VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-00794
Package ID: USCOURTS-cofc-1_21-vv-00794
Petitioner: Mary Saville
Filed: 2021-01-25
Decided: 2024-03-26
Vaccine: influenza
Vaccination date: 2018-11-05
Condition: cellulitis
Outcome: compensated
Award amount USD: 51809

AI-assisted case summary:
Mary Saville filed a petition on January 25, 2021, seeking compensation under the National Vaccine Injury Compensation Program, alleging she suffered cellulitis following receipt of the quadrivalent influenza and pneumococcal vaccines on November 5, 2018. Within hours of vaccination, she experienced pain and stiffness at the injection site, along with flu-like symptoms. The following day, her symptoms persisted, and she developed arm pain and swelling. On November 7, 2018, she presented to a nurse practitioner with headache, nausea, arm pain and swelling, and fever. An examination revealed erythema, edema, and warmth over her left upper arm. She was diagnosed with cellulitis or an inflammatory reaction and treated with antibiotics. The nurse practitioner opined the reaction was likely due to the pneumococcal vaccine, as she had not previously reacted to flu shots. The next day, Ms. Saville presented to the emergency room with worsening symptoms and shortness of breath. A physical exam showed a large area of erythema with central induration over her left arm. She was diagnosed with cellulitis of the left upper arm, received intravenous antibiotics, and was admitted to the hospital. A surgeon concurred with the cellulitis diagnosis, suggesting the infection may have been introduced after her vaccinations, and recommended surgery due to ongoing symptoms. After an infectious disease consult, she underwent incision and drainage of an abscess in her left arm on November 10, 2018. She was discharged on November 12, 2018, with a diagnosis of left upper extremity cellulitis with developing abscess, status post incision and drainage, and was prescribed oral antibiotics. Six months later, she reported persistent fatigue and bruising, but her primary care provider attributed the fatigue to reduced sleep and multiple demands, though she noted the presentation was similar to other case reports with pneumovax-23 and deferred further immunization. The public decision does not describe the specific mechanism of injury or detail the expert testimony beyond the report of Dr. Christina DeWitt, a dermatologist who opined that vaccines can cause local infections like cellulitis and abscess, and that the flu vaccine likely played a causal role in Ms. Saville's case. The Special Master, Brian H. Corcoran, granted entitlement, finding that the influenza vaccine was a substantial factor in causing her cellulitis, satisfying the Althen prongs for an off-Table claim. The parties then proceeded to damages. On March 26, 2024, Chief Special Master Corcoran awarded Mary Saville $51,809.77. This award included $50,000.00 for pain and suffering, $804.80 for past unreimbursable medical expenses, $1,000.00 for future care costs, and $4.97 for travel costs. The Special Master noted that claims of fatigue were not found to be attributable to the vaccine injury and would not be compensated.

Theory of causation field:
Petitioner Mary Saville, age 13, received quadrivalent influenza and pneumococcal vaccines on November 5, 2018. She alleged cellulitis as an injury. The Special Master granted entitlement, finding the influenza vaccine was a substantial factor in causing the cellulitis. The theory of causation, as supported by Dr. Christina DeWitt, was that vaccines can cause local infections leading to cellulitis. The medical records showed onset of symptoms within hours of vaccination, with progression over the next few days, including erythema, edema, warmth, pain, and swelling at the injection site, leading to a diagnosis of cellulitis and subsequent hospitalization, surgery for incision and drainage of an abscess, and antibiotic treatment. Treating physicians noted the possibility of a vaccine-related cause. The Special Master found the Althen prongs were met: (1) a medical theory connecting vaccines to local infections like cellulitis (supported by Dr. DeWitt); (2) a logical sequence of cause and effect supported by medical records and treating physician opinions, with the flu vaccine being a substantial factor; and (3) a medically acceptable temporal relationship, with symptom onset within hours of vaccination. The pneumococcal vaccine was also administered, and while its role was debated by treaters, the Special Master found it medically impossible to assign causality to one vaccine over the other, and the flu vaccine was deemed a substantial factor. The Special Master awarded $51,809.77, comprising $50,000.00 for pain and suffering, $804.80 for past medical expenses, $1,000.00 for future care, and $4.97 for travel costs. Chief Special Master Brian H. Corcoran issued the entitlement ruling on August 28, 2023, and the damages decision on March 26, 2024. Petitioner was represented by Renee J. Gentry, and Respondent by Madelyn Weeks.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-00794-0
Date issued/filed: 2023-09-22
Pages: 16
Docket text: PUBLIC ORDER/RULING (Originally filed: 8/28/2023) regarding 39 Ruling on Entitlement Signed by Chief Special Master Brian H. Corcoran. (ag) Service on parties made.
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Case 1:21-vv-00794-UNJ Document 40 Filed 09/22/23 Page 1 of 16
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-794V
(to be published)
* * * * * * * * * * * * * * *
MARY SAVILLE , * Chief Special Master Corcoran
*
Petitioner, *
* Dated: August 28, 2023
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * *
Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School,
Washington, DC, for Petitioner.
Madelyn Weeks, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT1
On January 25, 2021, Mary Saville filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleges she
suffered cellulitis following receipt of the quadrivalent influenza (“flu”) and pneumococcal
vaccines on November 5, 2018. Petition (ECF No. 1) at 3.
The parties have agreed that the matter could reasonably be resolved via ruling on the
record, and filed briefs in support of their respective positions. See Petitioner’s Motion, dated
March 29, 2023 (ECF No. 37) (“Mot.”); Respondent’s Opposition, dated April 28, 2023 (ECF No.
38) (“Opp.”). Now, after review of the medical records and briefs, I GRANT entitlement.
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Case 1:21-vv-00794-UNJ Document 40 Filed 09/22/23 Page 2 of 16
I. Factual Background
On November 5, 2018, Petitioner received flu3 and pneumococcal4 vaccines in her left
deltoid from Tanuja Sharma, M.D., at Tampa General Medical Group. Ex. 1 at 281, 302–03; Ex.
9 at 1 (“Saville Aff. I”); Ex. 16 at 1 (“Saville Aff. II”). Petitioner’s pre-vaccination medical history
was significant for depression, anxiety, hypothyroidism, transient ischemic attack (“TIA”),
arteriovenous malformation, and asthma. Ex. 1 at 5, 144; Ex. 18 at 8.
According to Petitioner’s affidavit, within hours of being vaccinated, she experienced pain
and stiffness at the injection site and “flu-like” symptoms, including chills, aches, weakness, and
a fever, for which she took Tylenol and ibuprofen. Saville Aff. I at 2; Saville Aff. II at 1–2. The
next morning (November 6, 2018), she reported that her flu-like symptoms had persisted despite
her taking over-the-counter pain medication. Saville Aff. I at 2; Saville Aff. II at 2. The pain and
soreness made it difficult to move her arm. Saville Aff. I at 2; Saville Aff. II at 2.
On November 7, 2018, Petitioner presented to nurse practitioner (“NP”) Mallory Lott at
Tampa General Medical Group Westchase, reporting that she had developed headache, nausea,
arm pain and swelling, and fever the day of her immunizations. Ex. 1 at 327. An examination
showed erythema, edema, and warmth over the left upper arm, which was firm and tender to touch.
Id. at 329–30. Her lab work noted a white blood cell count of 27.1, absolute neutrophil count of
24,905, and monocyte absolute value of 1,301. Id. at 326. Petitioner received a differential
diagnosis of cellulitis versus inflammatory reaction. Id. at 331. She was treated with cephalexin
and advised to apply heat to the arm as needed along with regular use of ibuprofen. Id. NP Lott
opined that because Petitioner had received yearly flu shots without experiencing adverse
reactions, the reaction was probably due to the pneumococcal vaccine.5 Id.
The next day (November 8, 2018), Petitioner presented to the emergency room (“ER”) at
the Medical Center of Trinity. Ex. 2 at 21; Saville Aff. I at 3; Saville Aff. II at 2. She reported that
she had recently received flu and pneumovax vaccinations, and “[s]everal hours later [developed]
3 Five years prior, Petitioner received the influenza trivalent preserve vaccine, but she had never received the
quadrivalent influenza vaccine. Saville Aff. I at 1.
4 The pneumococcal PPSV 23 vaccine that Petitioner received is not listed on the Vaccine Injury Table as a “covered”
vaccine. 42 C.F.R. § 100.3. As such, Petitioner would be precluded from receiving compensation under the Act if the
evidence demonstrated that the PPSV 23 vaccine alone caused her injuries, and she could not otherwise base a claim
on receipt of this vaccine.
5 According to Petitioner, NP Lott provided an incorrect summary. Mot. at 4 n.1. Petitioner’s medical records indicate
that her last receipt of the flu vaccine was in November 2013, five years prior, and she did not receive the quadrivalent
flu vaccine at that time. Ms. Saville had in fact never before received the quadrivalent version before, and received
the trivalent formulation five years prior. Ex. 1 at 281.
2

Case 1:21-vv-00794-UNJ Document 40 Filed 09/22/23 Page 3 of 16
a small red area that has progressed over several days.” Ex. 2 at 21. She also complained of
shortness of breath. Id. A physical exam of the skin established that Petitioner had “a large area of
erythema with central induration over the left arm . . . [t]he erythematous area is quite warm
compared to the surrounding tissue. It is minimally tender.” Id. at 23. Petitioner was diagnosed
with cellulitis of the left upper arm. Id. at 43. She was given cefazolin and vancomycin in the
emergency room, and admitted to the hospital for further treatment. Id. at 26, 28. A CT scan
showed possible cellulitis or fasciitis. Id. at 25.
On November 9, 2018, Petitioner was seen by a surgeon, Keith Chisholm, M.D., who
concurred with the cellulitis diagnosis, offering the opinion that Petitioner had a methicillin-
resistant staphylococcus aureus infection in her left arm. Ex. 2 at 46–47. Dr. Chisholm
recommended surgery because of the ongoing erythema, redness, and pain. Id. at 47. Notably, Dr.
Chisholm believed this “may have been introduced into subcu[sic] after her vaccinations.” Id.
After an infectious disease consult with Todd Groom, M.D., Dr. Chisolm also agreed with the
diagnosis of cellulitis/fasciitis that had failed oral antibiotics. Id. at 48–51. On November 10, 2018,
Petitioner was taken to surgery after a CT scan showed evidence of significant cellulitis with
fasciitis and a suspected developing abscess. Id. at 48, 50. Dr. Chisholm performed incision and
drainage of the left arm. Id. at 182–83.
Petitioner was discharged on November 12, 2018, with a diagnosis of left upper extremity
cellulitis with developing abscess, status post incision and drainage. Ex. 2 at 17; Saville Aff. I at
3; Saville Aff. II at 3. She was directed to take doxycycline orally for ten days. Ex. 2 at 17–18.
Six months later, on May 17, 2019, Petitioner presented to her primary care provider,
Kimberly Lamartin, M.D., at Tampa General Medical Group Armenia (“Armenia”), with
complaints of fatigue and bruising easily. Ex. 5 at 3-5, 19;6 Saville Aff. II at 3. She reported that
she had previously experienced an adverse reaction to the flu and pneumonia vaccines. Id. at 19.
She also reported persistent fatigue since that time but noted that she had four children, including
a 13-year-old with a significant medical condition. Id.; Saville Aff. II at 3.
Petitioner’s physical exam was normal, with no skin rash. Ex. 5 at 21–22. She was
diagnosed with fatigue, anxiety, depression, reaction to flu vaccine, and a history of anaphylaxis,
chronic low back pain, TIA, mild intermittent asthma, and hypothyroidism. Id. at 26. Dr. Lamartin
noted that Petitioner’s fatigue was “likely primarily due to reduced sleep, multiple demands. . . .”
Id. at 25. In an addendum written later that day, Dr. Lamartin noted that Petitioner had flu-like
symptoms and progressive erythema after receiving influenza and Pneumovax immunizations in
6 According to Petitioner, there is an error in the medical records in Ex. 5 at 5. Mot at 6 n.3. Dr. Lamartin erroneously
indicates “November 2019 with progressive erythema . . .”, but the records were created on May 17, 2019. Ex. 5 at 5.
Therefore, the date mentioned had not yet occurred, and Petitioner clarified that this record should read “November
2018.” Mot at 6 n.3.
3

Case 1:21-vv-00794-UNJ Document 40 Filed 09/22/23 Page 4 of 16
November 2018. Id. at 43. She further wrote that Petitioner’s presentation was similar to other case
reports with Pneumovax 23, and that she “[t]ypically would defer further immunization for
influenza or pneumovax due to [the] severity of [the] reaction,” but because Petitioner had a son
with significant immune deficiency, Dr. Lamartin wanted to refer Petitioner to an allergist for their
opinion on receiving future vaccinations. Id.
Between May 17, 2019, and March 8, 2021, Petitioner was treated for unrelated health
issues, including a broken tooth, sinusitis, and asthma. See Ex. 5 at 43, 55–60; Ex. 6 at 4–5; Ex. 7
at 8–9. On March 8, 2021, Petitioner presented to Danaysi Del Agua, APRN, at Armenia for a
refill of levothyroxine. Ex. 18 at 2. She reported that her hypothyroidism symptoms, including
fatigue, had been worsening. Id. at 2, 4. Petitioner expressed interest in receiving the COVID-19
vaccine, but stated that she had an allergy to the flu vaccine and Dr. Lamartin had recommended
that she see an allergist before proceeding with the vaccine. Id. at 2.
Two days later, on March 10, 2021, Petitioner established care with Roberto Garcia, M.D.,
an allergist. Ex. 17 at 23. She was seeking a recommendation on whether it was safe for her to
receive the COVID-19 vaccine. Id. Petitioner reported that in November 2018, she received
pneumococcal and influenza vaccines and within 48 hours had complications, including infection,
abscess, and cellulitis. Id. Petitioner stated that she was otherwise in good health, “but she is now
affected with chronic fatigue.” Id. A pulmonary function test was administered and revealed
moderate airway obstruction. Id. at 24. Dr. Garcia prescribed montelukast and Flonase spray. Id.
Petitioner attended follow-up appointments with Dr. Garcia through July 2021 to receive allergy
shots. See generally Ex. 17. Dr. Garcia’s records do not reflect any recommendations for or against
further vaccinations.
Petitioner returned to Dr. Lamartin on June 2, 2021, for a follow-up visit. Ex. 18 at 8. She
was taking levothyroxine, and her fatigue symptoms had improved. Id. Petitioner reported
receiving both COVID-19 vaccines without any adverse events. Id. She also complained of left
arm soreness, which she associated with her adverse reaction to the flu and pneumonia vaccines.
Id.
On December 2, 2021, Petitioner presented to Dr. Lamartin for a physical examination. Ex.
18 at 21. She reported being diagnosed with Ehlers-Danlos Syndrome and planned to establish
care with a cardiologist and a geneticist. Id. Dr. Lamartin ordered a brain MRI and referred
Petitioner to neurology. Id. at 25. Petitioner received a flu vaccination in her right deltoid, (despite
notes in her medical records that she had an allergy to influenza virus vaccines) to which Dr.
Lamartin noted that Petitioner “tolerated [it] well.” Id. at 27. There was no indication of an adverse
reaction to this vaccine.
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Petitioner underwent a brain MRI without contrast on December 15, 2021, which showed
a prominent developmental venous angioma but no associated hemorrhage, and was otherwise
within normal limits. Ex. 18 at 28.
Petitioner returned to Dr. Lamartin on December 17, 2021, for an unrelated health matter.
Ex. 18 at 29. During this visit, Petitioner complained of chronic left arm pain since an injection
complication. Id. at 34. She did not report any adverse reactions to her recent flu vaccination.
Petitioner reported that a friend who is a physical therapist advised her she might have a good
response to localized therapeutic massage. Id. at 30. Dr. Lamartin placed a referral to physical
therapy. Id. at 34. No further medical records have been filed, though Petitioner states that she still
feels pain when applying pressure to the scars that formed at each injection site.7 Saville Aff. I at
4; Saville Aff. II at 3.
II. Expert Report
Only one expert report was offered in this case—from Dr. Christina DeWitt, a board-
certified dermatologist, prepared one written report for Petitioner in support of the contention that
vaccines can cause cellulitis, abscess, and possibly fasciitis, and that the flu vaccine did so in this
case. Report, dated October 31, 2022, filed as Ex. 20 (ECF No. 33-2) (“DeWitt Rep.”).
Dr. DeWitt received her undergraduate and medical degree from the University of Missouri
– Columbia, Schoon of Medicine. Curriculum Vitae, filed as Ex. 21 on October 31, 2022 (ECF
No. 33-3) (“DeWitt CV”) at 1; DeWitt at 1. Dr. DeWitt completed an internship in internal
medicine and residency in dermatology at Southern Illinois University in Springfield, Illinois,
before completing a fellowship in immunodermatology at the National Institutes of Health in
Bethesda, Maryland. DeWitt CV at 1; DeWitt Rep. at 1. She is now an Assistant Professor of
Clinical Dermatology on faculty with the Georgetown University School of Medicine’s
Department of Dermatology. DeWitt CV at 1; DeWitt Rep. at 1. Dr. DeWitt is licensed to practice
medicine in Maryland and the District of Columbia, and is board certified by the American Board
of Dermatology. DeWitt CV at 1–2; DeWitt Rep. at 1. She has also published peer-reviewed
articles in the dermatology literature. DeWitt CV at 2; DeWitt Rep. at 1.
Dr. DeWitt spent most of her expert report summarizing the medical records. DeWitt Rep.
at 2–7. Of notable references, Dr. DeWitt observed (relying on Petitioner’s affidavits) that within
hours of receiving two vaccinations, Petitioner began experiencing significant pain, redness and
swelling at the local site of the injection. DeWitt at 7; Saville Aff. I at 2; Saville Aff. II at 1–2.
Within two days, the localized reaction progressed in both extent and severity, including the
development of flu-like systemic symptoms. DeWitt at 7; Saville Aff. I at 2; Saville Aff. II at 2.
7 Petitioner’s daughter and husband have submitted unsworn witness statements discussing the impact of Petitioner’s
injury on herself and their family. See generally Ex. 13–14.
5

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Petitioner had an elevated white blood cell count, and she was diagnosed with cellulitis and started
on oral cephalexin. DeWitt at 7; Ex. 1 at 326, 331. During the initial diagnosis of cellulitis, the
cause was attributed to the vaccines. DeWitt at 7; Ex. 1 at 331. Her symptoms persisted and
progressed, along with new developments—fever, necessitating the addition of oral clindamycin
and evaluation in the Emergency Department. DeWitt at 7; Ex. 2 at 21. Having failed oral
antibiotics, her white blood count remained elevated, and a CT scan was concerning for cellulitis
and possibly fasciitis, which prompted admission to the hospital for intravenous antibiotics.
DeWitt at 7; Ex. 2 at 25–26, 28. Despite her labs improving on IV antibiotics, she continued to
experience significant redness and pain, and ultimately, she required surgery to provide clinical
relief. DeWitt at 7; Ex. 2 at 182–83.
Petitioner was diagnosed with a concurrent cellulitis and abscess occurring at the site of
the two vaccine injections. DeWitt at 8. In a large review of medically attended infectious events
following parenteral vaccination, localized clinical syndromes were the most common, which
include the following diagnoses: cellulitis, infectious abscess, necrotizing fasciitis, pyomyositis,
osteomyelitis and septic arthritis. Among these, cellulitis is the most common. DeWitt at 8; I.
Cook, Sepsis, Parenteral Vaccination and Skin Disinfection, 12 Hum. Vaccines &
Immunotherapeutics 2546, 2547–48, 2550 (2016), filed as Ex. 24 (ECF No. 33-6) (“Cook”). Cook
did not demonstrate a higher risk association with any specific vaccination, but it provides
evidence that vaccines have the potential to cause serious local infections requiring medical
intervention. DeWitt at 8; Cook at 2555.
Treater views associating Petitioner’s vaccinations with her injuries were also, in Dr.
DeWitt’s view, supportive of the conclusion that the vaccines played a causal role. DeWitt at 7;
Ex. 1 at 331 (NP Lott); Ex. 2 at 47 (Dr. Chisholm). Her treaters otherwise did not propose an
alternative cause. DeWitt at 7.
Comparing the effects of the flu versus pneumococcal vaccine, Dr. DeWitt opined that both
could have been jointly contributory, despite medical record notations addressing only one
vaccine. DeWitt at 8. For instance, while a note on November 7, 2018 from NP Lott that Petitioner
“had never had a reaction to a flu shot before and received them every year so it was more likely
a reaction to the pneumococcal vaccine,” Dr. DeWitt observed that it was actually five years since
Petitioner received any season flu vaccine, and the one she had last received was a different
formulation. DeWitt at 7; Ex. 1 at 331. In any event, since Petitioner’s injury was infectious in
nature, prior and subsequent immunologic reactions to vaccines were irrelevant. DeWitt at 8. This,
Dr. DeWitt argued, was the most likely reason why Dr. Garcia provided no specific
recommendations for or against vaccinations, despite this being the primary reason for referral.
DeWitt at 8; Ex. 17 at 23–25. Another discussion from Petitioner’s PCP on May 17, 2019,
evaluated Petitioner’s fatigue and referenced a vaccine-associated reaction pertaining to the flu
vaccine, but made no mention of the pneumococcal vaccine. DeWitt at 7–8; Ex. 5 at 4. In fact, a
6

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"[r]eaction to influenza immunization" is the sole diagnosis listed on the referral to Allergy and
the only vaccination-related diagnosis documented during this encounter. DeWitt at 8; Ex. 5 at 68.
On the other hand, a different contemporaneous treater, Dr. Lamartin, expressed concern
about the pneumococcal vaccine as a cause of Petitioner’s reaction, because her presentation was
“similar to other case reports with pneumovax-23,” but no substantiation for this contention could
be found in the record. Ex. 5, at 4–5, 15. However, Dr. Dewitt opined, because the vaccinations
were administered at the same time and within an inch of each other, it would be medically
impossible to assign causation for an infectious local event to one over the other, so both likely
played a role. DeWitt at 8. Unlike cutaneous hypersensitivity reactions, the infectious nature of the
cellulitis injury provides no morphologic hints or clues as to how the organism entered the skin,
so it is impossible to claim the bacteria was preferentially introduced via the needle of one vaccine
over the other. DeWitt at 8; Preventing and Managing Adverse Reactions, Ctr.’s Disease Control
& Prevention 1, 4 (2022), filed as Ex. 22 (ECF No. 33-4) (discussing vaccine reactions generally);
J. Kelso, Allergic Reactions to Vaccines, UpToDate 1, 3–4 (2022), filed as Ex. 23 (ECF No. 33-5)
(same).
Finally, Dr. DeWitt did not address the question of timing for onset of Petitioner’s injury,
other than noting that Petitioner’s affidavits stated that her symptoms began within hours of
vaccination.
III. Procedural History
This case was initiated in January 2021, and was eventually reassigned to me after being
presided over for a period of time by a different special master. ECF No. 17. The parties then began
engaging in settlement discussions but were unable to reach an agreement. ECF No. 30.
Respondent filed his Rule 4(c) Report on May 16, 2022. ECF No. 31. Petitioner subsequently filed
Dr. DeWitt’s report. ECF No. 33. Respondent then filed an amended Rule 4(c) Report on January
18, 2023, stating that he would not continue to defend the case during further proceedings on
entitlement, and requested a Ruling on the Record instead. ECF No. 36. I thus set a briefing
schedule and the matter is now ripe for resolution.
IV. Parties’ Arguments
Petitioner argues that she was correctly diagnosed with concurrent cellulitis and abscess.
Mot. at 12–14. Statements from Dr. DeWitt, she purports, support a biologically plausible
connection between the flu vaccine and concurrent cellulitis and abscess, mediated by an infectious
event at the site of the vaccine needle’s incision. Mot. at 14–16. Ms. Saville next claims that she
has demonstrated a logical sequence of cause and effect that the vaccines she received “did cause”
her injury. Id. at 16–18. In support, she notes that her clinical picture was consistent with cellulitis
as she experienced swelling, redness, and erythema at the injection site, and treating physicians
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allowed for the possibility that the vaccine was related to her injuries. Id. Finally, the timing of her
onset—occurring hours after administration of the vaccines with symptoms worsening over the
next two to three days—is medically-acceptable. Id. 18–19.
In opposing entitlement, Respondent (as noted in his amended Rule 4(c) Report) maintains
that Petitioner has not met her burden of proof under the Vaccine Act, meaning dismissal is
appropriate, but no longer wishes to defend against Petitioner’s claim. Opp. at 1–8. Thus, other
than reciting the facts of the case and the law applicable to a causation-in-fact claim, Respondent
articulates no specific reason to decide this case against the Petitioner.
V. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).8
Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
8 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.
Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning
legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),
aff’d 104 F. App’x. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL
504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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.”
Each Althen prong requires a different showing. Under Althen prong one, petitioners must
provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type
of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
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 v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d
1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a
‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof.” (citing
Moberly, 592 F.3d at 1322)); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL
4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four
decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). And petitioners always have
the ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence.
W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted);
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Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the
petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a
preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, 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 v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). 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). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, 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. 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 & Hum. 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”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
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 & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align 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 & Hum.
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Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when examining
their patients in as accurate a manner as possible, so that they are aware of enough relevant facts
to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often found to be deserving of greater evidentiary weight than oral testimony—especially
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where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) may be
more persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any
norm based upon common sense and experience, this rule should not be treated as an absolute and
must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL
6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).
Ultimately, a determination regarding a witness's credibility is needed when determining the
weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of
Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person's failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional's failure to document everything
reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;
or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
12

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1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the
theory or technique has been subjected to peer review and publication; (3) whether
there is a known or potential rate of error and whether there are standards for
controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts in order to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master's decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
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(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed numerous items of medical and scientific literature in this case, but not
all such items factor into the outcome of this decision. While I have reviewed all the medical
literature submitted in this case, I discuss only those articles that are most relevant to my
determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed
every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,
2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master
considered the relevant record evidence even though he does not explicitly reference such evidence
in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F.
App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—
and likely undermines—the conclusion that it was not considered”).
E. Standards for Ruling on the Record
I am resolving Petitioner’s claim on the filed record, and the parties have not challenged
my determination to do so. Mot. at 1; Opp. at 1. The Vaccine Act and Rules not only contemplate
but encourage special masters to decide petitions on the papers where (in the exercise of their
discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
case on the papers in lieu of hearing and that decision was upheld). I am simply not required to
hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health
& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
ANALYSIS
The Program has recognized cellulitis as a possible vaccine injury, and petitioners have
been granted entitlement in some past cases (though many were settled or conceded without any
reasoned causation determination). See, e.g., Elzabad v. Sec'y of Health & Hum. Servs., No. 21-
1771V, 2023 WL 4418519, at *1 (Fed. Cl. Spec. Mstr. June 15, 2023); Skinner-Smith v. Sec'y of
14

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Health & Hum. Servs., No. 14-1212V, 2022 WL 4116896, at *1 (Fed. Cl. Spec. Mstr. Aug. 15,
2022), reconsideration denied, No. 14-1212V, 2022 WL 13461862 (Fed. Cl. Sept. 9, 2022);
Salinas v. Sec'y of Health & Hum. Servs., No. 17-0609V, 2018 WL 5270106, at *1 (Fed. Cl. Spec.
Mstr. Sept. 4, 2018); Codde v. Sec'y of Health & Hum. Servs., No. 16-0812V, 2016 WL 8378159,
at *1 (Fed. Cl. Spec. Mstr. Nov. 15, 2016); Perez v. Sec'y of Health & Hum. Servs., No. 15-1023V,
2015 WL 10739340, at *1 (Fed. Cl. Spec. Mstr. Dec. 10, 2015)
In this matter, the Althen analysis may be performed succinctly – especially given
Respondent’s determination to cease his defense, while offering no specific factual objection to
the claim. Althen prong one has been satisfied because Petitioner has demonstrated, through the
opinion of Dr. DeWitt, that vaccines have the potential to cause local infections that could give
rise to a cellulitis-like reaction. For Althen prong two, there is treater support associating
Petitioner’s cellulitis with the vaccines she received, which included the covered flu vaccine. Ex.
1 at 331; Ex. 2 at 47; Ex. 5 at 4. Admittedly, the record establishes that Petitioner’s
contemporaneous physicians did not agree on whether the pneumococcal (a non-covered vaccine)
and/or flu vaccine were primarily causal. As both vaccines were administered on the same day and
in the same location, there is no way to separate the two in terms of causality. But (applying what
is often referred to as a “Shyface analysis”), Program claimants need only show a vaccine was a
but for, substantial factor in causing an injury, even if another causal factor is present. Shyface,
165 F.3d at 1352–53. Here, preponderant evidence supports the conclusion that the flu vaccine
was such a substantial factor.
Finally, Petitioner notes that she began experiencing onset within hours of the vaccination,
and her symptoms persisted after she sought medical attention for her cellulitis days later—a
medically acceptable timeframe given the injury. Saville Aff. I at 2; Saville Aff. II at 1–2. Thus,
the third Althen prong is satisfied.
Otherwise, there are no other bases for denying entitlement. Respondent has offered no
evidence to suggest that Petitioner's cellulitis was caused by any factor unrelated to her
vaccination, for example. And I find as well (though the evidence is thin on this particular issue)
that six months of severity post-injury have been established. Petitioner’s witness statements aver
that she still feels pain when pressure is applied to the scars that formed at each injection site, and
that this sensation post-dated vaccination for some time. See Saville Aff. I at 4; Saville Aff. II at
3. This is enough to establish six months of severity attributable to cellulitis.
Importantly, however (for purpose of calculation of damages in this case), I cannot find on
the existing record that Petitioner’s claims of fatigue are related or attributable to her vaccine-
induced cellulitis. Nothing filed by Petitioner, including Dr. DeWitt’s report and associated
medical literature, suggests fatigue is a cellulitis sequela, and no other proof supports that finding.
15

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Any award of pain and suffering, or care costs associated with the cellulitis, will necessarily
exclude fatigue and costs associated thereto.
CONCLUSION
Petitioner has provided preponderant evidence a causation-in-fact claim. Petitioner is thus
entitled to compensation. The parties are hereby ordered to contact Chambers on or before
September 8, 2023, to set a mutually-acceptable date for a status conference to discuss the
resolution of damages.
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
16

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_21-vv-00794-1
Date issued/filed: 2024-04-23
Pages: 7
Docket text: PUBLIC DECISION (Originally filed: 03/26/2024) regarding 49 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
--------------------------------------------------------------------------------
Case 1:21-vv-00794-UNJ Document 52 Filed 04/23/24 Page 1 of 7
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-794V
* * * * * * * * * * * * * * *
MARY SAVILLE, * Chief Special Master Corcoran
*
Petitioner, *
* Dated: March 26, 2024
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * *
Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School,
Washington, DC, for Petitioner.
Madelyn Weeks, U.S. Department of Justice, Washington, DC, for Respondent.
DAMAGES DECISION1
On January 25, 2021, Mary Saville filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (the “Vaccine Program”).2 Petitioner alleges she
suffered cellulitis following receipt of the quadrivalent influenza and pneumococcal vaccines on
November 5, 2018. Petition (ECF No. 1) at 3. Based on the record and the parties’ written
submissions, I ruled for Petitioner on entitlement. See Ruling on Entitlement, dated Aug. 28, 2023
(ECF No. 39) (the “Entitlement Ruling”).
The parties have now briefed their damages positions. See Petitioner’s Motion, dated Jan.
17, 2024 (ECF No. 46) (“Mot.”); Respondent’s Opposition, dated Feb. 15, 2024 (ECF No. 47)
(“Opp.”); Petitioner’s Reply, dated Feb. 26, 2024 (ECF No. 48) (“Reply”). Petitioner requests
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Case 1:21-vv-00794-UNJ Document 52 Filed 04/23/24 Page 2 of 7
$92,000.00 for actual pain and suffering, plus $804.80 in unreimbursed past medical expenses,
$2,754.80 to $2,994.80 for future/anticipated out of pocket expenses, and $14.85 in travel
expenses. Respondent, by contrast, proposes $50,000.00 in pain and suffering, $804.80 in past out-
of-pocket medical expenses, no future care costs, and $4.97 in travel expenses.
My resolution of these disputed damages components is set forth below.
I. Factual Background
A more complete summary of the relevant medical history and factual background is
contained in the entitlement decision. See generally Entitlement Ruling at 2–5. I incorporate that
history herein. In short, Petitioner has been found to have suffered cellulitis due to receipt of two
covered vaccines in late 2018. The record showed treatment of Petitioner’s condition in the
immediate post-vaccination months, although the injury had mostly resolved not long after the six-
month severity “deadline” for Program claims. Id. at 15. She also alleged a variety of sequelae
from the vaccines, but I specifically noted in my ruling that they had not at all been shown to be
associated—and thus would not be relevant in calculating damages. Id. at 15–16.
II. Procedural History
This case was initiated in January 2021, and was eventually reassigned to me after being
presided over for a period of time by a different special master. ECF No. 17. The parties then began
engaging in settlement discussions but were unable to reach an agreement. ECF No. 30.
Respondent filed his Rule 4(c) Report on May 16, 2022. ECF No. 31. Petitioner subsequently filed
Dr. DeWitt’s report. ECF No. 33. Respondent then filed an amended Rule 4(c) Report on January
18, 2023, stating that he would not continue to defend the case during further proceedings on
entitlement, and requested a Ruling on the Record instead. ECF No. 36. After I ruled for Petitioner,
the parties briefed damages for my final determination.
III. Relevant Law on Damages Determinations
A. General Considerations
A petitioner may recover “actual unreimbursable expenses incurred before the date of
judgment awarding such expenses which (i) resulted from the vaccine-related injury for which the
petitioner seeks compensation, (ii) were incurred by or on behalf of the person who suffered such
injury, and (iii) were for diagnosis, medical or other remedial care, rehabilitation . . . determined
to be reasonably necessary.” Section 15(a)(1)(A)(i)–(iii). Petitioners bear the burden of proof with
respect to each element of compensation requested. Brewer v. Sec’y of Health & Hum. Servs., No.
93-0092V, 1996 WL 147722, at *22–23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996).
2

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As noted above, this provision of the Act permits recovery of costs to be incurred for future
care as well, although such costs must be shown to be “reasonably necessary.” Section
15(a)(1)(A)(iii)(I)–(II). The meaning of the phrase “reasonably necessary” is somewhat imprecise,
as I have recognized in other cases. Barone v. Sec’y of Health & Hum. Servs., No. 11-707V, 2016
WL 3577540 (Fed. CL. Spec. Mstr. May 12, 2016). But it encompasses the idea that additional
care aimed at maximizing an injured party’s overall well-being (no matter how personally
deserving the individual may be) is not in keeping with the scope of damages envisioned by the
Program. I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013 WL 2448135, at *6 (Fed.
Cl. Spec. Mstr. Apr. 19, 2013) (defining “reasonably necessary” to mean “that which is required
to meet the basic needs of the injured person . . . but short of that which may be required to optimize
the injured person’s quality of life”); see also Bedell v. Sec’y of Health & Hum. Servs., No. 90-
765V, 1992 WL 266285 (Cl. Ct. Spec. Mstr. Sept. 18, 1992) (defining the term to mean more than
merely barely adequate, but less than the most optimal imaginable). And it goes almost without
saying that such costs must also pertain to care associated with the alleged injury or its sequalae.
Medical care a petitioner might receive, even if needed, that is not aimed at treatment of the vaccine
injury at issue, or related to it, is not a reasonably necessary future care component.
B. Pain and Suffering
The Act caps pain and suffering awards at $250,000.00. Section 15(a)(4). There is no
mathematic formula for assigning a monetary value to a person’s pain and suffering and emotional
distress. I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed.
Cl. Spec. Mstr. May 14, 2013) (“[a]wards for emotional distress are inherently subjective and
cannot be determined by using a mathematical formula”); Stansfield v. Sec’y of Health & Human
Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the
assessment of pain and suffering is inherently a subjective evaluation”). Factors to be considered
when determining an award for pain and suffering include: 1) awareness of the injury; 2) severity
of the injury; and 3) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister
v. Sec’y of Health & Human Servs., No 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr.
Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)).
I may also consider prior pain and suffering awards to aid my resolution of the appropriate
amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health &
Human Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief
special master’s decision to refer to damages for pain and suffering awarded in other cases as an
aid in determining the proper amount of damages in this case.”). In so doing, I may rely on my
own experience adjudicating similar claims. Hodges v. Sec’y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (noting that Congress contemplated that special masters would use their
accumulated expertise in the field of vaccine injuries to judge the merits of individual claims).
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ANALYSIS
I. Pain and Suffering
Petitioner requests $92,000.00 in actual pain and suffering, emphasizing both that her
initial reaction was severe, that she continued thereafter to feel some residual pain at the situs of
injury, and that the adverse event she had experienced left her reluctant to receive vaccines in the
future, despite their medical advisability. Mot. at 4–7. To support these contentions, Petitioner
references both the medical records and her own witness statements. See Petitioner’s Witness
Statement, filed Ex. 9 (ECF No. 7-12); Second Witness Statement, filed as Ex. 16 (ECF No. 22-
8).
Petitioner further notes that in comparable cases involving cellulitis as the injury, claimants
have received between $84,000.00 and up to $145,000.00—meaning her demand falls reasonably
within that range. Mot. at 7. She also references several comparable cases—although many (if not
all) are not reasoned decisions, and therefore provide little guidance as to what might constitute a
fair pain and suffering award for this kind of injury. See, e.g., Baker v. Sec’y of Health & Hum.
Servs., 19-0289V, 2022 WL 17819550 (Fed. Cl. Spec. Mstr. Nov. 7, 2022) (awarding more than
$130,000.00 in pain and suffering on Respondent’s proffer); Agard v. Sec’y of Health & Hum.
Servs., No. 19-0185V, 2021 WL 1912384 (Fed. Cl. Spec. Mstr. Apr. 7, 2021) (awarding on
stipulation a lump sum of $95,000.00, but without any statement of what portion constituted the
pain and suffering award); Hughes v. Sec’y of Health & Hum. Servs., No. 16-546V, 2016 WL
8222020 (Fed. Cl. Spec. Mstr. Oct. 7, 2016) (decision on proffer awarding more than $125,000.00.
but without specifying what amount therein constituted compensation for pain and suffering);
Miller v. Sec’y of Health & Hum. Servs., No. 16-0595V, 2017 WL 6044322 (Fed. Cl. Spec. Mstr.
Apr. 10, 2017) (awarding approximately $99,000.00 based on parties’ stipulation).
Respondent counters that a more modest sum—$50,000.00—is appropriate. Opp. at 9. He
disputes the value of Petitioner’s various witness statements, observing that they are unsworn,
conclusory, or do no more than confirm the initial injury, while failing to demonstrate its lingering
impact. Id. at 7–8, 10. He further emphasizes that Petitioner has relied on stipulations or proffered
cases for her comparables (as noted above), as opposed to reasoned decisions that explain why a
particular award was appropriate. Id. at 10. However, Respondent then also relies on settled proffer
values (which have the same deficiencies as comparable case guideposts) to defend his proposed
pain and suffering amount. Id. at 10 n.4.
Nevertheless, Respondent does cite some reasoned decisions—and the amounts awarded
therein are significantly less than even what Respondent proposes. See, e.g., Skinner-Smith v. Sec’y
of Health & Hum. Servs., No. 14-1212V, 2023 WL 3043904 (Fed. Cl. Spec. Mstr. Apr. 21, 2023)
(awarding $10,125.00 for past pain and suffering due to cellulitis, plus $6,000.00 for future pain
and suffering); Yost v. Sec’y of Health & Hum. Servs., No. 18-288V, 2022 WL 4593029 (Fed. Cl.
Spec. Mstr. Aug. 29, 2022) ($10,000.00 in pain and suffering for an abscess and scarring at
vaccination situs); Amorella-Moore v. Sec’y of Health & Hum. Servs., No. 91-1558V, 1992 WL
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182194 (Fed. Cl. Spec. Mstr. July 13, 1992) ($500 in pain and suffering, given lack of evidence of
ongoing impact from abscess injury). Under the facts of this case, Respondent reasons, a
$50,000.00 award would be more than fair. Opp. at 13–14.
In her reply, Petitioner does not endeavor to address the three reasoned cases referenced
by Respondent. Rather, she maintains that proffers and stipulations have evidentiary value in
assessing the proper amount for a pain and suffering award. Reply at 1–2. And she maintains that
the facts show a more severe occurrence of cellulitis than in Respondent’s comparables, with
ongoing sequelae lasting three years. Id. at 2–3.
In this case, awareness of the injury is not disputed. The record reflects that at all times
Petitioner was a competent adult with no impairments that would impact her awareness of her
injury. Therefore, I analyze principally the severity and duration of her injury. In performing this
analysis, I have reviewed the record as a whole, including the medical records, affidavits, and all
assertions made by the parties in written documents. I also considered prior awards for pain and
suffering from comparable cases, although I ultimately base my determination on the
circumstances of this case.
Overall, I deem Petitioner’s injury to have been a moderate case of cellulitis—severe
initially, but which was successfully treated and mostly resolved not long after presentation.
Petitioner has persuasively shown some ongoing pain (albeit which was not severe enough to
compel her to seek much additional treatment). But Respondent’s reasoned decision comparable
cases were also quite relevant—and they show that cellulitis cases do not generally present the
kinds of circumstances in which significant pain and suffering awards are justified. In so finding,
I repeat my oft-noted observation that no matter how much the parties may rely on prior proffers
or stipulated sums as guidelines for settlement, they are not useful precedent in deciding a disputed
case. Hayes v. Sec’y of Health & Hum. Servs., No. 17-804V, 2021 WL 688628, at *2 (Fed. Cl.
Spec. Mstr. Jan. 6, 2021). Parties settle cases on their own for any number of reasons having
nothing to do with a claim’s underlying merits, and thus the fact that a type of case often settles in
the Program for a particular sum is not evidence that all such claims are “worth” the same.
Given the record, Respondent has offered an exceedingly generous amount in pain and
suffering that exceeds what special masters have awarded in comparable cases involving cellulitis
or some parallel skin-related vaccine injury. Petitioner, by contrast, has not defended the proposed
higher sum with any reasoned comparable decisions of her own. Accordingly, I will adopt
Respondent’s figure of $50,000.00. And I note that in future such cases, where reasoned decisions
suggest an amount lower than what a party has proposed to be defensible, there is a strong risk I
will embrace the lower figure as best justified by the law.
II. Unreimbursed Medical Expenses and Costs – Past and Future
Petitioner asks for several different components of damages reflecting medical costs. First,
she calculates $804.80 in unreimbursed out-of-pocket expenses based on eight treater visits in the
fall of 2018. Mot. at 10. Second, she demands $14.85 in travel expenses attributable to driving to
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these treater visits. Id. at 11. (On reply, Petitioner admitted that some of these costs were incurred
by her family in visiting her at the hospital. Reply at 5). Finally, she estimates the need for future
care—physical therapy to aid her in rehabilitation of the area on her arm where she experienced
cellulitis—projecting a need for two to three one-hour sessions over a six to eight-week period,
and hence asking for some amount in the range of $1,950.00 to $2,190.00. Mot. at 10–11.
Respondent concedes the past unreimbursed medical expense sum is acceptable, but denies
the propriety of a future expense award. Opp. at 15, 16. He deems these costs to be speculative in
nature, and not demonstrated to be medically necessary either, since it does not appear either that
physical therapy was recommended by a treater (except in the context of litigating this claim), or
that Petitioner had ever obtained it in the past five-plus years since the vaccine injury at issue. Id.
Respondent also only accepts $4.97 in travel costs, based on his determination that Petitioner made
only one single automobile trip to the hospital in November 2018. Id. at 16.
On reply, Petitioner defends the future care request. She maintains that she has continued
to suffer residual pain and related sequelae in the years since her primary treatment for cellulitis.
Reply at 2. While she may not have consistently sought treatment for it in that period, pain still
remained. Id. at 3. She also emphasizes the impact of the Pandemic in 2020 as affecting her ability
to treat her ongoing issues (especially since she has an immunocompromised son). Id. She stresses
that the best future care that she can even obtain is physical therapy-oriented (but this is not covered
by insurance). Id. at 3–4. And she disputes the concept that a treater projection of future needed
care is suspect simply because it is rendered at the damages stage of the case. Id. at 4.
Because the parties agree on the past amount of unreimbursed expenses to be awarded, I
only need decide the future sum and the mileage expense. Regarding the former, Petitioner has
established some need for additional care of her vaccination situs due to the cellulitis she
experienced. I agree with Respondent that the number requested has a speculative nature
(evidenced by, if nothing else, the range Petitioner offers rather than an exact figure), and that the
treatment gaps (while somewhat explained by Petitioner) lend support to the conclusion that
Petitioner’s ongoing sequelae are quite limited. However, because the evidence otherwise supports
Petitioner’s claim that she continues to experience some residual pain, and because it does appear
that the requested physical therapy will not be insurance-reimbursed, I will allow a smaller sum—
$1,000.00—for this future care cost. The lower award does take into account the somewhat larger
pain and suffering figure, which I deem quite generous under the circumstances, and which could
be applied toward additional physical therapy care if it proves necessary.
Otherwise, I will grant the lesser amount of $4.97 in travel care-associated costs, as
proposed by Respondent. Petitioner has not shown she incurred all of these travel costs in multiple
trips to a treater. Visits from family members during the time she was hospitalized, while wholly
understandable, do not constitute a reasonably-reimbursed expense.
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CONCLUSION
Based on the record as a whole and arguments of the parties, I award Petitioner a lump sum
payment of $51,809.77 (representing $50,000.00 for Petitioner’s past pain and suffering, $804.80
for past unreimbursable medical expenses, $1,000.00 in future care costs, and $4.97 in travel costs)
in the form of a check payable to Petitioner Mary Saville. This amount represents compensation
for all damages that would be available under Section 15(a).
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.3
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
3 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
7