In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1906V
Filed: October 11, 2018
UNPUBLISHED
JEANNE RAFFERTY,
Special Processing Unit (SPU);
Petitioner, Findings of Fact Regarding Site of
v. Vaccination and Onset of Pain;
Denial of Motion to Dismiss;
SECRETARY OF HEALTH AND Influenza (Flu) Vaccine; Shoulder
HUMAN SERVICES, Injury Related to Vaccine
Administration (SIRVA)
Respondent.
Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
petitioner.
Linda Sara Renzi, U.S. Department of Justice, Washington, DC, for respondent.
ORDER AND FACT RULING1
Dorsey, Chief Special Master:
On December 8, 2017, petitioner filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,2 (the
“Vaccine Act”). Petitioner alleges that she suffered a Shoulder Injury Related to
Vaccine Administration (“SIRVA”) caused in fact by the influenza vaccination she
received on October 17, 2016. Petition at 1, ¶¶ 1, 4 (ECF No. 1). The case was
assigned to the Special Processing Unit of the Office of Special Masters.
1 The undersigned intends to post this order and ruling on the United States Court of Federal Claims'
website. This means the order and ruling will be available to anyone with access to the internet. In
accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or
other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon
review, the undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material from public access. Because this unpublished order and ruling contains a reasoned
explanation for the action in this case, undersigned is 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).
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
On April 9, 2018, respondent filed a motion to dismiss petitioner’s case, arguing
that petitioner has failed to establish she is entitled to compensation because the
evidence shows she received the vaccination alleged as causal in her left, rather than
right, arm. Respondent’s Motion to Dismiss (“Res. Motion”) at 1. For the reasons
described below, the undersigned finds there is preponderant evidence sufficient to
establish petitioner received the vaccination in her right injured arm and denies
respondent’s motion to dismiss. Additionally, the undersigned finds there is
preponderant evidence to establish the onset of petitioner’s pain occurred within 48
hours of vaccination.
I. Procedural History
Shortly after filing her petition, petitioner filed her medical records and affidavit.
See Exhibits 1-9, filed Dec. 21, 2017 (ECF No. 7); Statement of Completion, filed Dec.
21, 2017 (ECF No. 8). The initial status conference was scheduled for January 24,
2018. The morning of the status conference, petitioner filed documentation regarding
the past revisions to her vaccination record and her requests to have the record further
edited. See Exhibit 10 (ECF No. 10).
Following the status conference, respondent was ordered to file a status report
indicating his tentative position regarding the merits of petitioner’s case. See Order,
issued Feb. 7, 2018 (ECF No. 11). Instead, respondent filed a motion to dismiss
petitioner’s case, arguing petitioner has failed to provide sufficient evidence to establish
she received the vaccination alleged as causal in her right injured arm. (ECF No. 12).
Petitioner filed a response on April 19, 2018, addressing respondent’s arguments and
asserting petitioner has provided sufficient evidence to establish she is entitled to
compensation. (ECF No. 13). She “urge[d] the [undersigned] to issue a decision
finding that petitioner received the vaccination in her right arm, and is therefore entitled
to vaccine compensation based on [her] review of the record as a whole.” Id. at 10.3
No reply was filed by respondent.
Respondent’s motion to dismiss is now ripe for adjudication.
II. Factual History
A. Medical Records
The medical records from petitioner’s primary care provider (“PCP”), Dr. Wah at
Carroll Health Group, show that petitioner underwent several surgeries after falling on
ice in 2006. See Exhibit 2 at 18 (summary from visit on Aug. 19, 2014). Petitioner
continued to suffer chronic back and hip pain and weakness in her lower extremities.4
3The undersigned will treat petitioner’s request as a motion for a ruling on the record but declines to rule
on entitlement at this time.
4Petitioner was assessed with chronic back pain and leg weakness on August 19, 2014. Exhibit 2 at 19.
The record of that visit provides a history of petitioner’s surgeries in 2006 and 2008 and complication
2
However, there is no mention of arm or shoulder pain in the medical records from prior
to vaccination.
Petitioner’s PCP records also show that she received influenza vaccinations on
September 24, 2014, November 2, 2015, and October 17, 2016. See Exhibit 2 at 14, 8,
5 (in order of the date of administration). The record for the first vaccination, on
September 24, 2014, does not indicate the arm in which the vaccination was
administered. Id. at 14. The records for the vaccinations in 2015 and 2016 both
indicate petitioner received the vaccinations in her left deltoid. Id. at 5, 8. However, the
record for the later vaccination,5 which is alleged to have caused petitioner’s SIRVA,
indicates the site of vaccination was initially identified as petitioner’s left vastus lateralis
(thigh)6 and was edited to change the site of administration to petitioner’s left deltoid.
See Exhibit 2 at 5. A snapshot of this record is as follows:
during a procedure in 2010. Id. at 18. On September 24, 2014, petitioner complained of left hip pain. Id.
at 15. Her continued back pain was also mentioned in that record. Id. An x-ray of petitioner’s left hip, the
results of which were normal, was performed on October 6, 2014. Id. at 30. On November 20, 2015, it
was noted that petitioner had slightly less strength in her lower right extremities. Id. at 11. Her back pain
was evaluated on June 22, 2016, and petitioner was instructed to continue her current pain medication.
Id. at 6-7.
5In addition to the record contained in the medical records from petitioner’s PCP (Exhibit 2 at 5), the
vaccination record was also filed as Exhibit 1. When citing this record, the undersigned will refer to the
copy filed as part of the medical records from petitioner’s PCP, Exhibit 2 at 5.
6Vastus lateralis is the largest muscle in the quadriceps group, located on the side of the thigh.
https://www.healthline.com/human-body-maps/vastus-lateralis-muscle (last visited on Aug. 31, 2018).
3
Id. (record of influenza vaccination administered on October 17, 2016).
It is not clear whether this revision (from left thigh to left deltoid) was made the
day of vaccination, October 17, 2016, or later on December 20, 2016. The record
indicates it was signed by the person who administered the vaccine, Shannon Gugliotta,
on October 17, 2016, revised by Dr. Mendoza that same day, and revised at two
different times by Ms. Gugliotta on December 20, 2016. Exhibit 2 at 5. In contrast, the
records of vaccination from 2014 and 2015 indicate, on the date of vaccination, they
were signed by the person administering the vaccination and co-signed by petitioner’s
PCP, Dr. Wah. Id. at 8, 14. A snapshot of this portion of the influenza vaccination
administered on September 24, 2014 is as follows:
Id. at 14.
On December 1, 2016, petitioner returned to her PCP, complaining of right arm
pain. Seen at this visit by Dr. Hirpara, D.O.,7 she reported pain which had been
“present since she received her Flu vaccine 5 weeks ago.” Exhibit 2 at 3. Petitioner
identified the injection site which Dr. Hirpara noted was “tender to touch.” Id.
Describing her pain as extending to her elbow, petitioner reported that lifting her arm
was “very painful.” Id. While examining petitioner, Dr. Hirpara observed minimal
swelling, erythema,8 and tenderness. Exhibit 2 at 4. He ordered an MRI and indicated
that, depending on the results of the MRI, he would refer petitioner to an orthopedist.
Id.
MRIs of petitioner’s right humerus and shoulder were performed on December 6,
2016. Exhibit 4 at 1-2. The MRI of her right shoulder showed “[b]ursal sided, partial
tearing of the distal supraspinatus tendon with a background of mild tendinosis,” “[m]ild
tendinosis of the distal infraspinatus tendon,” and mild osteoarthritis in the
acromioclavicular (AC) and glenohumeral joints. Id. at 2.
7D.O. stands for Doctorate of Osteopathic Medicine. Unless a particular degree is specified the first time
an individual is referenced, it is assumed any individual with the title of “Dr.” has earned a Doctor of
Medicine (M.D.). Doctors who have earned a D.O. may have received different training but have similar
privileges and responsibilities as doctors with an M.D.
8Erythema is “redness of the skin produced by congestion of the capillaries.” DORLAND’S ILLUSTRATED
MEDICAL DICTIONARY (“DORLAND’S”) at 643 (32nd ed. 2012).
4
On December 14, 2016, petitioner saw an orthopedist at the Carroll Health
Group, Dr. Rollo. Exhibit 69 at 5-7. At that visit, she reported two months of right
shoulder/arm pain with onset after receiving the influenza vaccination. Id. at 5.
Describing her pain as worse when attempting to lift objects, petitioner denied any
numbness or tingling. Id. Dr. Rollo reported that he observed “no swelling, deformity,
or atrophy," tenderness at her biceps tendon upon palpitation, and an active range of
motion (“ROM”) but with pain. Id. at 6. Noting bursal sided partial tearing of the
supraspinatus10 and arthritic changes, Dr. Rollo described the changes as
“degenerative in nature changes and not related to the injection.” Id. at 6-7. He
prescribed medication to include a prednisone taper and physical therapy (“PT”) to
begin a few days later. Id. at 7. Petitioner began formal PT at Wellspan Rehabilitation
on December 28, 2016. See Exhibit 7 at 71-72 (intake form).11
Petitioner followed up with Dr. Rollo on January 11, 2017, again describing right
shoulder pain which began after she received the influenza vaccination in her right
shoulder. Exhibit 6 at 2. Petitioner reported that her pain improved by 50% while on
steroids but returned when the medication was completed. Dr. Rollo observed that
petitioner’s ROM was further limited, to 80 degrees. Acknowledging that he “initially did
not believe the needles were long enough to cause any mechanical damage to the
underlying RTC [(rotator cuff)],” Dr. Rollo indicated that, after further research, he could
not “confirm or deny the injection as a cause of [petitioner’s] discomfort.” Id. Having
become aware of studies showing infiltration of the bursa is possible in thin women, Dr.
Rollo admitted he was “uncertain of the potential side effects of the vaccine itself.” Id.
He prescribed a daily dose of prednisone and continued PT. Id. at 3. Instructing
petitioner to return in one month for a re-evaluation, he added that a steroid injection
should be considered if petitioner continued to experience pain. Id.
On February 7, 2017, petitioner sought a second opinion from Dr. Bischoff at
Wellspan Hanover Orthopaedics. See Exhibit 7 at 56 (discharge record from PT
indicating petitioner’s visit to Dr. Bischoff was for a second opinion). At the initial visit to
Dr. Bischoff, petitioner provided a detailed history. See Exhibit 3 at 10. She again
described significant right shoulder pain, extending to her elbow, and beginning after
she received the influenza vaccination on October 17, 2016. Indicating that “the
injection was given high, . . . [petitioner] point[ed] to the region just underneath her
9These records show that, in 2014, petitioner was treated by another orthopedist at the Carroll Health
Group, Dr. Blue, for pain in her left thigh. See Exhibit 6 at 8-14.
10Dr. Rollo did not specify whether he was referring to the supraspinatus tendon or muscle. Given the
results of the MRI, showing partial tearing of the tendon, it can be inferred that Dr. Rollo was referring to
the supraspinatus tendon. See Exhibit 4 at 2 (results of MRI).
11 On her intake form, petitioner listed “flu shot administration” as the cause of her injury and dated the
injury as occurring on October 17, 2016. See Exhibit 7 at 71. Petitioner included information about her
earlier neck and back injury on the intake form. Id.
5
acromion laterally” which she stated occasionally felt swollen. Id. Although that area of
her right shoulder “ached significantly for the next 2 weeks” following vaccination,
petitioner recounted that she did not seek medical care earlier due to the death of a
friend. Id.
Dr. Biscoff reported, “[o]n examination of [petitioner’s] right shoulder, once again,
she points just inferior to the lateral ledge of the acromion as to where the injection was
given.” Exhibit 3 at 10. While indicating he could not “appreciate any significant
swelling about the shoulder, [and] [t]here is no erthythema or warmth,” Dr. Bischoff did
observe “mild tenderness to the palpitation about the shoulder girth itself,” adding that it
was non-specific. Id. He also reviewed the MRI of petitioner’s right shoulder, noting
that her “rotator cuff tendons appear to be intact, [t]here may be some evidence of a
tendinopathy, . . . “mild effusion within the soft tissues, . .. . [and] some subacromial
spurring and AC joint arthritis.” Id. He opined that the cause of petitioner’s right
shoulder pain was the influenza vaccination she received, adding that, although rare,
SIRVA is “described in the literature.” Id. He discussed options such as a steroid
injection or arthroscopic surgery, prescribed an additional tapering dose of prednisone,
and instructed petitioner to stop PT. Id.; see also Exhibit 7 at 56 (describing petitioner’s
discharge from PT upon the recommendation of Dr. Bischoff, after attending eight
sessions).
On March 1, 2017, petitioner visited Dr. Bischoff for a pre-operative physical,
having “elected to proceed with the right shoulder arthroscopy.” Exhibit 3 at 8. In the
record from that visit, it is noted that petitioner “once again describe[d] the pain as being
instantaneous at the time of the injection and it has not improved with time.” Id. Dr.
Bischoff described the planned surgery as “arthroscopic irrigation and debridement of
the subacromial space,” possibly including an acromioplasty.12 Exhibit 3 at 8.
Arthroscopic surgery on petitioner’s right shoulder was performed by Dr. Bischoff
on March 15, 2017. Exhibit 3 at 13-14; see also Exhibit 5 (records from Hanover
Hospital where the surgery was performed). According to Dr. Bischoff’s records,
general anesthesia was administered. Exhibit 3 at 13. Dr. Bischoff then created
several portals but elected not to enter the joint itself to avoid introducing any irritants.
He observed the bursa to be enlarged13 and hyperemic.14 Exhibit 3 at 13. Performing a
bursectomy, Dr. Bischoff used a shaver to debride the bursa, undersurface of the
12Acromioplasty is the “surgical removal of an anterior spur of the acromion to relieve mechanical
compression of the rotator cuff during movement of the glenohumeral joint.” DORLAND’S at 20.
13 Dr. Bischoff noted that petitioner had “an abundant amount of hypertrophic bursa.” Exhibit 3 at 13.
Hypertrophic is the adjective form of hypertrophy, “the enlargement or overgrowth of an organ or part due
to an increase in size of its constituent cells.” DORLAND’S at 898.
14 Hyperemic is the adjectival form of hyperemia, “an increase of blood in a part.” DORLAND’S at 888.
6
acromion, and coracoacromial ligament. Id. at 13-14. An acromioplasty was not
performed, but Dr. Bischoff debrided further in the subdeltoid interval. Id. at 14. He
observed no evidence of a rotator cuff tear. Id.
Petitioner returned to Wellspan Rehabilitation for her post-surgery PT on March
17, 2017. See Exhibit 7 at 50-51 (plan of care from Dr. Bischoff), 52-53 (initial
evaluation by physical therapist). She had post-surgical visits with Dr. Bischoff on
March 21, 24, April 25, June 6, and August 21, 2017. Exhibit 3 at 2-7, 16-17. At all
visits, petitioner was described as healing well, still experiencing some post-surgical
pain, and participating in PT. Id. Throughout the medical records from Dr. Bischoff and
Wellspan Rehabilitation, petitioner’s injured arm/shoulder is identified as her right
arm/shoulder. Petitioner was discharged from PT on May 30, 2017, having participated
in 21 sessions. Exhibit 7 at 21. At her last visit, on August 21, 2017, Dr. Bischoff noted
that petitioner was improving and “making good progress.” Exhibit 3 at 17. He
instructed her to continue her home exercise program and to return “on an as needed
basis.” Id.
On September 20, 2017, petitioner visited Wellspan Family Medicine to establish
new patient care. See Exhibit 8 at 2. Her recent shoulder surgery was included in
petitioner’s history, but no ongoing symptoms were noted. Id. at 2-5.
B. Petitioner’s Affidavit and Other Documents
In her affidavit, which was signed and notarized on December 15, 2017,
petitioner addresses the onset of her injury, the difficulties it has caused her, and her
attempts to amend the vaccination record to reflect vaccine administration in her right,
rather than left, arm. See Exhibit 9. She provided documents which describe her
efforts to amend the vaccination record and the responses she received. See Exhibit
10.
Regarding onset, petitioner alleges that she “immediately experienced severe
pain in [her] shoulder which was different than any other vaccine [she] had previously
received.” Exhibit 9 at ¶ 1. Indicating she had her three-year-old son with her,
petitioner maintains she did not say anything about her pain because she did not want
to frighten her son and “assumed it would feel fine in a short time.” Id. Petitioner
reports being unable to open the car door with her right arm after leaving the clinic.
Petitioner indicates, rather than subsiding, her “shoulder and arm pain worsened to the
point that [she] could no longer lift a cup of tea to my mouth with my right hand.” Id.
Petitioner describes the effects of her right shoulder injury over the subsequent
year. See Exhibit 9 at ¶¶ 2-4, 6. A mother of twin three-year-old sons, one of whom
has autism, petitioner contends she was unable to care for her sons or herself and was
forced to rely on her husband, mother, sister-in-law, and neighbor for help. Id. at ¶¶ 2-4.
7
Petitioner describes difficulty brushing her teeth, dressing, and washing her hair. Id. at
¶ 4. In addition to the physical difficulties she experienced, petitioner claims she and
her family suffered emotionally. Id. She credits the second orthopedist she saw, Dr.
Bischoff, for “the improvement and relief [she has experienced] thus far.” Id. at ¶ 6.
In her affidavit, petitioner claims her ordeal has been complicated by “the fact
that [her] vaccine record is not correct.” Exhibit 9 at ¶ 5. She indicates she was not
aware the record originally indicated she received the vaccination in her left thigh.
Further, she did not know that the record was revised to reflect administration in her left
deltoid until January 2017, after she contacted her PCP, in early December 2016,
regarding her shoulder injury. She indicates she requested the record be further
revised to indicate administration was in her right deltoid and “was told nothing could be
done.” Id.
In early April 2017, petitioner received a letter from Sandra Haines, the H.I.M.
Coordinator at Carroll Health Group, with a form petitioner could submit to request her
record be amended. Exhibit 9 at ¶ 5; see Exhibit 10 at 2 (copy of the letter dated March
30, 2017), at 3 (copy of partially completed form). Petitioner indicates she returned the
completed form in May 2017, after her shoulder surgery. Exhibit 9 at ¶ 5. It appears
the form was marked as denied on July 3, 2017, and returned to petitioner, along with a
second letter from Sandra Haines. See Exhibit 10 at 5 (copy of letter), at 10 (copy of
completed form, signed by petitioner on May 29, 2017, with July 3, 2017 denial). In the
letter, also dated July 3, 2017, Ms. Haines informed petitioner that her request had been
denied but that she could submit a rebuttal in a “statement of disagreement” which
would be included in her medical records and released, along with the medical records,
in response to any request authorized by petitioner. Exhibit 10 at 5.
Petitioner has provided an unsigned copy of her statement, dated August 14,
2017. See Exhibit 10 at 6-8. In the statement, she notes that her vaccination record
was revised twice in December 2017, and describes her attempts to amend the record
to reflect what she alleges is the correct information regarding the site of vaccination.
Id. at 6. She provides further information regarding the vaccination, recounting that her
vaccination “was given extremely high in [her] right shoulder" (id. at 7) and was
administered close enough to a red mole she has on her right arm/shoulder that the
mole was covered by the bandage placed over the injection site (id. at 7-8).
In a letter dated November 15, 2017, Ms. Haines acknowledged petitioner’s
statement had been received and that it, as well as the other written documents
pertaining to petitioner’s request, would be included in any subsequent authorized
release of her medical records. Exhibit 10 at 9.
8
III. Party Contentions
In his motion to dismiss, respondent argues that “[b]ecause the current record is
insufficient to establish that petitioner received a vaccination in her right arm, petitioner
cannot meet her burden to establish SIRVA injury under the Vaccine Act.” Res. Motion
at 3. Respondent bases his argument on the vaccination record and conclusion of the
administrator that this record was accurate. Id. at 1 (citing the vaccination record,
Exhibit 1), 3 (citing language in the denial of petitioner’s request for correction, Exhibit
10 at 10). Respondent dismisses the information contained in contemporaneously
created medical records as “based solely on the histories provided by petitioner.” Id. at
3. He also dismisses the information in petitioner’s affidavit and documentation
regarding her attempts to change the site of vaccination.
“Petitioner asserts that the overwhelming evidence in the record is that she
received the October 17, 2016 flu vaccination in her right arm.” Petitioner’s Response
to Res. Motion (“Pet. Response”), filed Apr. 19, 2018, at 2 (ECF No. 13). Arguing that
“[t]he medical records are replete with references that petitioner’s shoulder pain was
associated with the flu vaccination she received in her right arm on October 17, 2016,”
petitioner maintains that “[t]he single record relied upon by respondent is clearly in error
and stands in sharp contrast with the vast majority of other medical records in this
case.” Id.
Petitioner counters respondent’s criticism of the information contained in histories
provided by petitioner by asserting that, like other information in contemporaneously
created medical records, these histories are entitled to greater weight. Pet. Response
at 6. She argues that by questioning these histories, respondent is assuming that
petitioner was either mistaken or dishonest when she provided them. Id. at 7-8.
Moreover, petitioner notes that some information comes not from medical histories but
from physical examinations performed by petitioner’s treating physicians. Id. Stressing
that special masters are not bound by any particular medical record in vaccine cases,
petitioner argues that the vaccination record, already edited on at least one occasion, is
not reliable and should be given little weight. Id. at 9-10 (citing § 13(b)).
Petitioner maintains that, once the question of the site of administration is
resolved, “this is a straightforward Table case.” Pet. Response at 1. She asks that the
undersigned deny respondent’s motion and urges her “to issue a decision finding that
petitioner received the vaccination in her right arm, and is therefore entitled to vaccine
compensation based on the [undersigned’s] review of the record as a whole.” Id. at 10.
9
IV. Findings of Fact
A. Legal Standard
A petitioner must prove, by a preponderance of the evidence, the factual
circumstances surrounding her claim. § 13(a)(1)(A). Under that standard, the existence
of a fact must be shown to be “more probable than its nonexistence.” In re Winship,
397 U.S. 358, 371 (1970) (Harlan, J., concurring).
To resolve factual issues, the special master must weigh the evidence presented,
which may include contemporaneous medical records and testimony. See Burns v.
Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed.Cir.1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). As the Federal Circuit has noted, it is appropriate
for a special master to give greater weight to evidence contained in medical records
created closer in time to the vaccination, even if the information is provided as part of a
medical history. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528
(Fed. Cir. 1993) (medical records are generally trustworthy evidence). The Circuit Court
explained that
Medical records, in general, warrant consideration as trustworthy evidence.
The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These
records are also generally contemporaneous to the medical events.
Id.
Additionally, when determining the impact of the evidence presented, the special
master should consider factors such as the reliability and consistency of the evidence.
Burns, 3 F.3d at 416. “Written records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent. If a record was
prepared by a disinterested person who later acknowledged that the entry was incorrect
in some respect, the later correction must be taken into account.” Murphy v. Sec’y of
Health & Human Servs., No. 90-882V, 1991 WL 74931, at *4 (Fed. Cl. Spec. Mstr. Apr.
25, 1991), aff'd, 23 Cl. Ct. 726 (1991), aff'd per curium, 968 F.2d 1226 (Fed.Cir.1992).
B. Site of Vaccination
There is consistent evidence throughout the medical records sufficient to
establish petitioner received the influenza vaccination in her right arm. When seeking
treatment for her right arm/shoulder pain, petitioner regularly attributed her condition to
the influenza vaccination she received in her injured right arm. Not once does petitioner
indicate that she received the vaccination in her left arm.
10
On December 1, 2016, petitioner was examined by Dr. Hirpara, a physician in the
same practice as her PCP, Dr. Wahl, at the Carroll Health Group. At that visit, petitioner
identified the injection site to be the proximal deltoid region of her right arm. See Exhibit
2 at 3. Dr. Hirpara ordered an MRI and referred petitioner to an orthopedist at the
Carroll Health Group, Dr. Rollo. The MRI of petitioner’s right shoulder was performed
on December 6, 2016.
Petitioner saw Dr. Rollo on December 14, 2016 and January 11, 2017. At the
December 14, 2016 visit, petitioner again linked her right shoulder pain to the influenza
vaccination she received. See Exhibit 6 at 5. Dr. Rollo prescribed PT for petitioner’s
right shoulder, which petitioner began at Wellspan Rehabilitation on December 28,
2016.
Petitioner’s initial PT evaluation was performed by Elliot Kohr, DPT.15 In the
record from that evaluation, he documented petitioner “report[ed] receiving a right
shoulder flu shot on October 17, 2016.” Exhibit 7 at 69.
Petitioner sought a second opinion from Dr. Bischoff, an orthopedist at Wellspan
Hanover Orthopedics, on February 7, 2017. Dr. Bischoff treated petitioner through
August 2017, performing her surgery on March 15, 2016. At her initial visit with Dr.
Bischoff, petitioner described the injection as “given high.” Exhibit 3 at 10. While Dr.
Bischoff was examining her right shoulder, petitioner “point[ed] [to] just inferior to the
later edge of the acromion, as to where the injection was given.” Id.
Respondent correctly observes that this information was provided by petitioner,
but she did so relatively close in time to vaccination (within four months), for the
purpose of obtaining medical treatment. Moreover, the recorded observations of Dr.
Hirpara corroborate the information provided by petitioner. When Dr. Hirpara examined
the injection site identified by petitioner on December 1, 2016, he observed swelling,
redness, and tenderness at the injection site. See Exhibit 2 at 3-4. Although he
characterized these symptoms as minimal, Dr. Hirpara’s observations provide
substantial corroborating evidence that the vaccination was administered in petitioner’s
right deltoid as she reported.
Furthermore, the information provided by petitioner during her treatment and the
observations and conclusions of her treating physicians are consistent with diagnostic
findings and the clinical course of a SIRVA injury in petitioner’s right arm. The MRI of
petitioner’s right shoulder performed on December 6, 2016 revealed “[b]ursal sided,
partial tearing of the distal supraspinatus tendon with a background of mild tendinosis,”
“[m]ild tendinosis of the distal infraspinatus tendon,” and mild osteoarthritis in the
acromioclavicular (AC) and glenohumeral joints. Exhibit 4 at 2. During her March 15,
2017 shoulder surgery, Dr. Bischoff described petitioner’s bursa as enlarged and
hyperemic. Exhibit 3 at 13.
15 DPT stands for Doctorate of Physical Therapy.
11
Petitioner consistently reported that her right shoulder/arm pain occurred upon
vaccination and increased in severity when she attempted to lift her arm above her
shoulder or to lift a heavy object. E.g., Exhibits 2 at 3 (visit with Dr. Hirpara); 6 at 5
(initial visit with Dr. Rollo). Petitioner was described as experiencing right shoulder pain
when demonstrating her ROM. E.g., Exhibits 6 at 2 (initial visit to Dr. Rollo); 3 at 10
(initial visit with Dr. Bischoff). At her second visit with Dr. Rollo, the ROM for petitioner’s
right shoulder was observed to be limited to 80 degrees. Exhibit 6 at 2. Petitioner
attended eight PT sessions at Wellspan Rehabilitation from late December 2016 to
early February 2017. In the discharge report, completed by Lauren Miller, PT, it was
noted that petitioner “showed minimal to no progress with range of motion or strength”
in her right shoulder. Exhibit 7 at 56. The severity of petitioner’s right shoulder pain
decreased while on steroids but returned to its previous level when the medication was
stopped. Exhibit 6 at 2.
The first orthopedist seen by petitioner, Dr. Rollo at Carroll Health Group, initially
opined that he did not believe petitioner’s right shoulder injury was caused by her
influenza vaccination. Exhibit 6 at 7. However, after familiarizing himself with medical
literature showing infiltration of the bursa is possible in thin women, he took a neutral
position regarding causation. Id. at 2-3 (reflecting petitioner’s injury could or could not
be caused by her vaccination). The second orthopedist who treated petitioner, Dr.
Bischoff at Wellspan Hanover Orthopaedics, clearly linked petitioner’s right shoulder
pain to the influenza vaccination she received. See Exhibit 3 at 10. He stated, “[m]y
opinion is that the shoulder pain is coming from this injection, and there is an entity
called SIRVA, . . . that is rare, but it is described in the literature.” Id.
The only evidence in this case which contradicts petitioner’s claim that she
received the vaccination alleged as causal in her right injured arm is the record of
vaccination. See Exhibit 2 at 5. This record was revised on at least one, and possibly
three occasions. Revisions are noted on the date of administration, October 17, 2016,
and twice on December 20, 2016. Additionally, the record contains a notation stating it
has been edited to correct the site of vaccination, from left thigh to left deltoid. Id.
Given that the site of administration was originally identified as petitioner’s left thigh, it is
not unreasonable to conclude that the revised record, noting vaccination in petitioner’s
left deltoid, may still be incorrect.
According to petitioner, she was not aware of any issue regarding her vaccination
record until early January 2017. See Exhibits 9 at ¶ 5 (petitioner’s sworn affidavit
executed on December 15, 2017); 10 at 7 (unsigned copy of petitioner’s written
response to the denial of her request to amend her vaccination record dated August 14,
2017). She says that, prior to that time, on December 9, 27, and 29, 2016, she spoke to
individuals at her PCP’s clinic regarding what she viewed as their responsibility for her
shoulder injury and mounting medical bills. Exhibit 10 at 6. In early January 2017, she
discovered the record had been revised previously and documented that the vaccine
was administered in her left deltoid. Exhibit 9 at ¶ 5.
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Given the three alterations made to the vaccine administration record and the
fact that its original information was erroneous, the undersigned assigns less evidentiary
weight to this record. The undersigned is further swayed by the timing of the
alteration(s) in December 2016, which appears to have occurred after petitioner called
her PCP and raised concerns about her shoulder injury.
For all of the above reasons, the undersigned finds there is preponderant
evidence showing petitioner received the influenza vaccination alleged as causal in her
right injured arm.
C. Onset of Pain
After reviewing the entire record in this case, the undersigned also finds that the
onset of petitioner’s pain occurred within 48 hours of vaccination. When seeking
treatment for her shoulder pain, petitioner consistently indicated that her pain occurred
immediately after receiving the influenza vaccination on October 17, 2016.
For example, when petitioner first sought treatment from Dr. Hirpara at Carroll
Health Group on December 1, 2016, she described her pain as “present since”
vaccination. Exhibit 2 at 3. At her first visit to the orthopedist at Carroll Health Group,
Dr. Rollo, petitioner identified the onset of her pain as occurring “after receiving a flu
shot.” Exhibit 6 at 5. When evaluated by her physical therapist, Dr. Kohr, DPT,
petitioner “report[ed] significant pain during her flu shot” which progressed over the next
two weeks. Exhibit 7 at 69 (emphasis added). Petitioner again described her onset as
occurring after vaccination when seeking a second orthopedic opinion from Dr. Bischoff
at Wellspan Hanover Orthopaedics. Exhibit 3 at 10.
In her affidavit, petitioner alleges immediate and severe pain upon vaccination.
Exhibit 9 at 1. The undersigned finds that the medical records support this assertion.
Thus, there is preponderant evidence that the onset of petitioner’s pain occurred within
48 hours of her October 17, 2016 vaccination.
V. Conclusion
Respondent’s motion to dismiss is based solely on his assertion that the
evidence shows petitioner received the vaccination alleged as causal in her left, rather
than right, arm. In light of the undersigned’s finding that petitioner received this
vaccination in her right injured arm, respondent’s motion to dismiss is DENIED.
Although petitioner requested that the undersigned issue a decision on
entitlement, the undersigned will defer ruling on entitlement at this time. The
undersigned requests that petitioner submit a demand to respondent within 30 days.
Petitioner shall file a status report indicating that she has forwarded her
demand and supporting documentation to respondent by no later than Friday,
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November 09, 2018. Respondent shall file a status report 30 days thereafter
updating the undersigned on the parties’ settlement discussions.16
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
16 The exact date for respondent’s status report will be set after petitioner has filed her status report.
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