VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-00059
Package ID: USCOURTS-cofc-1_21-vv-00059
Petitioner: Brooke Biancucci
Filed: 2021-01-05
Decided: 2025-11-10
Vaccine: influenza
Vaccination date: 2019-09-25
Condition: left shoulder injury related to vaccine administration (SIRVA)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On January 5, 2021, Brooke Biancucci filed a petition alleging that an influenza vaccination administered in her left deltoid on September 25, 2019 caused a left shoulder injury related to vaccine administration. She was forty-seven years old at vaccination and had no documented prior left-shoulder pain.

Nine days after vaccination, Ms. Biancucci called her primary care practice reporting left arm pain and limited range of motion that began one to two days after the flu shot, extended from shoulder to elbow, and interfered with sleep. The same day, urgent care documented constant 6/10 pain radiating down the arm, moderately reduced range of motion, a normal shoulder x-ray, and a possible axillary nerve injury. On October 10, an orthopedic physician assistant recorded immediate left-arm pain after the flu shot, 9/10 shoulder pain, tenderness, and reduced strength. MRI showed subacromial-subdeltoid bursitis, supraspinatus tendonitis, and subscapularis tendinosis. On October 28, orthopedic surgeon Dr. David Gallagher diagnosed subacromial bursitis and an inflammatory reaction most likely secondary to subacromial flu injection, and gave a cortisone injection.

The problem for the claim was duration. After October 2019, Ms. Biancucci had at least seven visits for other medical issues, including left foot surgery, knee pain, leg pain, a head laceration, and an ingrown toenail, without shoulder complaints. She did not return for left-shoulder care until February 12, 2021, about fifteen months after the last shoulder visit, when she reported increased pain and decreased range of motion associated with shoveling and heavy work around the house. In her affidavit she said she had lived with discomfort during COVID restrictions and later regained some function through home exercises.

Respondent argued that the long silent gap defeated the Vaccine Act's six-month severity requirement. Chief Special Master Brian H. Corcoran agreed and dismissed the petition on November 10, 2025. He found that the early records supported a short-term shoulder injury, but did not prove residual effects through late March 2020, especially where Ms. Biancucci sought unrelated care during the gap without reporting ongoing shoulder problems. No compensation was awarded.

Theory of causation field:
Adult petitioner, age 47; influenza vaccine September 25, 2019; alleged left Table SIRVA. DISMISSED. Onset 1-2 days by Oct. 4 phone call; urgent care pain/limited ROM; Oct. 11 MRI bursitis/tendinosis; Oct. 28 Dr. Gallagher diagnosed inflammatory reaction/subacromial bursitis and gave cortisone injection. Respondent challenged six-month severity. Fifteen-month shoulder-treatment gap despite unrelated visits; Feb. 2021 return after shoveling/heavy work. SM Corcoran found severity not proven. Petition filed January 5, 2021; decision November 10, 2025. No award.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-00059-0
Date issued/filed: 2025-12-15
Pages: 6
Docket text: PUBLIC DECISION (Originally filed: 11/10/2025) regarding 35 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (cr) Service on parties made.
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Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 1 of 6
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-0059V
BROOKE BIANCUCCI,
Chief Special Master Corcoran
Petitioner,
v.
SECRETARY OF HEALTH AND Filed: November 10, 2025
HUMAN SERVICES,
Respondent.
Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner.
Felicia Langel, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION DISMISSING PETITION1
On January 5, 2021, Brooke Biancucci 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 alleged that as a result of an influenza (“flu”) vaccine she
received on September 25, 2019, she suffered a left shoulder injury related to vaccine
administration (“SIRVA”) as defined by the Vaccine Injury Table (the “Table”). Petition
(ECF No. 1) at 1. The case was assigned to the Special Processing Unit of the Office of
Special Masters.
1Because this decision contains a reasoned explanation for the action in this case, I am required to post it
on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services).
This means this Decision will be available to anyone with access to the internet. In accordance with
Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, 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 (2012).

Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 2 of 6
On January 10, 2023, Respondent filed a Rule 4(c) Report detailing its entitlement
opposition and grounds for so maintaining. Respondent’s Report dated January 10, 2023
(ECF No. 31) (“Report”). Specifically, Respondent argued (among other things) that
Petitioner could not meet the statutory severity requirement, since there was a treatment
gap of approximately 15 months. Id. at 4. During this interval Petitioner repeatedly sought
medical care, but did not complain of shoulder problems (and attributed visits to some
treaters in this period to left foot surgery and pain in both knees). Id. at 3–4.
Thereafter, I set a briefing schedule for Petitioner to show cause why the claim
should not be dismissed given the severity issues, setting deadline for both sides to offer
their position on the matter. Order to Show Cause, dated May 9, 2023 (Docket Entry
Order). Both parties filed their briefs in accordance. Petitioner’s brief, dated June 12, 2023
(ECF No. 33) (“Mot.”); Respondent’s brief, dated July 6, 2023 (ECF No. 34) (“Opp.”).
Petitioner did not opt to file a reply, and the matter is now fully briefed.
I. Relevant Medical History
1. Medical History
On September 25, 2019, Ms. Biancucci (47-years old) saw her primary care
provider (“PCP”) Gregory Mullen, M.D., for a wellness exam. Petitioner’s Exhibit (“Ex.”)
Ex. 7 at 77. She complained of fatigue and insomnia, and she received a seasonal flu
vaccine into her left deltoid. Ex. 4; Ex. 7 at 77, 79. The vaccination record states that
Petitioner received this vaccine in her left deltoid. Ex. 4 at 1. Petitioner had no history of
left shoulder pain. See generally Ex. 3.
On October 4, 2019, Ms. Biancucci spoke by telephone to a nurse in her PCP
practice and complained of pain and limited range of motion (“ROM”) in her left arm that
began one to two days after her vaccination. Ex. 7 at 75. Petitioner added that the pain
extended from her shoulder to her elbow, she had difficulty sleeping, and ibuprofen was
“somewhat relieving.” Id. at 76.
Later that day, Ms. Biancucci went to UHS Clinics Urgent Care and was seen by
Jessica Brooks, P.A. Ex. 5 at 16. Petitioner complained of constant 6/10 pain that radiated
down her left arm but had improved from a week ago. Id. On exam, PA Brooks noted that
Petitioner’s left shoulder was non-tender to palpation, but there was moderately reduced
ROM. Id. at 18. PA Brooks diagnosed Ms. Biancucci with “[p]ossible injury to [the] axillary
nerve,” administered Toradol intramuscularly, and prescribed Naproxen 500mg. Id. at 18–
19. PA Brooks ordered an X-ray of Petitioner’s left shoulder (which was normal, Ex. 5 at
2

Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 3 of 6
21), and recommended ice/heat, stretching, and a referral to orthopedics if the pain did
not improve. Id.
On October 10, 2019, Ms. Biancucci saw orthopedist Ryan Lowrie, P.A., at UHS
Orthopedic Center for a consultation. Ex. 8 at 119. Petitioner wrote on her medical intake
form that, after the flu shot, she had “immediate pain through [her] left arm [and] lack of
use since (without pain).” Id. at 131. At this visit, Petitioner complained of 9/10 left
shoulder pain. Id. PA Lowrie noted left shoulder tenderness and reduced strength. Id. at
118, 119. PA Lowrie reviewed Petitioner’s X-ray, ordered a left shoulder MRI, and
prescribed ibuprofen 800mg alternating with Tylenol. Id. at 118.
On October 11, 2019, Ms. Biancucci underwent an MRI of the left shoulder which
showed fluid in the subacromial subdeltoid bursa, consistent with bursitis, hyperintense
signal in the distal supraspinatus tendon, due to tendonitis, and subscapularis tendinosis.
Ex. 8 at 124-125.
On October 17, 2019, Ms. Biancucci followed up with PA Lowrie, who noted that
Petitioner “[s]till ha[d] quite a bit of pain, left shoulder, all from a flu shot a number of
weeks ago.” Ex. 7 at 73. On exam, PA Lowrie noted mild pain, “adequate” ROM, and
impingement with positive Hawkins and Neer tests. Id. PA Lowrie reviewed Petitioner’s
MRI, and he diagnosed her with left shoulder bursitis and rotator cuff tendinosis. Id. PA
Lowrie prescribed a Medrol Dosepak, and he referred petitioner to an orthopedic surgeon
in the same practice. Id.
On October 28, 2019 (now 33 days after vaccination), Ms. Biancucci saw
orthopedic surgeon David Gallagher, M.D. Ex. 8 at 97. Petitioner complained of 5/10 left
shoulder pain that was worse at night and had persisted despite oral steroids and home
exercises. Id. at 96, 97. On exam, Dr. Gallagher noted reduced strength and ROM and
positive impingement. Id. Dr. Gallagher reviewed Petitioner’s MRI, and he diagnosed her
with “[s]ubacromial bursitis and inflammatory reaction secondary to subacromial flu
injection, most likely.” Id. at 96. Dr. Gallagher administered a cortisone injection into
Petitioner’s left shoulder, and he recommended that she follow up as needed. Id.
Over the next 15 months, Ms. Biancucci was seen at least seven separate times
with several medical providers, but no records include reports or complaints of left
shoulder pain. See e.g., Ex. 7 at 54–58 (On December 16, 2019, Petitioner was seen at
her PCP practice for a preoperative exam for left foot surgery); Ex. 3 at 10-11 (On
February 11, 2020, Ms. Biancucci was seen by an orthopedist for right knee pain); Ex. 5
at 22-25 (On February 14, 2020, she was seen at Urgent Care for left leg pain); Ex. 3 at
7-8 (On March 12, 2020, Petitioner was seen by an orthopedist for left knee pain); Ex. 7
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Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 4 of 6
at 150-54 (On June 24, 2020, Ms. Biancucci was seen at the Emergency Department for
a head laceration); Ex. 7 at 37-38 (On July 6, 2020, Petitioner was seen by her PCP for
staple removal following the head laceration); Ex. 7 at 27-30( On November 25, 2020,
she was seen at her PCP practice for an ingrown toenail on her right foot).
On February 12, 2021 - 15 months and 15 days from her last appointment for her
left shoulder - Ms. Biancucci returned to PA Lowrie and complained of left shoulder
“increased pain and decreased ROM.” Ex. 8 at 50. Petitioner rated her pain at 2/10 and
described it as intermittent and associated with “shoveling and excessive work around
the house.” Id. On exam, PA Lowrie noted that Ms. Biancucci had mild diffuse left shoulder
pain and mildly positive impingement. Id. PA Lowrie diagnosed Petitioner with left rotator
cuff tendinosis, and recommended a cortisone injection, which Petitioner declined. Id. at
50–51.
In her supplemental affidavit, filed on March 31, 2022, Ms. Biancucci stated that
she had no prior left shoulder dysfunction and was very active. Id. at 1. She stated that
experienced immediate pain following the vaccine, and the pain became unimaginable.
Id. Petitioner explained that “36 days” after her flu vaccination, she “began to feel relief.”
Ex. 9 at 2. Petitioner claimed that she did not seek additional care for her left shoulder
until February 12, 2021, because her physical inactivity during COVID “lockdown,” and
immediately thereafter, did not aggravate her injury. Id. She stated that she lived with the
discomfort. Id. In January 2021, Petitioner stated that she began to experience increased
levels of pain. She returned to see her orthopedist and was given additional treatment
options. Id. Ms. Biancucci performed home exercises and eventually regained some
function. Id. She continued to experience limitations with use of her left shoulder. Id.
II. Analysis
Petitioners not asserting a vaccine-related death or other injury requiring a surgical
intervention and inpatient care must demonstrate that they suffered the residual effects
or complications from their vaccine-related injury for more than six months. Section
11(c)(1)(D); Cloer v. Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011).
Petitioners bear the burden of establishing this preponderantly. Song v. Sec’y of Health
& Hum. Servs., 31 Fed. Cl. 61, 65–66 (1994), aff’d, 41 F.3d 1520 (Fed. Cir. 1994). They
cannot establish the length or ongoing nature of an injury solely through personal
statements but rather must “submit supporting documentation which reasonably
demonstrates that the alleged injury or its sequelae lasted more than six months . . .”
Black v. Sec’y of Health & Hum. Servs., 33 Fed. Cl. 546, 550 (1995), aff’d, 93 F.3d (Fed.
Cir. 1996).
4

Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 5 of 6
While even mild symptoms that do not require intensive medical care may satisfy
the severity requirement, ongoing medical treatment for conditions unrelated to an alleged
vaccine injury do not. Compare Wyatt v. Sec’y of Health & Hum. Servs., No. 14-706V,
2018 WL 7017751, at *22–23 (Fed. Cl. Spec. Mstr. Dec. 17, 2018) (petitioner’s post-
vaccination GBS resolved within three months; subsequent ongoing medical treatment
for upper respiratory and gastrointestinal infections did not satisfy six-month requirement),
with Herren v. Sec’y of Health & Human Servs., No. 13-1000V, 2014 WL 3889070, at *3
(Fed. Cl. Spec. Mstr. July 18, 2014) (ongoing mild GBS symptoms that did not require
active medical care nevertheless satisfied severity requirement).
Because Petitioner received her vaccine on September 25, 2019, and alleges
immediate pain (or at least pain within the 48-hour Table timeframe for a SIRVA injury),
severity must be established at least through March 25-27, 2020 (six months after onset).
But as noted above, the record does not in the least establish that pain that is documented
in late September/early October likely persisted into March 2020. On the contrary—the
record indicates that Ms. Biancucci received nearly completely relief 36 days after
vaccination, and then the record is almost silent on the question for more than 15 months,
with Petitioner seeking treatment for other, unrelated issues which she does not attribute
to the vaccine (for example, a foot surgery and knee pain), and which otherwise could not
be construed as associated.
Although Ms. Biancucci was not seen again until February 2021, she claims there
is evidence of her ongoing left shoulder injury from this time forward, and that she had
left shoulder pain the entire time. Mot. at 8. Specifically, she argues that,
[t]his record does not indicate any new injury to the shoulder or offer any
indication that her shoulder pain resolved during the previous 15 months.
Rather, the record indicates a continuation of her initial injury, pain with
household activities and intermittent symptoms. Id. While this is notable, it
does not make up for the many visits made during the time without any
complaints of left shoulder pain.
Id. The medical record does establish that she was seen once for left shoulder issues in
February 2021. But the numerous medical visits Ms. Biancucci had during that 15-month
gap for other unrelated medical symptoms (at least seven separate visits) undermine her
claim of persistent injury. If Ms. Biancucci continued to experience left shoulder pain, she
would have likely been seen sooner. The gap in the record is simply too long, and too
silent, for me to conclude that six months of severity is met in this case.
5

Case 1:21-vv-00059-UNJ Document 41 Filed 12/15/25 Page 6 of 6
As Respondent noted, the facts in this case are very similar to Adkins v. Sec’y of
Health & Human Servs, No. 20-813V, 2022 WL 1134998 (Fed. Cl. Spec. Mstr. Mar. 24,
2022). In that case, I found that a petitioner did not meet the six-month severity
requirement where there was a 17-month gap between her complaints of shoulder pain,
and during which time she sought regular medical care for unrelated issues. Id. at *3.
Here, as I articulated in the Adkins case, the 15-month gap in the record during which
time Ms. Biancucci did not seek medical care for her allegedly persistent left shoulder
pain “[was] simply too long, and too silent” for her claim to meet the six-month severity
requirement. Thus, I find that there is insufficient evidence to support a finding that Ms.
Biancucci suffered the residual effects or complications of her alleged left-sided SIRVA
for more than six months after administration of the flu vaccine.
Conclusion
Based on the entire record in this case, I find that Petitioner has failed to prove by
preponderant evidence that her injury or its residual effects lasted more than six months.
Accordingly, Petitioner has not established entitlement to an award of damages (under
the Table or causation-in-fact version of the claim), and I must DISMISS the claim.
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 by each filing (either jointly
or separately) a notice renouncing their right to seek review.
6