Syed v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-1364V
UNPUBLISHED
SAEEDA SYED, Chief Special Master Corcoran
Petitioner, Filed: April 28, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Site of Vaccination
HUMAN SERVICES, Influenza (Flu) Vaccine; Shoulder
Injury Related to Vaccine
Respondent. Administration (SIRVA)
David Charles Richards, Christensen & Jensen, P.C., Salt Lake City, UT , for Petitioner.
Naseem Kourosh, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT1
On September 6, 2019, Saeeda Syed 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”), as defined in the Vaccine Table, after receiving the influenza
(“flu”) vaccine in her right deltoid on September 9, 2017. Petition at 1, ¶¶ 3, 41. The case
was assigned to the Special Processing Unit (“SPU”) of the Office of Special Masters.
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Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the fact ruling will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
For the reasons discussed below, I find the flu vaccine was administered in
Petitioner’s right deltoid as alleged.
I. Relevant Procedural History
Along with the Petition, Ms. Syed filed the majority of the medical records required
under the Vaccine Act. Exhibits 1-19, ECF No. 1; see Section 11 (c). She filed the
remaining records ten days later. Exhibits 20-21, ECF No. 6. On November 17, 2019, she
filed documentation regarding her medical expenses and updated physical therapy (“PT”)
records. Exhibits 22-23, ECF No. 11.
Following the initial status conference held on January 23, 2020, Respondent filed
a status report from Respondent’s counsel indicating she believed all required medical
records had been filed and had identified no factual issues which needed to be addressed
while awaiting the Health & Human Services review. ECF No. 17. On multiple occasions
during the subsequent ten-month period, Petitioner filed updated medical records and
periodic updates on the status of her demand. Exhibits 24-30, ECF Nos. 15, 15, 20, 26,
31-32, 37; e.g., Status Report, filed July 31, 2020, ECF No. 28 (regarding Petitioner’s
demand).
On December 8, 2020, Respondent filed a status report requesting clarification
and additional documentation regarding the site of vaccination. ECF No. 38. In one typed
entry in the vaccine record, the site of vaccination is listed as Petitioner’s left, rather than
right, deltoid. Exhibit 2 at 3. Other entries designated for information such as the site of
vaccination are blank. Exhibit 2 at 2.
During the subsequent four-month period, Petitioner filed multiple status reports
regarding her efforts to obtain additional documentation regarding the site of vaccination
and to finalize her demand. ECF Nos. 39-40, 42. On April 22, 2021, Petitioner filed a
status report providing answers to some of the questions and concerns raised in
Respondent’s December 8, 2020 status report, specifically those reiterated by court
personnel in email correspondence with the parties. ECF No. 44; see Informal Remark,
dated Apr. 5, 2021.
I have determined that a factual ruling regarding the site of vaccination is required
in this case, and will assist in its ultimate disposition.
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II. Issue
At issue is whether Petitioner received the vaccination alleged as causal in her
injured right deltoid, rather than her left deltoid as one typed entry in the vaccine
documentation indicates.
III. Authority
Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis,
conclusion, judgment, test result, report, or summary concerning the nature, causation,
and aggravation of petitioner’s injury or illness that is contained in a medical record.
Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy
evidence. The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in
the balance, accuracy has an extra premium. These records are also generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Human Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993).
Accordingly, where medical records are clear, consistent, and complete, they
should be afforded substantial weight. Lowrie v. Sec’y of Health & 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, 2005 WL 6117475, at *19.
The United States Court of Federal Claims has recognized that “medical records
may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed.
Cl. 381, 391 (1998). 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 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).
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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).
A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may
be made only upon demonstration by a preponderance of the evidence that the onset [of
the injury] . . . did in fact occur within the time period described in the Vaccine Injury
Table.” Id.The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v.
Sec’y of Health & 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).
IV. Finding of Fact
I make the finding regarding site of vaccination after a complete review of the
record to include all medical records, affidavits, and additional evidence filed. Specifically,
I base the findings on the following evidence:
• The vaccine record initially filed by Petitioner consists of the following:
o a Customer Statement Report providing the date, identifying
information, and payment for the flu vaccine administered on
September 9, 2017;
o the Vaccine Consent and Assessment signed by Petitioner;
o a page containing two lines of typed information indicating the
injection was administered intramuscularly in the left deltoid and that
the lot number and expiration date are not available;
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o an email, dated November 17, 2017, from an individual working at
Petitioner’s counsel’s law firm to Petitioner inquiring about the left
deltoid designation in the vaccine record which did not match the
reports of a right arm injury in Petitioner’s medical records and
Petitioner’s response confirming the vaccine was administered in her
right deltoid.
Exhibit 2. The sections of the vaccine consent form designated for more
detailed information such as lot number, expiration date, and site of
vaccination are all blank. Id. at 2.
• On September 16, 2017, seven days after vaccination, Petitioner visited the
emergency room (“ER”), “complaining of right arm pain since having a flu
shot a week[3] ago.” Exhibit 3 at 9 (emphasis added). Upon examination,
Petitioner “exhibit[ed] tenderness (at the deltoid and slight[ly] down the
anterior bicep) and pain. Id. at 11 (emphasis in original omitted).
• On October 1, 2017, Petitioner sought treatment for right shoulder pain
following a flu vaccine, identified as administered 30 days ago, from the
Greenwood Health Center at the University of Utah. Exhibit 4 at 1385-86.
Petitioner reported immediate swelling and redness, followed by pain and
bruising. Id. at 1385. She exhibited no redness or swelling but limited range
of motion (“ROM”), decreased strength, and numbness and tingling
radiating down her arm, into her fingers. Id. at 1386.
• A few days later, on October 6, 2017, Petitioner sought treatment at
Intermountain Healthcare - Cottonwood Family Practice for “right deltoid
pain after a flu shot.” Exhibit 6 at 7. While later entries, such as the physical
therapy referral, list tendonitis in Petitioner’s left deltoid (id. at 7, 12-13),
entries related to the history provided by Petitioner and chief complaint for
the visit in which the injury is attributed to the flu vaccine Petitioner received
refer to the right shoulder (id. at 7, 9).
• When seen for her initial PT evaluation, on October 27, 2017, the reason
for the PT is listed as constant pain in Petitioner’s right arm since receiving
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One entry later in the ER medical records indicates the vaccination was administered two weeks ago.
Exhibit 3 at 12. However, this one entry was from a registered nurse who examined Petitioner approximately
30 minutes after the initial intake. Id. Given the multiple entries provided by Petitioner during intake and at
least one entry from the same registered nurse indicating the vaccination was one week ago, this entry
appears to be incorrect, likely due to a simple mistake. Id. at 9, 11, 12.
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the flu shot on September 19,4 2017. Exhibit 7 at 1. Other entries also refer
to the vaccination and injury as occurring in Petitioner’s right arm and
contain the same consistent descriptions of initial swelling and then
radiating pain. Id. at 1, 2, 6.
• The medical record from Petitioner’s next visit to Cottonwood Family
Practice, on November 17, 2017, contains multiple entries referring to left
should pain or simply shoulder pain. Exhibit 6 at 13-18. In this medical
record, references to left arm pain are more prevalent than references to
right arm pain. However, there are no entries regarding the flu vaccine
Petitioner’s believes is the cause of her injury, and the medical record
contains one entry in which descriptions of both left and right arm pain are
used within the same sentence. Id. at 14.
• In her affidavit, Petitioner alleges she received the flu vaccine in her right
shoulder. Exhibit 1 at ¶ 4.
• In an April 22, 2021 status report, Petitioner indicated that she first
requested her vaccine records from Kroger Pharmacy on October 4, 2017.
Status Report at 1, ECF No. 44. On October 13, 2017, she received the
documentation filed, along with the October 17, 2017 email
correspondence. Id. at 1-2. Following subsequent requests to Kroger
Pharmacy on July 18, 2019 and February 20, 2021, Petitioner received the
same documentation. Id. at 2. Petitioner reported that the consent form,
which lacks any site designation, was provided by her when requesting
vaccination. She theorized that the notation regarding administration in
Petitioner’s left deltoid is from Kroger Pharmacy’s computer system and the
source of this information is from manual entry following vaccination by
pharmacy personnel. Id. However, she acknowledged she “has been
unable to verify this is the case as Kroger Pharmacy has been unwilling to
confirm this information.” Id. at 2-3.
The above medical entries show Petitioner consistently reported right shoulder
pain which she attributed to her September 2017 vaccination. She provided this history
to ER personnel, seen within six days of vaccination, to medical personnel at Greenwood
Health Center and Cottonwood Family Practice within one month of vaccination, and to
her physical therapist less than two months after vaccination. While originating from
Petitioner, these statements are set forth in contemporaneous record, and should
4
Due, most likely, to human error, this date is listed as September 19, 2017, rather than the correct date
of September 9, 2017.
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therefore be afforded greater weight than any current assertion or witness statement. The
Federal Circuit has stated that “[m]edical records, in general, warrant consideration as
trustworthy evidence . . . [as they] contain information supplied to or by health
professionals to facilitate diagnosis and treatment of medical conditions.” Cucuras, 993
F.2d at 1528 (emphasis added). Thus, the Circuit has instructed that greater weight
should be accorded to this class of information, even when the record in question simply
memorializes what the petitioner said at the time.
Additionally, these medical records contain information regarding examinations
and observations of Petitioner’s right arm/shoulder condition and symptoms. Except for
the medical records from Cottonwood Family Practice, which have been shown to be
unreliable, all medical records describe a right shoulder injury.
The only evidence supporting a finding that the vaccination was administered in
the left (opposite) arm is the typed, two line entry from the administration record provided
by Kroger Pharmacy. That document includes a statement that the lot number and
expiration date of the vaccine is unavailable. Exhibit 2 at 3. While the exact origin of this
entry is unclear, it was most likely generated from information found in Kroger Pharmacy’s
computer system.
Based upon my experience resolving SPU SIRVA cases (approximately 650 cases
since my appointment as Chief Special Master) as well as additional SIRVA cases
handled in chambers, I find it is not unusual for the information regarding site of
vaccination in computerized systems to be incorrect. Many of these systems use a
dropdown menu which may not be updated each time a separate vaccine is administered
to a different individual. See, e.g., Desai v. Sec’y of Health & Human Servs., No 14-0811V,
2020 WL 4919777, at *14 (Fed. Cl. Spec. Mstr. July 30, 2020); Rodgers v. Sec’y of Health
& Human Servs., No. 18-0559V, 2020 WL 1870268, at *5 (Fed. Cl. Spec. Mstr. Mar. 11,
2020); Stoliker v. Sec’y of Health & Human Servs., No. 17-0990V, 2018 WL 6718629, at
*4 (Fed. Cl. Spec. Mstr. Nov. 9, 2018).5 Thus, although such records are unquestionably
the first-generated documents bearing on issues pertaining to situs, they are not per se
reliable simply because they come first – and in fact the nature of their creation provides
some basis for not accepting them at face value.
5
Indeed, in a recent ruling by one of my special master colleagues, the pharmacist who had administered
the relevant vaccination testified that she inputs “left deltoid” into the computer system as a matter of course,
without confirming the actual site of vaccination, because most vaccinees are right-handed. Because this
ruling was issued on April 19, 2021, the period of any redaction request has not expired, and the ruling has
not yet been posted to the court’s website. However, the case number is 18-1977V, the pharmacist’s
testimony was deemed credible, and the ruling should be available to the public by May 2021.
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More reliable is vaccine documentation which requires specific action on the part
of the vaccine administrator to identify the site of vaccination which is performed close in
time to the vaccination. See, e.g., Marion v. Sec’y of Health & Human Servs., No. 19-
0495V, 2020 WL 7054414, at *8 (Fed. Cl. Spec. Mstr. Oct. 27, 2020). In this case,
however, the consent form which would usually contain this designation is blank. Exhibit
2 at 2.
Accordingly, there is a dearth of evidence to support the determination that the
vaccine was administered in Petitioner’s left arm – while sufficient other reliable evidence
supports the contrary finding. I thus determine, based on the record as a whole, that
preponderant evidence establishes that the flu vaccine Petitioner received was most likely
administered in her right deltoid on September 9, 2017.
V. Scheduling Order
During email correspondence regarding the next step in this case, Respondent’s
counsel represented that Respondent was interested in engaging in settlement
discussions if I determined there was sufficient evidence to support Petitioner’s claim
regarding the site of vaccination in this case. See Informal Remark, dated Apr. 5, 2021.
In her most recent status report regarding her demand, filed on March 23, 2021, Petitioner
estimated she could forward her finalized demand and supporting documentation to
respondent within 45 days, by May 15, 2021. ECF No. 42.
Petitioner shall file a status report updating me on the parties’ settlement
discussions by no later than Tuesday, June 01, 2021. The status report shall indicate
the date by which Petitioner provided, or intends to provide, a settlement demand and
supporting documentation to Respondent. Additionally, Petitioner shall confirm whether
any Medicaid lien exists, and if so, indicate the date by which Petitioner anticipates
providing Respondent a letter from the appropriate state agency verifying the amount of
the lien.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
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