Lapp explained that there are numerous different sets of
diagnostic criteria to screen for CFS. (Tr. 156.) In this case, however, he specifically
discussed only three – the so-called Fukuda criteria issued by the CDC in 1994, a 2003
set known as the Canadian criteria that was later updated in 2011 to become the
international case definition criteria (“ICC”), and a set developed by the IOM in 2015.
(Tr. 49-58, 64-66; Carruthers et al., supra, at Ex. 24; Fukuda Definition, supra, at Ex. 27;
IOM 2015 Diagnostic Criteria, CDC.GOV, https://www.cdc.gov/me-cfs/healthcare-
providers/diagnosis/iom-2015-diagnostic-criteria.html (last updated Apr. 27, 2021) (Ex.
28).) The Canadian criteria is more symptom based. It is generally considered effective
but cumbersome and Dr. Lapp disfavors it for that reason. (Tr. 65.) It was not
discussed at length in this case.

According to Dr. Lapp, the Fukuda criteria are primarily used for research as they
have exclusion requirements that are not conducive to clinical use. (Tr. 51-52.)
Nonetheless, he did opine that application of that criteria supports petitioner’s case.
(Ex. 21, p. 4.) Dr. Lapp suggested the IOM criteria is less strict than the Fukuda criteria
and should be considered a “screening tool” for CFS. (Tr. 57.) If a person meets the
IOM criteria, they should be referred to a specialist or further screened using the
Fukuda criteria. (Id.) According to Dr. Lapp, if a person met the IOM criteria but not the
Fukuda criteria, they should be monitored as a presumptive case of CFS to see how
symptoms develop. (Tr. 156-57.) However, Dr. Lapp considers that possibility to be
“very rare.” (Id.) In this case, Dr. Lapp applied both the Fukuda criteria and the IOM
criteria and concluded that petitioner meets both. (Ex. 21, p. 4.)

For his part, Dr. Oddis stressed that sets of diagnostic criteria are primarily for
clinical trials and that “you have to be more open-ended when you look at the individual
patient in the clinical setting.” (Tr. 249.) Although Dr. Oddis never disputed that CFS
constitutes a valid diagnostic entity, during the hearing he was difficult to pin down with
regard to any further detail, seeming to betray skepticism that CFS should be applied as
a diagnosis in most cases (he prefers “fibromyalgia with chronic fatigue”). (Tr. 265-73.)
Ultimately, however, while Dr. Oddis explained that he does not use the Fukuda criteria
in his own practice, he agreed that a person meeting the Fukuda criteria could be said
to be suffering CFS. (Tr. 272-73.) In his own report, Dr. Oddis relied on the 2015 IOM
criteria to discuss whether petitioner has CFS. (Ex. D, p. 4.)

In light of the above, there is preponderant evidence that either the Fukuda
criteria or the IOM criteria could be considered sufficiently authoritative to support a
diagnosis of CFS. The 2015 IOM criteria include three mandatory “symptoms”
accompanied by at least one of two “additional manifestations.” (IOM Criteria, supra, at
Ex. 28, p. 1.) Thus, under this criteria diagnosis requires (1) a substantial impairment in
the ability to engage in pre-illness levels of activity that lasts for at least six months and
is accompanied by fatigue, 16 (2) post-exertional malaise, (3) unrefreshing sleep, and (4)

16 The fatigue is further characterized as often profound, of new onset (not life-long), not the result of

ongoing or unusual excessive exertion, and not substantially alleviated by rest. (IOM Criteria, supra, at
Ex. 28, p. 1.)

34
either cognitive impairment or orthostatic intolerance. (Id.) The Fukuda criteria requires
chronic fatigue meeting a specific definition (similar in description to the IOM criteria) 17
accompanied by four or more of eight additionally listed symptoms18 as well as the
absence of any of a number of exclusionary conditions. 19 (Fukuda Definition, supra, at
Ex. 27, pp. 1-2.)

On respondent’s behalf, Dr. Oddis testified that, although he disagrees that
petitioner has all of the features required for CFS, he agrees that petitioner had chronic
fatigue. (Tr. 255.) Further to this chronic fatigue, Dr. Lapp’s CFS diagnosis rests on the
presence of malaise, insomnia, cognitive difficulties, lymphadenopathy in the neck and
groin, and arthralgia. (Tr. 155.) This is based in part on his own assessment with
petitioner, but also cites support from the contemporaneous medical records. (See Tr.
84-86 (discussing record of February 24, 2012 (Ex. 1, p. 661, et seq.) reporting myalgia,
muscle pain, and dizziness); Tr. 86-88 (discussing record of February 27, 2012 (Ex. 1,
pp. 675, et seq) reporting swollen lymph nodes); Tr. 89-90 (discussing record of March
7, 2012 (Ex. 3, p. 1) reporting nausea, fatigue, pain at the injection site); Tr. 90-92
(discussing record of April 17, 2012 (Ex. 4, pp. 1-2) diagnosing polyarthralgia and
reporting musculoskeletal pain and insomnia).) Although Dr. Oddis is correct to note
that none of petitioner’s treating physicians diagnosed CFS, his own competing
assessment is diminished by his lack of persuasiveness in asserting the presence of a
pain syndrome to otherwise explain petitioner’s presentation. It should also be noted
that, as Dr. Lapp explained, it is not even appropriate to consider a diagnosis of CFS
until symptoms have persisted for at least six months. (Tr. 150.) Accordingly, CFS
diagnosis generally does involve hindsight. Nor is there any competing consensus from
petitioner’s treating physicians that would offer any other diagnosis to holistically explain
her history or evidence any exclusionary condition. As Dr. Lapp frames it, the question
is ultimately whether petitioner had enough symptoms to qualify for the CFS diagnosis.
(Tr. 159.)

During the hearing respondent’s counsel also challenged Dr. Lapp on several
considerations relating to specific characteristics of chronic fatigue under the diagnostic
standards. Cross examination largely consisted of discussing certain medical record

17 Specifically: “[c]linically evaluated, unexplained persistent or relapsing chronic fatigue that is of new or

definite onset (i.e, not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest,
and results in substantial reduction in previous levels of occupational, educational, social, or personal
activities.” (Fukuda Definition, supra, at Ex. 27, p. 1.)

18 The additional symptoms are: (1) substantial impairment in short-term memory or concentration, (2)

sore throat, (3) tender lymph nodes, (4) muscle pain, (5) multi-joint pain without swelling or redness, (6)
headaches of a new type, pattern, or severity, (7) unrefreshing sleep, and (8) post-exertional malaise
lasting more than 24 hours. (Fukuda Definition, supra, at Ex. 27, p. 1.)

19 Conditions that exclude a diagnosis of CFS are: “Any active medical condition that may explain the

presence of chronic fatigue, such as untreated hypothyroidism, sleep apnea and narcolepsy, and
iatrogenic conditions such as side effects of medication,” some diagnosable illnesses that may relapse or
not completely resolve, such as malignancies, or chronic cases of hepatitis B or C, or “any past or current
diagnosis of a major depressive disorder with psychotic or melancholic features,” alcohol or other
substance abuse, or severe obesity. (Fukuda Definition, supra, at Ex. 27, pp. 1-2.)

35
entries that may cast doubt on Dr. Lapp’s assessment of the relevant symptoms. (Tr.
167-70 (raising that Ex. 14, p. 3 does not indicate fatigue); Tr. 176-79 (raising Ex. 2, pp.
11, 19 as records from May of 2012 and September of 2013 noting petitioner to be self-
reliant in daily activities); Tr. 185-87 (raising Ex. 1, p. 662 as February 24, 2012 physical
exam with no notation of muscle pain). Dr. Lapp provided specific answers to these
points; however, a broader point is reflected in the literature discussed below with
respect to Althen prongs two and three, which suggests that it is not unusual for CFS
symptoms to present intermittently for long periods (months to years) before becoming
constant. Accordingly, inconsistency over time within the medical records regarding
reported symptoms is not necessarily informative to the question of petitioner’s ultimate
diagnosis.

Respondent’s counsel also raised a further challenge with regard to whether
petitioner has untreated sleep apnea. Under the Fukuda criteria, sleep apnea is an
exclusionary criterion. (Fukuda Definition, supra, at Ex. 27, p. 1.) Under the IOM
criteria, unrefreshing sleep is a core criterion. (IOM Criteria, supra, at Ex. 28, p. 1.)
Respondent’s counsel questioned whether petitioner can be said to suffer unrefreshing
sleep if other conditions are preventing her from sleeping through the night. (Tr. 162-
67.) Dr. Lapp explained, however, that broken sleep patterns are typical of CFS. (Tr.
167.) Unrefreshing sleep means that the patient feels the same or worse upon waking
as they did the night before. (Tr. 164-67.) In petitioner’s own case, she does have
unrefreshing sleep and does not have confirmed sleep apnea. (Tr. 164-66.) Dr. Lapp
also explained that tiredness and sleepiness are not synonymous and that unrefreshing
sleep results in tiredness. (Tr. 193-95.)

Based on the record as a whole, Dr. Lapp is persuasive in opining that petitioner
can be diagnosed with CFS.

b. Althen Analysis

As explained above, in order to establish causation-in-fact petitioner must
preponderantly prove the three elements of the so-called Althen test. That is, petitioner
must show: (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. Althen, 418 F.3d at 1278. Once petitioner has presented a prima facie
case, respondent may still preponderantly demonstrate petitioner’s injury was
nonetheless due to factor(s) unrelated to vaccination. Id.

i. Cellulitis

Petitioner’s allegedly vaccine-caused cellulitis was the initial basis for the petition
in this case. The Althen analysis for that injury may be addressed very briefly as the
outcome is not controversial. Althen prong one is met insofar as both Dr. Lapp and Dr.
Oddis agree that a contaminated needle puncture can cause cellulitis. (Tr. 240-41,
280.) With regard to Althen prongs two and three, the finding of fact issued in this case

36
confirms the Tdap vaccine was administered in the same buttock as petitioner’s
cellulitis. (See n. 4, supra.) Additionally, petitioner’s medical records show that she
sought medical attention for her cellulitis within days of her vaccination. (Ex. 1, 441.)
The medical records clearly associate her cellulitis to the site of her Tdap injection. (Id.)
Petitioner has further represented that prior to administration, the syringe and nurse’s
gloves had been placed on a table surface she had observed to be dirty. (Ex. 14, pp. 3-
4; Tr. 39.) Dr. Lapp opined that this history of unclean administration and subsequent
infection are sufficient to support a causal opinion supporting vaccine-causation. (Tr.
240.) Respondent has offered no evidence to suggest that petitioner’s cellulitis was
caused by any factor unrelated to her vaccination. Dr. Oddis deferred to the medical
records with regard to the cellulitis diagnosis. (Tr. 280.)

Thus, even though it has not been the focus of litigation, petitioner’s cellulitis
constitutes a stand-alone vaccine injury separate from her CFS. However, given that
the cellulitis was a short-lived condition, this raises the question of whether it can satisfy
the Vaccine Act’s severity requirement without respect to the broader constellation of
chronic symptoms that petitioner characterizes as CFS. In order to state a claim for a
vaccine-related injury under the Vaccine Act, a vaccinee must have either:

(i) suffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.

§300aa-11(c)(1)(D).

As of February 14, 2012, follow-up treatment

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/8129311. Public record. Not legal advice.