VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00457
Package ID: USCOURTS-cofc-1_18-vv-00457
Petitioner: Laura Russell
Filed: 2019-12-20
Decided: 2020-01-22
Vaccine: influenza
Vaccination date: 2016-12-31
Condition: right shoulder injuries
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Laura Russell filed a petition on December 20, 2019, alleging she suffered right shoulder injuries as a result of an influenza vaccine administered on December 31, 2016. Respondent filed a report on March 22, 2019, concluding that compensation was not appropriate. The public decision does not describe the specific onset or symptoms of the alleged injury, nor does it detail any medical records, tests, or treatments. The record did not contain sufficient evidence to establish a Table Injury or that the injury was vaccine-caused, lacking medical records or expert opinion to demonstrate injury. On December 13, 2019, Ms. Russell moved to dismiss her petition, stating she no longer wished to pursue her case and understood this would result in a judgment against her. She elected to reject the Program judgment to preserve her right to file a civil action. Chief Special Master Brian H. Corcoran dismissed the case for insufficient proof, stating that to receive compensation, a petitioner must prove either a "Table Injury" or that the injury was actually caused by a vaccine. The record did not disclose sufficient evidence for either. The decision does not mention petitioner counsel or respondent counsel by name in the body of the decision, but notes Amy A. Senerth of Muller Brazil, LLP, for Petitioner and Traci R. Patton of the U.S. Department of Justice for Respondent. No award amount was granted as the case was dismissed.

Theory of causation field:
Petitioner Laura Russell alleged right shoulder injuries following an influenza vaccine administered on December 31, 2016. Respondent filed a report concluding compensation was not appropriate. The public decision states the record lacked sufficient evidence to establish a Table Injury or that the injury was vaccine-caused, noting the absence of medical records or expert opinion to demonstrate injury. Petitioner moved to dismiss her petition on December 13, 2019, electing to reject the Program judgment to preserve her right to file a civil action. Chief Special Master Brian H. Corcoran dismissed the case for insufficient proof on January 22, 2020. The public decision does not specify the mechanism of injury or name any experts. No award was made.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-00457-0
Date issued/filed: 2019-11-19
Pages: 9
Docket text: PUBLIC ORDER/RULING (Originally filed: 9/10/2019) regarding 29 Findings of Fact & Conclusions of Law, Signed by Special Master Nora Beth Dorsey. (ypb) Service on parties made.
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Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 1 of 9
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-457V
Filed: September 10, 2019
UNPUBLISHED
LAURA RUSSELL,
Petitioner, Special Processing Unit (SPU);
v. Findings of Fact; Onset and Site of
Vaccination; Influenza (Flu) Vaccine;
SECRETARY OF HEALTH AND Shoulder Injury Related to Vaccine
HUMAN SERVICES, Administration (SIRVA)
Respondent.
Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for petitioner.
Traci R. Patton, U.S. Department of Justice, Washington, DC, for respondent.
FINDINGS OF FACT1
Dorsey, Chief Special Master:
On March 28, 2018, 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 “right shoulder injuries” as a result of
an influenza (“flu”) vaccine administered on December 31, 2016. Petition at 1. The
case was assigned to the Special Processing Unit of the Office of Special Masters.
For the reasons discussed below, the undersigned finds that petitioner was
administered a flu vaccine on December 31, 2016 in her right arm and that the onset of
1 The undersigned intends to post this ruling on the United States Court of Federal Claims' website. This
means the ruling will be available to anyone with access to the internet. In accordance with Vaccine
Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned
agrees that the identified material fits within this definition, the undersigned will redact such material from
public access. Because this unpublished 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).
2 National 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).

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 2 of 9
her shoulder symptoms occurred within 48 hours of vaccination. Specifically, petitioner
suffered shoulder pain within 48 hours of vaccination.
I. Relevant Procedural History
Following the initial status conference held on May 11, 2018, respondent was
ordered to file a status report indicating how he intends to proceed in this case. ECF
No. 8. On February 11, 2019, respondent filed a status report confirming that he
intends to defend this case and requesting a deadline for the filing of his Rule 4(c)
Report. ECF No. 19.
Respondent filed his Rule 4(c) Report (“Res. Report”) on March 22, 2019. ECF
No. 21. In his report, respondent argued that, although petitioner alleged that she
received the December 31, 2016 flu vaccination in her injured right arm, her medical
records indicate the flu vaccination was administered in her left arm. Res. Report at 5.
Respondent further asserted that petitioner has not established all of the elements
necessary for a shoulder injury related to vaccine administration (“SIRVA”) Table Injury,
including onset of the shoulder injury within 48 hours of the vaccination. Id. at 5-7.
Thereafter, a scheduling order was issued ordering petitioner to file a motion for
subpoena authority to obtain additional vaccination records from Rite Aid. ECF No. 22.
Petitioner filed vaccination records collected pursuant to subpoena on May 17, 2019.
ECF No. 25.
On May 31, 2019, a scheduling order was issued noting that the undersigned
had reviewed respondent’s Rule 4(c) Report and the evidence filed to date in this case.
ECF No. 27. The undersigned stated that briefing and a hearing were not necessary to
make findings of fact regarding the site of petitioner’s flu vaccination and the onset of
her alleged injury. Id. The undersigned set a deadline for the parties to file any
additional relevant evidence they wished to have considered regarding these issues. Id.
No additional evidence was filed. This matter is now ripe for adjudication.
II. Issues
There are two issues in this case: (1) whether petitioner was administered a flu
vaccine on December 31, 2016 in her injured right arm, and (2) whether petitioner’s first
symptom or manifestation of onset after vaccine administration was within 48 hours as
set forth in the Vaccine Injury Table. 42 C.F.R. § 100.3(a) XIV.B. (2017) (influenza
vaccination). Additionally, the Qualifications and aids to interpretation (“QAI”) for a
Table SIRVA also require that a petitioner’s pain occurs within 48 hours. 42 C.F.R. §
100.3(c)(10).
III. Authority
Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
2

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 3 of 9
§ 11(c)(1). 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.” Vaccine Act § 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.
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.
Vaccine Act § 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.” Curcuras v. Sec’y of Health &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Additionally, when determining the impact of the evidence presented, the special
master should consider factors such as the reliability and consistency of the evidence.
See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 416 (Fed. Cir. 1993).
“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), mot. for rev. denied, 23 Cl. Ct. 726 (1991), aff'd per curium, 968 F.2d 1226 (Fed.
Cir. 1992).
IV. Findings of Fact
a. Site of Vaccination
The undersigned finds that the record in this case establishes that petitioner was
administered a flu vaccination in her right arm on December 31, 2016. The undersigned
makes the aforementioned finding after a complete review of the record, including all
medical records, petitioner’s affidavit, and respondent’s Rule 4(c) Report.
Specifically, the undersigned bases the finding on the following evidence:
• The “Corp Pharmacy: Prescription Inquiry” and “Corp Pharmacy:
Service Details” forms from Rite Aid document that a flu vaccine was
administered intramuscularly in petitioner’s left upper arm on
December 31, 2016. Petitioner’s Exhibits (“Pet. Exs.”) 1 at 2; 9 at 2. A
“Screening Questionnaire and Consent Form” from Rite Aid reflects an
entry of “LA,” or left arm, under the site of administration section for the
December 31, 2016 flu vaccination. Pet. Ex. 9 at 4.
3

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 4 of 9
• On March 6, 2017, petitioner presented to Fusion Healthcare for a
medical appointment following an emergency room admission on
January 22, 2017.3 Pet. Ex. 2 at 17. Petitioner reported that she had
suffered a “reaction” to a flu vaccine administered on December 31,
2016 and had experienced right arm soreness since that time. Id.
Petitioner specified that the flu vaccine was administered in her right
arm. Id.
• A March 27, 2017 MRI of petitioner’s right shoulder revealed, in
pertinent part, mild supraspinatus and infraspinatus tendinopathy; trace
amount of joint fluid; and minimal degenerative changes of the
acromioclavicular joint. Pet. Ex. 3 at 3. These imaging findings are
suggestive of a SIRVA. See Court Exhibit I, attached (S. Atanasoff, et
al., Shoulder injury related to vaccine administration (SIRVA), 28
Vaccine 8049, 8051-52 (2010) (noting that shoulder MRI findings such
as fluid collection, localized tendon inflammation, and bursitis may be
consistent with over-penetration of the vaccine needle into the synovial
space of the shoulder.)).
• On May 18, 2017, petitioner presented to Anderson Physical Therapy
for an initial evaluation. Pet. Ex. 3 at 40. Petitioner noted that in
“December 2016” she had received a flu vaccine in her “right side” and
had experienced shoulder pain since that time. Id.
• On June 18, 2018, petitioner filed a detailed affidavit providing
additional information regarding her December 31, 2016 flu
vaccination. Pet. Ex. 8. At the time of the vaccination, petitioner
recalled that she was sitting in a private room and had turned sideways
to the left-facing wall while her right arm faced the vaccine
administrator. Id. at ¶ 7. Petitioner confirmed that she was
administered the flu vaccination in her right arm. Id.
b. Onset
Based upon the record as a whole, and specifically the evidence cited below, the
undersigned finds that the onset of petitioner’s right shoulder pain occurred within 48
hours after the administration of the December 31, 2016 flu vaccine.
• As established above, petitioner received a flu vaccine in her right arm
on December 31, 2016.
• On March 6, 2017, petitioner presented to Fusion Healthcare with
complaints of “right shoulder/arm pain” following a December 31, 2016
flu vaccination. Pet. Ex. 2 at 17. Petitioner stated that she had been
3 Petitioner presented to the emergency room on January 22, 2017 with complaints of sore throat and
difficulty breathing. Pet. Ex. 4 at 5. Petitioner was discharged the same day in stable condition with
diagnoses of acute pharyngitis and acute anxiety. Id. at 6-7.
4

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 5 of 9
experiencing soreness since receiving the flu vaccination and denied
any previous injury or trauma. Id. On examination, petitioner
presented with right shoulder tenderness to palpation, “very guarded”
range of motion, inability to move her arm behind her back, and
positive scarf and empty can testing. Id. at 18.
• On May 18, 2017, petitioner presented to Anderson Physical Therapy
for an initial evaluation. Pet. Ex. 3 at 40. Petitioner noted that in
“December 2016” she had received a flu vaccine in her “right side” and
had experienced shoulder pain since that time. Id. A
contemporaneous “Physical Therapy Evaluation and Treatment Plan”
form linked the onset of petitioner’s shoulder condition to the flu
vaccination and noted that her arm “never got better.” Id. at 47. On
examination, petitioner presented with tightness, right shoulder
tenderness to palpation, reduced range of motion, and reduced
strength. Id. at 40.
• On June 18, 2018, petitioner filed a detailed affidavit providing
additional information regarding her December 31, 2016 flu
vaccination. Pet. Ex. 8. Petitioner noted that her right shoulder
symptoms, including pain, began “immediately” following vaccination.
Id. at ¶¶ 7, 9. Petitioner averred that her symptoms did not subside but
instead grew worse over time. Id. at ¶¶ 8-9. Petitioner indicated that
her injury limited her ability to perform activities of daily living. Id. at ¶¶
9, 12. Petitioner averred that, although her symptoms have improved,
she continues to suffer from right shoulder pain. Id. at ¶ 13.
V. Conclusion
In light of all of the above and in view of the record as a whole, the undersigned
finds that (1) petitioner was administered an influenza vaccine in her right arm on
December 31, 2016, and (2) the onset of petitioner’s right shoulder symptoms, including
pain, occurred within 48 hours of vaccination.
The parties are encouraged to consider an informal resolution of this claim.
Petitioner shall file a joint status report by no later than Friday, October 11, 2019,
updating the court on the status of the parties’ settlement discussions.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
5

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 6 of 9
Vaccine 28 (2010) 8049-8052
Contents lists available at ScienceDirect
Vaccine
ELSEVIER journal homepage: www.elsevier.com/locate/vaccine
Short communication
Shoulder injury related to vaccine administration (SIRVA)*
S. AtanasofP ··, T. Ryana, R. Lightfootb, R.Johann-Lianga
•US.Department of Health and Human Services. Health Resources and Services Administration. National Vaccine Injury Compensation Program, United States
bThe Division of Rheumatology and Women's Health, University of Kentucky School of Medicine, United States
ART I CLE I N FO ABSTRACT
Article history: Shoulder pain is a common transient side-effect of vaccination. Infrequently, patients can develop pro
Received 30 July 2010 longed shoulder pain and dysfunction following vaccination. A series of 13 cases are described in which
Received in revised form 1 October 2010 persistent shoulder dysfunction and pain developed following immunization. Common clinical char
Accepted 3 October 2010
acteristics include absence of a history of prior shoulder dysfunction, previous exposure to vaccine
Available online 16 October 2010
administered, rapid onset of pain, and limited range of motion. The proposed mechanism of injury is
the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated
Keywords:
inflammatory reaction. Careful consideration should be given to appropriate injection technique when
Vaccination
administering intramuscular vaccinations to reduce the risk of shoulder injury.
Shoulder pain
Published by Elsevier Ltd.
Immune-mediated inflammatory reaction
Bursitis
Tendonitis
1. Introduction findings in patients with shoulder pain related to vaccine adminis
tration and offers considerations for reducing the risk of shoulder
The Vaccine Injury Compensation Program (VICP) was created injury related to vaccine administration.
in 1988 to ensure an adequate supply of vaccines, stabilize vaccine
costs, and establish and maintain an accessible and efficient forum
2. Materials and methods
for individuals found to be injured by certain vaccines. The VICP
is a no-fault alternative to the traditional tort system for resolving
The Vaccine Injury Compensation Program houses an adminis
vaccine injury claims and provides compensation to people found
trative database containing information on recent claims submitted
to be injured by specific covered vaccines [ 1 ). At its inception, the
to the Program. A query of the database was conducted to identify
vast majority ofVICP cases involved evaluation of possible vaccine
potentially relevant cases based on a claimed injury of "shoul
related injuries in children. In recent years. however, the program's
der pain," "arm pain", "shoulder dysfunction", "frozen shoulder".
demographics have shifted dramatically with more than 50% of
"adhesive capsulitis", or "shoulder bursitis". "Brachia I neuritis" was
submitted cases now involving adults (2).
also included since this injury is frequently claimed when the arm
Thousands ofv accinations are administered to children, adoles
is involved regardless of the actual diagnosis. Case histories of all
cents and adults every day in the United States with transient pain
submitted medical records were reviewed in detail to verify vacci
at the vaccine injection site recognized as one of the more com
nation date, symptom onset and clinical course.
monly seen side-effects of vaccination [3). The experience at VICP
Cases consistent with a diagnosis ofbrachial neuritis or complex
suggests that vaccination may infrequently cause more severe, per
regional pain syndrome were excluded, as were cases of superficial
sistent shoulder pain with prolonged restriction of function. This
localized soft tissue swelling with pain and/or superficial scarring.
report summarizes a series of cases in which persistent shoulder
Two cases claiming arm pain were excluded because the onset of
pain following vaccination was felt to be related to administra
arm pain was reported many months following vaccination and
tion of the vaccine, proposes a mechanism by which such injuries
records lacked sufficient documentation to verify any association
may occur, identifies common historical and physical examination
between the onset of symptoms and vaccination. Following the
review, 13 potential cases submitted between 2006 and 2010 were
identified for inclusion in this report.
*
Several oft he authors are employees of the United States Department of Health A literature search was conducted using PubMed and search
and Human Services. The positions expressed and recommendations made in this
terms of "vaccination," with "shoulder," "shoulder dysfunction,"
paper do not necessarily represent those of the United States Government
* Corresponding author. Tel.: +1 301 443 2377; fax: +1 301 443 5443. "arm pain," "needle length," and "BMI." The literature search was
E-mail addresses: satanasoff@hrsa.gov. tryan@hrsa.gov (S. Atanasoff). limited to publications in English.
0264-41 OX/$ - see front matter. Published by Elsevier Ltd.
doi: 10.1016/j.vaccine2010.10.005
Court Exhibit I, p.1

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 7 of 9
8050 S.Atanasoffetal./Vaccine28 (2010) 8049–8052
Table1
ClinicalCharacteristicsofn=13patientswithshoulderinjuryrelatedtovaccination.
Demographics:gender 11Female(85%) 2Male(15%)
Demographics:age Meanage:50years Agerange:26–83
Bodyhabitus BMImean:27.2 BMIrange:19.4–41.3 Overweight/Obese8(62%)
Vaccine 8Influenza(62%) 2Td(15%) 2Tdap(15%) 1HPV(8%)
Repeatorsequentialvaccination Confirmed:11(85%) Unconfirmed:2(15%)
Onsetofpain Immediate:7(54%) Within24h:5(39%) Within4days:1(8%)
Commentinrecords Vaccineinjection“toohigh”:6(46%)
Signsandsymptoms Shoulderpain(100%) LimitedROM11(85%) Alteredsensation4(31%) Weakness4(31%)
Localinjectionsitereactions(0%)reduceddeeptendonreflexes(0%)
Diagnostictests MRI MRIperformed9(69%)Fluidcollectionsindeepdeltoid/overlyingtendons,fluidinbursa,
tendonitis,tears
X-ray X-rayperformed7(54%)Nodiagnosticbenefit
EMG/NCV EMG/NCV5(39%)Noindicationofneurologicaldisordersuchasbrachialneuritis
Surgicalexploration Surgicalexploration1(8%):pathofvaccineadministrationreplicatedbyinsertinganeedleintothe
deltoid,areacontainedaninflamedandscarredbursa/thickenedtissuearoundadamagedtendon.
Treatment NSAIDs:8(62%) Steroidinjection:8(62%) Physicaltherapy:6(46%) Surgery:4(31%)
Clinicalcourse Fullrecovery:4(31%) Residualsymptoms9(69%)
3. Results rotatorcufftendonwasnoted.Sixty-threepercentoftheMRIsper-
formedinourcaseserieswereconductedwithinthreemonthsof
Inthecourseofreviewingclaimssubmittedfrom2006through the date of symptom onset and half were performed within six
2010, the VICP identified 13 claims in which it appeared that weeks of symptom onset. Routine X-rays of the shoulder were
vaccine administration led to significant shoulder pain and dys- performedlessfrequentlyanddidnotprovidehelpfuldiagnostic
function.Thedemographicandclinicalcharacteristicsofthese13 informationamongpatientsinthisseries.
casesareshowninTable1.Allindividualsinthiscaseserieswere
adults, 85% were women, and, with one exception, all received 3.3. Clinicalcourse
eitherinfluenzavaccineoratetanus-containingvaccinepriortothe
onsetofsymptoms.Themeanbodymassindex(BMI)ofpatientsin Theseverityanddurationofshoulderdysfunctionvariedamong
thecaseserieswas27.2(range19.4–41.3). patientsinthiscaseseries.Morethanhalfofthepatientsrequired
A history of prior immunization with the same vaccine was atleastoneinjectionofacorticosteroidovertime.Surgicalinter-
confirmed in 85% of the cases. Among patients in whom a his- vention was performed in 31% of cases with half of those cases
toryofpreviousvaccinationwasconfirmed,theintervalbetween requiringasecondsurgicalintervention.Reviewoftheavailable
vaccinationswasnolessthan10yearsforthosereceivingtetanus- recordsshowedthatshouldersymptomspersistedamongourcases
containing vaccines and no less than 11 months for influenza from six months to many years. All patients had symptoms for
vaccine. One patient developed shoulder symptoms following atleastsixmonths.Lessthanonethirdofpatientshadcomplete
administrationofthethirdofathreedoseseriesofhumanpapil- recoverywhilethemajorityofpatientsinthisserieshadcontinu-
lomavirus (HPV) vaccine which was administered three months ingsymptomsincludingpersistentpain,limitedrangeofmotion,
followingthesecondHPVvaccination. andpainonrangeofmotionatlastfollow-up.
3.1. Historyandphysicalexamination 4. Discussion
Shoulder pain was present in all patients. Onset of pain was Bodor and Montalvo [4] reported two cases of shoulder pain,
reportedasoccurringlessthan24haftervaccinationin93%and weakness,andreducedrangeofmotionfollowingvaccinationwith
occurred immediately following injection in 54% of our cases. theonsetofsymptomsinbothcasesoccurringtwodaysaftervacci-
Forty-sixpercentofthepatientsvoicedconcernsregardingvaccine nation.Bothpatientshadshoulderdysfunctionandpaininvolving
administration,specificallythatthevaccinationhadbeenadmin- multiplestructuresoftheshoulderwithreducedrangeofshoulder
istered “too high” in the deltoid. The most common findings on motion.Onepatientdevelopedadhesivecapsulitis.Bothrequired
examinationwerelimitedandpainfulrangeofmotion.Skinand multiplesteroidinjectionsinlocationsincludingthesubacromial
localinjectionsitereactionswerenotreportedandsensorysymp- bursa,bicipitaltendonsheathandglenohumeraljointtoreachcom-
tomssuchastinglingandnumbnessintheaffectedextremitywere pleteresolutionofpain.Usingultrasoundtheauthorsinvestigated
uncommon. Weakness was not a common finding in any of the thelocationanddepthofthesubdeltoidbursaintheirtwopatients
casesduringtheinitialexaminationandwhenfoundwasattributed and in 21 healthy controls. They found that the bursa extended
topain.Deeptendonreflexes,whentested,werenotedtobenor- from3.0to6.0cm(1.18–2.36in.)beyondthelateralborderofthe
mal. acromionandthatitlayanywherefrom0.8to1.6cm(0.31–0.62in.)
belowtheskinsurface;depthseasilyreachedbythe1in.needle
3.2. Diagnosticevaluation usedinbothpatients.Theauthorshypothesizedthatthevaccine
wasinjectedintothesubdeltoidbursainbothoftheirpatientscaus-
Among the 39% of patients who underwent electrodiagnostic ingarobustlocalinflammatoryandimmuneresponse.Theyfurther
studies, none had findings suggestive of a neurological disorder hypothesizedthatsincethesubdeltoid1 bursaiscontiguouswith
suchasbrachialneuritis.Whenperformed,MRIfindingsvariedbut thesubacromialbursa,thisledtobursitis,tendonitis,andinflam-
includedfluidcollectionsinthedeepdeltoidoroverlyingtherota- mation of the shoulder capsule. We found no other case reports
torcufftendons(39%),bursitis,fluid“greaterthantypicallyseen”
withinthebursa,tendonitis,rotatorcufftears,and,inonepatient,
subchondral changes in the humerus with overlying severe ten-
1 Forconsistencyandtoreduceconfusion,wewillusetheterm“subacromial
donitisandfluidaccumulation.Acompleterotatorcufftearwas
bursa”torefertoboththesubdeltoidbursaandsubacromialbursaintheremainder
foundin15%ofcasesand,inonecase,associatedatrophyofthe ofthepaper.
Court Exhibit I, p.2

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 8 of 9
S.Atanasoffetal./Vaccine28 (2010) 8049–8052 8051
ACROMION existbetweenvaccineadministrationandshoulderdysfunctionin
somecases[12].Theclinicaldetailsofthepatientsinthisseries
SUBACROMIAL togetherwiththepublishedresearchliteratureonthissubjectmeet
BURSA SPACE
manyofHill’ssuggestedcriteriaforacausalrelationshipincluding
specificity,temporalassociation,biologicalplausibility,coherence,
DELTOID
and experimental evidence. Of the patients in our series, none
MUSCLE
had a history of symptomatic shoulder problems prior to vacci-
nation.Theyallreceivedavaccinetowhichtheyhadpreviously
been exposed. They all experienced the rapid onset of shoulder
pain(range:immediatetofourdays)followingvaccination.They
alldevelopedshouldersymptomslimitedtothevaccinatedshoul-
der.Theyallhadsymptomsandphysicalfindingsconsistentwith
alocalimmune-mediatedinflammatorymusculoskeletalshoulder
~ injury.
SCAPULA Oneofourcasesprovidedadditionalevidencetosupportvac-
(SHOULDER BLADE) cineadministrationasacausalelementinthistypeofinjury.In
thiscase,surgeonsreplicatedthepathofvaccineadministration
SHOULDER JOINT SPACE
byinsertinganeedleintothedeltoidareaatthelocationidentified
bythepatientastheinjectionsiteduringreparativearthroscopic
BICEPS TENDON shouldersurgery.Thepathoftheneedleledthroughanareacon-
GROOVE
taininganinflamedandscarredbursaandthickenedtissuearound
Fig. 1. Anatomy of the shoulder girdle. The relationships of the subdel- adamagedtendon.Beneaththetendontheneedlecameintocon-
toid/subacromialbursaandshoulderjointspacetothesupraspinatustendonand tactwithabnormallyfriableboneonthegreatertuberosityofthe
tothegreatertuberosityonwhichitinserts. humerusthatgavewaywithpressurefromtheneedle.Webelieve
itislikelythatthispatientaswellastheotherpatientsinourseries
orepidemiologicstudiesregardingshoulderdysfunctionresulting developedshoulderpainanddysfunctionthroughthemechanism
fromvaccination. proposedbyBodoranddemonstratedexperimentallybyDumonde.
There have been several larger studies which utilized body Although shoulder dysfunction due to mechanical or overuse
weight,gender,and/orbodymassindex(BMI)togetherwithultra- injuryisalwaysadiagnosticconsideration,therapidonsetofpain
sound evaluation of deltoid fat pad and skin fold thickness to withlimitedrangeofmotionfollowingvaccinationinourseries
determinetheappropriateneedlelengthforintramuscularinjec- of patients is consistent with a robust and prolonged immune
tion in different patient groups [5–7]. In one of the few studies responsewithinalready-sensitizedshoulderstructuresfollowing
addressing the risk of injecting into shoulder tissues underlying injectionofantigenicsubstanceintothesubacromialbursaorthe
thedeltoidmuscle,LippertandWall[8]assessedtheriskofover- areaaroundtherotatorcufftendon.Webelievethatthistypeof
penetrationthroughthedeltoidmuscleinchildrenages3–18using phenomenonisnotduetoaspecificvaccinebutresultsfrominjec-
theneedlelengthsrecommendedbytheCentersforDiseaseCon- tion of a vaccine antigen to which a person has previously been
trol.Theyreportedariskofover-penetrationrangingfrom11to61% sensitizedasaresultofpreviousnaturallyoccurringinfectionor
whenusingtheneedlelengthsrecommendedforeachagegroup. pastvaccination.Thisconceptisconsistentwiththevaccineswhich
Wefoundnopublicationsregardingtheriskofover-penetration weregiveninthiscaseseries,namelyinfluenzaandtetanusvac-
duetoneedlelengthinanadultpopulation.However,considering cineswhicharegivenrepeatedlyovertimeandHPVvaccinewhich
theultrasoundmeasurementfindingsbyBodorandMontalvo,itis isgivenasaseriesofinjections.Weconfirmedthatalmostallof
conceivablethataneedlelengthofoneinchorgreatercouldreach our cases had received at least one dose of the same vaccine in
thebursaorothertissuesinsomepatients,particularlyadultswith thepast.Thetwocasesforwhichpriorvaccinationcouldnotbe
alowerBMI(Fig.1). confirmedbythemedicalrecordsincludedonecaseofinfluenza
Theactofinsertinganeedleorinjectinganon-antigenicsub- vaccineadministrationandonecaseinvolvingadministrationofa
stance into the deltoid muscle would not be expected to cause tetanus-containingvaccine.Itislikelythatanadultpatientwould
animmune-mediatedinflammatoryresponse.Evenwhenanindi- havereceivedapriortetanus-containingvaccinationatsomepoint
vidual is vaccinated in the deltoid muscle with a previously intheirlifetime.Althoughitispossiblethatanadultmayreceivea
administered vaccine any local injection site reaction caused by first-timeinfluenzavaccine,itisunlikelythatanadultwouldnot
vaccineantigen–antibodyinteractionisexpectedtoberelatively havehadexposuretoinfluenzavirusoraninfluenzainfectioninthe
brief and resolve as the antigen is cleared from the soft tissues past.Theimmuneresponsetobothvaccinesandinfectionswanes
over a period of several days. If, however, a vaccine is inadver- overtimeandmayexplainsomeofthevariationinseverityand
tently injected into the synovial space of the shoulder (bursa or durationofsymptomsinourcaseseries.
joint), pre-existing antibody in the synovial tissues, present as a Ingeneral,chronicshoulderpainwithorwithoutreducedshoul-
resultofearliernaturallyoccurringinfectionorvaccination,may derjointfunctioncanbecausedbyanumberofcommonconditions
leadtoamoreprolongedinflammatoryresponse[9,10].Astudy including impingement syndrome, rotator cuff tear, biceps ten-
byDumondeusingrabbitsdemonstratedthatantigeninjectedinto donitis,osteoarthritisandadhesivecapsulitis[13].Inmanycases,
thesynovialspacewasboundtoexistingantibodyintheconnec- theseconditionsmaycausenosymptomsuntilprovokedbytrauma
tivetissuesofthejointleadingtoformationofantigen–antibody or other events. Reilly et al. [14] reviewed a series of shoulder
complexesandacuteinflammationwhichlastedforsixweeks[11]. ultrasoundandMRIstudiesobtainedinasymptomaticpersonspast
We took these publications into consideration as we ana- middleageandfoundpartialorcompleterotatorcufftearsin39%of
lyzedourcaseseriestodeterminewhethertheinjuriescouldbe thoseindividuals.Therefore,someoftheMRIfindingsinourcase
caused by vaccine administration. Since it is usually not possi- series,suchasrotatorcufftears,mayhavebeenpresentpriorto
ble to attribute causation from a case series, we took Sir Austin vaccination and became symptomatic as a result of vaccination-
Bradford Hill’s proposed set of nine criteria or “viewpoints” into associated synovial inflammation. Other findings such as fluid
considerationindeterminingwhetheracausalrelationshipmight collections,localizedtendoninflammation,andbursitisaremore
Court Exhibit I, p.3

Case 1:18-vv-00457-UNJ Document 32 Filed 11/19/19 Page 9 of 9
8052 S.Atanasoffetal./Vaccine28 (2010) 8049–8052
consistent with the vaccine needle over-penetration mechanism toid muscle due to inappropriate needle length and/or injection
proposedhere. technique[4–8].Theresearchliteraturesupportsthepotentialfor
The fact that six patients in our case series reported vaccine inducingaprolongedimmune-mediatedinflammatoryreactionif
administration“toohigh”intheshoulderindicatesthatinsomeof avaccineantigenisinjectedintosynovialtissuestructuresunder-
ourcasestheinjurymayhavebeentheresultofimproperinjection lyingthedeltoidmuscle[9–11].
technique.Giventhat62%ofourcaseswereoverweightorobese Ourclinicalcaseseriesprovidesadditionalevidencesupporting
based upon BMI and that no case was considered underweight, the report by Bodor and Montalvo [4] that vaccine administra-
needlelengthalonemaynothavebeenthecauseofinjectioninto tion in the upper third of the deltoid area can have long-lasting
tissuesotherthanthedeltoid.Bodor’sultrasoundfindingsrevealed consequencesunrelatedtothespecificvaccineadministered.Com-
thatthesubacromialbursacanextendover2.36in.laterallyfrom monalitiesofhistoryandphysicalexaminationamongpatientsin
theacromioninsomecases.Therefore,weagreewithBodorthat ourcaseseriesmaybehelpfulinidentifyingpatientswhomayhave
avoidingthetopthirdofthedeltoidwouldhelptoreducetheriskof developed shoulder pain and dysfunction as a result of inadver-
penetratingthebursa.Inaddition,whilepatientsareoftenseated tentvaccinationintothebursaorothertissuesbeneaththedeltoid
for vaccinations, the standing position of the provider adminis- muscle.
teringtheinjectionmayalsocontributetoinjectinginadvertently Softtissueatrophyincludingtendonatrophyorruptureisarec-
highintothedeltoid.Aseatedpatientmayhelptoreducetherisk ognizedsideeffectofcorticosteroidinjection.Insituationswhere
of injury during a syncopal episode, but an awareness of proper recent vaccination is suspected as a possible cause of shoulder
injectiontechniqueonthepartofthevaccineadministratorshould pain we suggest consideration of non-invasive imaging such as
alsobeemphasized.Thus,concurrentseatingpositionsforboththe MRIorhighresolutionmusculoskeletalultrasonography,priorto
administratorandthereceivermayminimizetheriskoftheinjec- steroid injection to define any pre-existing anatomic abnormal-
tionbeing“toohigh”.Additionalconsiderationsforpossiblefuture ities. Non-invasive imaging might assume greater importance if
studywouldincludethebenefitofabductingthearmafewdegrees symptomspersistandadditionalsteroidinjectionsarebeingcon-
laterallysothatthebulkofthebursaisprotectedbytheacromion sidered.
processandpossiblyexploringalternateinjectionsitesinpatients Theriskofvaccineadministration-relatedshoulderinjurymay
withlittleshouldermusclemass. bereducedbygivingcarefulconsiderationtoappropriateneedle
Thereisanotableabsenceofchildreninourcaseseriesdespite lengthbasedonindividualpatientcharacteristicssuchasgender
thefactthattheyhaveexposuretoabroadrangeofvaccineantigens and body mass index. Care should be taken to insure that the
inthefirstdecadeoflife.Anumberoffactorsmayexplaintheirlack needle is not inserted into the upper third of the deltoid mus-
ofrepresentationinthiscaseseries.Thethighisthepreferredsite cle.
ofvaccinationintoddlersandinfantsthuseliminatingtheriskof
shoulderinjuryinthisgroup.Inolderchildrenandadolescents,the References
subacromialbursamaynotbeasdevelopedorasextensiveasthose
inadults.Vaccineadministrationinolderchildrenmaymorecom- [1] For more information on the VICP go to http://www.hrsa.gov/
Vaccinecompensation/.
monlyincludetechniquessuchas“bunching”ofthesubcutaneous
[2] Johann-Liang R. Institute of medicine project review of adverse events,
anddeltoidtissuepriortovaccinationthusincreasingthedistance http://www.hrsa.gov/vaccinecompensation/Docs/Transcript-ACCV-6-5-
betweentheskinandsubacromialbursa.Children,asagroup,have 09.pdf,p.82–94[accessed07.12.10].
a much lower likelihood of pre-existing asymptomatic shoulder [3] Possible side-effects from vaccines, http://www.cdc.gov/vaccines/vac-gen/
side-effects.htm[accessed7.12.10].
injurieswhichmightbeaggravatedasaresultofaninflammatory [4] Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine
reactionrelatedtovaccination.Finally,annualinfluenzavaccina- 2006;25(4):585–7.
tion, the most common vaccine associated with shoulder injury [5] PolandGA,BorrudA,JacobsonRM,McDermottK.Determinationofdeltoidfat
padthickness:implicationsforneedlelengthinadultimmunizations.JAMA
inthisseries,mayhavebeenmoreselectivelyencouragedforchil-
1997;277(21):1709–11.
drenathigherriskforinfluenza-relatedcomplicationsinpastyears [6] CookIF,WilliamsonM,PondD.Definitionofneedlelengthrequiredforintra-
thusreducingthepossibilityofvaccine-relatedshoulderinjuryin musculardeltoidinjectioninelderlyadults:anultrasonographicstudy.Vaccine
2006;24(7):937–40.
childrenbychancealone.
[7] Koster MP, Stellato N, Kohn N, Rubin LG. Needle length for immu-
Ourstudyislimitedbytheabsenceofacontrolgrouptoallow nization of early adolescents as determined by ultrasound. Pediatrics
comparison of outcomes. Additionally, patients submitting peti- 2009;124(2):667–72.
[8] LippertWC,WallEJ.Optimalintramuscularneedle-penetrationdepth.Pedi-
tions to the Vaccine Injury Compensation Program may not be
atrics2008;122(30):e556–563.
representative of the general public, leading to the possibility of [9] CookeTD,JasinHE.Thepathogenesisofchronicinflammationinexperimental
areportingbiassimilartothatwhichmightbeseenwiththeVac- antigen-inducedarthritis.I.Theroleofantigenonthelocalimmuneresponse.
ArthritisRheum1972;15(4):327.
cineAdverseEventReportingSystem(VAERS)[15].Thestrength
[10] CookeTD,HurdER,ZiffM,JasinHE.Thepathogenesisofchronicinflamma-
ofourcaseseriesisthatthemedicalrecordsinVICPpetitionsare tioninexperimentalantigen-inducedarthritis.II.Preferentiallocalizationof
typicallyvoluminousandcomprehensive,allowingdetailedanaly- antigen-antibodycomplexestocollagenoustissues.JExpMed1972;135(2):
sisofeachcase.Thus,althoughthereisnospecificdiagnostictest 323.
[11] DumondeDC,GlynnLE.Theproductionofarthritisinrabbitsbyanimmuno-
forshoulderdysfunctionduetovaccineneedleover-penetration, logicalreactiontofibrin.BritJExpPathol1962;43:373.
weareabletodescribeclinicalqualificationsandaidstodiagnosis [12] HillAB.Theenvironmentanddisease:associationorcausation?ProcRSocMed
forthisentityallowingidentificationofpossiblecasesofshoulder 1965;58:295–300.
[13] WoodwardT,BestT.Thepainfulshoulder.PartII.Acuteandchronicdisorders.
injuryrelatedtovaccineadministration(SIRVA).
AmFamPhysician2000;61:3000–291.
[14] ReillyP,MacleodI,MacfarlaneR,WindleyJ,EmeryRJ.Deadmenandradiolo-
5. Conclusions gistsdon’tlie:areviewofcadavericandradiologicalstudiesofrotatorcufftear
prevalence.AnnRCollSurgEngl2006;88(2):116–21.
[15] TheMainLimitationsofVAERSData.AbouttheVAERSProgram,http://vaers.
The medical literature supports the possibility that a vaccine hhs.gov/about/index[accessed7.12.10].
canbeunintentionallyinjectedintostructuresunderlyingthedel-
Court Exhibit I, p.4

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DOCUMENT 2: USCOURTS-cofc-1_18-vv-00457-1
Date issued/filed: 2020-01-22
Pages: 2
Docket text: PUBLIC DECISION (Originally filed: 12/20/2019) regarding 34 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made.
--------------------------------------------------------------------------------
Case 1:18-vv-00457-UNJ Document 38 Filed 01/22/20 Page 1 of 2
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-457V
UNPUBLISHED
LAURA RUSSELL, Chief Special Master Corcoran
Petitioner, Filed: December 20, 2019
v.
Petitioner’s Motion for a Decision
SECRETARY OF HEALTH AND Dismissing Her Petition; Influenza
HUMAN SERVICES, (Flu) Vaccine; Shoulder Injury
Related to Vaccine Administration
Respondent. (SIRVA); Special Processing Unit
(SPU)
Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for Petitioner.
Traci R. Patton, U.S. Department of Justice, Washington, DC, for Respondent.
DISMISSAL DECISION1
On March 28, 2018, Laura Russell filed a petition for compensation under the
National Vaccine Injury Compensation Program (“the Program”), 42 U.S.C. §300aa-10,
et seq.,2 (the “Vaccine Act”). Petitioner alleges that she suffered “right shoulder injuries”
as a result of an influenza (“flu”) vaccine administered on December 31, 2016. Petition
at 1. Respondent filed a Rule 4(c) Report concluding that compensation is not appropriate
in this case on March 22, 2019. ECF No. 21. The information in the record does not
show entitlement to an award under the program.
On December 13, 2019, Petitioner moved for a decision dismissing the petition,
noting that “she no longer wishes to pursue her case.” ECF No. 33. Petitioner indicated
that she “understands that a decision by the Chief Special Master dismissing her
petition will result in a judgment against her. She has been advised that such a
judgment will end all of her rights in the Vaccine Program.” Id. Petitioner noted that
1 Because this unpublished 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 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 “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:18-vv-00457-UNJ Document 38 Filed 01/22/20 Page 2 of 2
she “does intend to protect her rights to file a civil action in the future. Therefore,
pursuant to 42 U.S.C. §300aa-21(a)(2), she intends to elect to reject the Vaccine
Program judgment against her and elect to file a civil action.” Id.
To receive compensation under the Program, Petitioner must prove either 1) that
she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of her vaccinations, or 2) that she suffered an injury that was
actually caused by a vaccine. See §§ 13(a)(1)(A) and 11(c)(1). Examination of the record
does not disclose sufficient evidence to establish that Petitioner suffered a “Table Injury.”
Further, the record does not contain a medical expert’s opinion or any other persuasive
evidence indicating that Petitioner’s alleged injury was vaccine-caused.
Under the Vaccine Act, a petitioner may not be awarded compensation based on
the petitioner’s claims alone. Rather, the petition must be supported by either the medical
records or by a medical opinion. § 13(a)(1). In this case, the record does not contain
medical records or a medical opinion sufficient to demonstrate that the vaccinee was
injured by a vaccine.
For these reasons, in accordance with § 12(d)(3)(A), Petitioner’s claim for
compensation is denied and this case is dismissed for insufficient proof. The Clerk
shall enter judgment accordingly.3
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
2