VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-01217
Package ID: USCOURTS-cofc-1_19-vv-01217
Petitioner: Larry Bulman
Filed: 2019-08-15
Decided: 2023-08-16
Vaccine: influenza
Vaccination date: 2018-09-25
Condition: left Shoulder Injury Related to Vaccine Administration (SIRVA)
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Larry Bulman, a 76-year-old man, received an influenza vaccine on September 25, 2018. He filed a petition alleging a Shoulder Injury Related to Vaccine Administration (SIRVA). Initially, the case was handled as a potential Table claim, but it was determined that Mr. Bulman could not preponderantly establish that his pain began within 48 hours of vaccination, a key element for a Table SIRVA claim. The case was then transferred to an individual docket to assess entitlement under an off-Table, causation-in-fact theory. Mr. Bulman's medical records indicated he first reported left shoulder pain approximately three months after vaccination, on January 22, 2019, with a diagnosis of rotator cuff tendonitis. He claimed immediate pain after the vaccine that worsened over days, but his first medical visit to discuss shoulder pain was three months later. Petitioner's expert, Dr. Natanzi, opined that the vaccine caused SIRVA through an inflammatory response and that delayed treatment is common. Respondent's expert, Dr. Abrams, argued that calcific tendonitis or idiopathic frozen shoulder were more likely causes and that the temporal relationship between vaccination and reported pain was not medically acceptable for SIRVA. The Chief Special Master denied entitlement, finding that Mr. Bulman failed to establish a medically acceptable temporal relationship between the vaccination and his injury (Althen prongs two and three). The court also noted that alternative explanations like calcific tendonitis, supported by Dr. Abrams, undermined the claim that the vaccine was the cause. The case was decided on the record without a hearing.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-01217-0
Date issued/filed: 2021-09-14
Pages: 8
Docket text: PUBLIC ORDER/RULING (Originally filed: 08/12/2021) regarding 24 Findings of Fact & Conclusions of Law,, Scheduling Order, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made.
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Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 1 of 8
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-1217V
UNPUBLISHED
LARRY BULMAN, Chief Special Master Corcoran
Petitioner, Filed: August 12, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza
HUMAN SERVICES, (Flu) Vaccine; Shoulder Injury
Related to Vaccine Administration
Respondent. (SIRVA)
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Claudia Barnes Gangi, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT1
On August 15, 2019, Larry Bulman 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 he suffered a left shoulder injury related to vaccine
administration (“SIRVA”) caused by an influenza (“flu”) vaccine administered on
September 25, 2018. Petition at 1. The case was assigned to the Special Processing Unit
of the Office of Special Masters.
1 Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the Fact Ruling will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 2 of 8
For the reasons discussed below, I find Petitioner’s SIRVA Table claim must be
dismissed, for failure to establish onset within the 48 hours following the administration of
vaccination as required to establish a Table injury.
I. Relevant Procedural History
After an initial status conference, Petitioner was ordered to file any additional
vaccination administration records and an amended statement of completion. ECF 9.
Petitioner di so, and also forwarded a settlement demand to Respondent on September
11, 2020. ECF 10; ECF 11; ECF 18.
Respondent subsequently filed a status report indicating that he “intends to contest
entitlement” and proposing a deadline for his Rule 4(c) report, which he filed on January
15, 2021. ECF 19; ECF 20. In it, Respondent asserted that there is not a preponderance
of evidence demonstrating the requisite facts necessary to establish a Table SIRVA
injury. ECF 20. Specifically, “[P]etitioner’s contemporaneous medical records do not
support the onset of left shoulder pain within 48 hours of vaccine administration.” Id. at 1.
Respondent further argued that Petitioner had failed to prove actual causation because
he had yet to offer the evidence necessary to meet the Federal Circuit test. Id. at 6 (citing
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)).
After holding a telephonic status conference with the parties to discuss
Respondent’s objections to entitlement, I provided the parties with the opportunity to file
any additional evidence or memoranda relevant to onset. ECF 21. Petitioner filed a
memorandum regarding onset and damages on April 12, 2021.3 ECF 23. Respondent did
not submit any additional filings. Therefore, this matter is ripe for adjudication.
II. Issue
At issue is whether Petitioner’s first symptom or manifestation of onset after
vaccine administration (specifically pain) occurred within 48 hours as set forth in the
Vaccine Injury Table and Qualifications and Aids to Interpretation (“QAI”) for a Table
SIRVA. 42 C.F.R. § 100.3(c)(10)(ii).
3 Petitioner also briefed damages in his Memorandum, although he had been advised in the Scheduling
Order dated March 12, 2021, to limit his argument to the issue of onset. ECF 21. Respondent relied on this
Order in choosing not to file any additional evidence. See Informal Communication dated 4/23/2021.
Accordingly, I find Petitioner’s briefing of damages premature (although if any further briefing of damages
is called for, Petitioner will be given the opportunity to update or supplement any facts or argument made
on this subject to date).
2

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 3 of 8
III. Authority
Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis,
conclusion, judgment, test result, report, or summary concerning the nature, causation,
and aggravation of petitioner’s injury or illness that is contained in a medical record.
Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy
evidence. The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in
the balance, accuracy has an extra premium. These records are also generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Human Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where medical records are clear,
consistent, and complete, they should be afforded substantial weight. Lowrie v. Sec’y of
Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr.
Dec. 12, 2005).
However, the United States Court of Federal Claims has recognized that “medical
records may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs.,
42 Fed. Cl. 381, 391 (1998). The Court later outlined four possible explanations for
inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that
happened during the relevant time period; (2) the medical professional’s failure to
document everything reported to her or him; (3) a person’s faulty recollection of the events
when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did
not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013),
aff’d, 746 F.3d 1335 (Fed. Cir. 2014).
The Court has also said that medical records may be outweighed by testimony that
is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed.
Cl. at 391 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering
such testimony must also be determined. Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d
1570, 1575 (Fed. Cir. 1993).
A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may
3

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 4 of 8
be made only upon demonstration by a preponderance of the evidence that the onset [of
the injury] . . . did in fact occur within the time period described in the Vaccine Injury
Table.” Id.
The special master is also obligated to fully consider and compare the medical
records, testimony, and all other “relevant and reliable evidence contained in the record.”
La Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns
v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is
within the special master’s discretion to determine whether to afford greater weight to
medical records or to other evidence, such as oral testimony surrounding the events in
question that was given at a later date, provided that such determination is rational).
IV. Finding of Fact
I make the following findings after a complete review of the record, including the
filed medical records, affidavits, and Respondent’s Rule 4 report:
• Petitioner received a flu vaccination in his left arm on September 25, 2018.
Ex 1 at 4-5.
• On December 26, 2018 (three months post-vaccination), Petitioner
presented for an appointment with Dr. Prakash Bandari, an internist, with
complaints of low back pain. Ex 3 at 98. Petitioner did not report any
shoulder pain, and a musculoskeletal examination revealed normal
findings. Id. at 100. Petitioner was not diagnosed with any shoulder-related
condition. Id. at 100-01.
• One month later, on January 22, 2019, Petitioner returned to Dr. Bandari.
Ex 3 at 93. At that time, he reported “left shoulder pain x 4 months.” Id.
Petitioner further stated (somewhat incorrectly) that “he was given flu shot
in October and since then he had pain in shoulder.” Id. Physical examination
(PE) by Dr. Bandari revealed restricted range of motion in the left shoulder,
and Petitioner was diagnosed with rotator cuff tendonitis. Id. at 95-96.
• An x-ray of Petitioner’s left shoulder was performed on January 29, 2019,
which showed a 4mm calcification adjacent to the humeral head, consistent
with calcific tendinitis. Ex 3 at 684.
• On April 2, 2019, Petitioner presented for a follow-up appointment with Dr.
Vikas Desai, his cardiologist.4 Ex 3 at 7. He did not report shoulder pain at
this visit. Id.
4 Petitioner has a longstanding history of congestive heart failure/cardiomyopathy and paroxysmal atrial
fibrillation. See, e.g., Ex 3 at 7; Ex 5 at 4.
4

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 5 of 8
• On June 11, 2019, Petitioner returned to Dr. Bandari, and he again reported
left shoulder pain. Ex 4 at 10. There is no reference to the onset of
Petitioner’s pain in the records from this visit. Id. at 10-14. PE again
revealed restricted range of motion. Id. at 12.
• In his affidavit, Petitioner averred that “immediately after receiving the flu
shot, there was pain, discomfort and soreness in my left shoulder that was
unusual” compared with his experience receiving flu vaccines for the prior
eight years. Ex 2 at 2.
• Petitioner further alleged in his affidavit that “[o]ver the next several days,
the pain never subsided and in fact, the pain increased to the point where it
began to affect all types of movement with [his] shoulder.” Ex 2 at 2. He also
stated that “[b]y September 27, 2018, [he] had ongoing severe pain in [his]
left shoulder that [he] knew could not be normal post vaccine soreness” and
that “[i]n the weeks that followed the flu shot, [his] left shoulder pain never
improved.” Id.
• In his affidavit, Petitioner stated that he experienced “sharp and shooting
pains into [his] shoulder” when “reaching for objects, pushing doors open,
turning the steering wheel, sleeping on [his] left side, cooking, cleaning, and
getting dressed.” Ex 2 at 2-3.
• In a supplemental affidavit, Petitioner stated that despite the fact that his
shoulder pain began immediately after vaccination, he “had a previously
scheduled appointment with Dr. Bandari on December 26, 2018,” so he
“decided to wait until that appointment to mention [his] shoulder pain.” Ex 7
at 2.
• Petitioner alleges that the pain, discomfort, and decreased range of motion
“persisted and never improved” from September 25, 2018 until December
26, 2018, the date of his visit with Dr. Bandari. Ex 2 at 3. In his affidavit,
Petitioner avers that he reported his shoulder pain and other symptoms to
Dr. Bandari at this visit, but he was “instructed . . . to make another
appointment specifically for [his] left shoulder pain.” Id.
To explain the absence of shoulder-related complaints in the treatment records
from his December 2018 appointment, Petitioner alleges that Dr. Bandari informed him
that “he could not examine [Petitioner’s] shoulder at that visit due to insurance/billing
reasons” because this appointment was solely to discuss his low back pain. Ex 7 at 2.
However, Dr. Bandari’s notes from this visit include a discussion of other conditions (in
addition to back pain), as well as the report from a full physical examination.5 Ex 3 at 98-
100.
5 In fact, the physical examination revealed normal findings with regard to Petitioner’s extremities. Ex 3 at
100.
5

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 6 of 8
Furthermore, Dr. Bandari had been Petitioner’s primary care physician for four
years, and his treatment notes are quite thorough (always reflecting a range of complaints
and instructions for future visits). See Ex 3; Ex 4. It is unlikely that Dr. Bandari would not
have at least noted the existence of Petitioner’s pain – especially since Petitioner now
alleges that at this very time he was experiencing “severe” shoulder pain on a daily basis,
when he performed simple tasks such as “reaching for objects, pushing doors open,
turning the steering wheel, sleeping on [his] left side, cooking, cleaning, and getting
dressed,” and that this pain was impacting his ability to serve as caregiver for his ill wife.
Ex 2 at 2-3. At a minimum, it seems reasonable to assume that if Petitioner had reported
a three-month history of severe shoulder pain at the December 2018 visit, Dr. Bandari
would have at least indicated that he advised Petitioner to make a separate appointment
to address his shoulder.6
Petitioner’s allegations that he experienced onset of his shoulder pain within 48
hours after vaccination are further undermined by the lack of specificity in the medical
records. The notes from Petitioner’s visit with Dr. Bandari in January 2019 reflect a
complaint of “left shoulder pain x 4 months” that Petitioner had been experiencing “since”
receiving a flu shot that fall. While such language certainly supports a finding that
Petitioner suffered left-sided shoulder pain some time after his receipt of the flu vaccine,
it does not support a finding that he more likely than not suffered onset of his condition
within 48 hours of vaccination. The June 2019 record similarly says nothing about onset.
Treatment gaps are a further issue in identifying onset. Persistent delays
established in the medical record can undermine a Petitioner’s contentions regarding
onset. Pitts v. Sec’y Health & Human Servs., 18-1512V, 2020 WL 2959421 (Fed. Cl.
Spec. Mstr. Apr. 29, 2020); Eshraghi v. Sec’y of Health & Human Servs., 19-0039V, 2021
WL 2809590 (Fed. Cl. Spec. Mstr. June 4, 2021). Delay is not uncommon in SIRVA cases
(since injured parties may reasonably misapprehend the scope of their injury, believing
that is will prove transitory).7 But once a claimant first reports what may be a vaccine
6 See Sanchez v. Sec'y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec.
Mstr. Apr. 10, 2013), vacated on other grounds, Sanchez by & through Sanchez v. Sec'y of Health & Human
Servs., No. 2019-1753, 2020 WL 1685554 (Fed. Cir. Apr. 7, 2020) (presumption that contemporaneously
generated medical records are probative “is based on the linked propositions that (i) sick people visit
medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii)
medical professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions”) (emphasis added); James-Cornelius v. Sec’y of Health & Human Servs., 984 F.3d 1374, 1380
(Fed. Cir 2021) (medical records are based on the statements made by patients regarding the symptoms
they are experiencing, and such records may serve as corroborating evidence for evaluating credibility).
7 See, e.g., Cooper v. Sec’y of Health & Human Servs., 16-1387V, 2018 WL 1835179 (Fed. Cl. Spec. Mstr.
Jan. 18, 2018); Marino v. Sec’y of Health & Human Servs., 16-622V, 2018 WL 2224736 (Fed. Cl. Spec.
Mstr. Mar. 26, 2018).
6

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 7 of 8
injury, the record should reflect greater attention to its treatment. Here, the repeated gaps
make it harder to overlook the delay.
Finally, Petitioner’s treatment history is inconsistent with his allegations regarding
the severity of his pain.8 As a general matter, “[i]t is reasonable to expect that the average
Program claimant might seek medical treatment sooner if in fact the person was
experiencing sudden post-vaccination pain.” Pitts, 2020 WL 2959421, at *5. Given the
disabling pain Petitioner describes, it would be reasonable to expect that he would have
sought treatment earlier, or at a minimum, requested an urgent appointment at his
December 2018 visit with Dr. Bandari. Instead, Petitioner waited another month for a
follow-up appointment, delaying treatment for his shoulder for a total of four months.
Indeed, Petitioner acknowledged in his affidavit that he decided to delay treatment until a
previously scheduled appointment with Dr. Bandari, three months after vaccination, even
though he was experiencing pain that he described as “unusual” compared with his
experience receiving prior flu vaccines, that occurred “immediately” after vaccination, and
that “persisted and never improved” during those three months. Ex 2 at 3; Ex 7 at 2. In
some cases, this would merely constitute a limitation on damages to be awarded
(specifically pain and suffering) – but here it further undermines the contention that the
shoulder pain was in fact as sudden as alleged.
I acknowledge that the standard applied to SIRVA claims on the onset issue is
fairly liberal. Even in the absence of direct proof, that standard will often permit a
determination that onset began within the 48-hour timeframe set by the Table, based on
records prepared a few months after vaccination, and/or corroborated by sworn witness
statements intended to amplify otherwise-vague records. There are many situations in
which compelling testimony may be more persuasive than written records, such as where
records are deemed to be incomplete or inaccurate. DeGeorge v. Sec’y of Health &
Human Servs., 18-1815V, 2021 WL 2433250, at *6 (Fed. Cl. Spec. Mstr. May 13, 2021);
Campbell v. Sec'y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006); Lowrie, 2005
WL 6117475, at *19. But not every SIRVA claim can be so preponderantly established,
and certainly not where the sequential and contemporaneous record does not lend overall
support to the Petitioner’s allegations.
Therefore, after considering the record as a whole, I find there is not preponderant
evidence to establish that Petitioner suffered the onset of symptoms within 48 hours of
his flu vaccination as required by the Vaccine Injury Table. 42 C.F.R. § 100.3(a)(I)(C).
However, I also note that the other Table indicia of a valid SIRVA claim do seem
to exist – meaning that this is likely a viable non-Table claim even if Table onset cannot
8 Described in his affidavit as “severe” and “sharp and shooting.” Ex 2 at 2-3.
7

Case 1:19-vv-01217-UNJ Document 26 Filed 09/14/21 Page 8 of 8
be proven. To that end, I urge the parties to make one final brief attempt at settlement –
as I would anticipate that even after transfer, Petitioner’s claim will likely be seen favorably
by the special master who receives it.
V. Scheduling Order
Petitioner has not preponderantly established that onset of his pain occurred within
48 hours of vaccination. Accordingly, he cannot satisfy the requirements for a SIRVA
Table claim, although the claim may be successful if the causation-in-fact standards for
entitlement can be bet. The parties shall file a final settlement status report on or
before Monday, September 13, 2021. The matter shall be transferred thereafter if the
parties do not report significant progress in reaching an agreement at that time.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
8

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DOCUMENT 2: USCOURTS-cofc-1_19-vv-01217-1
Date issued/filed: 2023-09-11
Pages: 21
Docket text: PUBLIC DECISION (Originally filed: 08/16/2023) regarding 42 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made.
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Case 1:19-vv-01217-UNJ Document 43 Filed 09/11/23 Page 1 of 21
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-1217V
(to be published)
* * * * * * * * * * * * * * *
LARRY BULMAN, * Chief Special Master Corcoran
*
Petitioner, *
* Dated: August 16, 2023
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * *
David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.
Claudia Barnes Gangi, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On August 15, 2019, Larry Bulman filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleges he
suffered a left Shoulder Injury Related to Vaccine Administration (“SIRVA”) following receipt of
an influenza (“flu”) vaccine on September 25, 2018. Petition (ECF No. 1) (“Pet.”) at 1. The matter
was originally assigned to the Special Processing Unit (“SPU”), but it was determined that
Petitioner could not preponderantly establish that onset of his pain had occurred within 48 hours
of vaccination, thus not satisfying a SIRVA Table claim element—and preventing recovery on that
basis. Bulman v. Sec'y of Health & Hum. Servs., No. 19-1217V, 2021 WL 4165349, at *2–3 (Fed.
Cl. Spec. Mstr. Aug. 12, 2021) (the “Finding of Fact”).
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Case 1:19-vv-01217-UNJ Document 43 Filed 09/11/23 Page 2 of 21
However, I also found that the claim might still be successful if the causation-in-fact
standards for entitlement could be met, and therefore the matter was transferred out of SPU and to
my individual docket. After expert input was obtained, I proposed that the underlying issue of
entitlement be decided on the record, and the parties have offered briefs in support of their
respective positions. Petitioner’s Motion, dated December 9, 2022 (ECF No. 38) (“Mot.”);
Respondent’s Opposition, dated February 10, 2023 (ECF No. 40) (“Opp.”); Petitioner’s Reply,
dated March 3, 2023 (ECF No. 41) (“Reply”).
Now, after review of the medical records and briefs, I deny entitlement. It has not been
preponderantly established that a SIRVA can likely occur if onset begins several days to more than
a week post-vaccination, and Petitioner’s history (as explained by the experts) does not permit me
to conclude the flu vaccine was more than temporally related to his injury (however it is
characterized).
I. Factual Background
Some of the factual summary was obtained from the fact determinations made prior to the
claim’s transfer out of SPU, based upon a complete review of the medical records,
affidavits/witness statements, and Respondent’s Rule 4(c) Report. Finding of Fact at *2–3. These
findings stand as “law of the case”—and I note that no additional records or other, non-expert
evidence has since been filed.
• Petitioner (who was 76 years old at the time) received a flu vaccine in his left arm on
September 25, 2018. Ex 1 at 4–5.
• On December 26, 2018 (three months post-vaccination), Petitioner presented for an
appointment with Dr. Prakash Bandari, an internist, with complaints of low back pain. Ex
3 at 98. Petitioner did not report any shoulder pain at this time, however, and a
musculoskeletal examination revealed normal findings. Id. at 100. In fact, it was noted
upon physical examination that he was able to move all four extremities. Id. Petitioner was
also not then diagnosed with any shoulder-related condition. Id. at 100–01.
• One month later, on January 22, 2019, Petitioner returned to Dr. Bandari. Ex 3 at 93. He
now reported “left shoulder pain x 4 months.” Id. Petitioner further stated (somewhat
incorrectly) that “he was given [a] flu shot in October and since then he had pain in
shoulder.” Id. Physical examination (“PE”) by Dr. Bandari revealed restricted range of
motion in the left shoulder, and Petitioner was diagnosed with rotator cuff tendonitis. Id.
at 95–96.
2

Case 1:19-vv-01217-UNJ Document 43 Filed 09/11/23 Page 3 of 21
• An X-ray of Petitioner's left shoulder was performed on January 29, 2019, and it showed a
4mm calcification adjacent to the humeral head, consistent with calcific tendinitis. Ex 3 at
684. The impression provided was calcific tendinitis. Id.
• On April 2, 2019, Petitioner presented for a follow-up appointment with Dr. Vikas Desai,
his cardiologist.3 Ex 3 at 7. He did not report shoulder pain at this visit. Id.
• Two months later, on June 11, 2019, Petitioner returned to Dr. Bandari, and he again
reported left shoulder pain. Ex 4 at 10. There is no reference to the onset of Petitioner's
pain in the records from this visit. Id. at 10–14. PE again revealed restricted range of
motion. Id. at 12.
• In his affidavit, Petitioner avers that “immediately after receiving the flu shot, there was
pain, discomfort and soreness in my left shoulder that was unusual” compared with his
experience receiving flu vaccines for the prior eight years. Ex 2 at 2.
• Petitioner has further maintained that “[o]ver the next several days, the pain never subsided
and in fact, the pain increased to the point where it began to affect all types of movement
with [his] shoulder.” Ex 2 at 2. He also stated that “[b]y September 27, 2018, [he] had
ongoing severe pain in [his] left shoulder that [he] knew could not be normal post vaccine
soreness” and that “[i]n the weeks that followed the flu shot, [his] left shoulder pain never
improved.” Id.
• In his affidavit, Petitioner stated that he experienced “sharp and shooting pains into [his]
shoulder” when “reaching for objects, pushing doors open, turning the steering wheel,
sleeping on [his] left side, cooking, cleaning, and getting dressed.” Ex 2 at 2–3.
• In a supplemental affidavit, Petitioner stated that despite the fact that his shoulder pain
began immediately after vaccination, he “had a previously scheduled appointment with Dr.
Bandari on December 26, 2018,” so he “decided to wait until that appointment to mention
[his] shoulder pain.” Ex 7 at 2.
• Petitioner alleges that the pain, discomfort, and decreased range of motion “persisted and
never improved” from September 25, 2018 until December 26, 2018, the date of his visit
with Dr. Bandari. Ex 2 at 3. In his affidavit, Petitioner avers that he reported his shoulder
pain and other symptoms to Dr. Bandari at this visit, but he was “instructed . . . to make
another appointment specifically for [his] left shoulder pain.” Id.
3 Petitioner has a longstanding history of congestive heart failure/cardiomyopathy and paroxysmal atrial fibrillation.
See, e.g., Ex 3 at 7; Ex 5 at 4.
3

Case 1:19-vv-01217-UNJ Document 43 Filed 09/11/23 Page 4 of 21
• The Finding of Fact concluded that Table onset for a SIRVA claim could not be established,
but that the record as it existed did seem to support other elements of such a claim. Finding
of Fact at 7–8.
II. Expert Reports
A. Petitioner’s Expert – Naveed Mayer Natanzi, D.O.
Dr. Natanzi, a board-certified specialist in physical medicine and rehabilitation, prepared
two written reports for Petitioner in support of the contention that the flu vaccine can cause SIRVA,
and that it did so in this case within the medically acceptable timeframe. Report, dated January 3,
2021, filed as Ex. P8 (ECF No. 30-1) (“Natanzi First Rep.”); Report, dated February 16, 2022,
filed as Ex. P11 (ECF No. 33-1) (“Natanzi Second Rep.”).
Dr. Natanzi received a Bachelor of Arts in Biological Studies at the University of
California, Santa Barbara in 2007, and attended medical school at Western University of Health
Sciences, where he received a Doctor of Osteopathy in June 2012. Curriculum Vitae, filed as Ex.
P10 on January 3, 2022 (ECF No. 30-2) (“Natanzi CV”) at 2. Dr. Natanzi completed an internship
at Downey Regional Medical Center from 2012-2013, then completed his residency in physical
medicine and rehabilitation at the University of California, Irvine from 2013-2016. Natanzi CV at
1–2. Dr. Natanzi completed a fellowship at the Bodor Clinic in Napa, California from January
2017-August 2017. Id. at 1. From 2017-2018, Dr. Natanzi worked at the Pasadena Rehab Institute
as an attending physician specializing in interventional pain management. Id. In November 2017,
Dr. Natanzi founded the Regenerative Sports and Spine Institute, and since April 2018, Dr. Natanzi
has been a staff physician at the VA Long Beach Healthcare System. Id.; Natanzi First Rep. at 1.
Dr. Natanzi is board certified by the American Academy of Physical Medicine and Rehabilitation
and is board-eligible by the American Board of Pain Management. Natanzi CV at 1; Natanzi First
Rep. at 1.
First Report
After a summary of the medical records, Dr. Natanzi began with an overview of SIRVA
injuries and the criteria for their diagnosis. Natanzi Rep. at 1–5, 8. In so doing, he summarized the
Table elements. Id. at 8; Section 14(c)(10). SIRVA injuries occur, he explained, when there is an
inadvertent overpenetration of the vaccination needle resulting in subacromial bursa and/or rotator
cuff penetration. Natanzi First Rep. at 7. The vaccine interacts with naturally-occurring antibodies
from a prior vaccination, resulting in an exaggerated, robust, and prolonged inflammatory
response, which creates inflammation of the rotator cuff tendons and/or bursa causing pain. Id.
In Dr. Natanzi’s opinion, Petitioner’s injury clearly was consistent with the Table SIRVA
element specific to the provided definition. Natanzi Rep. at 8–9; S. Atanasoff et al., Shoulder Injury
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Related to Vaccine Administration (SIRVA), 28 Vaccine 8049, 8050 (2010), filed as Ex. 9(d) (ECF
No. 31-4) (discussing the clinical characteristics of 13 patients with SIRVAs) (“Atanasoff”); M.
Barnes et al., "A “Needling” Problem: Shoulder Injury Related to Vaccine Administration, 25 J.
Am. Bd. Family Med. 919, 921 (2012), filed as Ex. 9(e) (ECF No. 31-5) (describing one SIRVA
case) (“Barnes”). Such literature all consistently set forth certain symptomatic criteria—shoulder
pain, decreased range of motion, adhesive capsulitis, rotator cuff tearing/tendinopathy,
subacromial bursitis, clinical signs of impingement, weakness, and bicipital tendinitis—consistent
with what Petitioner had experienced. Natanzi Rep. at 8. And his lack of a history of shoulder pain
prior to vaccination supported the diagnosis (especially in comparison to what he experienced
thereafter). Natanzi First Rep. at 7, 9; Ex 2 at 2–3; Ex. 3 at 93; Ex. 4 at 10; Ex. 7 at 2.
Dr. Natanzi acknowledged that the record contained limited discussion of shoulder pain
overall, no musculoskeletal exam was performed on Petitioner’s shoulder, and there was no MRI
imaging available either. Natanzi First Rep. at 7. The X-ray obtained in January 2019 revealed
calcific tendinopathy, but Dr. Natanzi deemed this to be a chronic, age-related finding separate
from the reported post-vaccination pain, and in any event X-rays are not useful in the diagnosis of
acute inflammatory tendinopathy or bursitis (which can be indicia for SIRVA). Id.
Dr. Natanzi then addressed the issue of onset. Natanzi First Rep. at 6. In his view, most
people are unaware that a vaccine can cause significant shoulder dysfunction, and thus they do not
usually attribute symptoms they might experience post-vaccination to a vaccine. Natanzi First Rep.
at 6. Accordingly, many patients (like Petitioner) wait to see if the injuries they are experiencing
might self-resolve before seeking actual professional treatment. Natanzi First Rep. at 6; J. Taber
et al., Why Do People Avoid Medical Care? A Qualitative Study Using National Data, 30 J.
General Internal Med. 290, 290–91 (2015), filed as Ex. 9(a) (ECF No. 31-1) (exploring the
question of why patients avoid medical care and finding that 12.2 percent of patients experienced
a low perceived need to seek medical care, often because they believed symptoms would self-
improve over time).
Mr. Bulman’s record revealed a complex medical history with several comorbidities (e.g.,
cardiomyopathy, atrial fibrillation and heart failure, pulmonary hypertension, and deep vein
thrombosis) that required specialized treatments. In the context of addressing such unrelated
concerns, Dr. Natanzi maintained, it was unlikely that every other possible concern a patient might
have would be discussed. Natanzi First Rep. at 6. And in fact, the Petitioner had noted he was
unable to discuss his new shoulder pain issue with Dr. Bandari on December 26, 2018 and had to
wait until the following visit on January 22, 2019. Id.; Ex. 2 at 3; Ex. 7 at 2. Otherwise, Dr. Natanzi
emphasized the statements in Petitioner’s affidavits, which reflected immediate pain that later
worsened—consistent with SIRVA. Natanzi First Rep. at 6, 9.
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Second Report
Dr. Natanzi’s Second Report focused on two topics: whether calcific tendinopathy
explained Petitioner’s injury, and then the temporal relationship of symptoms with vaccination.
Natanzi Second Rep. at 1.
Dr. Natanzi defined calcific tendinopathy to be the build-up of calcium in the tendons,
which usually occurs because of repetitive use or microtrauma associated with a person’s day-to-
day activity over the course of a lifetime. Natanzi Second Rep. at 1; M. ElShewy, Calcific
Tendinitis of the Rotator Cuff, 7 World J. Orthopedics 55, 55 (2016), filed as Ex. 12 (ECF No. 33-
2) (“ElShewy”). This type of calcification is usually asymptomatic. Natanzi Second Rep. at 1;
ElShewy at 55. Calcification can also be caused by a sudden, more robust injury to a tendon. In
theory, this could happen due to vaccine needle overpenetration causing a rotator cuff injury.
Natanzi Second Rep. at 1. Taking into account Petitioner’s age, Dr. Natanzi opined that the calcific
tendinopathy seen on Petitioner’s X-ray was consistent with an age-related condition that was
likely asymptomatic, both pre- and post-vaccination. Id.
SIRVA, on the other hand, is an acute inflammatory process brought on by vaccine
interaction with naturally-occurring antibodies, resulting in an exaggerated, robust, and prolonged
inflammatory response. Natanzi Second Rep. at 1; Section 14(c)(10). This in turn leads to
inflammation of the rotator cuff tendons and/or bursa, which causes pain, limitation in motion, and
dysfunction. Natanzi Second Rep. at 1; Section 14(c)(10). Such an acute process was consistent
with Petitioner’s presentation. Natanzi Second Rep. at 1.
Dr. Natanzi next revisited the temporal relationship between the flu vaccine and
Petitioner’s injury (although it was a subject already ruled upon by the Finding of Fact). He again
attempted to argue that the totality of the evidence—Petitioner’s affidavit and statements in
medical records several months post-vaccination—confirmed a one-day onset. Natanzi Second
Rep. at 2; Ex. 3 at 93. He also repeated his contention that delay in treatment of SIRVA is common.
Natanzi Second Rep. at 2; M. Bodor & E. Montalvo, Vaccination-Related Shoulder Dysfunction,
25 Vaccine 585, 586 (2007), filed as Ex. 9(i) (ECF No. 31-9) (noting how a patient suffered a
SIRVA injury but did not seek medical help until two months later); Barnes at 919 (reporting a
SIRVA injury in a 22-year-old female who did not initially present to her care provider until two
months after vaccination).
However, Dr. Natanzi also opined that even if Petitioner’s onset had occurred longer than
48 hours after vaccination (the finding I had made in dismissing the Table claim), a SIRVA injury
was still possible. Natanzi Second Rep. at 2. Although SIRVA typically presents within the first
few days, there were examples of patients whose symptoms manifested several days later. See
Atanasoff at 8050 (noting of a series of 13 case studies, one patient presented with symptoms after
four days). Given in this case that there is no other explanation for Petitioner’s injury pre-
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vaccination, SIRVA remained as the most likely classification for the injury, in Dr. Natanzi’s view.
Natanzi Second Rep. at 2.
B. Respondent’s Expert – Geoffrey D. Abrams, M.D.
Dr. Abrams, a board-certified orthopedic surgeon, prepared one written report for
Respondent, opining therein that Petitioner cannot establish a causation-in-fact claim based on the
record. Report, dated August 15, 2022, filed as Ex. A (ECF No. 37-1) (“Abrams Rep.”).
Dr. Abrams received a Bachelor of Arts in Human Biology with a concentration in
Neuroscience from Stanford University in 2000. Curriculum Vitae, filed as Ex. B on August 15,
2022 (ECF No. 37-4) (“Abrams CV”) at 1; Abrams Rep. at 1. He received his medical degree from
the University of California, San Diego. Abrams CV at 1. He completed a surgical internship at
Stanford University in 2008. Id. Dr. Abrams completed his residency at Stanford University
Hospital and Clinics in 2012, and a fellowship at Rush University Medical Center in 2013. Id. Dr.
Abrams is board certified in Orthopedic Surgery, with a subspeciality in Orthopedic Sports
Medicine. Id.; Abrams Rep. at 1. He is licensed to practice medicine in Illinois and California and
is a California Fluoroscopy Supervisor and Operator. Abrams CV at 2. He holds academic
appointments at the Stanford University School of Medicine and the Veterans Administration
Hospital of Palo Alto. Id. at 1; Abrams Rep. at 1. He serves as the head team physician for several
of Stanford University's varsity teams, and is also an assistant team physician for the San Francisco
49ers. Abrams CV at 23; Abrams Rep. at 1.
Dr. Abrams summarized the pertinent medical facts and only briefly addressed Petitioner’s
causation theory, purporting that it breaks down in the second and third Althen prong—since there
is no direct evidence that the vaccine Petitioner received either caused his left shoulder symptoms
or was temporally related to them. Abrams Rep. at 2–3.
First, Dr. Abrams opined that Petitioner’s shoulder injury was not likely related to his flu
vaccine. Abrams Rep. at 3. Rather, two other explanations existed: (1) calcific tendonitis, or (2)
an idiopathic manifestation of frozen shoulder. Id. at 4. The record provided support for calcific
tendonitis as the most likely cause. It was seen on Petitioner’s X-rays, and (as Dr. Natanzi
admitted) it was age-related, thereby consistent with Petitioner’s own age when he received the
relevant vaccine. Id. at 3–4; Natanzi First Rep. at 7; Natanzi Second Rep. at 1. Petitioner’s calcific
tendonitis was also likely present prior to vaccination. Abrams Rep. at 4. While calcific tendonitis
can be asymptomatic, it can also later lead to significant shoulder dysfunction, including suddenly-
manifesting pain. Id.; A. De Carli et al., Calcific Tendonitis of the Shoulder, 2 Joints 130, 131
(2014), filed as Ex. A, Tab 1 (ECF No. 37-2). And Dr. Abrams disputed Dr. Natanzi’s contention
that there is a connection between SIRVA and calcific tendonitis, maintaining that this is not
supported in the literature. Abrams Rep. at 3.
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Sudden manifestation of symptoms attributable to an idiopathic occurrence of frozen
shoulder could also explain Petitioner’s presentation. Frozen shoulder, Dr. Abrams opined, can
arise without an identified cause. Abrams Rep. at 4. It is a commonly-diagnosed condition
associated with increased age and medical comorbidities, and can be persistent in patients like Mr.
Bulman, who (this record reveals) do not obtain physical therapy and/or a cortisone injection as
treatment after their symptoms manifest. Id.; C. M. Robinson et al., Frozen Shoulder, 94 J. Bone
& Joint Surgery – British 1, 8 (2012), filed as Ex. B, Tab 2 (ECF No. 37-3) (describing diagnosis
of frozen shoulder) (“Robinson”). Petitioner’s clinical symptoms of pain and decreased motion
also matched the clinical picture of frozen shoulder. Abrams Rep. at 3–4; Ex. 3 at 12, 95–96. In
fact, Dr. Abrams proposed that calcific tendonitis itself could causally explain frozen shoulder.
Abrams Rep. at 4; Robinson at 1–2.
Second, Dr. Abrams addressed the issue of onset and its relationship to vaccination. In so
doing, he noted that the Finding of Fact had determined that a 48-hour onset from the time of
vaccination was not supported by the record. Abrams Rep. at 3. On top of that, Mr. Bulman had
not sought medical treatment for his shoulder pain until four months post-vaccination. Id. And Dr.
Natanzi’s explanation for treatment delay (that patients expected their pain to resolve on its own,
and thus waited to seek care) was undercut by the fact that Petitioner had sought medical care from
his PCP on December 26, 2018—three months after the vaccination—but did not at this time report
shoulder pain. Id. In fact, the record of this visit documented a number of medical problems,
suggesting to Dr. Abrams that shoulder pain would have also been mentioned at this time had it
been a concern, and thus that the failure to mention pain by this time was meaningful. Id. Dr.
Abrams also disputed Dr. Natanzi’s contention that SIRVA could occur even if onset exceeded
vaccination by more than two days, maintaining that a very close-in-time onset is a central and
defining characteristic of SIRVA. Id. at 4.
III. Procedural History
After the case’s initiation in the summer of 2019, it was assigned to SPU, since it asserts a
SIRVA claim—a kind of vaccine injury that routinely results in settlement or other prompt
resolution. However, Respondent filed a status report indicating that he intended to contest
entitlement, and subsequently filed his Rule 4(c) Report explaining there was not a preponderance
of evidence demonstrating the requisite facts necessary to establish a Table SIRVA injury
(particularly as it relates to a 48-hour onset). ECF No. 20. I provided the parties with the
opportunity to file any additional evidence or memoranda relevant to onset, and ultimately
dismissed the Table claim for failure to meet that element. ECF No 26. After the case was
transferred from SPU, I set deadlines for expert reports ,and eventually a scheduling order for
briefing on entitlement. The matter is now ripe for resolution.
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IV. Parties’ Arguments
Petitioner argues that he was correctly diagnosed with a SIRVA injury. Mot. at 16.4 He
further maintains that he has met the causation-in-fact burden based on the factors established by
the Federal Circuit in Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005);
Reply at 4. Statements from Petitioner’s expert, he purports, support the contention that the flu
vaccine can cause SIRVA via a prolonged inflammatory response. Mot. at 15–19; Reply at 5–7.
And Petitioner proposes that he has demonstrated a logical sequence of cause and effect that the
flu vaccine “did cause” his injury. Mot. at 23–24; Reply at 9–10. No other causal agent was
documented in the medical records that preceded his vaccination. Mot. at 23–24; Reply at 9.
Respondent’s expert can only opine on the possibility of idiopathic frozen shoulder (without
evidentiary basis) or calcific tendinitis (incidental, asymptomatic findings on an MRI). Mot. at 24–
25; Reply at 9–10. Finally, the timing of his onset began immediately (within 48 hours)—
according to Petitioner’s affidavit and medical records (though admittedly, not the visit following
vaccination). Mot. 20–22; Reply at 7–9. He states there is no evidence in the record to contradict
onset beginning close in time to vaccination. Reply at 9. However, even an onset exceeding 48
hours would be medically acceptable, given the literature and the testimony of Dr. Natanzi. Id. at
8–9; Mot. 20–22.
In opposing entitlement, Respondent questions the “existential” basis for the alleged injury,
maintaining that SIRVA is defined by administrative rulemaking rather than a recognized medical
diagnosis. Opp. at 10–13; Lasnetski, 128 Fed. Cl. at 262; Lombardi, 656 F.3d at 1352;
Broekelschen, 618 F.3d at 1349. Additionally, even if Petitioner could prove a medically
recognized injury, whether called SIRVA or something else, Petitioner has not preponderantly
established a reliable medical theory causally connecting his vaccination to his injury. Opp. at 13–
15. Petitioner relies on the theory of an immune-mediated inflammatory response, but the intended
purpose in vaccination does not equate to a pathogenic process resulting in injury. Id. at 13 n.4.
Petitioner also relies on case reports that do not assist in establishing causation. Id. at 13–14.
4 Petitioner also argues that SIRVA is a recognized vaccine injury, maintaining that Respondent erroneously relies on
several decisions that discuss the context in which post-vaccination symptoms have not been deemed to constitute an
injury. Reply at 2–4; Lasnetski v. Sec'y of Health & Hum. Servs., 128 Fed. Cl. 242 (Fed. Cir. 2017) (finding that
petitioner failed to identify the underlying injury and thus determining she was not entitled to compensation);
Lombardi v. Sec'y of Health & Hum. Servs., 656 F.3d 1343 (Fed. Cir. 2011) (holding that it was appropriate for the
special master to first determine what injury, if any, was supported by the evidence before applying the Althen test in
the fact of extreme disagreement among experts as to diagnosis); Broekelschen v. Sec'y of Health & Hum. Servs., 618
F.3d 1339 (Fed. Cir. 2010) (determining that identification of a petitioner’s injury is a prerequisite to an Althen analysis
when there is more than one proposed injury that have significantly different pathologies). However, resolution of the
present claim does not turn on whether a non-Table SIRVA is or is not an injury, but rather whether the facts of this
case undercut the conclusion that Petitioner’s at least SIRVA-like presentation could be vaccine-associated—given
the non-Table onset plus evidence of other explanations for the injury.
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Althen prong two is also unmet, Respondent argues, because Petitioner has failed to
establish a logical sequence of cause and effect—noting that a mere proximate temporal
relationship between vaccination and injury is not enough. Opp. at 16–19. There are also two viable
alternative causes for his shoulder pain evident in the medical record: calcific tendinitis and
idiopathic frozen shoulder. Id. at 18–19. And Petitioner’s showing under Althen prong three also
fails, since its primary foundation is his repeated assertion (in direct contravention to the Finding
of Fact) that his injury occurred within 48 hours of vaccination. Id. at 15–16. Indeed, no showing
of a medically-acceptable relationship between vaccine and injury is possible, because insufficient
support for an onset even a few days after vaccination has been established in this case. Id. at 15.
V. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).5
My Finding of Fact precludes recovery on the basis of a Table SIRVA claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
5 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.
Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning
legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),
aff’d 104 F. App’x. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL
504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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.”
Each Althen prong requires a different showing. Under Althen prong one, petitioners must
provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type
of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d
1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a
‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof.” (citing
Moberly, 592 F.3d at 1322)); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL
4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four
decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). And petitioners always have
the ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence.
W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted);
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Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the
petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a
preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
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Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when examining
their patients in as accurate a manner as possible, so that they are aware of enough relevant facts
to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often found to be deserving of greater evidentiary weight than oral testimony—especially
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where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) may be
more persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any
norm based upon common sense and experience, this rule should not be treated as an absolute and
must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL
6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).
Ultimately, a determination regarding a witness's credibility is needed when determining the
weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of
Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person's failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional's failure to document everything
reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;
or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
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1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the
theory or technique has been subjected to peer review and publication; (3) whether
there is a known or potential rate of error and whether there are standards for
controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts in order to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master's decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
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(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not all such items factor
into the outcome of this decision. While I have reviewed all the medical literature submitted, I
discuss only those articles that are most relevant to my determination and/or are central to
Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed.
Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir.
Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir.
2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).
E. Standards for Ruling on the Record
I am resolving Petitioner’s claim on the filed record, and the parties have not challenged
my determination to do so. Mot. at 1; Opp. at 1. The Vaccine Act and Rules not only contemplate
but encourage special masters to decide petitions on the papers where (in the exercise of their
discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
case on the papers in lieu of hearing and that decision was upheld). I am simply not required to
hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health
& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
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ANALYSIS
I. Interplay Between Table and Non-Table Claims Based on Same Facts
It is not uncommon for the same facts relevant to an alleged vaccine injury to be the basis
for both a Table and non-Table claim, such that the latter can viable even if the former is not.
Indeed, in the SIRVA context in particular, I routinely find6 (as here) that a Table element could
not be met, but then transfer the case out of SPU for resolution as a non-Table claim. At that point,
however, the context for analysis changes substantively. The nature of the specific showing that
must be met to obtain entitlement for a non-Table claim is quite different.
Causation is presumed for Table claims—meaning the Government has already made a
determination, when announcing the existence of a Table claim, that sufficient scientific and
medical evidence exists to allow Program claimants to seek damages without also requiring them
to prove, for example, that a particular vaccine “can cause” an injury. In addition, Table claimants
need only prove facts sufficient to meet certain elements of the claim at issue. See 42 C.F.R. §
100.3(b)(10). Most of the time, this means the petitioner must factually prove that (a) he received
a covered vaccine, (b) he suffered a specific injury (consistent with the Table’s “qualifications and
aids to interpretation,” which provide detailed definitions), and (c) the injury occurred in a defined
timeframe measured from the time/date of vaccination. Germaine v. Sec'y of Health & Hum.
Servs., 155 Fed. Cl. 226, 227 (2021) (discussing the elements needed for compensation of a Table
injury compared to those of a non-Table injury); Spaans v. Sec'y of Dep't of Health & Hum. Servs.,
No. 12-585V, 2012 WL 5928730, at *1 (Fed. Cl. Spec. Mstr. Nov. 6, 2012) (dismissing a claim
involving a non-covered vaccine).7
The specific Table elements relevant to a defined injury tend to be synergistically related,
based on medical science about how (and when) a putative vaccine injury is most likely to occur.
SIRVA provides an excellent example. SIRVA is believed to occur almost immediately after the
improper administration of a vaccine. G. Cross et al., Don't Aim Too High: Avoiding Shoulder
Injury Related to Vaccine Administration, 45 Australian Family Physician 303, 303 (2016), filed
as Ex. 9(c) (ECF No. 31-3). Thus, a Table SIRVA is only viable if preponderant evidence exists
establishing pain very close in time to vaccination. While more often than not Table claimants
allege immediate pain, a Table SIRVA can succeed even if the pain does not manifest until up to
48 hours post-vaccination. The claim’s most likely temporal “target” for occurrence has thus been
widened somewhat, in fairness to possible claimants. See, e.g., National Vaccine Injury
Compensation Program: Revisions to the Vaccine Injury Table, 80 FR 45132-01 (“[i]n order to
6 The Chief Special Master is responsible for adjudicating all SPU claims.
7 Sometimes expert input is required to adjudicate Table claims (for example, when a diagnosis is disputed), although
it is not common.
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capture the broader array of potential injuries, the Secretary proposes to add SIRVA for all tetanus
toxoid-containing vaccines that are administered intramuscularly through percutaneous injection
into the upper arm. The interval of onset will be less than or equal to 48 hours”).
Unsuccessful Table claims are not usually dismissed in their entirety even if it is
determined that one or more Table elements cannot be met.8 Nevertheless, thereafter the “road to
entitlement” becomes more difficult (although the preponderant burden of proof is consistent) once
the claim becomes subject to the non-Table, causation in fact analysis. Although non-Table
claimants may often be able to take advantage of the evidence that resulted in the Table
presumption in their effort to satisfy the first, “can cause” Althen prong,9 they cannot rely on how
close they came to meeting the Table requirements. See, e.g., Fantini v. Sec'y of Health & Hum.
Servs., No. 15-1332V, 2022 WL 1760730, at *22 (Fed. Cl. Spec. Mstr. May 2, 2022) (“. . . Program
claimants cannot “piggyback” on the Table requirements when attempting to prove a non-Table
claim.”); Greene v. Sec'y of Health & Hum. Servs., No. 11-631V, 2018 WL 3238611, at *9 (Fed.
Cl. Spec. Mstr. May 7, 2018) (noting that an expert’s opinion on the timing issue of a brachial
neuritis claim relied on conclusory determinations that the “Table time periods were not that far
off the time period in question (something Program law says is not permitted)”). Rather, they must
support each prong with sufficient preponderant evidence.
II. Petitioner has Not Carried his Burden of Proof
As noted, I have already determined that Table onset could not be met in this case. As a
result, I disregard Dr. Natanzi’s efforts to vouch for a more immediate onset despite my fact
finding. Also important is the fact that I did not identify a likely onset date for Petitioner’s pain.
The January 22nd record actually allowed for the possibility of pain occurring any time from after
September 27th (more than two days post-vaccination) to sometime in October. Ex. 3 at 93, 95–
96.
8 The failure of a Table claim would usually only produce the case’s full dismissal if it was preponderantly established
by the record evidence that no form of the claim could succeed. For example, flu vaccine/Guillain-Barré syndrome
cases cannot succeed as Table claims when onset exceeds 42 days—but a case where onset was extremely long (say,
three months) would not likely be entertained as a non-Table claim either, since special masters have almost never
found onset to be medically acceptable outside of eight weeks/two months (and even that timeframe is not universally
embraced among the special masters). See, e.g., Chinea v. Sec'y of Health & Human Servs., No. 15-095V, 2019 WL
1873322, at *33 (Fed. Cl. Mar. 15, 2019), mot. for review den'd, 144 Fed. Cl. 378 (2019) (finding that the onset of the
petitioner's GBS occurred eleven to twelve weeks after her vaccination, well beyond the six- to eight-week medically
appropriate timeframe for the occurrence of vaccine-induced GBS).
9 See L.J. v. Sec'y of Health & Hum. Servs., No. 17-0059V, 2021 WL 6845593, at *14 (Fed. Cl. Spec. Mstr. Dec. 2,
2021) (“[s]uch recognition by Respondent of the evidence supporting a causal link between vaccine and injury – since
the very decision to add a claim reflects Respondent's determination that valid science supports revising the Table -
has been held to support the establishment of the theory required by the first Althen prong”).
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This claim fails primarily on the second and third Althen prongs.10 First, and most
significantly, the record does not support the conclusion that Petitioner’s onset occurred in
medically-acceptable time from vaccination. Even if it is assumed (somewhat reasonably) that
vaccines can cause SIRVA, it is far more likely than not that the onset would be close to
vaccination. Indeed, the mechanism of the injury almost presupposes that, as Dr. Abrams
persuasively established. But it cannot be ascertained on this record when Petitioner’s onset most
likely occurred—and even then, Dr. Natanzi has not established that a range of post-vaccination
pain onset, occurring any time between more than two days to a week (or more) post-vaccination,
would be medically acceptable. The delay in treatment also interfered with a finding on the third
prong; even if it is reasonable to expect that sometimes individuals were delay treatment, it can
also be evidence of a moderate, tolerable condition, and here that kind of less-acute course suggests
a later onset inconsistent with SIRVA.
Program case law recognizes that not all post-vaccination injuries are vaccine-caused
simply because vaccination predated them. See Galindo v. HHS, No. 16-203V, 2019 WL 2419552,
at *20 (Fed. Cl. Spec. Mstr. May 14, 2019) (citing U.S. Steel Group v. United States, 96 F. 3d
1352, 1358 (Fed Cir. 1996) (“[b]ut to claim that the temporal link between these events proves that
they are casually related is simply to repeat the ancient fallacy: post hoc ergo propter hoc”). And
I do not find compelling case reports, or instances of longer onset described in literature like
Atanasoff, to be reliable proof of a causal association, or to shed light on what timeframe exceeding
the Table period would be reasonable.
Second, it has not been preponderantly established that Mr. Bulman’s vaccination likely
caused his shoulder injury, however defined. In so determining, I do not embrace Respondent’s
suggestion that SIRVA is solely a creature of administrative creation. It may well in fact be an
injury that could in some instances manifest more slowly. But this SIRVA claim fell out of the
Table—and although the nature of some of Petitioner’s symptoms were not inconsistent with a
SIRVA (as I alluded to in my Finding of Fact), the evidence adduced herein since that time (which
included two experts, as discussed above) reveals other potential causes for Petitioner’s injury that
undermine the vaccine’s purported role. The calcific tendonitis finding in particular, as endorsed
by Dr. Abrams, could explain Petitioner’s symptoms directly, or could have produced a frozen
shoulder that explains them. These explanations are as consistent with an onset several days after
vaccination as the vaccine itself, and could also result in sudden pain manifestation (albeit
10 Since all three Althen prongs must be met, I need not discuss Petitioner’s success on the “can cause” prong. I note,
however, that the science supporting SIRVA as a cognizable injury is intertwined with the associated pain occurring
very close in time to vaccination, if not immediately thereafter. A claimant could theoretically establish, through
citation to literature and other expert inputs, that the process leading to a SIRVA might take longer than what the
Table allows—but the case can be decided on the other Althen prongs, so I leave determination of that issue to another
day.
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occurring longer than a few days post-vaccination). In fact, the calcific tendonitis could well have
predated vaccination.
In making this determination, I am not finding that an alternative cause has been
established, to the exclusion of the flu vaccine. I cannot do so on this record, which does not
unambiguously point to a clear explanation for the claimant’s shoulder pain. But precedent clearly
permits me to consider all evidence bearing on the “did cause” prong, and this includes evidence
about possible confounding factors that undercut the conclusion a vaccine was causal. Indeed, such
evidence is relevant to a Table SIRVA. Lutz v. Sec'y of Health & Hum. Servs., No. 20-1553V,
2022 WL 17820779, at *2 (Fed. Cl. Spec. Mstr. Nov. 15, 2022) (citing 42 C.F.R. § 100.3(c)(10)(iv)
(noting that no other condition or abnormality can be present that would explain the patient’s
symptoms for a vaccine recipient to be considered to have suffer SIRVA)). Symptoms that would
appear to constitute SIRVA become less likely vaccine-related the further onset is separated from
vaccination date—as here—and even more so when other possible explanations for the injury are
found in the record, but not adequately distinguished.11
This is also not a case in which one side’s expert possessed superior knowledge of the
relevant injury. Both experts were well-qualified to testify, and proved knowledgeable about the
topic at issue. However, Dr. Natanzi in this case did a better job of defending SIRVA as a Table
claim than he did in explaining how a non-Table, SIRVA-like presentation, with an onset
exceeding the Table time by a meaningful amount (if not an inordinately lengthy period) could
still be a compensable claim. Dr. Abrams more compellingly interpreted the Petitioner’s record,
and more persuasively explained why a combination of the Petitioner’s age and calcific tendonitis
findings undercut the determination that his vaccination was causal.
Ultimately, the mix of facts presented by this case (a long delay in reporting pain; no
preponderant showing of Table onset; evidence of confounding factors) do not support the claim.
This does not mean that all non-Table SIRVAs will fail, or should. But a more robust showing
must be made than was offered in this case if they are going to succeed. Compare L.J. v. Sec'y of
Health & Hum. Servs., No. 17-0059V, 2021 WL 6845593, at *15–17 (Fed. Cl. Spec. Mstr. Dec.
2, 2021) (noting that petitioner provided preponderant evidence to prevail under the Althen test).12
11 I also do not find, however, that this case presents a “Shyface” context—in which a vaccine and alternative cause
coexist, but where one cause cannot be deemed predominant, but both were likely substantial. M.R. v. Sec'y of Health
& Hum. Servs., No. 16-1024V, 2022 WL 16956497 (Fed. Cl. Spec. Mstr. Oct. 3, 2022), review granted, opinion
vacated sub nom. M.R. v. United States, No. 16-1024V, 2023 WL 4930490 (Fed. Cl. Aug. 2, 2023), on remand M.R.
v. Sec'y of Health & Hum. Servs., No. 16-1024V, 2023 WL 4936727, at *28–29 (Fed. Cl. Spec. Mstr. June 30, 2023).
First, although vaccines can cause SIRVAs as defined by the Table, it is not established that they do so when onset
occurs more than two days post-vaccination. Second, I cannot on this record find that any causal explanation exists
for Petitioner’s injury, however defined.
12 Although L.J. stands as an example of a successful non-Table SIRVA claim, the facts and circumstances posed
therein are distinguishable (and highlight why the present case could not similarly succeed). For starters, the L.J.
Petition was filed prior to the time when SIRVA was added to the Vaccine Table (although I looked to the Table
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CONCLUSION
Based on the entire record in this case, I find that Petitioner has not carried his burden of
proof. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.13
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
elements for guidance). L.J., 2021 WL 6845593, at *8. In addition, it was undisputed in L.J. that the claimant satisfied
the first two QAI Table criteria—and thus was able to establish 48-hour onset, unlike in this case. Id. at *15, 17.
Otherwise, L.J. turned on different fact questions involving pain experienced elsewhere in the body.
13 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
21