Court Opinion

ID: 4306401
Source: CourtListenerOpinion
Date Created: 2018-08-22 20:01:45.71204+00
Date Added: 2024-06-11T14:38:21.461968
License: Public Domain

In the United States Court of Federal Claims
                                                          OFFICE OF SPECIAL MASTERS
                                                                   No. 16-0340V
                                                               Filed: April 20, 2018
                                                                  UNPUBLISHED

                                                                         
    HILDA ALMANZAR,                                                      
                                                                             Special Processing Unit (SPU) ;
                                           Petitioner,                       Entitlement; Ruling on the Record;
    v.                                                                       Decision Without a Hearing;
                                                                             Causation-In-Fact; Influenza (Flu)
    SECRETARY OF HEALTH                                                      Vaccine; Shoulder Injury Related to
    AND HUMAN SERVICES,                                                      Vaccine Administration (SIRVA)

                                         Respondent.

                                                                         
Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner.
Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for respondent.
 
                                                               RULING ON ENTITLEMENT1
Dorsey, Chief Special Master:
         On March 16, 2016, Hilda Almanzar (“petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa-10, et seq.,2 (the “Vaccine Act”). Petitioner alleges that she suffered a right
shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza
(“flu”) vaccination she received on October 9, 2014. Petition at 1-2. The case was
assigned to the Special Processing Unit of the Office of Special Masters. For the
reasons discussed herein, the undersigned finds that petitioner is entitled to
compensation.

                                                            
1
  Because this unpublished ruling contains a reasoned explanation for the action in this case, the
undersigned intends 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). 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.
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).

 
 

       I.     Procedural History

              a. From Petition filing to Fact Hearing

       On March 16, 2016, Ms. Almanzar filed her petition, medical records and
Statement of Completion marked as exhibits 1-4. (ECF Nos. 1-2.) Subsequently, on
April 20, 2016, an initial status conference held where additional outstanding medical
records were identified. (ECF No. 8.) Those outstanding records and an amended
Statement of Completion were filed on June 20, 2016 and October 5-6, 2016. (ECF
Nos. 9-10, 15-16.)

       On November 7, 2016, respondent filed a status report stating he was interested
in pursuing settlement discussions and requested that the deadline for the Rule 4(c)
report be suspended. (ECF No. 17). The deadline for respondent to file the Rule 4(c)
report was suspended and petitioner was ordered to file a status report in 30 days
updating the undersigned on the status of the parties’ settlement discussions. (ECF No.
18).

        Over the next six months, the parties attempted to informally resolve this matter.
On May 8, 2017, petitioner filed a status report stating that the parties had reached an
impasse and were requesting a fact hearing. (ECF No. 34). Respondent proposed
filing a Rule 4(c) report by June 30, 2017. This request was granted. (ECF No. 35).

       On June 30, 2017, respondent filed his Rule 4(c) Report. (ECF No. 36.)
Respondent recommended against awarding compensation to petitioner in this case.
Id. Respondent argued, inter alia, that the evidence was insufficient to show a logical
sequence of cause and effect or a temporal relationship between vaccination and injury
because petitioner did not seek medical attention for her shoulder injury until four
months after her vaccination. Id. at 7. Respondent argued that the record was unclear
regarding the timing of onset of petitioner’s injury and as such, petitioner had failed to
established causation-in-fact by a preponderance of the evidence. Id.

       Thereafter, following a status conference held by the staff attorney managing this
case, the undersigned concluded that the case was ripe for a fact hearing. (ECF No.
37.) In preparation for the hearing, petitioner filed additional information requested by
respondent in her Rule 4(c) report and another Statement of Completion on August 30,
2017. (ECF No. 39-40.)

              b. Fact Hearing and Ruling

       A fact hearing was held in Washington, D.C., on December 5, 2017. Ms.
Almanzar was the sole witness and she appeared via video-conferencing from New
Jersey with her attorney. At the conclusion of the hearing, the undersigned informed
the parties that she intended to issue her fact ruling from the bench. The parties
consented. The fact ruling, which was memorialized in a written ruling on December 21,
2017, found that the onset of petitioner’s symptoms occurred within 48 hours of the

                                             2 
 
 

administration of the flu vaccine to Ms. Almanzar. The undersigned also found that Ms.
Almanzar had no history of pain, inflammation or dysfunction of her right shoulder prior
to her flu vaccine administration, that the pain and reduced range of motion was limited
to her right shoulder which is the shoulder in which the vaccine was administered, and
that there was no other condition or abnormality that would explain petitioner’s
symptoms.

        The undersigned also found that given the totality of the facts and circumstances
set forth in the medical records, other exhibits, and testimony, that there was
preponderant evidence of causation establishing that petitioner has proven a clinical
course consistent with a SIRVA (shoulder injury related to vaccine administration) claim.
The written ruling memorializing these findings was issued on December 20, 2017.
(ECF No. 43).

              c. Procedural History Subsequent to the Fact Hearing and Ruling

       On December 20, 2017, the undersigned filed two articles pertaining to causation
of vaccine-related shoulder injuries which were filed as court exhibits. These articles
are: B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28
Vaccine 8049 (2010), filed as Court Exhibit I, and M. Bodor and E Montalvo,
Vaccination Related Shoulder Dysfunction, 25 Vaccine 585 (2007), filed as Court
Exhibit II. (ECF No. 47.) The parties were given until January 19, 2018, to provide any
additional evidence regarding entitlement or any response to the court exhibits. (Id.) No
further filings were made and the undersigned considers the record as to entitlement
closed as of January 19, 2018. (ECF No. 42.) The matter is now ripe for adjudication.

       II.    Factual History
       Ms. Almanzar was a 57-year-old property manager when she received the flu
vaccine in her right arm at a Shoprite pharmacy on October 9, 2014. Petitioner’s Exhibit
(“Pet. Ex.”) 1 at 1; Pet. Ex. 3 at 1; Pet. Ex. 5. She had no prior history of shoulder pain
or shoulder injury.

       On February 11, 2015, approximately four months after vaccination, petitioner
presented to Virtua Family Medicine complaining of right arm pain. Pet. Ex. 2 at 1-4.
She reported experiencing non-radiating, constant but dull pain in her arm for four
months. Id. On examination, Ms. Almanzar’s right shoulder was tender laterally, her
thumb down test was positive, she had signs of impingement, and she had reduced
range of motion (“ROM”). Id. Her cervical spine exam was normal. Id. The
assessment was right shoulder tendonitis and acromioclavicular joint pain. Id. The
physician ordered an x-ray and, after petitioner “insist[ed],” an MRI. Id. at 1. Petitioner
was prescribed meloxicam and referred to physical therapy (“PT”). Id.

       An MRI was conducted on February 18, 2015 and showed “[m]ild to moderate
supraspinatus and infraspinatus tendinosis with more advanced tendinosis at the
junction of the supraspinatus and infraspinatus tendons,” and mild subacromial and
subdeltoid bursitis. Pet. Ex. 2 at 9. An x-ray taken the same day revealed likely calcific

                                             3 
 
 

tendinitis or bursitis, and “[q]uestionable small loose body in the glenohumeral joint.” Id.
at 11.

       On March 19, 2015, Ms. Almanzar presented to orthopedic surgeon Mark
Schwartz, M.D. Pet. Ex. 3 at 1. She reported experiencing five months of right
shoulder pain and Dr. Schwartz noted, “[s]he attribute[d] this to a flu [shot] in October.”
Id. Petitioner’s exam showed a painful arc of motion of the right shoulder, as well as a
positive impingement sign, and painful resistance testing. Id. at 2. Dr. Swartz’s
assessment was tendinitis and shoulder calcification, and he administered a
subacromial steroid injection. Id. at 3.

        Ms. Almanzar returned to Dr. Schwartz on April 16, 2015, complaining of
continued shoulder pain. Pet. Ex. 3 at 4. The record indicates that Ms. Almanzar had a
limited motion despite a “comprehensive course of physiotherapy.” Id. On exam,
petitioner had a limited ROM, positive impingement signs, and painful resistance
testing. Id. Dr. Schwartz recommended arthroscopic surgery and possible rotator cuff
repair “because of a lack of improvement with conservative treatment.” Id.

       On May 5, 2015, Ms. Almanzar underwent surgery on her right shoulder,
including manipulation, adhesion lysis, rotator cuff repair, subacromial decompression,
and acromioplasty. Pet. Ex. 3 at 12-13. Petitioner’s post-operative diagnosis was
adhesive capsulitis and a rotator cuff tear. Id. at 12.

        Petitioner returned for post-operative follow-up visits with Dr. Schwartz on May 7
and May 21, 2015. Pet. Ex. 3 at 6-7. At both visits, Dr. Schwartz noted improved range
of motion. Id. at 6-7. On June 8, 2015, Ms. Almanzar returned for her one month post-
operative visit. Id. at 8. Her ROM continued to improve, but she suffered strength
deficits. Id. at 8.

         On June 17, 2015, Ms. Almanzar presented for her first post-surgery PT
appointment at NovaCare Rehabilitation. Pet. Ex. 4 at 1. Petitioner reported that her
ability to lift and reach and to dress herself was limited, and that she suffered from
nightly sleep disturbances. Id. Ms. Almanzar rated her pain at 2 out of 10, and 5 out of
10 at its worst. Id. The physical therapist noted that petitioner reported “insidious onset
of pain starting . . . after 10/9/14 flu vaccine.” Id.

       Petitioner returned to Dr. Schwartz for a two month post-operative appointment
on July 8, 2015. Pet. Ex. 3 at 9. Her range of motion continued to improve, but she still
experienced strength deficits. Id.

       On September 10, 2015, Dr. Schwartz noted that petitioner’s range of motion and
strength were improving but that she still had some mild discomfort. Pet. Ex. 3 at 10.
Dr. Schwartz administered another steroid injection and instructed her to follow up in a
month. Id.

                                             4 
 
 

         Between June 17 and November 11, 2015, Ms. Almanzar attended 38 physical
therapy sessions. Pet. Ex. 4. By November 11, 2015, her passive and active range of
motion slowly improved. Pet. Ex. 4 at 124. Petitioner reported dressing with minimal
difficulty and that she only struggled to lift heavy objects. Id. She also noted fewer
sleep disturbances and rated her pain at 2 out of 10 at its worst. Id.

        On November 18, 2015, Ms. Almanzar contacted her physical therapist to report
increased pain in her right shoulder. Pet. Ex. 7 at 7. She declined to come into therapy
for a reevaluation appointment prior to her appointment with her primary care physician
due to concerns with increased pain. Id. Petitioner denied any exacerbating incident.
Id. The following day, Ms. Almanzar returned to Dr. Schwartz and reported
“predominantly right-sided neck pain which spreads across her shoulder blade.” Pet.
Ex. 9 at 2. A cervical spine exam showed her “shoulder show motion [sic] to lateral
rotation and some trigger points posteriorly on the right side.” Id. Dr. Schwartz
prescribed Skelaxin and referred petitioner to physical therapy for her cervical spine. Id.

        On December 28, 2015, Ms. Almanzar presented to Orthopedic & Spine
Rehabilitation for an evaluation with continued complaints of right shoulder pain and
stiffness. Pet. Ex. 8 at 1. She reported that the pain in her right shoulder began
suddenly after a flu shot on October 9, 2014. Id.

       On January 5, 2016, petitioner was discharged from physical therapy at
NovaCare Rehabilitation. Pet. Ex. 7 at 9. During her final reevaluation, it was noted
that petitioner demonstrated good improvement since her prior reevaluation. Id. She
had improved range of motion with her shoulder internal rotation which was her primary
area of deficit and concern. Id.

        Petitioner than began physical therapy sessions at Orthopedic & Spine
Rehabilitation. Between December 28, 2015 and March 24, 2016, petitioner attended
19 physical therapy sessions with some improvement. Pet. Ex. 8. On April 7, 2016,
Ms. Almanzar returned to Dr. Schwartz complaining of increased pain in her shoulder
over the preceding few months. Pet. Ex. 9 at 3. Dr. Schwartz noted that petitioner was
distressed by the continued pain in her shoulder. Id. He administered a steroid
injection and prescribed Mobic. Id. Dr. Schwartz advised petitioner to follow up in three
weeks. Id.

        Ms. Almanzar filed an affidavit dated May 1, 2017, in which she averred that
”[i]mmediately after the vaccination, [she] felt some pain in [her] right shoulder,” and
“[o]ver the next two weeks, [she] developed more significant discomfort, pain and range
of motion issues . . . .” Pet. Ex. 14 at ¶ 3. She stated that in the injection did not initially
“debilitate [her] to the point where [she] had to see a doctor.” Id. ¶ 4. Petitioner stated
that she tried to schedule an appointment with her family doctor, but she was booked
from December 14, 2014 to January 2015. Id. ¶ 5. Petitioner averred that she
scheduled appointments on January 6 and 26, 2015, both of which were canceled due
to snow storms. Id. Petitioner stated that she reported the vaccine as the cause of her

                                               5 
 
 

shoulder injury at her February 11, 2015 appointment, and that she was “surprised and
upset that was not mentioned in the medical records.” Id. ¶ 6.

      III.   Legal Standard

         Because petitioner’s claim predates the inclusion of SIRVA on the Vaccine Injury
Table, petitioner must prove her claim by showing that her injury was “caused-in-fact” by
the vaccination in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a
situation, the presumptions available under the Vaccine Injury Table are inoperative.
The burden is on the petitioner to introduce evidence demonstrating that the vaccination
actually caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d
1518, 1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the
“preponderance of the evidence” standard, the same standard ordinarily used in tort
litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at
1525. Under that standard, the petitioner must show that it is “more probable than not”
that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279.

      A petitioner need not show that the vaccination was the sole cause or even the
predominant cause of the injury or condition, but must demonstrate that the vaccination
was at least a “substantial factor” in causing the condition, and was a “but for” cause.
Shyface v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).

       Under the leading Althen test, petitioner must satisfy three elements. The Althen
court explained this “causation-in-fact” standard, as follows:
      Concisely stated, Althen’s burden is to show by preponderant evidence
      that the vaccination brought about her injury by providing: (1) a medical
      theory causally connecting the vaccination and the injury; (2) a logical
      sequence of cause and effect showing that the vaccination was the reason
      for the injury; and (3) a showing of proximate temporal relationship
      between vaccination and injury. If Althen satisfies this burden, she is
      “entitled to recover unless the [government] shows, also by a
      preponderance of the evidence, that the injury was in fact caused by
      factors unrelated to the vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program
fact-finder may rely upon “circumstantial evidence,” which the court found to be
consistent with the “system created by Congress, in which close calls regarding
causation are resolved in favor of injured claimants.” Id. at 1280.

                                            6 
 
 

IV.    Analysis - Althen Prongs

             i. A Medical Theory Causally Connecting the Vaccination and Injury

       To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford v. Sec’y of Health & Human Servs.,
2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). The petitioner must offer a medical theory
which is reputable and reliable. See, e.g., Pafford v. Sec’y of Health & Human Servs.,
451 F.3d 1352, 1355 (reputable); Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1324 (Fed. Cir. 2010) (reliable). The petitioner must prove this prong by
preponderant evidence. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d
1339, 1350 (Fed. Cir. 2010).

                            1. SIRVA Injury

        Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and aids
to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner’s claim was filed before
SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury,
the undersigned’s findings were informed by the Qualifications and Aids to Interpretation
for SIRVA criteria used to evaluate such claims. The criteria are as follows:

       A vaccine recipient shall be considered to have suffered SIRVA if such
       recipient manifests all of the following: (i) No history of pain, inflammation
       or dysfunction of the affected shoulder prior to intramuscular vaccine
       administration that would explain the alleged signs, symptoms,
       examination findings, and/or diagnostic studies occurring after vaccine
       injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and
       reduced range of motion are limited to the shoulder in which the
       intramuscular vaccine was administered; and (iv) No other condition or
       abnormality is present that would explain the patient’s symptoms (e.g.
       NCS/EMG or clinical evidence of radiculopathy, brachial neuritis,
       mononeuropathies, or any other neuropathy).

Id.; see also National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July
29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010,
Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-
8052).

                                   a. The elements of petitioner’s SIRVA claim

       The undersigned’s findings and conclusions are as follows:

                                              7 
 
 

    1. Petitioner did not have a history of pain, inflammation or dysfunction of the
       affected shoulder prior to vaccine intramuscular administration.

       The undersigned reviewed Ms. Almanzar’s medical history prior to her influenza
vaccination. The medical records demonstrate that Ms. Almanzar did not have a history
of pain, inflammation or dysfunction of the affected (right) shoulder prior to vaccination.
The records of petitioner’s primary care physician and orthopedic surgeon do not reveal
a history of prior right shoulder problems. Additionally, petitioner’s testimony during the
fact hearing supports this finding. Thus, petitioner has satisfied this criterion.

    2. Onset occurred within the specified time frame.

        Based upon the evidence set forth in the medical records, affidavits and
petitioner’s testimony during the fact hearing, the undersigned held that onset of
petitioner’s shoulder pain was within 48 hours of the September 30, 2014 flu
vaccination, and therefore, is within the Vaccine Table specified time frame of <48
hours. § 13(a)(1)(A) (preponderant standard). See e.g., Pet. Ex. 2 at 1(petitioner
reported that she had experienced right arm pain “since 09/2014 (since flu vac
received)”; Pet. Ex. 2 at 104 (“marked discomfort to [right] arm where influenza
vacc[ination] administered[.]”); Pet. Ex. at 18 (“[Patient] [complains of] throbbing pain
[right] humerus immediately after getting her flu vaccine back in late September. .
..[Right] arm pain that started after she received the flu shot[.]”); Pet. Ex. 26 at 1(“The flu
vaccine was injected into my right arm. Later that evening, my arm started to ache.”).

        The undersigned notes that there is one conflicting piece of evidence, a note by
physical therapist, Todd Updike, on June 17, 2015, which states that petitioner had an
“insidious onset of pain.” See Pet. Ex. 4 at 1. The use of the word ‘insidious’ implies
that the problem developed gradually. However, this entry can be explained by
petitioner’s affidavit, paragraph three, where she states, “Immediately after the
vaccination, I felt some pain in my right shoulder. Over the next two weeks, I developed
more significant discomfort, pain and range of motion issues in the shoulder.” Pet. Ex.
14 at 1. Thus, the undersigned finds by preponderant evidence, that the onset was
immediate, and sudden, as documented by Mr. Harris, gradually worsened and was
insidious as documented by Mr. Updike.

        Regarding petitioner’s delay in seeking treatment until February, 2015, the
undersigned found the reasons for the delay as set forth in petitioner’s affidavit and as
described during her testimony at the fact hearing to be credible and reasonable.
Specifically, petitioner described that she tried to schedule an earlier appointment with
her primary care physician, Dr. Sapna Jain, but there were no available appointments
until January 2015. An appointment that was scheduled for January 6, 2015, was
subsequently cancelled due to inclement weather. Another appointment scheduled for
January 26, 2015 was also cancelled due to inclement weather. For these reasons,
petitioner was unable to see a doctor for her shoulder until February 11, 2015. The
undersigned found this delay in seeking treatment to be reasonable given these specific
facts and circumstances. Thus, the undersigned finds that petitioner has presented

                                               8 
 
 

preponderant evidence that the onset of her shoulder pain occurred immediately after
the flu vaccine was administered and that this was within the specified time frame of 48
hours.

    3. Pain and reduced range of motion are limited to the shoulder in which the
       intramuscular vaccine was administered.

      As discussed above, Ms. Almanzar received the flu vaccination to her right
shoulder and all of her reports of pain, the objective examinations of reduced range of
motion, impingement and bursitis, and all of the treatments she received due to these
complaints have been limited to her right shoulder.

      For the above reasons, the undersigned finds that Ms. Almanzar experienced
pain and reduced range of motion limited to the shoulder in which she received the
vaccine.

    4. No other condition or abnormality is present that would explain the
       patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
       brachial neuritis, mononeuropathies, or any other neuropathy).

      The undersigned finds that there are no conditions or abnormalities present that
would explain petitioner’s right shoulder symptoms.

                  i. Logical sequence of cause and effect showing the vaccine was
                     the reason for the injury

        Guided by the criteria for evaluating a Table SIRVA injury, the undersigned finds
that Ms. Almanzar has shown, by a preponderance of the evidence, a logical sequence
of cause and effect showing that her October 9, 2015 flu vaccine was the reason for her
shoulder injury. The SIRVA criteria provides a perfectly logical sequence of cause and
effect including (1) no history of pain, inflammation or dysfunction of the affected
shoulder prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies occurring after
vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced
range of motion are limited to the shoulder in which the intramuscular vaccine was
administered; and (iv) No other condition or abnormality is present that would explain
the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial
neuritis, mononeuropathies, or any other neuropathy). The undersigned has found,
infra, that petitioner has satisfied all these requirements and thus has satisfied Althen
prong two.

       Moreover, based on the undersigned’s knowledge and experience reviewing a
large number of SIRVA claims, petitioner’s clinical course is consistent with SIRVA.
The undersigned further bases this finding on the previously filed articles, Court Exhibit I
(B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28

                                             9 
 
 

Vaccine 8049 (2010)) and Court Exhibit II (M. Bodor and E Montalvo, Vaccination
Related Shoulder Dysfunction, 25 Vaccine 585 (2007)).

                 ii.    Proximate temporal relationship between vaccination and
                       injury
      
       “The proximate temporal relationship prong [under Althen] requires preponderant
proof that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352
(Fed. Cir. 2008). This analysis involves two inquiries: (1) considering the medical basis
of the proffered theory, how long after vaccination would onset or worsening of the
disease occur; and (2) did onset or worsening of the disease actually occur in the
expected timeframe. The first inquiry necessarily intersects with the prong one
analysis. See Langland v. Sec’y of Health & Human Servs., 109 Fed. Cl. 421, 443
(2013); Veryzer v. HHS, 100 Fed. Cl. 344, 356 (2011).

        As discussed above, under the SIRVA criteria, the onset of the symptoms of
petitioner’s shoulder injury must begin within 48 hour or less of the vaccination. The
undersigned has found that the onset of petitioner’s shoulder injury began within 48
hours of the vaccination, and thus, petitioner has satisfied Althen prong two.

V.       Conclusion
        A cause-in-fact injury is established when petitioner demonstrates by a
preponderance of the evidence: (1) she received a vaccine set forth on the Vaccine
Injury Table; (2) she received the vaccine in the United States; (3) he sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the
vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A).
To satisfy the burden of proving causation in fact, petitioner must establish each of three
factors announced by the Federal Circuit in Althen v. Sec’y of Health & Human Servs.
by preponderant evidence: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a proximate temporal relationship between vaccination
and injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991).

       In light of all of the above, and in view of the submitted evidence, including
the medical records and the parties’ respective motions, the undersigned finds
petitioner entitled to Vaccine Act compensation.

IT IS SO ORDERED.
                                   s/Nora Beth Dorsey
                                   Nora Beth Dorsey
                                   Chief Special Master

                                            10