The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-2043V
DEBORAH BELKER-FRECHETTE,
Chief Special Master Corcoran
Petitioner,
Filed: December 6, 2024
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Sarah Black Rifkin, U.S. Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT 1
On October 19, 2021, Deborah Belker-Frechette filed a petition for compensation
under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2
(the “Vaccine Act”). Petitioner alleges that she suffered a left shoulder injury related to
vaccine administration (“SIRVA”), a defined Table injury, due to an influenza (“flu”)
vaccine she received on October 5, 2020. Petition at 1, ¶¶ 3, 16.
Respondent disputes Petitioner has established pain onset timing consistent with
the requirements of a Table SIRVA. For the reasons discussed below, I find that the onset
1 Because this Ruling contains a reasoned explanation for the action taken in this case, it must be made
publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government
Services). This means the Ruling will be available to anyone with access to the internet. In accordance
with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information,
the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that
the identified material fits within this definition, I will redact such material from public access .
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2018).
of Petitioner’s left shoulder pain occurred within 48 hours of vaccination, and that she has
satisfied the other requirements of a compensable Table SIRVA injury. Petitioner is thus
entitled to compensation under the Vaccine Act.
I. Relevant Procedural History
After several months of records-filing, the case was activated and assigned to the
“Special Processing Unit” (OSM’s adjudicatory system for resolution of cases deemed
likely to settle). ECF No. 13. Because the vaccination record did not indicate the site of
administration (Exhibit 1 at 14), I allowed Petitioner the opportunity to present additional
situs evidence and briefing. ECF No. 16; see Exhibits 10-12, ECF No. 18; Petitioner’s
Motion for Ruling on the Record Regarding Vaccine Situs, ECF No. 19. On April 6, 2023,
I issued a fact ruling determining that the flu vaccine was most likely administered in
Petitioner’s left deltoid, as alleged. ECF No. 22.
The parties thereafter attempted to settle the claim, but reached an impasse in
August 2023. Status Report, ECF No. 28. They subsequently filed additional documents
presenting their arguments related to entitlement. ECF Nos. 29-32. In his last filing,
Respondent confirmed that his only objection to compensation related the onset Table
requirement. Respondent’s Response to Petitioner’s Motion for Ruling on the Record at
5, 5 n.6 (stating “Respondent does not contest that [P]etitioner meets the remaining QAI
for SIRVA”). The issue of entitlement is now ripe for adjudication. 3
II. Finding of Fact Regarding Onset
At issue is whether Petitioner’s first symptom or manifestation of onset after
vaccine administration (specifically pain) occurred within 48 hours as set forth in the
Vaccine Injury Table and Qualifications and Aids to Interpretation (“QAI”) for a Table
SIRVA. 42 C.F.R. § 100.3(a)XIV.B. (influenza vaccination); 42 C.F.R. § 100.3(c)(10)(ii)
(required onset for pain listed in the QAI).
A. Authority
Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis,
3 In her last filing, Petitioner also addressed the question of compensation, stating that she seeks
$72,000.00 for her pain and suffering. ECF No. 32. Because all prior filings addressed only the issue of
entitlement, I will allow the parties to provide further briefing before determining the appropriate pain and
suffering award in this case. I will, however, briefly discuss my initial assessment regarding damages in this
ruling. See infra Section IV.
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conclusion, judgment, test result, report, or summary concerning the nature, causation,
and aggravation of petitioner’s injury or illness that is contained in a medical record.
Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy
evidence. The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in
the balance, accuracy has an extra premium. These records are also generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993
F.2d 1525, 1528 (Fed. Cir. 1993).
Accordingly, where medical records are clear, consistent, and complete, 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). However, this rule
does not always apply. “Written records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent.” Murphy v. Sec’y of
Health & Hum. Servs., No. 90-882V, 1991 WL 74931, *4 (Fed. Cl. Spec. Mstr. April 25,
1991), quoted with approval in decision denying review, 23 Cl. Ct. 726, 733 (1991), aff'd
per curiam, 968 F.2d 1226 (Fed.Cir.1992)). And the Federal Circuit recently “reject[ed] as
incorrect the presumption that medical records are accurate and complete as to all the
patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378,
1383 (Fed. Cir. 2021).
The United States Court of Federal Claims has outlined 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 1335 (Fed. Cir. 2014).
The Court has also said that medical records may be outweighed by testimony that
is given later in time that is “consistent, clear, cogent, and compelling.” Camery v. Sec’y
of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health
& Hum. Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998).
The credibility of the individual offering such fact testimony must also be determined.
Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley
v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
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the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may
be made only upon demonstration by a preponderance of the evidence that the onset [of
the injury] . . . did in fact occur within the time period described in the Vaccine Injury
Table.” Id.
The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v.
Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within
the special master’s discretion to determine whether to afford greater weight to medical
records or to other evidence, such as oral testimony surrounding the events in question
that was given at a later date, provided that such determination is rational).
B. Analysis
I make the following onset finding after a complete review of the record to include
all medical records, affidavits or declarations, and additional evidence filed. As the record
shows:
• Approximately eleven months before receiving the 2020 flu vaccine alleged
as causal (in late October 2019), Petitioner visited her current primary care
provider (“PCP”) expressing a desire to discuss recent events and to obtain
a “full baseline check.” Exhibit 1 at 15. It was noted that Petitioner “does not
seek out medical care routinely” (id.), and the record indicates the visit was
“to establish care” (id. at 18).
• During this PCP visit, Petitioner described a recent episode of mid-chest
discomfort and mild numbness in her left arm (characterized as a chronic
condition) after loading 600 pounds of corn into her truck. Exhibit 1 at 15.
When listing her past symptoms over the last one to two years, she reported
an earlier episode of chest discomfort, “intermittent neck pain, numbness of
[her] upper left arm at times,” and itching in her right armpit. Id. The PCP
assessed Petitioner as having noncardiac-related chest pain, prescribed
medication for acid reflux, and administered a flu vaccine. Id. at 9 (list of
immunizations), 9-13 (testing), 17-18 (PCP’s assessment and instructions).
• On October 5, 2020, Petitioner (then 62 years old) visited her PCP clinic for
administration of the flu vaccine alleged as causal, and received it at that
time. Exhibit 1 at 14; see id. at 9 (list of immunizations).
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• On November 13th, Petitioner returned to her PCP complaining of left
shoulder pain and limited range of motion (“ROM”) which she attributed to
the vaccination she received six weeks earlier. 4 Exhibit 1 at 19. She
reported that her pain began “[f]airly abruptly” after vaccination, and that
she believed the vaccine had been administered “higher than usual.” Id.
Stating that she preferred to avoid medications, Petitioner described
difficulty sleeping, lifting her arm overhead or behind her back, and one
episode of left shoulder numbness. Id.
• Encouraging Petitioner to apply ice and heat and to take over the counter
pain medication, the PCP prescribed topical gel and physical therapy (“PT”).
Exhibit 1 at 21. Although he noted that such injuries are rare, the PCP
opined Petitioner was suffering from a “[p]possible shoulder injury related
to vaccination.” Id.
• At her initial PT evaluation, Petitioner again reported left shoulder pain and
limited ROM post-vaccination. Exhibit 8 at 10. Specially, she characterized
her pain onset as “[s]udden” (id. at 9), providing an onset date of October
5, 2020 (id. at 6) - the date of her vaccination. Describing her pain as
constant, Petitioner estimated her severity was initially four out of ten, but
lessened to two out of ten after four weeks. Id. at 7.
• Petitioner continued to improve over the course of nine PT sessions in
December 2020 to January 2021, but was directed to return to her PCP for
further diagnostic testing after experiencing a few days of increasing pain
prior to her last session on January 4th. Exhibit 8 at 16-17. At that time, it
was noted that her pain ranged from two to seven. Id. at 16.
• When seen by her PCP the next day (January 5th), Petitioner again reported
left shoulder pain after receiving a flu vaccine that was administered too
high. Exhibit 1 at 22. In this record, it was noted that she “[c]orrelates onset
to after receiving seasonal influenza vaccination.” Id. After Petitioner shared
a reluctance to use the prescribed gel due to a concern about its potential
side effects (id.) and declined a steroid injection, the PCP referred her to an
orthopedist and suggested acupuncture, if desired. Id. at 24.
• Petitioner was discharged from PT without receiving further treatment on
February 11, 2021. Exhibit 8 at 8.
4 Petitioner also described ongoing difficulties related to acid reflux. Exhibit 1 at 19-21.
5
• At her first acupuncture session on January 12th, Petitioner again reported
left shoulder pain after receiving a flu vaccine three months earlier. Exhibit
3 at 1.
• By her fourth acupuncture session on January 22nd , Petitioner reported 50
percent improvement, even after shoveling snow. Exhibit 3 at 3. However,
her pain had increased by her next session on January 24 th, a change
attributed to the use of a massage gun. Id. at 4.
• On March 10th, Petitioner began attending massage therapy. Exhibit 4 at 5.
She again reported that her left shoulder pain was due to the vaccine she
received, characterizing her injury as a “SIRVA – shoulder injury due to
vaccine administration.” Id. at 6.
• During her next PCP appointment (held telephonically on March 24th),
Petitioner reported “[s]ome improvement in ROM but no change in pain.”
Exhibit 1 at 25. Noting that she had tried PT, Petitioner indicated she was
attending acupuncture and had started massage therapy and yoga. She
again declined a steroid injection, indicating she was “[t]errified of another
injection.” Id. The PCP ordered an MRI and prescribed pain medication and
a muscle relaxant. Exhibit 1 at 26-27.
• When undergoing an MRI on April 8th, Petitioner again reported “[s]houlder
pain following vaccination fall 2020.” Exhibit 1 at 7. The MRI revealed “mild
tendinosis of the supraspinatus and subscapularis tendons, [n]o rotator cuff
tear, . . . [g]lenohumeral joint capsulitis, . . . [m]ild tendinosis of the long
head biceps tendon, . . . [and] [m]ild degenerative arthrosis of the AC joint .
. . [but] [n]o subacromial-subdeltoid bursal fluid.” Id. at 7-8.
• Petitioner continued to attend acupuncture sessions throughout April, May,
and early June 2021. Exhibit 5 at 3-22. She attended massage therapy until
November 2021. Exhibit 6 at 4, 8-10.
• In her initial signed declaration, Petitioner described left shoulder pain onset
immediately upon vaccination. Exhibit 2 at ¶ 8. She indicated that she
believed the vaccine was given “much higher than any of [her] previous flu
shots.” Id.
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• In her supplemental signed declaration, Petitioner maintains that the left
shoulder pain she experienced after vaccination was different than her 2019
soreness. Exhibit 10 at ¶¶ 5-7, 9.
• In their signed statements, Petitioner’s friends recalling observations and
communications from Petitioner which support her claims of immediate pain
onset. Exhibits 11 at ¶¶ 5-6; Exhibit 12 at ¶ 5.
The above medical records establish that when seeking treatment, Petitioner
consistently described left shoulder pain that she attributed to a flu vaccine she received
on October 5, 2020. Characterizing her pain as sudden and abrupt on at least one
occasion, she provided the date of vaccination as the onset date for her pain. Petitioner
provided these histories during the year following vaccination to her PCP, physical
therapist, acupuncturist, massage therapist, and the technician performing her April 2021
MRI. And in both medical records and her first signed declaration, she described the flu
vaccine as improperly administered – given too high in her left deltoid.
While originating from Petitioner, these statements are also set forth in
contemporaneous records, and should therefore be afforded greater weight than any
subsequent assertion or witness statement. The Federal Circuit has stated that “[m]edical
records, in general, warrant consideration as trustworthy evidence . . . [as they] contain
information supplied to or by health professionals to facilitate diagnosis and treatment of
medical conditions.” Cucuras, 993 F.2d at 1528 (emphasis added). Thus, the Circuit has
instructed that greater weight should be accorded to this class of information, even when
the record in question simply memorializes what the petitioner said at the time.
In addition, there is a dearth of evidence supporting a different pain onset. I thus
determine, based on the entire record, that Petitioner has provided preponderant
evidence establishing that her pain occurred within 48 hours of vaccination.
III. Additional Requirements for Entitlement
A. Legal Standards
In addition to requirements concerning the vaccination received, the pain onset
(discussed above in Section II), symptoms duration, and the lack of other award or
settlement,5 a petitioner must establish that she suffered an injury meeting the Table
5 In summary, a petitioner must establish that he received a vaccine covered by the Program, administered
either in the United States and its territories or in another geographical area but qualifying for a limited
exception; suffered the residual effects of his injury for more than six months, died from his injury, or
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criteria, in which case causation is presumed, or an injury shown to be caused-in-fact by
the vaccination she received. Section 11(c)(1)(C).
The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,
identifies the vaccines covered under the Program, the corresponding injuries, and the
time period in which the particular injuries must occur after vaccination. Section 14(a).
Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48
hours of the administration of a flu vaccine. 42 C.F. R. § 100.3(a)(VIX)(B). The criteria
establishing a SIRVA under the accompanying QAI are as follows:
Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests
as shoulder pain and limited range of motion occurring after the
administration of a vaccine intended for intramuscular administration in the
upper arm. These symptoms are thought to occur as a result of unintended
injection of vaccine antigen or trauma from the needle into and around the
underlying bursa of the shoulder resulting in an inflammatory reaction.
SIRVA is caused by an injury to the musculoskeletal structures of the
shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological
injury and abnormalities on neurological examination or nerve conduction
studies (NCS) and/or electromyographic (EMG) studies would not support
SIRVA as a diagnosis (even if the condition causing the neurological
abnormality is not known). A vaccine recipient shall be considered to have
suffered SIRVA if such recipient manifests all of the following:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring
after vaccine injection;
(ii) Pain occurs within the specified time frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which
the intramuscular vaccine was administered; and
(iv) No other condition or abnormality is present that would explain the
patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected
an award or settlement for her injury. See Section 11(c)(1)(A)(B)(D)(E).
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42 C.F.R. § 100.3(c)(10).
B. Analysis
Respondent has stated no further objections to compensation, and I find Petitioner
has otherwise satisfied all criteria for a Table SIRVA injury following receipt of the flu
vaccine. Although Petitioner experienced several instances of itching, numbness, and
pain in her upper arm, as well as chest and neck, these episodes do prevent Petition from
satisfying the QAI requirements related to a prior condition or alternative cause, especially
considering Respondent’s lack of objection. See 42 C.F.R. § 100.3(c)(10)(i), (iv) (first and
fourth QAI criteria). And Petitioner exhibited pain and limitations in ROM solely in her left,
injured shoulder. E.g., Exhibit 1 at 20, 23 (PCP visits); Exhibit 6 at 8-10 (acupuncture
records); Exhibit 8 at 5, 8, 16-17 (PT records); see 42 C.F.R. § 100.3(c)(10)(iii) (third QAI
criterion).
As I have determined in this ruling, the record supports a finding that Petitioner
suffered pain within 48 hours of vaccination. See supra Section II.B.; 42 C.F.R. §
100.3(c)(10)(ii) (second QAI criterion). Additionally, the medical records show Petitioner
suffered the residual effects of her injury for more than six-months. Exhibit 1 at 7-8 (MRI
performed on March 8, 2021), 25-27 (March 24, 2021 PCP vists); see Section
11(c)(1)(D)(i) (six-month severity requirement). And the vaccine record shows Petitioner
received the flu vaccine at her PCP’s clinic in Chanhassen, Minnesota. Exhibit 1 at 9, 14;
see Section 11(c)(1)(A) (requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i)
(requiring administration within the United States or its territories). Furthermore, there is
no evidence that Petitioner has collected a civil award for his injury. See Section
11(c)(1)(E) (lack of prior civil award). Thus, Petitioner has satisfied all requirements for
entitlement under the Vaccine Act.
IV. Appropriate Amount of Compensation
Although I have found Petitioner entitled to compensation, I do not expect the
amount awarded for Petitioner’s past pain and suffering to be significant. Throughout the
medical records, Petitioner reported moderate pain levels (from two to seven). And she
did not seek treatment initially until more than a month post-vaccination. Although her
pain increased again in early January 2021, Petitioner received some relief from PT
sessions in December 2020. In 2021, Petitioner declined two offers of a steroid injection
from her PCP, preferring to treat her symptoms using acupuncture and massage therapy.
And there is some evidence in these records showing her symptoms were aggravated by
her continued physical activity, and included pain in other areas that appear unrelated to
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her SIRVA. See, e.g., Exhibit 5 at 3-4 (describing back and arm pain after weeding and
muscle tension primarily in her trapezius). In attempting to resolve damages, the parties
should keep in mind that this does not appear to be a case in which a significant pain and
suffering award is warranted.
Conclusion
Based on the entire record in this case, I find that Petitioner has provided
preponderant evidence satisfying all requirements for a Table SIRVA. Petitioner is
entitled to compensation in this case.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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