In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: November 2, 2020
* * * * * * * * * * * * * UNPUBLISHED
ALLA GOLDMAN, *
* No. 16-1523V
Petitioner, *
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Ruling on Entitlement; Influenza
AND HUMAN SERVICES, * (Flu) Vaccine; Shoulder Injury
* Related to Vaccine Administration
Respondent. * (SIRVA).
* * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Kyle E. Pozza, U.S. Department of Justice, Washington, D.C., for respondent.
RULING ON ENTITLEMENT1
On November 6, 2016, Alla Goldman (“petitioner”), filed a petitioner for compensation
under the National Vaccine Injury Compensation Program.2 Petitioner alleges that she suffered a
left shoulder injury related to vaccine administration (“SIRVA”) as a result of receiving an
influenza (“flu) vaccination on October 23, 2015. Petition at Preamble. (ECF No. 1). Based on a
full review of all the evidence and testimony presented at the entitlement and damages hearing
held via videoconference on May 19, 2020, I find that petitioner is entitled to compensation.3
1
Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I am required to post it on the website of the United States Court of
Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. This means the
opinion will be available to anyone with access to the Internet. Before the opinion is posted on the court’s
website, each party has 14 days to file a motion requesting 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). An objecting party must provide the court with a proposed redacted version of the
opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will be posted on the
court’s website without any changes. Id.
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.
3
Pursuant to §300aa-13(a)(1), in order to reach my conclusion, I considered the entire record, including all of the
medical records, affidavits, and testimony submitted by both parties. This opinion discusses the elements of the
record I found most relevant to the present ruling on entitlement as well as a forthcoming ruling on damages, which
will fully incorporate the same factual summary.
I. Procedural History
Petitioner (by and through her original counsel at Muller Brazil LLP) filed the petition
accompanied by Petitioner’s Exhibits (Pet. Exs.) 1-6. The claim was originally assigned to the
Chief Special Master’s Special Processing Unit (SPU) docket, which is designed to expedite to
the processing of claims that have historically been resolved without extensive litigation. (ECF
No. 5). On December 21, 2016, the Chief Special Master directed respondent to file a status
report indicating how he intended to proceed in this case. Scheduling Order (ECF No. 8).
On March 21, 2017, respondent advised that he was willing to engage in discussions
regarding a reasonable settlement of petitioner’s claim. Respondent’s (Resp.) Status Report
(ECF No. 10). On April 21, 2017, petitioner advised that she had conveyed a settlement
demand. Pet. Status Report (ECF No. 13). Petitioner also filed additional records. Pet. Exs. 7-9.
Then on July 24, 2017, petitioner then advised that the parties had explored settlement but were
unable to reach an agreement. Pet. Status Report (ECF No. 20). On August 2, 2017, the SPU
staff attorney held a status conference at the parties’ request to discuss further proceedings.
Scheduling Order (ECF No. 21). Subsequently on August 22, 2017, the parties advised that they
had discussed mediation and did not believe it would be beneficial in this case. Joint Status
Report (ECF No. 22).
On October 10, 2017, respondent filed his report pursuant to Vaccine Rule 4(c) (Resp.
Rep’t) (ECF No. 23). Respondent averred that pages appeared to be missing from the records of
a July 11, 2016 appointment with a pain management specialist, Dr. Ramundo. Petitioner was
requested to obtain these records. Id. at n. 1 (referencing Pet. Ex. 5. Respondent averred that the
case was not appropriate for entitlement under the terms of the Vaccine Act. Respondent first
noted that it appeared that petitioner was claiming a SIRVA claim, but the petition was filed
prior to the addition of SIRVA as an injury on the Table. Id. at n. 2, citing 42 C.F.R. §
100.3(e)(1); Fed. Reg. 11321 (Fed. 22, 2017). Respondent averred that even if the amended
Table did apply to this petition, it would not meet the Table criteria, because (1) the
contemporaneous medical records do not support onset within 48 hours after the vaccination and
(2) there is electrodiagnostic evidence that petitioner suffers a left-sided C8 radiculopathy which
would prohibit a finding that petitioner suffered a Table SIRVA injury. Id. at n. 2.
On October 11, 2017, petitioner filed a statement from the treating physician Dr.
Ramundo in support of vaccine causation. Pet. Ex. 10. On October 13, 2017, the Chief Special
Master reassigned the claim to my docket. Order (ECF No. 26). On October 23, 2017, I held an
initial status conference with counsel. Scheduling Order (ECF No. 27).
On November 8, 2017, petitioner filed notice that she had transferred her representation
in this claim from Muller Brazil, LLP to attorney Richard Gage. Pet. Mot. (ECF No. 29).
On December 20, 2017, I held another status conference, then directed petitioner to file
updated records and explore the prospects for settlement. Petitioner also requested that I reserve
hearing dates in May 2020. The parties agreed that if the case did proceed to a hearing, it should
address both entitlement and damages. Scheduling Order (ECF No. 30).
2
On March 19, 2018, petitioner filed an amended petition expressly alleging a shoulder
injury related to vaccine administration (SIRVA) beginning within 48 hours of the influenza
vaccine, as listed on the Vaccine Injury Table. Amended Petition (ECF No. 34). Petitioner filed
additional records as Pet. Exs. 9-11.4
On June 8, 2018, the parties advised that the record appeared to be complete and that
petitioner would convey a demand to respondent within 30 days. Joint Status Report (ECF No.
41). On July 6, 2018, respondent advised that tentative settlement was discussed with
petitioner’s prior counsel, but not with current counsel. Resp. Status Report (ECF No. 42). That
same day, petitioner advised that respondent’s prior offer was inadequate for petitioner’s injury
and that further settlement negotiations would not be successful. Petitioner’s counsel wished to
retain a life care planner and proceed to the hearing which was scheduled for May 14-15, 2020.
Pet. Status Report (ECF No. 43). On August 2, 2018, I convened a status conference during
which the parties confirmed their positions. Petitioner advised that he wished to retain a life care
planner closer in time to the scheduled hearing, with which plan the respondent agreed. I
advised that absent other developments, I intended to revisit the case in approximately June
2019. Scheduling Order (ECF No. 44). Afterwards, respondent’s counsel changed from Lynn
Ricciardella to Heather Pearlman (ECF No. 45), then to Kyle M. Pozza. (ECF No. 46).
On July 1, 2019, I convened a status conference to revisit the case. Petitioner was
ordered to file outstanding records, specifically of the MRI of the cervical spine in June or July
2016 and the missing pages from the July 11, 2016 appointment with Dr. Ramundo (previously
requested in respondent’s Rule 4(c) report). Petitioner was also directed to file affidavits
addressing the onset of her shoulder injury and updated medical records. I allowed the parties to
retain life care planners, but also encouraged continued efforts towards informal resolution.
Scheduling (ECF No. 47).
On August 2, 2019, petitioner filed the missing medical records. Pet. Exs. 12-14. She
also filed supplemental affidavits from herself, her husband Walter Goldman, and her daughter
Rachel Goldman. Pet. Exs. 15-17. She also filed documentation of out-of-pocket costs. Pet. Ex.
18. Petitioner also conveyed a demand and her proposed life care plan to respondent. Pet. Status
Reports (ECF Nos. 51, 58). Respondent retained his own life care planner, who requested
additional records. Resp. Status Reports (ECF Nos. 60, 62). Petitioner filed the additional
records as Pet. Exs. 20-26.
Following a status conference on March 17, 2020, see Scheduling Order (ECF No. 71),
the parties filed their proposed life care plans. Pet. Ex. 27; Resp. Ex. A.
4
These somewhat overlap with prior filings. Mr. Gage’s Pet. Ex. 9 (ECF No. 36-1) appears to be duplicative of
Muller Brazil’s Pet. Ex. 6 (ECF No. 1-9): Institute of Neurology and Neurosurgery of St. Barnabas records
pertaining to an EMG/NCS study on August 16, 2016.
Mr. Gage’s Pet. Ex. 10 (ECF No. 36-2) contains some new records and some duplicates of records filed as Muller
Brazil’s Pet. Ex. 8 (ECF No. 18-1). Both are records from petitioner’s pain management physician Dr. Ramundo.
3
During another status conference on April 30, 2020, the parties confirmed that they
continued to discuss informal resolution, but petitioner felt that they remained too far apart on
pain and suffering. I provided my tentative views regarding a reasonable life care plan.
Scheduling Order (ECF No. 77, attaching Ct. Ex. 1 – Resp. Life Care Plan Annotated).
Afterwards, the parties filed additional information regarding equipment costs to be included in
the life care plan. Pet. Ex. 28; Resp. Ex. C. Petitioner also filed Dr. Ramundo’s curriculum vitae
(CV) as Pet. Ex. 29.
A hearing on both entitlement and damages was held via videoconference on May 19,
2020.5 The witnesses were petitioner, her husband Mr. Walter Goldman, and her treating
physician Dr. Ramundo. Respondent did not present any witnesses. See Transcript (Tr.) (ECF
No. 85). Petitioner filed a post-hearing brief on May 26, 2020 (ECF No. 82), to which
respondent responded on June 26, 2020 (ECF No. 87), and petitioner replied on July 13, 2020
(ECF No. 88). Accordingly, the matter is ripe for a ruling on entitlement.
II. Factual Record
A. Medical Records
1. Pre-Vaccination
Petitioner was born in 1959. Pet. Ex. 1 at 2. She resided in New Jersey with her husband
and daughter. She was employed as a marketing director for the Jordache Jeans brand until
approximately December 1999. See Tr. 73, 85; Pet. Ex. 23 at 10, 159.
Petitioner was determined to be disabled under the Social Security Administration’s rules
as of November 30, 1999 and entitled to Social Security Disability (SSD) benefits beginning in
May 2000. Pet. Ex. 25 at 1. The supporting medical records and paperwork reflects a working
diagnosis of chronic fatigue syndrome. See, e.g. Pet. Ex. 23 at 60, 64, 118, 119, 128, 159, 160,
162, 181, 184, 187, 189, 222, 223. Many other complaints are mentioned including fibromyalgia
with trigger points, headaches, and insomnia. The SSD file details how petitioner’s chronic
fatigue syndrome and other complaints affected her life. In August 2000, petitioner completed
an “Activities of Daily Living (ADL) Questionnaire”. She wrote that on a typical day, she would
get up very late. She would read or watch television but had trouble concentrating. She would
go out of the house to get some air. In the afternoon she would just rest or go to her doctor.
Then she would have dinner and go to bed. Pet. Ex. 23 at 19. Petitioner wrote that her husband
did the shopping and most of the house cleaning. Id. at 19-20. Occasionally they hired help for
the household maintenance. Id. at 20. Petitioner could not manage their money because of her
difficulties with concentration and memory. Id. She was too sick to cook so she ate prepared
meals. Id. She could drive only short distances without getting dizzy and fatigued. Id. Her
husband drove most of the time and for longer distances. Id. However, petitioner was able to
groom herself (e.g., washing, bathing, dressing, shaving). Id. at 23. Additionally, the SSD file
5
Due to the COVID-19 pandemic, the hearing was held via videoconference with participants located in
Washington, District of Columbia; Annapolis, Maryland; Cheyenne, Wyoming; and two locations in northern New
Jersey.
4
does not reflect any pain, limitations in range of motion, or other complaints specific to
petitioner’s left shoulder. The SSD file covers approximately 1999 – 2002.
There are no further medical records from 2002 until October 2012, which marks three
years prior to the vaccination at issue. The records from October 2012 and onward reflect that
petitioner had the same chronic conditions that were detailed in her original SSD file and she
continued to have regular appointments with her longtime primary care provider, Dr. Leon
Smith. For example, at a June 23, 2015 appointment, petitioner was recorded to have a history
of severe fatigue, right leg pain, labyrinthitis, trigger points, fibromyalgia, and insomnia. Pet.
Ex. 2 at 88. She reported some relief of muscle pain with L-carnitine. Id. She had no change in
muscle weakness or fatigue. Id. Despite the muscle weakness, she had “no limitation in range of
motion, no paresthesias or numbness, no swelling.” Id. Dr. Smith’s impression was chronic
fatigue syndrome and possible apnea for which petitioner refused a sleep test. Id. at 89.
On October 20, 2015 (three days prior to the vaccination), petitioner returned to Dr.
Smith complaining of fatigue associated with muscle pain and weakness. Pet. Ex. 2 at 81-83.
On review of the musculoskeletal system, petitioner “report[ed] myalgias” (without specifying
any particular part of the body). However, Dr. Smith recorded that she had “no joint pain. No
limitation of range of motion, no paresthesias or numbness, no swelling.” Id. at 82. Dr. Smith’s
assessment was orthostatic hypertension, dizziness, and myalgia, and fibromyalgia. Id. at 83.
2. Post-Vaccination
On October 23, 2015, petitioner received an intramuscular flu vaccination at Walgreens
Pharmacy. Pet. Ex. 1 at 2. While not indicated in the Walgreens record, the later records and
testimony provide preponderant evidence that petitioner is right-hand dominant and that she
received the vaccine in the left arm. See, e.g., Pet. Ex. 2 at 75; Pet. Ex. 3 at 21; Tr. 56-57, 95.
The first record of medical care following the flu vaccine is from January 12, 2016, when
petitioner returned to Dr. Smith. He recorded that petitioner “present[ed] with left arm pain after
receiving influenza vaccine. Associated symptoms include limited ROM. Denies swelling,
erythema. [Petitioner] reports she has difficulty carrying out daily tasks including getting
dressed, putting on a seatbelt, driving the car. Reports no relief with Tylenol.” Pet. Ex. 2 at 75.
On review of the musculoskeletal system, petitioner reported arm pain. Id. Dr. Smith recorded
on examination: “Tenderness, limited ROM to left upper arm”. Id. Dr. Smith’s assessment was
left shoulder bursitis. He advised that petitioner manage her pain by applying heat and also
taking non-steroidal anti-inflammatory medication (NSAIDs), namely the over-the-counter
medication Aleve and the prescription medication Mobic (meloxicam). He also referred
petitioner to physical therapy. Id. at 75-76.
Dr. Smith also ordered an x-ray of the left shoulder, which was performed on February
24, 2016. The report reflects a history of pain and bursitis. The impression was unremarkable.
Pet. Ex. 2 at 77.
5
On March 7, 2016, petitioner began treatment for her left shoulder at JAG Physical
Therapy. The history provides: “Patient’s shoulder pain began in OCT 2015, after she received a
flu shot in the left shoulder. Her ROM became limited in January 2016 when she followed up
with her PCP who prescribed meloxicam and PT.” Pet. Ex. 4 at 91. Petitioner reported
consistent dully/achy pain in her left shoulder that became sharp with movement; difficulty with
all functional reaching activities which impeded her self-care and ADLs, and that the pain and
discomfort interrupted her sleep pattern. Id. Petitioner rated her pain to be currently and at best
six out of ten; at worst it was eight out of ten. Id. On physical examination, petitioner could
actively bring the left shoulder on flexion to 70 degrees, abduction to 45 degrees, reach on
external rotation to her ear, and reach on internal rotation to her sacrum. Id. at 92. Petitioner had
difficulty lifting her arm against gravity due to pain. Id. Passive range of motion achieved
flexion to 110 degrees; abduction to 100 degrees, and external rotation in neutral position to 45
degrees. Id. These passive measures were also associated with pain. Id. Her left shoulder
muscle strength in all measures (flexion, abduction, internal rotation, and external rotation) were
all 3/5 compared to the right shoulder at 5/5. Id. Petitioner was also recorded to have “postural
dysfunctions and poor scapular stabilizers that affect biomechanics at shoulder with
movements.” Id. The physical therapist’s assessment was that petitioner’s primary functional
limitation was carrying, moving, and handling objects. Id. at 93. She was at least sixty per cent
(60%) but less than eighty per cent (80%) impaired in this function. Id. Her rehabilitation
potential was “good” with skilled physical therapy. Id.
On March 29, 2016, Dr. Smith recorded that petitioner had persisting left shoulder pain
with some relief from NSAIDs and physical therapy. Dr. Smith maintained the diagnosis of
bursitis. Pet. Ex. 2 at 61-63.
Dr. Smith also ordered an MRI of the left shoulder which took place the following day,
March 30, 2016. The original report provides: “History: 2 months of shoulder pain and limited
range of motion.” Pet. Ex. 3 at 23. On April 5, 2016, the same radiologist noted “an error in the
clinical history of this patient. The clinical history should read: “History: Shoulder pain and
limited range of motion since the end of October.” Id. at 22-24. The findings were suggestive of
adhesive capsulitis and mild glenohumeral joint osteoarthritis. Id. at 23.
On April 12, 2016, Dr. Smith recorded petitioner’s repeated history of left shoulder pain
after receiving flu vaccine. Pet. Ex. 2 at 56. She had been attending physical therapy but had
missed the last two weeks due to cold symptoms. Id. Consistent with the shoulder MRI report,
Dr. Smith’s impression was left shoulder adhesive capsulitis. Id. at 57, 58. Dr. Smith planned
continued physical therapy, NSAIDs, and a referral to an orthopedist. Id. at 57.
Petitioner had attended regular physical therapy sessions three times a week through to
March 30, 2016. Pet. Ex. 4 at 67. She then missed nearly a month of physical therapy due to a
“severe case of the flu.” She resumed physical therapy on April 25, 2016. Id. at 66. On May
18, 2016, she was discharged from physical therapy due to reaching the Medicare reimbursement
cap for physical therapy sessions and being unable to choose the self-pay option. Id. at 50.
6
On June 1, 2016, petitioner (on referral from Dr. Smith) presented as a new patient to
Columbia University Medical Center, Orthopedics Center. Petitioner completed a new patient
intake form on which she endorsed a history of chronic fatigue syndrome. Pet. Ex. 3 at 19. On
review of systems, petitioner endorsed numerous symptoms within the past six to twelve (6 – 12)
months including headache. Id. at 20. The specific reason for the visit was “Shoulder pain/
injury (left)”. Id. at 19. Petitioner provided additional information about the left shoulder injury
including that it occurred “following flu shot on Oct. 23, 2015”. Id. at 21, 22. The pain was
associated with “limited range of motion.” Id. at 21, 22. It was also associated with “neck pain,
headache.” Id. at 22. During this appointment, the orthopedist, Dr. Christopher Ahmad,
recorded: “She has had many months of left shoulder pain, onset in early October.” Pet. Ex. 3 at
15. Three months later, Dr. Ahmad amended his record to note that the intake form reflected
onset of left shoulder pain following a flu shot on October 23, 2015. Id. At this June 1, 2016,
appointment, Dr. Ahmad conducted a physical exam and recorded an impression of: “Left
shoulder glenohumeral joint arthritis and rotator cuff tendinosis.” Id. Dr. Ahmad discussed
treatment options. Petitioner declined a cortisone injection. Id. Accordingly, Dr. Ahmad
recommended NSAIDs and further physical therapy. Id.
On June 8, 2016, petitioner completed a patient health questionnaire for purposes of
resuming treatment at JAG Physical Therapy, including the following fields:
1. Describe your symptoms: Left shoulder/ upper arm, neck pain, headaches.
a. When did your symptoms start?: Following the flu shot of 10/23/2015.
b. How did your symptoms begin?: With severe shoulder pain.
Pet. Ex. 4 at 6. Petitioner also endorsed having a history of headaches. Id. at 7.
At the June 13, 2016 physical therapy re-examination, petitioner reported that since
stopping therapy a month prior, her left shoulder condition had regressed. She was moderately
impaired in all ADLs and self-care activities such as brushing and washing her hair, washing her
back, overhead reaching, lifting, carrying, and pushing objects. Pet. Ex. 7 at 61. Petitioner also
reported that her pain remained at best six out of ten and at worst eight out of ten. Id. However,
compared to the initial evaluation in March 2016, the objective findings were slightly improved.
Petitioner could achieve active flexion to 85 degrees and active abduction to 90 degrees, albeit
with pain. Id. at 62. She was between forty per cent (40%) and sixty per cent (60%) impaired.
Id. Her rehabilitation potential with skilled therapy remained “good”. Id. This appointment
marked the resumption of regular physical therapy sessions approximately three times per week,
as before.
The primary care provider Dr. Smith referred petitioner to Giovanni Ramundo, M.D.6
Dr. Ramundo continued to treat petitioner over the subsequent years; wrote a September 2017
6
With regard to qualifications, Dr. Ramundo graduated from Lafayette College with a bachelors’ degree in Biology,
with honors, in 1986. Pet. Ex. 29 at 2. He obtained a medical degree from Penn State University – the Milton S.
Hershey Medical Center in 1990. Id. He then served as an internal medicine intern from 1990 – 1991; an
anesthesiology resident from 1991 – 1993; and an anesthesiology chief resident from 1993 – 1994. Id. Dr.
Ramundo worked at a clinical anesthesiology practice in Florida from 1994 – 1996. Id. Afterwards, he returned to
Hershey Medical Center where he served as a pain medicine fellow and clinical instructor from 1996 – 1997. Id. In
1997, Dr. Ramundo began practicing pain medicine in the state of New Jersey. Id. He opened his current practice,
7
“narrative report” supporting that the October 2015 flu vaccination caused her left shoulder pain
and limited range of motion (with sequelae of left arm weakness, pain radiating into the neck,
and headaches); and testified at the 2020 hearing on entitlement and damages. The following
section relies primarily on his contemporaneous medical records, with additional detail from his
narrative report and his testimony at the May 2020 hearing.
At the June 27, 2016 initial consult, Dr. Ramundo recorded that petitioner had a history
of chronic fatigue syndrome. Pet. Ex. 5 at 14. But at that visit, her chief complaint was “left
shoulder pain that radiates into her neck. Her pain was associated with headaches. She has also
noticed she has weakness in the left arm compared to the right. Pain started about 8 months ago,
after a flu shot, before the flu shot she never had this pain.” Id. Dr. Ramundo observed limited
range of motion on examination and his initial impression was cervicalgia. Id. at 17.
At the hearing, Dr. Ramundo opined that the neck and shoulder are closely related. Pain
originating in the shoulder can radiate to the neck; conversely, pain originating in the neck can
radiate to the shoulder. Both scenarios can be confusing. The key with any pain condition is to
make the right diagnosis. Accordingly, Dr. Ramundo will painstakingly rule out any other
pathology as the course of pain. Tr. 8-10.
In petitioner’s case, Dr. Ramundo first ordered an MRI of the cervical spine, see Pet. Ex.
5 at 17, which occurred on June 28, 2016, Pet. Ex. 12 at 1. The original report provides: “One-
month history of neck and left shoulder pain.” Id. Approximately two weeks later, the same
radiologist entered an addendum providing that was an error and the history should read: “One-
month history of neck pain AND LEFT SHOULDER PAIN SINCE 2015.” Id. at 2. Of note,
there was “no evidence for disc herniation, central stenosis, or neural foraminal stenosis” at C7-
T1. Id. The impression was: “Mild degenerative changes of the cervical spine with mild right-
sided foraminal narrowing at C4-5 and no lateralizing findings on the left. Tiny left-sided
thyroid nodule.” Id.
On July 11, 2016, petitioner returned to Dr. Ramundo who reviewed the MRI report, then
ordered an EMG “to determine where her left arm pain is coming from.” Pet. Ex. 19 at 3. He
also recommended additional physical therapy and unspecified injections. Id. He recorded that
petitioner “prefer[red] to avoid surgery if possible.” Id.
On August 5, 2016, petitioner was again discharged from physical therapy due to
reaching the Medicare reimbursement cap. She was instructed to follow a home exercise
program until she was recertified. Pet. Ex. 7 at 33-34.
At a follow-up appointment on August 16, 2016, Dr. Smith recorded that petitioner was
“refusing the surgical option for her frozen shoulder”. Pet. Ex. 2 at 3.
Pain Medicine Physicians LLC in Millburn, New Jersey, in 2012. Id. His board certifications include pain
medicine, EMG testing, and anesthesiology. Id. Dr. Ramundo testified that his current practice is “probably 90
percent pain, 10 percent anesthesia.” Tr. 7.
8
On August 23, 2016, Dr. Ramundo recorded that petitioner continued to have pain in her
left shoulder, pain radiating into her neck, headache, and weakness in the left arm compared to
the right. Pet. Ex. 5 at 7. Petitioner rated her current pain at three or four out of ten. Id. This
pain interfered with her sleep. Id. Dr. Ramundo reviewed an EMG/NCS which showed
“electrodiagnostic evidence for chronic and ongoing mild left C8 radiculopathy [and] a mild left
median neuropathy at the wrist as seen in carpal tunnel syndrome”, without evidence for a left
ulnar neuropathy or left brachial plexopathy. See Pet. Ex. 6. However, Dr. Ramundo recorded:
“Her pain is not in a C8 pattern”. Pet. Ex. 5 at 11. He noted the temporal association with the
flu vaccine. Id. His assessment was bursitis and frozen shoulder (also known as adhesive
capsulitis). Id. at 7-8. He recorded: “She is not interested in any injections at this time because
she feels her pain problem is from the vaccine injection and does not want any more injections.”
Pet. Ex. 5 at 7-11; see also Pet. Ex. 10 at 2; Tr. 12-14.
On September 7, 2016, the orthopedist Dr. Ahmad saw petitioner on follow-up. He
conducted a physical exam. He reviewed the EMG report with an impression of chronic, mild
left C8 radiculopathy and mild left median neuropathy at the wrist as seen in carpal tunnel
syndrome. Pet. Ex. 3 at 9. Dr. Ahmad’s impression was: “left shoulder glenohumeral joint
arthritis and rotator cuff tendinitis with cervical radiculopathy and mild carpal tunnel syndrome.”
Id. However, Dr. Ahmed did not seem to review the MRI of the cervical spine which did not
have any significant findings that would correlate with a C8 radiculopathy. This MRI had been
ordered by Dr. Ramundo and obtained on June 28, 2016, prior to the September 7, 2016 follow-
up with Dr. Ahmad. Thus, Dr. Ahmad’s assessment of a cervical radiculopathy was not based on
all of the available information and is therefore less persuasive. Dr. Ahmad and petitioner
discussed again the treatment options including arthroscopy, cortisone injection, and physical
therapy. Id. at 10. Petitioner chose to continue with physical therapy. Id. The record provides
that petitioner would follow up with Dr. Ahmad in four to six weeks, but there are no further
records from his practice. Id.
After a one-month gap, on September 7, 2016, petitioner had a physical therapy
recertification. She continued to complain of left shoulder pain, again rated at best six out of ten
and at worst eight out of ten. However, the “frequency and duration ha[d] improved”. Pet. Ex. 7
at 27. Petitioner continued to report similar restrictions to ADLs due to pain, weakness, and
fatigue through the left upper extremity. Id. The left shoulder objective findings were again
slightly improved, with active flexion to 90 degrees, active abduction to 100 degrees, and
external rotation beyond the ear to the sub-cranial region. Id. at 28. She also had improved
passive range of motion with flexion to 115 degrees, abduction to 110 degrees, external rotation
to 80 degrees, and internal rotation to 20 degrees. Id. These measures were associated with
pain. Id. The physical therapist recorded: “Every time patient stops PT she returns with less
functional abilities and decreased ROM. Pain intensity and frequency has decreased with PT…”
Id. at 29.
In fall 2016 with the resumption of physical therapy, petitioner had decreased pain but
continued weakness in the left shoulder. On September 21, 2016, she reported: “My pain is
tolerable but the weakness is what is most bothersome to me now.” Pet. Ex. 7 at 23. On
September 28, 2016, “the weakness is what is bothering [petitioner] most lately.” Id. at 21. On
October 5, 2016, she reported: “The pain came back a little this weekend but then went away.
9
The weakness is still there.” Id. at 19. On October 19 and again on October 26, 2016, the
weakness was “the most troublesome.” Id. at 15, 17. At the next several appointments,
petitioner’s primary concern was neck pain. Id. at 9, 11, 13. On November 30, 2016, petitioner
reported that within the past few weeks, her pain had improved to the point that it was “minimal
during her ADLs.” Id. at 7. She rated her pain to be at best zero out of ten, at present three out
of ten, and at worst eight out of ten. Id. She had continued weakness which disrupted ADLs
such as reaching into a cabinet, picking up heavy objects or even a jug of water, or certain self-
care tasks such as washing her hair. Id. She reported that she was also experiencing weakness in
her lower extremities for which she would follow up with a doctor. Id. Petitioner provided a
similar report at another session on December 7, 2016, see also id. at 1-2, after which there is a
gap in the physical therapy records.
On December 14, 2016, Dr. Ramundo recorded a similar description of petitioner’s left
shoulder pain and neck. She also had new pain in her mid-back and weakness in her lower
extremities. Dr. Ramundo ordered an MRI of the lumbar spine and an EMG/NCS of the bilateral
lower extremities. Pet. Ex. 8 at 17-20; see also Pet. Ex. 10 at 2; Tr. 15-16.
On January 23, 2017, Dr. Ramundo recorded that petitioner had taken a break from
physical therapy “due to insurance not paying for visits and she will resume next week.” Pet. Ex.
8 at 12. Dr. Ramundo recorded: “Her main concern is the weakness and tingling in lower
extremities right worse than left, left arm weakness, and her low back pain. Left shoulder pain
radiates into her neck and is associated with left-sided headaches. Her shoulder and back pain
both interfere with her sleep. Currently she rates her left shoulder and back pain a 5/10.” Id.
Petitioner was still taking the NSAID meloxicam for her pain. Id. Dr. Ramundo reviewed that
an MRI of the lumbar spine revealed a right L4 and L5 radiculopathy. Id. at 14. Dr. Ramundo
planned an EMG of the lower extremities to evaluate for her weakness. Id. at 14; see also Pet.
Ex. 10 at 2. Dr. Ramundo testified that at this point, physical therapy was “absolutely”
beneficial for her left shoulder and that should be continued. Tr. 16-18.
On February 27, 2017, Dr. Ramundo recorded that as a result of her mother passing
away, petitioner still had not resumed physical therapy. Pet. Ex. 8 at 8. She was doing only
home exercises that were not providing any relief. Id. Dr. Ramundo recorded: “Currently she
rates her left shoulder and back pain a 5/10. Her left shoulder and low back pain both interfere
with her sleep… She has not had prior treatment for her low back. She currently rates her back
pain at a 6-7/10.” Id. Dr. Ramundo was still waiting for the EMG/NCS to evaluate petitioner’s
lower extremity weakness. Id. at 11. He wrote that if the weakness continued, petitioner would
need to see a neurologist and possibly a spine surgeon. Id. However, petitioner wanted to do
physical therapy and see if the weakness would resolve on its own. Id. Dr. Ramundo testified
that he recommended also resuming physical therapy for her left shoulder because: “When she
did therapy, she felt better. Her pain was diminished. Ultimately, I think it would minimize her
risk of developing an adhesive capsulitis to the point where she would lose range of motion in
the entire shoulder.” Tr. 18. Dr. Ramundo also believed that physical therapy might help
somewhat with the left arm weakness. Id.
10
On March 20, 2017, Dr, Ramundo recorded that the EMG confirmed right L4 and L5
radiculopathies. Pet. Ex. 8 at 1. In addition, petitioner had “continued left shoulder pain that
seems to be getting wors[e] since she has not been undergoing PT. She states reaching is
difficult and painful compared to her right shoulder.” Id. Petitioner rated both “her left shoulder
and back pain at 5/10. Her left shoulder and low back pain both interfere with her sleep.” Id.
Dr. Ramundo recorded: “The plan is to start physical therapy for her neck pain, left shoulder
pain, and low back pain. Patient was getting relief from PT for her left shoulder therefore she
will start it for her neck and low back.” Id. at 4; see also Pet. Ex. 10 at 2; Tr. 18-19.
On April 12, 2017, petitioner was reexamined at JAG Physical Therapy for “pain in
shoulder and neck with frequent occurrence of HA [headaches]”, which was associated with
“overhead reaching, lifting, carrying, pushing, and pulling.” Pet. Ex. 9 at 4. She reported that
her left shoulder pain was at best zero out of ten, at present three out of ten, and at worst eight
out of ten. Id. Since the last physical therapy appointment several months prior, petitioner’s
active range of motion had improved; flexion was to 150 degrees and abduction to 100 degrees.
Id. at 5. She had maintained external rotation to the subcranial area and internal rotation to the
sacrum. Id. During this physical therapy examination, petitioner also reported “LE [lower
extremity] weakness leading to dysfunction when getting dressed in the morning, cooking,
cleaning, and performing housework… prolonged standing, bending, squatting, and walking < 1
mile”. Id. at 4. She reported that her lower back pain was zero out of ten, at present four out of
ten, and at worst four out of ten. Id. The physical therapist developed a plan of treatment for the
left shoulder and would follow up with petitioner’s doctor (presumably Dr. Ramundo) on the
objective findings relating to her lower extremities. Id. at 7. There are no further records from
JAG Physical Therapy; as discussed below, petitioner underwent additional physical therapy to
Dr. Ramundo’s practice Pain Medicine Physicians LLC.
On July 10, 2017, Dr. Ramundo recorded that petitioner had completed the course of
physical therapy. She rated both her left shoulder pain and low back pain to be approximately
4/10. Both interfered with her sleep. Petitioner still did “not wish to have any injections or
surgeries” and wanted to continue conservative treatment. Gage Pet. Ex. 10 at 9. Dr. Ramundo
recommended further physical therapy. Id. at 12; see also Pet. Ex. 10 at 2; Tr. 19-21.
In August 2017, petitioner began treatment with Joseph Musso, C.C.S.P., at the Musso
Chiropractic Center for a total of four complaints: 1) bilateral neck pain; 2) bilateral low back
pain; 3) bilateral mid-back pain; and 4) left shoulder pain. Pet. Ex. 11 at 1. Dr. Musso recorded
on physical examination of the left shoulder that flexion was to 160 degrees, extension to 40
degrees, internal rotation to 80 degrees, external rotation to 70 degrees, abduction to 140 degrees,
and adduction to 25 degrees. Id. at 3. Most of these measures were achieved with “moderate
pain”. Id.7
7
Dr. Musso’s record does not state whether these measures are of active or passive range of motion. During the
hearing, Dr. Ramundo reviewed this record and testified that his understanding was that Dr. Musso was measuring
passive range of motion. Tr. 22.
11
On September 25, 2017, Dr. Ramundo wrote a narrative report. After reviewing
petitioner’s past medical history, work-up and treatment, he wrote:
My impression at this time is that her chronic pain syndrome is secondary to the
left flu shot. She may have been predisposed to a cervical radiculopathy and
lumbar radiculopathy, but all her complaints occurred after her flu shot. The flu
shot led to an adhesive capsulitis in the left shoulder and I believe this affected the
mechanics of her neck. Her EMG did show a C8 radiculopathy; however, she did
not have any significant pathology noted on MRI at C7-T1. She had some mild
degenerative changes of the cervical spine with some right-sided foraminal
narrowing at C4-5, but all her pain complaints were on the left side involving the
shoulder. In my medical opinion, her chronic neck pain, shoulder pain, and
headaches are secondary to the flu shot that she received because there is not
enough pathology warranted on MRI to cause the type of pain syndrome that she
has.”
Pet. Ex. 10 at 3; see also Tr. 26-28.
On October 23, 2017, Dr. Ramundo recorded that petitioner rated her left shoulder pain at
four out of ten. She was unable to raise her shoulder above 90 degrees due to pain. Her pain
varied depending on her activity level. She was taking meloxicam when her pain was severe.
Pet. Ex. 10 at 27-30.
Four months into the course of chiropractic treatment, on December 15, 2017, Dr. Musso
recorded that petitioner’s left shoulder flexion was to 170 degrees, extension to 45 degrees,
internal rotation to 80 degrees, external rotation to 70 degrees, abduction to 160 degrees, and
adduction to 30 degrees. Pet. Ex. 11 at 47. These measures were achieved with “mild pain”. Id.
The further chiropractic records – dating to May 2019 – list petitioner’s complaints of and
treatments for pain in the left shoulder as well as neck, mid-back and lower back. However, the
further records do not include further physical examinations of the left shoulder. See generally
Pet. Ex. 11 at 49-70; Pet. Ex. 13; Pet. Ex. 21.
On January 16, 2018, Dr. Ramundo recorded that petitioner again presented with left
shoulder pain. She was having difficulty lifting overhead, putting on clothes, combing her hair,
and lifting grocery bags, pots, and pans. She rated her shoulder pain with activity as nine out of
ten. Pet. Ex. 10 at 39-41. Dr. Ramundo testified that a person with this level of pain would
barely be able to get out of bed. Tr. 30.
Also on January 16, 2018, at the same practice of Pain Medicine Physicians LLC,
petitioner began physical therapy. The “chief complaint” listed low back pain which was
associated with difficulty sitting, standing for more than fifteen minutes, walking more than two
blocks, lifting grocery bag, bending over and tying her shoe laces, and putting on her pants.
Gage Ex. 10 at 39. The “chief complaint” also listed left shoulder pain which was associated
with moving overhead, fastening a bra behind her back, putting on other clothes, doing her hair,
and lifting grocery bags, pots, and pans. Id. The physical therapist planned a course of treatment
which would address both her low back and her left shoulder issues. Id. at 41.
12
Dr. Ramundo continued to see petitioner over the next two years. His last medical record
filed is from February 4, 2020, at which petitioner reported shoulder pain at four out of ten. She
also had pain in her low back and her knee. She was taking several alternative medicines (milk
thistle, Boswellia, turmeric root extract). Pet. Ex. 22 at 6. She also had a prescription for
meloxicam, specifically 7.5 mg, 1 tablet per day. Id. However, petitioner took meloxicam “only
when her pain was severe”. Id. at 9.
Dr. Ramundo testified that at this point, petitioner had “chronic” and “permanent” left
shoulder pain, limited range of motion, and limited activities of daily living. She will always
need to “wal[k] the tight rope” between too little activity (which will further decrease her range
of motion) and too much activity (which will be associated with increased pain). Tr. 40-41. Dr.
Ramundo testified that physical therapy and chiropractic treatment were both helpful in
maintaining the range of motion petitioner had, although that remained abnormal and she
continued to have pain. Dr. Ramundo testified that at this point, petitioner’s shoulder injury
appeared to be chronic and not going away. Tr. 22-26, 29, 31-42.
Dr. Ramundo summarized that petitioner developed bursitis. Tr. 13. He explained that
the bursa is a soft fluid sac which allows tendon to slide in the shoulder under bones without
causing friction. Id. at 14. Inflammation of the bursa can cause bursitis, which causes pain with
movement. Id. Dr. Ramundo opined that petitioner also developed adhesive capsulitis (also
known as frozen shoulder). Id. at 15. He concluded that these conditions were “referring pain
up to her neck, and then the neck was going into spasm because of the decreased range of motion
of the left shoulder, and that was causing headaches.” Tr. 10. Dr. Ramundo opined that
petitioner was the first individual he had treated for a shoulder injury related to vaccine
administration (SIRVA). Tr. 42-43. He opined that “millions of flu shots are given, and it’s a
very uncommon finding.” Id. at 43.
Dr. Ramundo testified that when he first evaluated petitioner, he was not aware that she
previously applied for Social Security Disability based on chronic fatigue syndrome and
additional symptoms, including headaches. Tr. 44-45. However, he had been aware that Dr.
Smith had made the assessment of chronic fatigue syndrome. Tr. 46-47. Dr. Ramundo opined
that the flu vaccination caused petitioner’s left shoulder pain and limited range of motion (and as
described above, sequelae extending to left arm weakness; neck pain; and headaches). He did
not opine that the flu vaccination caused or contributed to lower back or lower extremity
symptoms. Id. at 43, 49-50.
B. Additional Affidavits and Testimony
1. Alla Goldman
At the entitlement hearing, petitioner was questioned about the August 2000 ADL
questionnaire (described above) and asked whether her routine differed significantly in the year
leading up to the October 23, 2015 flu vaccination. Tr. 81-83. She recalled cooking meals
“sometimes”, “no more than two” dinners per week. Tr. 83-84. She recalled doing “not
extensive house cleaning” but some simple vacuuming and dusting. Tr. 84. Petitioner also
13
recalled that she was driving to some extent. Tr. 87. Petitioner also stated: “I was not in pain
[before the vaccine].” Tr. 87-88.
Petitioner testified that she had previously received vaccinations at medical offices. In
that setting, she sat on an exam table and the doctor was level with her. Tr. 57. In contrast, upon
receiving the 2015 vaccine at Walgreens, she recalled “sitting on the low bench, fully dressed,
with just my left sleeve pulled down a little, and the pharmacist was standing right above me,
and I just know that we were not leveled.” Tr. 56-57. She recalled that the pharmacist
administered the vaccination in her “left upper arm”. Tr. 56. She confirmed that she was right-
hand dominant. Tr. 97.
Petitioner testified that upon receiving the vaccination, it hurt initially “as… usual”. Tr.
58. But then, as the day went on, she continued to have pain which was severe. Id.
I asked whether petitioner remembered the time of day that she received the vaccination.
Tr. 58. She believed that it was in the afternoon. Id. Petitioner stated that she had pain at
dinnertime. Tr. 59. She rated this pain as eleven on a scale from zero out of ten. Tr. 59-60.
Petitioner recalled having difficulty sleeping on her left side “almost immediately”. Pet.
Ex. 15 at ¶ 4; Tr. 60, 92. She also recalled having difficulty getting dressed, especially putting
her arm into sleeves, beginning the first morning after the vaccination. Pet. Ex. 15 at ¶ 4; Tr. 60,
92. She also recalled having difficulty reaching things overhead and fastening her seat belt. Tr.
60. Her husband helped as much as he could, but he was not always around. Id.
Petitioner recalled that at first, she took over-the-counter pain medications (e.g., Tylenol,
Aleve) and hoped that her pain would go away over time. However, it persisted throughout
November and December 2015. Pet. Ex. 15 at ¶¶ 6-7; Tr. 58-61. Her husband wanted her to
seek medical attention. Pet. Ex. 15 at ¶ 7; see also Tr. 62. However, her primary care provider,
Dr. Smith, was away for the holidays and she had an appointment scheduled for January; she
decided to hold off until then rather than seeing a different doctor. Pet. Ex. 15 at ¶ 7; see also Tr.
61-62, 92-93. On January 12, 2016, petitioner had the scheduled appointment with Dr. Smith,
who assessed bursitis and recommended physical therapy. Pet. Ex. 15 at ¶ 8; Tr. 62-63.
Petitioner testified that physical therapy was helpful. Pet. Ex. 15 at ¶ 14; Tr. 63.
However, in summer 2016, she continued to have left shoulder pain (which was “not as severe as
it was in the beginning”, but still present), limited range of motion, and weakness. She had
difficulty with simple household tasks and driving a car. Tr. 64-65. At this point, Dr. Smith
referred to Dr. Ramundo, who prescribed further physical therapy, chiropractic treatment,
alternative medications, and a TENS unit. Tr. 66-69. Petitioner testified that she continues all of
these recommendations, which are all helpful, especially the physical therapy and chiropractic
treatment, without which her shoulder pain and range of motion get worse. Tr. 66-69, 73-74; see
also Pet. Ex. 15 at ¶ 14. On cross-examination, petitioner acknowledged that at physical therapy
sessions, she “gets something done for [her] back” but stated that “most concentration is… on
[her] shoulder”. Tr. 93.
14
Petitioner confirmed that she has not undergone surgery for her left shoulder. Tr. 93.
Neither has she received any steroid injections for her left shoulder. Tr. 94. Dr. Ramundo
suggested a steroid injection once, but petitioner refused because she is “absolutely terrified of
needles, especially knowing that all this started with a simple needle.” Id. Petitioner also
averred that Dr. Ramundo said that any steroid injection would provide only a “temporary”
benefit which “would help to some extent, but it would have to be repeated.” Tr. 94-95.
Petitioner testified that she is also concerned about the side effects of both steroids and
meloxicam. Tr. 94-95.
Petitioner testified that on a good day, her left shoulder pain is rated at about two or three
out of ten. Tr. 70; see also Pet. Ex. 15 at ¶ 13. When she is more active, her pain level increases
to five or six out of ten. Tr. 70-72; Pet. Ex. 15 at ¶ 10. Petitioner understands her condition to be
permanent. Tr. 73-74.
2. Petitioner’s Husband
Petitioner’s husband submitted an affidavit dated July 30, 2019. Pet. Ex. 16. He also
testified at the hearing. Tr. 97-106. The husband testified that throughout the relevant time, he
has worked full-time in sales. Tr. 101-02. He went into the office every day. Id. at 102.
Because of petitioner’s chronic fatigue syndrome diagnosis, he was already “doing most of the
shopping” and “the heavy-duty homework”. Tr. 103; see also id. at 105-06.
He averred: “Following my wife’s flu shot on October 23, 2015, she was talking about
how uncomfortable and stiff her left shoulder and arm felt.” Pet. Ex. 16 at ¶ 2. He testified that
when he came home from work that day, petitioner “was complaining of unusual pain and
numbness in her arm and shoulder, which was kind of unusual because she had previous flu
shots and never had the same feeling.” Tr. 98-99. He recalled that this was on a Friday night.
Tr. 104.8
He averred that petitioner experienced “pain that was progressing daily.” Pet. Ex. 16 at ¶
3. He testified that the initial pain was “unbearable.” Tr. 99. She had pain and stiffness “in the
initial day or two”, “increasing gradually”. Tr. 99-100. He noticed that she was having
difficulty brushing her hair and holding objects within the first week after the flu vaccination.
Tr. 105.
The husband recalled that petitioner continued to have increasing pain and stiffness in her
left shoulder throughout November and December 2015. Id. at 99-100. The husband testified
that during the holidays, they would usually see friends, but that was more difficult because
petitioner was in constant pain and did not want to see anyone. Id. at 100. Throughout this
period, petitioner’s pain was increasing day by day, and she was crying as a result, but she
waited for her previously scheduled appointment with Dr. Smith in January 2016. Id.; see also
Pet. Ex. 16 at ¶ 7.
8
See also October 2015 calendar, available at
https://www.timeanddate.com/calendar/monthly.html?year=2015&month=10&country=1 (reflecting that the date of
vaccination, October 23, 2015, was a Friday).
15
The husband testified that petitioner has good days and bad days. Tr. 101. While he
already did most of the shopping and housework, since petitioner sustained this left shoulder
injury, he does a greater share and also helps with her activities of daily living, such as getting
dressed. Id. at 102-03. Petitioner’s more or less “constant” pain also affects her mood, which
has an impact on their relationship. Id. at 103.
3. Petitioner’s Daughter
Petitioner’s adult daughter also submitted an affidavit dated August 1, 2019. Pet. Ex. 15.
She averred: “Following my mother’s flu shot on October 23, 2015, she experienced unusual
shoulder discomfort and pain.” Id. at ¶ 2. The daughter also averred, consistent with the other
witnesses, that petitioner’s symptoms worsened over time but she put off seeking medical
attention until her prescheduled appointment with Dr. Smith in January 2016. Id. at ¶¶ 3-5. The
daughter did not testify at the hearing.
III. Finding of Fact
Prior to determining vaccine causation, there is one factual issue that must be resolved.
The question is whether petitioner suffered the onset of left shoulder pain within 48 hours after
receipt of the flu vaccination on October 23, 2015.
A. Legal Standard
Petitioner bears the burden of establishing the facts necessary for entitlement to an award
by a “preponderance of the evidence.” § 300aa-12(a)(1)(A). The special master “may not make
such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by
medical opinion.” § 300aa-13(a)(1).
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records, which are required to be filed with the petition.
§11(c)(2). The Federal Circuit has made clear that medical records “warrant consideration as
trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d at 1528. Medical
records that are created contemporaneously with the events they describe are presumed to be
accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems).
Cucuras, 993 F.2d at 1528.
Accordingly, where medical records are clear, consistent, and complete, they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always
apply. In Lowrie, the special master wrote that “written records which are, themselves,
inconsistent, should be accorded less deference than those which are internally consistent.”
Lowrie, at *19.
The Court of Federal Claims has recognized that “medical records may be incomplete or
inaccurate.” Camery, 42 Fed. Cl. at 391. The Court later 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
16
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 &
Human 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, 42 Fed. Cl. at 391
(citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed.
Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must
also be determined. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir.
2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
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 § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Human
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. Party Contentions
Respondent contends that the medical records do not establish that petitioner suffered the
first symptoms or manifestation of onset of a shoulder injury within 48 hours of the October
2015 flu vaccination. Respondent observes a gap in the medical records between the October 23,
2015 flu vaccination and the next medical encounter on January 12, 2016. Respondent argues
that the January 12, 2016 encounter does not clearly establish the onset of pain, indicating only
“that the pain occurred ‘after’ the flu vaccine.” Resp. Report at 5, citing Pet. Ex. 2 at 75.
Respondent also argues that at the initial physical therapy evaluation on March 7, 2016,
“petitioner reported that her range of motion in her affected shoulder was not limited until
January 2016, over two-and-a-half months after her October 23, 2015, flu vaccination.” Resp.
Report at 5, citing Pet. Ex. 4 at 91.
After the submission of additional affidavits and testimony at the May 2020 hearing,
respondent maintains that petitioner has not established onset within 48 hours. Respondent
avers: “[I]t is undisputed that petitioner did not seek medical treatment until January 12, 2016,
which is over two months post-vaccination.” Resp. Post-Hearing Brief at 2, citing Tr. 61:15-20.
“And the only evidence that her pain began within 48 hours after vaccination is petitioner’s own
testimony, which is insufficient as a matter of law.” Resp. Post-Hearing Brief at 2-3, citing 42
U.S.C. § 300aa-13(a)(1).
Petitioner maintains that she has established onset within 48 hours of the flu vaccination.
She avers that it is illogical to require production of “medical records from the time of onset or
lose as a matter of law.” Pet. Post-Hearing Reply at 1. Petitioner avers that especially in a
SIRVA case, there are many reasons for not seeking immediate treatment. Id. Petitioner avers
that she initially thought that her shoulder pain would go away without medical intervention and
17
it was not life-threatening. Id. at 1-2. Petitioner also observes that the Vaccine Act requires that
a special master make a determination based on the record as a whole. Id. at 2, citing 42 U.S.C.
§ 300aa-13(a)(1). Moreover, a special master may find that the time period for the first symptom
or manifestation of onset required for a Table injury is satisfied “even though the occurrence of
such symptom or manifestation was not recorded or was incorrectly recorded as having recorded
outside such a period”. Id., citing 42 U.S.C. § 300aa-13(b)(2). A determination of onset must
instead be based on “a preponderance of the evidence”. Id., citing, e.g., Tenneson v. Sec’y of
Health & Human Servs., No. 16-1664v, 2018 WL 3083140 at *5 (Fed. Cl. Spec. Mstr. Mar. 30,
2018) (holding that despite a six-month delay in seeking treatment, the petitioner established
onset of shoulder pain within 48 hours), mot. for rev. denied, 42 Fed. Cl. 329 (2019). Petitioner
argues that similar to the petitioner in Tenneson, she did not seek immediate treatment for her
shoulder injury, but a preponderance of evidence – including Dr. Ramundo’s later medical
records and her own testimony – support onset after the flu vaccination. Pet. Post-Hearing Reply
at 3. She argues that “there is no cause to dispute immediate onset.” Id.
C. Discussion and Conclusion
Following a review of the entire record and the parties’ briefs, I find that there is
preponderant evidence that petitioner experienced the onset of left shoulder pain within 48 hours
of the flu vaccination administered on October 23, 2015.
First, the lack of contemporaneous medical records reflecting petitioner’s left shoulder
injury until January 12, 2016 does not defeat petitioner’s claim. There are no medical encounters
in the intervening period. The available records reflect that petitioner relied on periodic
scheduled appointments with her established primary care provider, Dr. Smith, for her
longstanding chronic fatigue syndrome and associated symptoms. Petitioner avers consistently
throughout her affidavit, testimony, and post-hearing reply brief that she waited until her next
scheduled appointment with Dr. Smith on January 12, 2016, to seek treatment for her new
shoulder injury. Petitioner also avers that she initially treated the shoulder with over-the-counter
pain medications and hoped that it would get better. She did not believe the injury to warrant
emergency attention. She additionally described that the shoulder pain and limitations to range
of motion were “progressive” leading up to that appointment with Dr. Smith.
Once petitioner did seek medical attention for her left shoulder, the records consistently
reflect a temporal association with the flu vaccine. In the first record on January 12, 2016, Dr.
Smith recorded simply: “left arm pain after receiving influenza vaccine”. Pet. Ex. 2 at 75.
While Dr. Smith does not expressly state that this pain began within 48 hours of the vaccine, he
does not suggest any longer period of time either. Dr. Smith’s record certainly indicates that
petitioner dated and attributed the onset of her pain to the receipt of her flu shot, which is
consistent with petitioner and her husband’s later, more detailed recollections in affidavits and
testimony. I am not inclined to construe the record against petitioner merely because Dr. Smith
did not specifically note onset beginning within 48 hours, which is a legal and not a medical
standard.
18
Respondent emphasizes that the March 7, 2016, physical therapy initial consult record
provides that “petitioner reported that her range of motion in her affected shoulder was not
limited until January 2016, over two-and-a-half months after her October 23, 2015, flu
vaccination.” Resp. Report at 5, citing Pet. Ex. 4 at 91. This is a selective quotation from the
record, which in fact states, “Patient’s shoulder pain began in OCT 2015, after she received a flu
shot in the left shoulder. Her ROM became limited in January 2016...” Pet. Ex. 4 at 91. This
physical therapy record is in fact consistent with petitioner’s account that her shoulder pain
began within 48 hours of the vaccination and range of motion became limited later.
Later medical records are consistent with the above. See, e.g., Pet. Ex. 3 at 22-23 (MRI
report with the corrected clinical history of “shoulder pain and limited range of motion since the
end of October”); Pet. Ex. 3 at 3 at 21-22 (petitioner’s new patient intake form for orthopedist
Dr. Ahmad, providing that the left shoulder injury occurred “following flu shot on Oct. 23,
2015”); Pet. Ex. 4 at 6 (petitioner’s physical therapy patient health questionnaire, providing that
she began to have “severe shoulder pain”, “following the flu shot of 10/23/15”); Pet. Ex. 5 at 14
(Dr. Ramundo’s record, during the June 2016 initial consult, that petitioner’s left shoulder pain
“began about 8 months ago, after a flu shot”).
The later affidavits and testimony do not conflict with these medical records. Rather,
they are consistent and provide additional detail. Accordingly, there is preponderant evidence
that petitioner experienced the onset of left shoulder pain within 48 hours of the flu vaccination
administered on October 23, 2015.
IV. Ruling on Entitlement
A. Legal Standard
The Vaccine Act provides two avenues for petitioners to receive compensation. The
petitioner may demonstrate either that she suffered a “Table” injury, or that she suffered a
different injury which was caused-in-fact by a vaccine listed on the Vaccine Injury Table. §§
3000aa-13(a)(1)(A), 11(c)(1); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1319-20 (Fed. Cir. 2006). To establish causation in fact, by preponderant evidence: “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
B. Althen Prong One
Althen prong one requires preponderant evidence of a medical theory that the vaccine at
issue can cause the injury alleged. Althen, 418 F.3d at 1278. Respondent argues that petitioner
bears this burden because she initiated her claim on November 22, 2016, and it is therefore
governed by a version of the Vaccine Injury Table which does not list SIRVA as a recognized
injury within 48 hours of flu vaccines intended for intramuscular administration, that is, a
“Table” injury. Resp. Report at 5, n. 2.
19
However, the Federal Circuit has held that respondent’s recognition of a link between a
specific vaccine and a specific injury, through its addition to the Vaccine Injury Table, supports
petitioner’s burden under Althen prong one. Doe 21 v. Sec’y of Health & Human Servs., 88 Fed.
Cl. 178, 193 (2009), rev’d on other grounds, Paterek v. Sec’y of Health & Human Servs., 527
Fed. Appx. 875 (Fed. Cir. 2013). Here, respondent acknowledges that he revised the Vaccine
Injury Table to create a presumption of causation for SIRVA with onset within 48 hours of flu
vaccine intended for intramuscular administration. The revised Table is effective for claims filed
on or after March 21, 2017, merely four months after the filing of petitioner’s claim. See Resp.
Report at n. 2, citing 42 C.F.R. §§ 100.3(a)(XIV)(B), (e)(1); 82. Fed. Reg. 11321 (Fed. 22,
2017).9
Here, while respondent argues that the revised Table does not govern petitioner’s claim,
he does not dispute that flu vaccine intended for intramuscular administration can cause SIRVA.
Former Chief Special Master Dorsey has noted the “well-established track record of awards of
compensation for SIRVA being made on a cause-in-fact basis in this program.” See, e.g.,
Gentile v. Sec’y of Health & Human Servs., No. 16-980V, 2018 WL 6540025 at *8 (Fed. Cl. Oct.
29, 2018) (collecting cases). Based on respondent’s consistent recognition that flu vaccines
intended for intramuscular administration can cause SIRVA, petitioner’s claim which is
consistent with numerous claims falling under the revised Table, and the supportive opinion from
petitioner’s treating physician, I find that there is preponderant evidence for Althen prong one.
C. Althen Prong Two
Under Althen prong two, petitioner must prove “a logical sequence of cause and effect
showing that the vaccination was the reason for [her] injury.” Althen, 418 F.3d at 1278. This
prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the
vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is
relative to the injury, a petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of
causation. See Grant v. Sec’y of Health & Human Servs., 9556 F.2d 1144, 1148 (Fed. Cir.
1992). This sequence of cause and effect is usually supported by facts derived from petitioner’s
medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at
1326; Grant, 956 F.2d at 1148.
Although petitioner’s claim was filed four months too early to be governed by the revised
Vaccine Injury Table listing SIRVA as a Table injury, the Table’s qualifications and aids for
interpretation (QAI) for SIRVA are persuasive regarding the factors necessary to demonstrate a
logical sequence of cause and effect. See, e.g., Tenneson, 2018 WL 3083140 at *7; Gentile,
2018 WL 6540025 at *9.
9
Indeed, if petitioner had filed her claim just a few months later, after the effective date of the addition of SIRVA, it
still would have been timely filed. See 42 U.S.C. § 300aa-16(a)(2) (providing that a petition for compensation for an
injury in association with a vaccine set forth in the Vaccine Injury Table which is administered after October 1,
1988, must be filed within “36 months after the date of the occurrence of the first symptom or manifestation of
onset… of such injury”); Amended Petition (alleging that petitioner experienced the onset of left shoulder pain
within 48 hours of the flu vaccination administered on October 23, 2015).
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The QAI provide that a vaccine recipient shall be considered to have suffered SIRVA if
such recipient manifests all four criteria, quoted in the following subheadings and applied below
to petitioner’s specific case. 82 Fed. Reg. 6303, codified at 42 C.F.R. § 100.3(c)(10)(i) – (iv).
1. “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”. 42 C.F.R. § 100.3(c)(10)(i).
Respondent avers that petitioner cannot establish this first criteria because she has not
filed all necessary records.
Early in this case, petitioner filed medical records beginning in October 2012, three years
prior to the vaccination. These records reflect regular care by Dr. Smith for chronic fatigue
syndrome, fibromyalgia with trigger points, headaches, dizziness, and insomnia. Pet. Ex. 2.
Neither respondent nor I, in my own review, identified any complaints of left shoulder pain,
inflammation, or dysfunction in the three years prior to the vaccination on October 16, 2015.
Later in the life of the case, respondent retained his own expert to evaluate petitioner’s
proposed life care plan. On January 16, 2020, respondent’s counsel – apparently on behalf of his
life care planner – requested additional records from petitioner including Social Security
Disability (SSD) records and Medicare records. Resp. Status Report filed January 21, 2020
(ECF No. 62); Resp. Status Report filed February 24, 2020 (ECF No. 64). Petitioner
subsequently filed several categories of records, including the file from her initial determination
of eligibility for SSD payments. Petitioner was found to be disabled based on a diagnosis of
chronic fatigue syndrome. There are no specific references to the left shoulder. The SSD file
contained medical records from approximately 1999 – 2002. See Pet. Exs. 23, 25. However,
petitioner did not file any further SSD records or any Medicare records. Nor did petitioner
acknowledge respondent’s requests for those records in a status report filed on March 2, 2020
(ECF No. 67).
On March 17, 2020, I held a lengthy status conference on topics including respondent’s
requests for records. According to my order memorializing the status conference, respondent did
not state that he was seeking any SSD records beyond what had already been filed. Respondent
did note his prior requests for Medicare records. Petitioner’s counsel had not pursued that
request to date. During the call, petitioner’s counsel averred that obtaining documentation of
what particular healthcare services were rendered to petitioner and covered by Medicare would
be difficult and time-consuming. Petitioner’s counsel also stated that Medicare’s scope of
coverage is in the public record and suggested that was more efficient to determining what
offsets were required in this case. I encouraged petitioner’s counsel and life care planner to
locate that information. In addition:
I also encourage[d] respondent’s counsel and life care planner to evaluate whether
the information they are seeking from Medicare is indeed necessary. If
respondent continues to believe that it is, respondent should file a status report
explaining why and I will consider the issue at that time. However, I am currently
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not inclined to delay the hearing in this case while we wait for Medicare billing
records without a compelling reason to do so.
Scheduling Order filed March 18, 2020 (ECF No. 71) at 2. Respondent did not raise this issue
again before the hearing in May 2020.
In his post-hearing brief, respondent avers that the record is not complete because
petitioner was still receiving SSD benefits on the date of vaccination in 2015, and that: “Further,
per the finding of disability and award, the decision was to be reviewed every three years and
petitioner admitted that she continued to send records of her doctors’ visits to the Social Security
Administration (SSA).” Resp. Post-Hearing Response at 3, citing Tr. 88-89. “However, the only
records that were filed from SSA were from 2000 – 2002.” Id. Respondent avers that without
additional SSA records – from 2002 to 2015? – as well as Medicare records, the record is
incomplete. Resp. Post-Hearing Response at 3.
I disagree with respondent’s assertion that the record is not sufficiently complete to
evaluate petitioner’s pre-existing condition. A Vaccine Act petition must be accompanied by all
“pre- and post-injury physician or clinic records (including all relevant growth charts and test
results.” 42 U.S.C. § 300aa(11)(c); see also Vaccine Rule 2(c)(2)(A) (providing no additional
detail about what pre-vaccination records must be filed). The Vaccine Guidelines recommend
that in a claim involving a vaccinee who is an adult, “the filed records should include all records
from all primary care providers for three years prior to the administration of the vaccine(s)
alleged to be causal.”10 Petitioner has filed these records from her primary care provider Dr.
Smith. See Pet. Ex. 2 at 1 (cover page requesting “all medical, vaccination and billing records in
your [Dr. Smith’s office’s] possession relating to Alla Goldman from 10/1/12 to the present”).
Additionally, petitioner has filed multiple records from other medical providers which appear to
provide a comprehensive picture of her medical condition.
Respondent is not only seeking the records required by the Vaccine Act, but copies of
those records required by the Social Security Administration to evaluate whether petitioner
remains eligible for SSD payments for an entirely separate medical condition which is not at
issue in this case. As an initial matter, as noted above I had some concern that this request will
create additional delay in the resolution of this claim that has already been sufficiently delayed.
See Vaccine Rule 1(b) (providing that in any matter not specifically addressed by the Vaccine
Rules, the special master or the court shall uphold the purpose of the Vaccine Act “to decide the
case promptly and efficiently”). More significantly, it is highly likely that any records produced
would be entirely duplicative of records already filed. Requesting fifteen years of Medicare
billing records appeared to me to be little more than a fishing expedition by respondent’s life
care planner. Thus, I do not find respondent’s requests (for either the SSA’s copies of records or
Medicare billing statements) likely to yield additional records from either Dr. Smith or other
medical providers from prior to the vaccination, nor that they are “reasonable and necessary” to
my resolution of whether petitioner had any pre-vaccination history of pain, inflammation or
dysfunction of the affected shoulder that would explain the injury alleged here. See Vaccine
10
Guidelines for Practice Under the National Vaccine Injury Compensation Program (as revised April 24, 2020),
available at https://www.uscfc.uscourts.gov/vaccine-guidelines.
22
Rule 7 (providing that there is no discovery as a matter of right and that the special master shall
determine the scope of discovery); See also In re Claims for Vaccine Injuries Resulting in Autism
Spectrum Disorder or a Similar Neurodevelopmental Disorder, Various Petitioners v. Sec’y of
Health & Human Servs., 2007 WL 1983780 at *6 (Fed. Cl. Spec. Mstrs. May 25, 2007)
(providing that a special master has “broad discretion” in determining what material is necessary
or not, in the overall context of the case). Accordingly, petitioner has established the first QAI
criteria.
2. “Pain occurs within the specified time period [within 48 hours after
vaccination]”, 42 C.F.R. §§ 100.3(a), (c)(10)(ii).
As discussed above, I have made a finding of fact that petitioner suffered the onset of left
shoulder pain within 48 hours after receipt of the flu vaccination on October 23, 2015.
Accordingly, petitioner has established the second QAI criteria.
3. “Pain and reduced range of motion are limited to the shoulder in which the
intramuscular vaccine was administered”. 42 C.F.R. § 100.3(c)(10)(iii).
As acknowledged above, petitioner had chronic fatigue and generalized myalgias for at
least fifteen years before the October 23, 2015 flu vaccination. But afterwards, she had a new,
distinct complaint of left shoulder pain and limited range of motion. See, e,g., Pet. Ex. 2 at 75-76
(January 12, 2016 record by Dr. Smith); Pet. Ex. 4 at 91-92 (March 7, 2016 physical therapy
initial consult). This complaint remained static for approximately six months.
Then beginning on June 1, 2016, petitioner added a complaint of headache and neck pain.
Pet. Ex. 3 at 19-22; see also Pet. Ex. 4 at 6; Pet. Ex. 5 at 14-17. As an initial matter, it must be
noted that petitioner’s pre-vaccination medical history consistently included headaches and
generalized myalgias. However, her treating pain medicine physician Dr. Ramundo explained
that the shoulder and neck anatomy are connected, and pain in one area can radiate to the other.
Tr. 8-10. Dr. Ramundo opined that petitioner’s documented bursitis and adhesive capsulitis
“was referring pain up to her neck, [which…] was going into spasm [which…] was causing
headaches.” Tr. 10.
Respondent argues that Dr. Ramundo’s opinion is “pure speculation” because he was not
aware of petitioner’s prior history. Resp. Post-Hearing Response at 6. Upon review, Dr.
Ramundo testified that he was not aware that petitioner had applied for SSD fifteen years before
the vaccination, and he was not aware of the prior history of headaches. However, he was aware
of her prior diagnosis of chronic fatigue syndrome (the basis of her eligibility for SSD payments)
and he had reviewed the prior records from Dr. Smith. Tr. 44-47.
It is observed that Dr. Ramundo, certainly when he first established care of petitioner,
was first and foremost a treating physician. He has board certifications in pain management as
well as reading electrodiagnostic tests and anesthesiology. While he was not originally aware of
her SSD payments, he was aware of the underlying diagnoses. He also conducted a reasonably
comprehensive evaluation of her presenting complaint of left shoulder pain and limited range of
motion, associated with neck pain and headaches. This evaluation included obtaining MRIs of
both the left shoulder and the cervical spine, as well as an EMG. Based on all of this data, Dr.
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Ramundo’s opinion – both in his medical records and his more recent testimony – was that the
left shoulder pain explained the other symptoms which were recorded later in the course. I found
Dr. Ramundo’s testimony, which was based upon his extensive treatment of petitioner and his
review of her other medical records, to be credible and persuasive. His explanation that the flu
vaccine caused petitioner’s left shoulder chronic pain and adhesive capsulitis, which affected the
mechanics and her shoulder and neck, giving rise to subsequent pain in the neck was well-
reasoned particularly in light of the cervical spine MRI which did not reveal any significant
pathology at C7-T1 that would explain a C8 radiculopathy. I find that Dr. Ramundo’s
explanation is reasonably well-supported and grounded in petitioner’s medical history, imaging
and treatment. In addition, respondent did not retain a medical expert to rebut Dr. Ramundo.
4. “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)”. 42 C.F.R.
§100.3(c)(10)(iv).
Respondent argues that this criteria cannot be met because “there is electrodiagnostic
evidence that petitioner suffers a left-sided C8 radiculopathy”. Resp. Report at n. 2. In support
of this proposition, respondent cites to the record of a September 26, 2016 appointment by
orthopedist Dr. Ahmad. Pet. Ex. 3 at 9. Dr. Ahmad apparently did not believe that this apparent
C8 radiculopathy fully explained petitioner’s symptoms. He recorded an impression of “left
shoulder glenohumeral joint arthritis and rotator cuff tendinosis with cervical radiculopathy and
mild carpal tunnel syndrome.” Id.
Dr. Ramundo – who is board-certified in both pain medicine and electrodiagnostic
medicine – seems well-qualified to evaluate a possible C8 radiculopathy. He is actually the
treating physician who ordered the EMG. Afterwards, he reviewed the EMG report but observed
that petitioner’s “pain is not in a C8 pattern”. Pet. Ex. 5 at 11. Dr. Ramundo also ordered an
MRI of the cervical spine, which found “no evidence for disc herniation, central stenosis, or
neural foraminal stenosis” at C7-T1. Pet. Ex. 12 at 2.11 In his narrative report, Dr. Ramundo
discounted the EMG findings based on this lack of “any significant pathology noted on MRI at
C7-T1”. Pet. Ex. 10 at 3. Dr. Ramundo concluded: In my medical opinion, her chronic neck
pain, shoulder pain, and headaches are secondary to the flu shot that she received because there
is not enough pathology warranted on MRI to cause the type of pain syndrome that she has.” Id.
Respondent has not directly responded to this opinion or retained his own medical expert to
opine about whether petitioner’s symptoms are explained by a left-sided C8 radiculopathy.12
Based on the evidence before me, I am persuaded by Dr. Ramundo’s assessment of the records
and find that petitioner has fulfilled the fourth QAI criteria.
11
Dr. Ahmad’s record does not contain any indication that he reviewed the cervical spine MRI. See Pet. Ex. 3 at 9-
10.
12
The 2016 EMG also revealed a mild left median neuropathy as seen in carpal tunnel syndrome (which involves
symptoms of numbness and tingling in the hand). See Pet. Ex. 3 at 9. Respondent has not asserted and I do not see
support – either from petitioner’s medical records or my underlying knowledge and experience – that this mild left
median neuropathy would explain petitioner’s symptoms centered in the left shoulder.
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5. Conclusion
For the foregoing reasons, petitioner has presented preponderant evidence of a logical
sequence of cause and effect satisfying Althen prong two.
D. Althen Prong Three
Under Althen Prong Three, petitioner must establish a “medically acceptable temporal
relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. Here,
both parties agree that the relevant timeframe for onset of SIRVA is within 48 hours of
vaccination. Resp. Post-Hearing Response at 2; Pet. Post-Hearing Reply at 1. In light of the
above finding of fact that petitioner suffered the onset of left shoulder pain within 48 hours after
receipt of the flu vaccination on October 23, 2015, petitioner has necessarily satisfied Althen
prong three.
E. Alternative Cause
Respondent has not asserted, nor do I find, that any evidence in the record supports
respondent’s burden of establishing an alternative cause for petitioner’s left shoulder injury
which is unrelated to vaccination.
V. Conclusion
Thus, for all the foregoing reasons, I find that petitioner established by a preponderance
of the evidence that she suffered the onset of left shoulder pain within 48 hours after receipt of
the October 23, 2015 flu vaccination. Petitioner has also established by a preponderance of the
evidence that the flu vaccination was the cause-in-fact of her left shoulder injury. Accordingly,
she is entitled to compensation for that injury. A separate damages ruling will be issued.
IT IS SO ORDERED.
s/ Thomas L. Gowen
Thomas L. Gowen
Special Master
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