Court Opinion

ID: 4457091
Source: CourtListenerOpinion
Date Created: 2019-11-19 21:02:04.866195+00
Date Added: 2024-06-11T14:51:19.375649
License: Public Domain

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                                          UNPUBLISHED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
1The 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 Because this unpublished ruling contains a reasoned explanation for the action in this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).

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).
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
§ 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
                •   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

3Petitioner 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
                 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
                                                                     Vaccine 28 (2010) 8049-8052

                                                              Contents lists available at ScienceDirect

                                                                             Vaccine
ELSEVIER                                      jo u rnal homep a ge : www.e lsevier.com/l ocate/vacc ine

Short communication

Shoulder injury related to vaccine administration (SIRVA)*
S. AtanasofP ·· , T. Ryan a, R. Lightfoot b, R.Johann-Liang a
•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 C L E          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:
Vaccination
                                                       inflammatory reaction. Careful consideration should be given to appropriate injection techn ique when
Shoulder pain
                                                       administering intramuscular vaccinations to reduce the risk of shoulder injury.
Immune-mediated inflammatory reaction                                                                                                   Published by Elsevier Ltd.
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-fau lt a lternative 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 t he 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 d ramatically with more than 50% of
                                                                                       "adhesive capsulitis", or "shoulder bursitis". "Brachia I neuritis" was
submitted cases now involving adults (2).
                                                                                       a lso included since this injury is frequently claimed when the arm
    Thousands of vaccinations are administered to child ren, adoles-
                                                                                       is involved rega rdless 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 ve rify 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-
                                                                                       a rm pai n was reported many months following vaccination and
tion of the vaccine, proposes a mechanism by which such injuries
                                                                                       records lacked sufficient documentation to ve rify 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 we re
                                                                                       identified for inclusion in this report.
 * Several of the 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
paper do not necessarily represent those of the United States Government               ter ms of "vaccination," with "shoulder," "shoulder dysfunction,"
 * 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
8050                                                             S. Atanasoff et al. / Vaccine 28 (2010) 8049–8052

Table 1
Clinical Characteristics of n = 13 patients with shoulder injury related to vaccination.

  Demographics: gender                                                    11 Female (85%)                         2 Male (15%)
  Demographics: age                                                       Mean age: 50 years                      Age range: 26–83
  Body habitus                       BMI mean: 27.2                       BMI range: 19.4–41.3                    Overweight/Obese 8 (62%)
  Vaccine                            8 Inﬂuenza (62%)                     2 Td (15%)                              2 Tdap (15%)                           1 HPV (8%)
  Repeat or sequential vaccination                                        Conﬁrmed: 11 (85%)                      Unconﬁrmed: 2 (15%)
  Onset of pain                      Immediate: 7 (54%)                   Within 24 h: 5 (39%)                    Within 4 days: 1 (8%)
  Comment in records                 Vaccine injection “too high”: 6 (46%)
  Signs and symptoms                 Shoulder pain (100%)                 Limited ROM 11 (85%)                    Altered sensation 4 (31%)              Weakness 4 (31%)
                                     Local injection site reactions (0%) reduced deep tendon reﬂexes (0%)
  Diagnostic tests                   MRI                                  MRI performed 9 (69%) Fluid collections in deep deltoid/overlying tendons, ﬂuid in bursa,
                                                                          tendonitis, tears
                                     X-ray                                X-ray performed 7 (54%) No diagnostic beneﬁt
                                     EMG/NCV                              EMG/NCV 5 (39%) No indication of neurological disorder such as brachial neuritis
                                     Surgical exploration                 Surgical exploration 1 (8%): path of vaccine administration replicated by inserting a needle into the
                                                                          deltoid, area contained an inﬂamed and scarred bursa/thickened tissue around a damaged tendon.
  Treatment                          NSAIDs: 8 (62%)                      Steroid injection: 8 (62%)              Physical therapy: 6 (46%)              Surgery: 4 (31%)
  Clinical course                    Full recovery: 4 (31%)               Residual symptoms 9 (69%)

3. Results                                                                                  rotator cuff tendon was noted. Sixty-three percent of the MRIs per-
                                                                                            formed in our case series were conducted within three months of
    In the course of reviewing claims submitted from 2006 through                           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-                             performed less frequently and did not provide helpful diagnostic
function. The demographic and clinical characteristics of these 13                          information among patients in this series.
cases are shown in Table 1. All individuals in this case series were
adults, 85% were women, and, with one exception, all received                               3.3. Clinical course
either inﬂuenza vaccine or a tetanus-containing vaccine prior to the
onset of symptoms. The mean body mass index (BMI) of patients in                                The severity and duration of shoulder dysfunction varied among
the case series was 27.2 (range 19.4–41.3).                                                 patients in this case series. More than half of the patients required
    A history of prior immunization with the same vaccine was                               at least one injection of a corticosteroid over time. Surgical inter-
conﬁrmed in 85% of the cases. Among patients in whom a his-                                 vention was performed in 31% of cases with half of those cases
tory of previous vaccination was conﬁrmed, the interval between                             requiring a second surgical intervention. Review of the available
vaccinations was no less than 10 years for those receiving tetanus-                         records showed that shoulder symptoms persisted among our cases
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                                  at least six months. Less than one third of patients had complete
administration of the third of a three dose series of human papil-                          recovery while the majority of patients in this series had continu-
lomavirus (HPV) vaccine which was administered three months                                 ing symptoms including persistent pain, limited range of motion,
following the second HPV vaccination.                                                       and pain on range of motion at last follow-up.

3.1. History and physical examination                                                       4. Discussion

    Shoulder pain was present in all patients. Onset of pain was                               Bodor and Montalvo [4] reported two cases of shoulder pain,
reported as occurring less than 24 h after vaccination in 93% and                           weakness, and reduced range of motion following vaccination with
occurred immediately following injection in 54% of our cases.                               the onset of symptoms in both cases occurring two days after vacci-
Forty-six percent of the patients voiced concerns regarding vaccine                         nation. Both patients had shoulder dysfunction and pain involving
administration, speciﬁcally that the vaccination had been admin-                            multiple structures of the shoulder with reduced range of shoulder
istered “too high” in the deltoid. The most common ﬁndings on                               motion. One patient developed adhesive capsulitis. Both required
examination were limited and painful range of motion. Skin and                              multiple steroid injections in locations including the subacromial
local injection site reactions were not reported and sensory symp-                          bursa, bicipital tendon sheath and glenohumeral joint to reach com-
toms such as tingling and numbness in the affected extremity were                           plete resolution of pain. Using ultrasound the authors investigated
uncommon. Weakness was not a common ﬁnding in any of the                                    the location and depth of the subdeltoid bursa in their two patients
cases during the initial examination and when found was attributed                          and in 21 healthy controls. They found that the bursa extended
to pain. Deep tendon reﬂexes, when tested, were noted to be nor-                            from 3.0 to 6.0 cm (1.18–2.36 in.) beyond the lateral border of the
mal.                                                                                        acromion and that it lay anywhere from 0.8 to 1.6 cm (0.31–0.62 in.)
                                                                                            below the skin surface; depths easily reached by the 1 in. needle
3.2. Diagnostic evaluation                                                                  used in both patients. The authors hypothesized that the vaccine
                                                                                            was injected into the subdeltoid bursa in both of their patients caus-
   Among the 39% of patients who underwent electrodiagnostic                                ing a robust local inﬂammatory and immune response. They further
studies, none had ﬁndings suggestive of a neurological disorder                             hypothesized that since the subdeltoid1 bursa is contiguous with
such as brachial neuritis. When performed, MRI ﬁndings varied but                           the subacromial bursa, this led to bursitis, tendonitis, and inﬂam-
included ﬂuid collections in the deep deltoid or overlying the rota-                        mation of the shoulder capsule. We found no other case reports
tor cuff tendons (39%), bursitis, ﬂuid “greater than typically seen”
within the bursa, tendonitis, rotator cuff tears, and, in one patient,
subchondral changes in the humerus with overlying severe ten-                                 1
                                                                                                For consistency and to reduce confusion, we will use the term “subacromial
donitis and ﬂuid accumulation. A complete rotator cuff tear was                             bursa” to refer to both the subdeltoid bursa and subacromial bursa in the remainder
found in 15% of cases and, in one case, associated atrophy of the                           of the paper.

                                                                                                                                                Court Exhibit I, p.2
                                                           S. Atanasoff et al. / Vaccine 28 (2010) 8049–8052                                               8051

                   ACROMION                                                           exist between vaccine administration and shoulder dysfunction in
                                                                                      some cases [12]. The clinical details of the patients in this series
     SUBACROM IAL
                                                                                      together with the published research literature on this subject meet
      BURSA SPACE
                                                                                      many of Hill’s suggested criteria for a causal relationship including
                                                                                      speciﬁcity, temporal association, biological plausibility, coherence,
 DELTOID
 MUSCLE                                                                               and experimental evidence. Of the patients in our series, none
                                                                                      had a history of symptomatic shoulder problems prior to vacci-
                                                                                      nation. They all received a vaccine to which they had previously
                                                                                      been exposed. They all experienced the rapid onset of shoulder
                                                                                      pain (range: immediate to four days) following vaccination. They
                                                                                      all developed shoulder symptoms limited to the vaccinated shoul-
                                                                                      der. They all had symptoms and physical ﬁndings consistent with
                                                                                      a local immune-mediated inﬂammatory musculoskeletal shoulder
                                                     ~SCAPULA
                                                                                      injury.
                                                                                           One of our cases provided additional evidence to support vac-
                                                       (SHOULDER BLADE)
                                                                                      cine administration as a causal element in this type of injury. In
                                                                                      this case, surgeons replicated the path of vaccine administration
                                                SHOULDER JOINT SPACE
                                                                                      by inserting a needle into the deltoid area at the location identiﬁed
                                                                                      by the patient as the injection site during reparative arthroscopic
                                         BICEPS TENDON
                                                                                      shoulder surgery. The path of the needle led through an area con-
                                            GROOVE
                                                                                      taining an inﬂamed and scarred bursa and thickened tissue around
Fig. 1. Anatomy of the shoulder girdle. The relationships of the subdel-              a damaged tendon. Beneath the tendon the needle came into con-
toid/subacromial bursa and shoulder joint space to the supraspinatus tendon and       tact with abnormally friable bone on the greater tuberosity of the
to the greater tuberosity on which it inserts.                                        humerus that gave way with pressure from the needle. We believe
                                                                                      it is likely that this patient as well as the other patients in our series
or epidemiologic studies regarding shoulder dysfunction resulting                     developed shoulder pain and dysfunction through the mechanism
from vaccination.                                                                     proposed by Bodor and demonstrated experimentally by Dumonde.
    There have been several larger studies which utilized body                             Although shoulder dysfunction due to mechanical or overuse
weight, gender, and/or body mass index (BMI) together with ultra-                     injury is always a diagnostic consideration, the rapid onset of pain
sound evaluation of deltoid fat pad and skin fold thickness to                        with limited range of motion following vaccination in our series
determine the appropriate needle length for intramuscular injec-                      of patients is consistent with a robust and prolonged immune
tion in different patient groups [5–7]. In one of the few studies                     response within already-sensitized shoulder structures following
addressing the risk of injecting into shoulder tissues underlying                     injection of antigenic substance into the subacromial bursa or the
the deltoid muscle, Lippert and Wall [8] assessed the risk of over-                   area around the rotator cuff tendon. We believe that this type of
penetration through the deltoid muscle in children ages 3–18 using                    phenomenon is not due to a speciﬁc vaccine but results from injec-
the needle lengths recommended by the Centers for Disease Con-                        tion of a vaccine antigen to which a person has previously been
trol. They reported a risk of over-penetration ranging from 11 to 61%                 sensitized as a result of previous naturally occurring infection or
when using the needle lengths recommended for each age group.                         past vaccination. This concept is consistent with the vaccines which
We found no publications regarding the risk of over-penetration                       were given in this case series, namely inﬂuenza and tetanus vac-
due to needle length in an adult population. However, considering                     cines which are given repeatedly over time and HPV vaccine which
the ultrasound measurement ﬁndings by Bodor and Montalvo, it is                       is given as a series of injections. We conﬁrmed that almost all of
conceivable that a needle length of one inch or greater could reach                   our cases had received at least one dose of the same vaccine in
the bursa or other tissues in some patients, particularly adults with                 the past. The two cases for which prior vaccination could not be
a lower BMI (Fig. 1).                                                                 conﬁrmed by the medical records included one case of inﬂuenza
    The act of inserting a needle or injecting a non-antigenic sub-                   vaccine administration and one case involving administration of a
stance into the deltoid muscle would not be expected to cause                         tetanus-containing vaccine. It is likely that an adult patient would
an immune-mediated inﬂammatory response. Even when an indi-                           have received a prior tetanus-containing vaccination at some point
vidual is vaccinated in the deltoid muscle with a previously                          in their lifetime. Although it is possible that an adult may receive a
administered vaccine any local injection site reaction caused by                      ﬁrst-time inﬂuenza vaccine, it is unlikely that an adult would not
vaccine antigen–antibody interaction is expected to be relatively                     have had exposure to inﬂuenza virus or an inﬂuenza infection in the
brief and resolve as the antigen is cleared from the soft tissues                     past. The immune response to both vaccines and infections wanes
over a period of several days. If, however, a vaccine is inadver-                     over time and may explain some of the variation in severity and
tently injected into the synovial space of the shoulder (bursa or                     duration of symptoms in our case series.
joint), pre-existing antibody in the synovial tissues, present as a                        In general, chronic shoulder pain with or without reduced shoul-
result of earlier naturally occurring infection or vaccination, may                   der joint function can be caused by a number of common conditions
lead to a more prolonged inﬂammatory response [9,10]. A study                         including impingement syndrome, rotator cuff tear, biceps ten-
by Dumonde using rabbits demonstrated that antigen injected into                      donitis, osteoarthritis and adhesive capsulitis [13]. In many cases,
the synovial space was bound to existing antibody in the connec-                      these conditions may cause no symptoms until provoked by trauma
tive tissues of the joint leading to formation of antigen–antibody                    or other events. Reilly et al. [14] reviewed a series of shoulder
complexes and acute inﬂammation which lasted for six weeks [11].                      ultrasound and MRI studies obtained in asymptomatic persons past
    We took these publications into consideration as we ana-                          middle age and found partial or complete rotator cuff tears in 39% of
lyzed our case series to determine whether the injuries could be                      those individuals. Therefore, some of the MRI ﬁndings in our case
caused by vaccine administration. Since it is usually not possi-                      series, such as rotator cuff tears, may have been present prior to
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
consideration in determining whether a causal relationship might                      collections, localized tendon inﬂammation, and bursitis are more

                                                                                                                                Court Exhibit I, p.3
8052                                                S. Atanasoff et al. / Vaccine 28 (2010) 8049–8052

consistent with the vaccine needle over-penetration mechanism                  toid muscle due to inappropriate needle length and/or injection
proposed here.                                                                 technique [4–8]. The research literature supports the potential for
    The fact that six patients in our case series reported vaccine             inducing a prolonged immune-mediated inﬂammatory reaction if
administration “too high” in the shoulder indicates that in some of            a vaccine antigen is injected into synovial tissue structures under-
our cases the injury may have been the result of improper injection            lying the deltoid muscle [9–11].
technique. Given that 62% of our cases were overweight or obese                    Our clinical case series provides additional evidence supporting
based upon BMI and that no case was considered underweight,                    the report by Bodor and Montalvo [4] that vaccine administra-
needle length alone may not have been the cause of injection into              tion in the upper third of the deltoid area can have long-lasting
tissues other than the deltoid. Bodor’s ultrasound ﬁndings revealed            consequences unrelated to the speciﬁc vaccine administered. Com-
that the subacromial bursa can extend over 2.36 in. laterally from             monalities of history and physical examination among patients in
the acromion in some cases. Therefore, we agree with Bodor that                our case series may be helpful in identifying patients who may have
avoiding the top third of the deltoid would help to reduce the risk of         developed shoulder pain and dysfunction as a result of inadver-
penetrating the bursa. In addition, while patients are often seated            tent vaccination into the bursa or other tissues beneath the deltoid
for vaccinations, the standing position of the provider adminis-               muscle.
tering the injection may also contribute to injecting inadvertently                Soft tissue atrophy including tendon atrophy or rupture is a rec-
high into the deltoid. A seated patient may help to reduce the risk            ognized side effect of corticosteroid injection. In situations where
of injury during a syncopal episode, but an awareness of proper                recent vaccination is suspected as a possible cause of shoulder
injection technique on the part of the vaccine administrator should            pain we suggest consideration of non-invasive imaging such as
also be emphasized. Thus, concurrent seating positions for both the            MRI or high resolution musculoskeletal ultrasonography, prior to
administrator and the receiver may minimize the risk of the injec-             steroid injection to deﬁne any pre-existing anatomic abnormal-
tion being “too high”. Additional considerations for possible future           ities. Non-invasive imaging might assume greater importance if
study would include the beneﬁt of abducting the arm a few degrees              symptoms persist and additional steroid injections are being con-
laterally so that the bulk of the bursa is protected by the acromion           sidered.
process and possibly exploring alternate injection sites in patients               The risk of vaccine administration-related shoulder injury may
with little shoulder muscle mass.                                              be reduced by giving careful consideration to appropriate needle
    There is a notable absence of children in our case series despite          length based on individual patient characteristics such as gender
the fact that they have exposure to a broad range of vaccine antigens          and body mass index. Care should be taken to insure that the
in the ﬁrst decade of life. A number of factors may explain their lack         needle is not inserted into the upper third of the deltoid mus-
of representation in this case series. The thigh is the preferred site         cle.
of vaccination in toddlers and infants thus eliminating the risk of
shoulder injury in this group. In older children and adolescents, the          References
subacromial bursa may not be as developed or as extensive as those
in adults. Vaccine administration in older children may more com-               [1] For more information on the VICP go to http://www.hrsa.gov/
                                                                                    Vaccinecompensation/.
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                                                                               [14] Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiolo-
                                                                                    gists don’t lie: a review of cadaveric and radiological studies of rotator cuff tear
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can be unintentionally injected into structures underlying the del-

                                                                                                                                      Court Exhibit I, p.4