Skinner-Smith v. Secretary of Health and Human Services

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.)

29

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.

32

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 confirmed the cellulitis to be

resolved, but with a residual tender mass at the injection site. (Id. at 451.) Subsequent

exams did confirm petitioner continued to have an abnormality at the site of injection

after her cellulitis had resolved and throughout the remainder of February 2012. (Ex. 1,

p. 676 (exam noting “small pea sized area of induration” at injection site); Id. at 698

(exam noting “little knot” as of February 27, 2012); Id. at 436 (exam noting “palpable

nodule” as of February 29, 2012). These notations document only the first month of

petitioner’s injury. Thereafter, the focus of petitioner’s medical records shifted to her

other complaints; however, petitioner did specifically complain of continued left buttock

pain related to her vaccination at encounters of August 30, 2012 (Ex. 1, p. 22) and

September 21, 2012 (Ex. 6, pp. 2-3), which are both beyond six months from the date of

her vaccination. Petitioner also testified that as of the time of the hearing she still has

that nodule, explaining that “[w]hen I feel it, I can take it and squeeze it . . . .” (Tr. 14.)

In Wright v. Secretary of Health and Human Services, the Federal Circuit

explained that within the meaning of the statute a “residual effect” is “suffered” if it is a

somatic condition that is detrimental (meaning endured with distress, especially

painfully) and represents a lingering sign or symptom of the original injury. 22 F. 4th

999, 1006 (Fed. Cir. 2022). A “complication” is similarly understood, but without

37

representing an “essential part of the disease.” 20 Id. Here, petitioner’s medical records

corroborate that petitioner had a “knot” or “nodule” remaining after her cellulitis had

resolved and nothing in the medical records suggests that this remaining defect ever

subsequently resolved. She is also reported in the contemporaneous medical records

as having complained of left buttock pain for over six months. Petitioner also testified

that her minor disfigurement persisted to the present day and Dr. Lapp testified that it is

medically reasonable to conclude that the disfigurement petitioner described in her

testimony constitutes scar tissue from her cellulitis. (Tr. 13-14, 240-41.) Dr. Oddis

effectively agreed. (Tr. 280.) Accordingly, there is preponderant evidence that

petitioner’s cellulitis caused complications or residual effects that lasted for more than

six months. 21

All of this is sufficient to preponderantly establish that petitioner’s cellulitis was

caused-in-fact by her vaccination and that petitioner’s cellulitis caused complications or

residual effects that lasted for more than six months. Petitioner is therefore entitled to

compensation for her cellulitis injury. Importantly, however, Dr. Lapp disclaimed any

causal connection between petitioner’s cellulitis and her alleged CFS. (Tr. 212; Ex. 22,

p. 1.) Accordingly, petitioner’s entitlement to compensation for her cellulitis has no

20 It has also been suggested that the Federal Circuit’s Wright decision should counsel close analysis of

the record where the injury at issue is considered “minor.” Cummings v. Sec’y of Health & Human Servs.,

No. 20-1358V, 2022 WL 962520, at *4 (Fed. Cl. Spec. Mstr. Feb. 24, 2022). Thus, for example, in

Bangerter v. Secretary of Health & Human Services, temporary weight gain in an infant that was

attributable to medication taken in treatment of a vaccine injury was not “suffered” within the meaning of

the statute for the reasons discussed in Wright. No. 15-1186V, 2022 WL 439535, at *37 (Fed. Cl. Spec.

Mstr. Jan. 18, 2022). Key to that determination was the fact that the vaccinee was an infant, his weight

normalized again as he grew, and petitioner was unpersuasive in suggesting that the temporary weight

gain had any effect on the child’s growth and development in the interim. Accordingly, while the

temporary weight gain was clearly noticed by the parents, it had not represented any detrimental effect.

Here, petitioner’s scarring or induration is by all reasonable accounts minor and inconspicuous, leaving

this a close question. However, whereas weight may be gained or lost throughout life and may be subject

to a range of interpretations as to what is healthy or appropriate, scarring is a harm in itself – that is, a

scar is indisputably damage to tissue. Moreover, in this case it appears to be permanent. Thus,

petitioner’s scar tissue might be said to be inherently detrimental regardless of whether it is painfully

endured. In any event, however, petitioner did also report experiencing continued pain in her buttock.

(Tr. 13; Ex. 1, p. 22; Ex. 6, pp. 2-3.)

21 Theoretically, petitioner’s testimony could be definitively corroborated by requiring petitioner to reveal

her disfigurement for review, likely in a photograph. In this case, however, the condition is located in a

relatively sensitive area of the body. Moreover, neither petitioner’s nor respondent’s expert suggested

any need to visually inspect petitioner’s skin before accepting her testimony based on their general

medical knowledge. In Kirby v. Secretary of Health and Human Services, the Federal Circuit held that

where medical records are silent as to whether a condition remains ongoing, a petitioner can demonstrate

the severity requirement through corroborated testimony and expert opinion confirming her symptoms are

consistent with her diagnosed injury. 997 F.3d 1378, 1381-82. On a more thoroughly contested issue

involving a less sensitive area of the body, photographic evidence may be appropriate. Here, that added

step is not warranted. Petitioner’s testimony is corroborated both by its acceptance by both parties’

experts as well as the medical records documenting the abnormality to have remained after resolution of

the initiating cellulitis. Moreover, even if the contemporaneous medical records are inadequate to fully

corroborate the fact of the scar tissue, the contemporaneous medical records do indicate that petitioner

reported pain at that location for greater than six months.

38

bearing on whether she is also entitled to compensation for her alleged CFS. That

question must be answered by a separate Althen analysis relative to that injury.

ii. CFS

1. Althen Prong One 22

Under Althen prong one, a petitioner must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford v.

Sec’y of Health & Human Servs., 451 F.3d 1352, 1355–56 (Fed. Cir. 2006) (citations

omitted). To satisfy this prong, petitioner's theory must be based on a “sound and

reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548. Such a theory

must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Generally, however, petitioners may satisfy the first Althen prong without resort to

medical literature, epidemiological studies, demonstration of a specific mechanism, or a

generally accepted medical theory. Andreu, 569 F.3d at 1378-79 (citing Capizzano v.

Sec’y of Health & Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir. 2006)). In this

case, petitioner has not met her burden under Althen prong one relative to her CFS.

There is no dispute that CFS is an immune-related condition the cause(s) of

which remain unknown. (Ex. C, p. 3; Ex. 16, p. 3.) Dr. Lapp offered some indication

that it might have an autoimmune component, but ultimately explained that the reason

CFS patients tend to have autoantibodies is unknown. (Tr. 146.) Rather, the

understanding that CFS is an immune-related condition is largely based on the

observation that it is generally preceded by a flu-like illness and has been associated

with certain viruses. (Devanur & Kerr, supra, at Ex. 17, pp. 2, 5; IOM (Institute of

Medicine), Beyond Myalgic Encephalomyelitis/Chronic fatigue syndrome, NAT. ACAD.

PRESS 1, 15 (2015) (Ex. 23).)

Dr. Lapp further hypothesizes, however, that an infection (or, according to him,

also a vaccine) can cause what becomes a chronic immune dysregulation due to an

uncontrolled production of cytokines. During the hearing, Dr. Lapp illustrated this by

reference to the below diagram presented during the hearing and later filed as Exhibit

33.

22 In her pre-hearing brief, petitioner actually presented two theories of causation. (ECF No. 132, pp. 12-

13.) The first is the one discussed below. The second theory was that petitioner’s cellulitis constituted an

infection that in turn caused her CFS. This was based on Dr. He’s statement in his expert report that

petitioner’s infection was a more likely contributor to her CFS than vaccination. (Id. at 13.) As noted in

the preceding section, however, petitioner’s own expert disclaimed any causal relationship between

petitioner’s cellulitis and her CFS. (Tr. 212; Ex. 22, p. 1.) During the hearing Dr. He also clarified, in

effect, that the fact that he indicates a local infection such as cellulitis is more likely than a vaccine to

contribute to CFS does not mean he opines that either is likely to cause CFS. (Tr. 290-92.) Dr. He

agreed with Dr. Lapp that cellulitis is unlikely to have caused CFS. (Id.)

39

(Ex. 33.)

According to Dr. Lapp, when a foreign antigen (marked as a V in the upper left of

the diagram) comes in contact with a macrophage as part of the body’s immune

response, the macrophage releases cytokines, specifically the cytokine Interleukin-1

(“IL-1”). (Tr. 139.) IL-1 in turn causes lymphocytes to release further cytokines,

specifically “IL-2.” (Id.) Dr. Lapp indicates that IL-2 is then responsible for multiplying

the immune response by entering the bloodstream and activating lymphocytes to begin

a number of different processes, including producing different kinds of T-cells as well as

what are called “natural killer” (“NK”) cells. (Tr. 140.) NK cells circulate in the blood and

destroy infected cells. 23 (Id.) Important to Dr. Lapp’s theory, one of the T-cells

produced as part of the immune response is “CD8/11b,” which acts as a suppressor of

the IL-1 that initiated the process depicted. (Tr. 140-41.) Without the CD8/11b

suppressor cells, the immune response will not down-regulate as it should. (Tr. 140,

223-24.) Dr. Lapp suggests that those with CFS have low NK activity as well as

dysfunction in the CD8/11b suppressor response, explaining the chronicity of CFS. (Tr.

140-41.) This leads to perpetuation of cytokine production and cytokine production

leads to the symptoms of CFS. 24 (Tr. 141.) This underlying immunology speaks to the

chronicity of CFS but does not in itself reveal what potential triggers may provoke CFS.

23 Dr. He challenged this understanding of the immune response. He characterized Dr. Lapp’s diagram

as “severely outdated” and raised specific objection to the understanding that macrophages (as opposed

to dendric cells) begin the process and the specific role of NK cells. (Tr. 286-87.) To the extent Dr. He

appeared to suggest in testimony that these differences in discussing the immune system should be

viewed as fatal to petitioner’s theory, he did not specifically explain why.

24 Dr. He was also critical of Dr. Lapp’s reliance on the “CD8/11b” suppressor cell terminology, suggesting

it is no longer consistent with how these cells are currently characterized in the field of immunology. (Tr.

287.) As with the critique noted in n. 23, supra, Dr. He’s testimony was not entirely clear as to the

significance of this issue. Because Dr. He did not fully explain his criticisms of Dr. Lapp’s understanding

of the immunology, and because this case ultimately turns on other factors, I assume for purposes of this

decision that Dr. Lapp’s diagram at Exhibit 33 reasonably depicts the relevant immune response without

actually deciding that issue. Dr. He agreed that CFS symptoms are ultimately related to overproduction

of cytokines. (Ex. C, p. 3 (expressing agreement with limited aspects of Ex. 16, p. 3).)

40

Important to Dr. Lapp’s theory of vaccine causation, the T-cell response can be

further divided into two profiles, “Th1” and “Th2.” (Tr. 60-61.) These two profiles

produced different cytokines. (Id.) Ordinarily, in a healthy body there is a balance

between these two profiles favoring the Th1 profile, which is the profile that helps the

body respond to viruses and yeasts. (Tr. 61.) However, CFS is thought to be a

disorder leading to an imbalance toward the Th2 profile. (Tr. 58 (citing Devanur & Kerr,

supra, at Ex. 17).) According to Dr. Lapp, the literature demonstrates the symptoms of

a fatiguing illness, such as CFS, as being related to the cytokines produced as part of

the Th2 profile. (Tr. 58, 60-61.) Dr. Lapp posits that the pertussis component of the

Tdap vaccine has been shown to result in the production of IL-4, which has in turn been

shown to initiate a shift toward a Th2 profile. (Tr. 59.) Thus, because Dr. Lapp

suggests that vaccinations “for all intents and purposes” cause low-grade infections (Tr.

138-39), he opines that the initial Th2 shift caused by the pertussis-containing

vaccination can lead to a chronic disease-causing shift to a Th2 profile due to the low

NK activity and CD8/11b dysfunction among those susceptible to CFS. 25 Four articles

are key to Dr. Lapp’s theory – Mu and Sewell (1993), Rook and Zumla (1997),

Devanour and Kerr (2006), and Hardcastle, et al (2015). (Exs. 35, 34, 17, 18.)

However, these articles fall short of demonstrating what Dr. Lapp claims they support.

In 1993, Mu and Sewell, examined the effects of pertussis toxin in mice. (Hong-

Hua Mu & William Sewell, enhancement of Interleukin-4 production by pertussis toxin,

61(7) INFECT. & IMMUNITY 1 (1993) (Ex. 35).) They found that administering pertussis

toxin resulted in increased production of IL-4 and a promotion of an IgE response. (Id.)

This paper does not specifically address CFS; however, Dr. Lapp testified that this study

“states specifically that when pertussis is administered to mice cells and to human

beings, that [it] . . . directly stimulates Interleukin 4, which then drives the immune

system toward a Th2 status. And that, of course, is accompanied by other

autoantibodies and other cytokines that cause the symptoms that these patients are

having.” (Tr. 144.) The inference here is that a pertussis-containing vaccine, such as

petitioner’s Tdap vaccine, would act in the same manner.

Subsequently, in 1997, Rook and Zumla hypothesized that Gulf War Syndrome,

which is considered a fatiguing condition similar to CFS, may be due to a systemic shift

in cytokine balance toward a Th2 profile. (G.A. Rook & A. Zumla, Gulf War syndrome:

25 Dr. Lapp also cited a case report of a patient purportedly experiencing “autoimmune inflammatory

syndrome induced by adjuvants” or “ASIA” for the proposition that “[r]esearch has shown that vaccines

with adjuvants can result in chronic heightened immune response.” (Ex. 16, p. 3 (citing Ex. 19); Tr. 64,

152.) Again, however, he indicated that he could not explain why CFS patients have a tendency to have

autoantibodies. (Tr. 146.) Accordingly, he has not substantiated the relevance of literature addressing

autoimmune disease. In any event, Dr. Lapp confirmed during the hearing that while he believes the

ASIA concept supports his opinion, ASIA is not necessary to his opinion. (Tr. 238.) ASIA has been

heavily criticized in prior cases. See, e.g., D'Angiolini v. Sec'y of Health & Human Servs., No. 99-578V,

2014 WL 1678145, at *60 (Fed. Cl. Spec. Mstr. Mar. 27, 2014), mot. for review den'd, 122 Fed. Cl. 86

(2015), aff'd, 645 F. App'x. 1002 (Fed. Cir. 2016); Rowan v Sec'y of Health & Human Servs., No. 10-

272V, 2015 WL 3562409 (Fed. Cl. May 18, 2015); Harris v. Sec'y of Health & Human Servs., No. 10-

332V, 2014 WL 3159377, at *16 (Fed. Cl. Spec. Mstr. June 10, 2014).

41

Is it due to a systemic shift in cytokine balance towards a Th2 profile? 349 LANCET 1

(1997) (Ex. 34).) Among other factors discussed, Rook and Zumla asserted that

soldiers had been administered multiple vaccinations capable of shifting from a Th1

immune profile to a Th2 profile. In support of this assertion, they cited the above-

discussed Mu study for the proposition that vaccines adjuvanted with pertussis are

“potently Th2.” 26 (Rook & Zumla, supra, at Ex. 34, p. 2.) Dr. Lapp asserts that this

provides further evidence that a pertussis-containing vaccine can itself “cause a shift in

the immune system toward a Th2 pattern and bring on the symptoms of chronic fatigue

syndrome.” (Tr. 59.) However, even by the authors’ own characterization, this paper

presents merely a hypothesis. Moreover, the authors cited a number of factors that

working together may account for their observations. Specifically, in addition to some of

the vaccinations at issue being adjuvanted with pertussis, the authors found it significant

that the soldiers received an usually high antigen load given the multiple immunizations

administered. They also found it significant these exposures occurred in a war zone

(leading into increased cortisol and decreased dehydroepiandrosterone), and that

soldiers were also exposed to carbamate and organophosphate insecticides. (Rook &

Zumla, supra, at Ex. 34, p. 2.) The latter two factors are especially notable because

they could potentially act independent of any vaccination.

In 2006, Devanur and Kerr conducted a review of CFS literature, including Rook

and Zumla’s 1997 paper. (Devanur & Kerr, supra, at Ex. 17.) Rook and Zumula were

cited for the proposition that the pertussis adjuvant in the anthrax vaccine may cause a

systemic shift in the immune response toward Th2. (Id. at 7.) However, Devanur and

Kerr suggested that the potential relationship between Gulf War Syndrome and

vaccinations may be stronger than between vaccinations and CFS because the

immunization schedule administered to the soldiers was “intensive” and involved

multiple vaccinations. (Id.) They also again noted the stress of wartime deployment

and further observed that experimental evidence in mice suggested a causal role for the

anti-nerve gas agent pyridostimine. (Id.) In any event, respondent has also filed more

recent literature casting doubt on the hypothesis, suggesting the evidence that Gulf War

Syndrome is vaccine-caused is limited and has “inadequate support” and further

discussing other more likely causes. (Roberta F. White et al., Recent research on Gulf

War illness and other health problems in veterans of the 1991 Gulf War: Effects of

toxicant exposures during employment, 74 CORTEX 1 (2016) (Ex. C, Tab 3).)

With respect to CFS more broadly, Devanur and Kerr explained that the

pathogenesis of CFS is likely multifactorial but not completely understood. (Devanur &

Kerr, supra, at Ex. 17, p. 2.) In particular, “the precise role played by the immune

response remains to be clarified.” (Id.) The authors note, consistent with Dr. Lapp’s

opinion, that “[v]arious studies suggest that CFS exhibits a Th2 profile of CD4 helper T

lymphocyte responsiveness.” (Id. at 3.) However, the authors also explain that a

number of studies have demonstrated other potentially relevant immune findings. For

example, CFS patients have been shown to have significantly increased neutrophil

26 Rook and Zumla do not indicate what specific vaccines are adjuvanted with pertussis toxin; however,

Devanaur and Kerr (discussed below) suggest that the anthrax vaccine received by Gulf war soldiers is

adjuvanted with pertussis toxin. (Ex. 17, p. 7.)

42

apoptosis and decreases in circulating IgG. (Id.) According to the authors, these

findings suggest the presence of an ongoing infection and a deficiency in anti-viral

immune activity. (Id.) Based on this literature review, the authors conclude that “[t]aken

together, these findings suggest that an underlying infection may be present in these

individuals and that the immune system is chronically activated in response.” (Id.)

Finally, the most recent of the papers stressed in this case, is a 2015 study by

Hardcastle, et al, examining immune proteins in CFS. (Sharni Lee Hardcastle et al.,

Serum immune proteins in moderate and severe chronic fatigue syndrome/myalgic

encephalomyelitis patients, 12(10) INT. J. MED. SCI. 1 (2015) (Ex. 18).) The study

compared cytokine profiles among three groups – healthy controls, moderate cases of

CFS, and severe cases of CFS. According to Dr. Lapp, this study is significant for two

reasons. First, it confirms the above-discussed decrease in NK cell and CD8 T cell

activity. Second, it shows that symptom presentation in CFS is correlated to cytokine

activity. (Tr. 62-63, 141-42.) Hardcastle, et al., indicate that prior studies have been

inconsistent in identifying alterations in cytokine patterns among CFS patients.

(Hardcastle et al., supra, at Ex. 18, p.1.) However, these prior studies involved only

moderately affected patients. The Hardcastle study purports to be the first to include

severe cases of CFS. (Id. at 5.) Importantly, however, the Hardcastle study found no

statistically significant difference in IL-4 among the groups studied, effectively

acknowledging that the study did not replicate prior studies that had suggested a Th2

profile based on increased IL-4. (Id. at 4.) The ability of the pertussis toxin generally to

enhance IL-4 in mice as observed by Mu and Sewell was the starting premise for Dr.

Lapp’s suggestion that a vaccine could trigger CFS – meaning this study directly

undercuts Dr. Lapp’s extrapolation from Mu and Sewell’s mouse model.

In sum, Dr. Lapp has presented a mouse model that suggests pertussis toxin

may increase IL-4. (Mu & Sewell, supra, at Ex. 35.) This finding contributed to a

preliminary hypothesis that a different, but potentially similar condition of Gulf War

Syndrome, might have multiple vaccinations among a number of other underlying

causal factors. (Devanur & Kerr, supra, at Ex. 17; Rook & Zumla, supra, at Ex. 34.)

However, more recent literature filed by respondent has cast doubt on that hypothesis

and Dr. Lapp himself has filed a study that failed to find any significant increase in IL-4

among actual CFS patients. (White et al., supra, at Ex. C, Tab 3; Hardcastle et al.,

supra, at Ex. 18.) On the whole, while Dr. Lapp is persuasive in suggesting CFS may

involve an aberrant chronic immune response and that CFS symptoms may be

cytokine-related, the literature suggests the underlying immune response implicated in

CFS is not well understood and with little to no evidence directly supporting vaccine

causation. This does not preponderantly support petitioner’s claim that the Tdap

vaccine can cause CFS.

Moreover, it is also difficult to square Dr. Lapp’s suggestion that vaccines are

implicated as “low grade infections” (Tr. 138-39) with his additional acknowledgment

that, whatever the immune trigger, “it would have to be a significant challenge” (Tr. 210).

When asked what he meant by a “significant” challenge, Dr. Lapp turned back to the

fact, noted above, that most CFS cases (more than seventy percent) follow infections.

43

(Tr. 210.) Dr. Lapp acknowledged that a Tdap vaccine is not equivalent to an infection

and does not reproduce within the body as a live infection; however, he would not agree

that the immune system responds differently to a vaccine than an infection. (Tr. 211.)

Instead, he suggested he does not know “one way or the other.” (Id.)

In that regard, however, Dr. He indicated that vaccination and infection have

“major” differences that are both qualitative and quantitative. (Tr. 285.) He explained

that whereas an infection involves an uncontrolled response with systemwide

immunopathic replication, the response to immunization is a controlled response

happening only locally due to the fact that the vaccine antigen does not replicate like a

live infection. (Tr. 286, 301-03.) When an immunization results in a systemic response,

only the cytokines spread throughout the body. (Tr. 303.) That is, while an

immunization or local infection sees an immune response in one part of the body that

may stimulate cytokines that spread from that one location, a systemic infection

stimulates cytokines throughout the body.

Dr. Lapp acknowledged that a small, localized infection “usually” would not cause

CFS, explaining that the illnesses that precede CFS are “usually very significant

illnesses.” (Tr. 212; Ex. 22, p. 1.) And, again, as explained above, the Devanur and

Kerr article relied upon by Dr. Lapp explains that there are prior studies that include

specific immune findings beyond the Th2 shift suggestive of ongoing infection as the

driver of CFS. (Devanur & Kerr, supra, at Ex. 17, p .3.)

In one prior case, Dr. Lapp’s opinion has been accepted under Althen prong one

as supporting vaccine-causation of CFS. Bryan v. Sec’y of Health & Human Servs., No.

14-898V, 2020 WL 7089841 (Fed. Cl. Spec. Mstr Oct. 9, 2020). Importantly, however,

that case involved the flu vaccine rather than the Tdap vaccine at issue in this case.

Among other differences, in that case Dr. Lapp presented a study demonstrating that

CFS patients had statistically significantly increased IL-4 following the flu vaccine when

compared to controls. Id. at *23 (discussing Brenu, et al., The Effects of Influenza

Vaccination on Immune Function in Patients with Chronic Fatigue Syndrome/Myalgic

Encephalomyelitis, 3 INT’L J. CLIN. MED. 551-54 (2012).) That study was important to

informing the special master’s conclusion that Dr. Lapp had established that the flu

vaccine in particular can have an effect on the immune dysregulation typical of CFS.

However, there is nothing in the record of this case comparable to the Brenu study in its

ability to causally implicate the Tdap vaccine. Even with the benefit of the Brenu study,

the Bryan special master observed that the evidence supporting petitioner’s theory was

“not robust.” Id.

2. Althen Prongs Two and Three

Assuming arguendo petitioner had demonstrated that her Tdap vaccine is

capable of causing CFS, she would also have to establish that it did cause CFS in this

specific case. Pafford, 451 F.3d at 1356. This latter aspect of petitioner’s prima facie

showing is generally broken down into two further questions pursuant to Althen prongs

two and three. The second Althen prong requires proof of a logical sequence of cause

44

and effect between the vaccination and injury. Althen, 418 F.3d at 1278; Andreu, 569

F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant, 956 F.2d at 1148. The third

Althen prong requires establishing a “proximate temporal relationship” between the

vaccination and the injury alleged. Althen, 418 F.3d at 1281.

The second Althen prong, requiring proof of a logical sequence of cause and

effect, is usually supported by facts derived from a petitioner's medical records. Althen,

418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant,

956 F.2d at 1148. In establishing that a vaccine “did cause” injury, the opinions and

views of the injured party's treating physicians are entitled to some weight. Andreu, 569

F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as treating physicians are likely to be in the

best position to determine whether a ‘logical sequence of cause and effect show[s] that

the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280).

However, medical records and/or statements of a treating physician's views do not per

se bind the special master to adopt the conclusions of such an individual, even if they

must be considered and carefully evaluated. See Section 13(b)(1) (providing that “[a]ny

such diagnosis, conclusion, judgment, test result, report, or summary shall not be

binding on the special master or court”); Snyder v. Sec'y of Health & Human Servs., 88

Fed. Cl. 706, 746 n.67 (2009) (“there is nothing ... that mandates that the testimony of a

treating physician is sacrosanct—that it must be accepted in its entirety and cannot be

rebutted”).

The third Althen prong requires establishing a “proximate temporal relationship”

between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term

has been equated to the phrase “medically-acceptable temporal relationship.” Id. A

petitioner must offer “preponderant proof that the onset of symptoms occurred within a

timeframe which, given the medical understanding of the disorder's etiology, it is

medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs.,

539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically

acceptable timeframe must also coincide with the theory of how the relevant vaccine

can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of

Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105

Fed. Cl. 353 (2012), aff'd mem., 503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of

Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30,

2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir.

2014).

Here, these two prongs are closely intertwined and will be addressed together.

On the surface, there is a striking temporality in this case. Petitioner received a Tdap

vaccination on February 6, 2012, reported unusual symptoms beginning that same

night, and sought follow up care rather promptly. (Ex. 1, p. 441.) Thereafter, Dr. Lapp

opines that she developed classic signs of CFS within two weeks. (Tr. 97, 114, 152.)

However, upon closer examination of Dr. Lapp’s opinion, there is no basis for finding

significance in that temporality. Even if petitioner could theoretically satisfy Althen

prong three in the sense that what Dr. Lapp proposes is generally consistent with the

45

known patterns of CFS onset, the relevant literature shows these known onset patterns

to be so broad, and the basis for identifying them so vague, as to prevent Dr. Lapp from

either identifying a relevant timeframe during which causation could be inferred

pursuant to Althen prong three and/or distinguishing petitioner’s Tdap vaccine as a

more likely cause of her CFS pursuant to Althen prong two.

Petitioner was never diagnosed with CFS by any of her treating physicians prior

to consulting Dr. Lapp. Accordingly, while the treating physicians felt a vaccine reaction

was possible, they did not offer any contemporaneous opinion that petitioner suffered

vaccine-caused CFS. Instead, petitioner’s claim is based entirely on Dr. Lapp’s

hindsight. Taking petitioner’s symptoms and the close temporal relationship to

vaccination, the treating physicians were willing to opine that petitioner was suffering an

adverse vaccine reaction in the form of a likely serum sickness. (Ex. 1, p. 706; Ex. 3,

pp. 1-3.) Dr. Lapp, however, has opined that petitioner never suffered any serum

sickness reaction. Instead, he opines that the symptoms the treating physicians

identified as serum sickness were actually symptoms of the CFS itself. (Tr. 230.)

Moreover, even if petitioner did suffer a temporary serum sickness that explains her

initial symptoms, Dr. Lapp further opined that “I have never known serum sickness to

lead to chronic fatigue syndrome.” (Tr. 231.) Additionally, to the extent he opined that

petitioner suffered a vaccine-caused cellulitis, he also opined that the cellulitis would not

have caused petitioner’s CFS. (Tr. 212.) Thus, Dr. Lapp rejects either cellulitis or

serum sickness as part of the relevant causal chain, thereby dismissing any causal

connection between petitioner’s CFS and any illness documented in the medical record

that may have in turn been causally connected to the vaccination.

Instead, Dr. Lapp opines that petitioner’s initial post-vaccination presentation

constituted evidence of an inflammatory, cytokine-drive response. (Tr. 151-53.) He

opines this is evidenced by fever and flu-like symptoms as well as by elevated

sedimentation rate (“ESR”), elevated C-reactive protein (“CRP”), positive cyclic

citrullinated peptide (“CCP”), and positive antinuclear antibodies (“ANA”). 27 (Id.)

However, Dr. Lapp has explained that CFS is itself an inflammatory condition and often

is accompanied by a flu-like presentation. As discussed above, regarding Althen prong

one, Dr. Lapp is unpersuasive in seeking to extend the association between active

infection and CFS to the type of immune response that follows vaccination.

Accordingly, neither these symptoms nor these lab results necessarily point to a specific

inciting event. Additionally, in this case, petitioner’s lab work during the immediate post-

vaccination period showed normal CRP and only slightly elevated ESR. (Ex. 1, pp. 666,

668, 680.) The laboratory findings Dr. Lapp culled as significant (Tr. 132-33; Ex. 31)

were drawn later. The earliest collection date for any sample from the lab results in

petitioner’s Exhibit 31 is from March of 2018.

27 Petitioner’s EBV early antigen was also positive, which he opines evidences a viral reactivation and a

Th2 status. (Tr. 132-33, 151-53.) Dr. Lapp explained that the EBV early antigen relates to the chronic

shift toward Th2 rather than the initial cause of petitioner’s CFS and the test was not administered until

June of 2019, so the result is not helpful regarding the period of onset. (Tr. 223-24; 240.)

46

This leaves the coincident timing as the main factor leading to a suspicion of

vaccine causation. Here, too, however, Dr. Lapp is unpersuasive in trying to leverage

what is broadly true of CFS as evidence that this case of CFS is vaccine-caused.

When pressed to clarify the timing of the immunology underlying his theory, Dr. Lapp

testified that he was unable to offer specifics. (Tr. 235-36.) He agreed that there would

be some latency, but suggested that it would generally be rapid, suggesting hours to

days. (Tr. 236.) Dr. Lapp primarily based his opinion on two articles that speak to the

pattern of onset for CFS, one by Evans and Jason and one by Chu, et al. (Meredyth

Evans & Leonard Jason, Onset patterns of chronic fatigue syndrome and myalgic

encephalomyelitis, 2(1) RES. CHRON. DIS. 1 (2018) (Ex. 30); Lily Chu et al., Onset

patterns and course of myalgic encephalomyelitis/chronic fatigue syndrome, 7(12)

FRONT. PEDIATR. 1 (2019) (Ex. 30). Dr. Lapp testified that

retrospectively, I feel confident that the illness started at the time of the

injection, and when you look at the records, by the time two weeks have

passed, she had all of the symptoms of chronic fatigue syndrome, so she

clearly – somewhere between immediately and two weeks, she definitely

had the chronic fatigue syndrome . . . so I think certainly her symptoms and

the onset of her illness fell within the typical onset that was described by

Chu and by Evans . . .

(Tr. 152-53 (emphasis added).) However, these papers do not reliably identify any

specific temporal relationship between CFS and a specific antecedent event.

In 2018, Evans and Jason conducted a study regarding onset patterns for CFS.

(Evans & Jason, supra, at Ex. 29.) To the extent Evans and Jason look at underlying

immune triggers, th

This text is long and has been trimmed here. Open the source document for the complete record.