VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00997
Package ID: USCOURTS-cofc-1_13-vv-00997
Petitioner: Jessica Graffeo
Filed: 2015-10-13
Decided: 2016-04-20
Vaccine: influenza
Vaccination date: 2011-12-14
Condition: acute respiratory failure, pneumonia, coma, death
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Sheila Graffeo filed a petition on behalf of her deceased daughter, Jessica Graffeo, on December 17, 2013, seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that Jessica's acute respiratory failure, pneumonia, coma, and death were caused by her receipt of a Pneumovax 23 and an influenza (flu) vaccine on December 14, 2011. Jessica was 26 years old at the time of vaccination and had a history of poorly controlled, insulin-dependent diabetes since childhood. The petitioner requested a ruling on the record as it existed. The Special Master reviewed the medical records, which indicated that Jessica had been hospitalized on December 13, 2011, with nausea and vomiting, and was diagnosed with uncontrolled diabetes mellitus with ketoacidosis. She received the flu and pneumococcal vaccinations prior to discharge on December 14, 2011. Four days later, on December 18, 2011, Jessica returned to the hospital with shortness of breath and fever, diagnosed with pneumonia, diabetic ketoacidosis, hypotension, and uncontrolled diabetes. She was intubated and transferred to another hospital, where her condition was assessed as acute respiratory failure with acute lung injury, possible ARDS, possible healthcare-acquired pneumonia with sepsis, acute renal failure, shock, SIRS, and elevated liver function tests. The medical records from this hospitalization did not connect her condition to the flu vaccine. Jessica was discharged on February 6, 2012, with diagnoses of acute respiratory failure (resolved), Type 1 diabetes, and hypothyroidism. Her rehabilitation diagnosis noted "debilitation following diabetic ketoacidosis resulting in an ICU stay and mechanical ventilation due to respiratory failure," with a contributing factor of a "long history of poorly controlled type 1 diabetes." No mention of the flu vaccine's role was made in these records. Jessica's medical history from 2012 through 2013 was marked by repeated hospitalizations and emergency room visits for symptoms similar to her previous ones, including renal failure, and she often failed to comply with dialysis treatments and insulin regimens. She was last hospitalized on October 25, 2013, with acute DKA, progressing to hypotension and sepsis, requiring intubation. She passed away on November 2, 2013, after signing a "do not resuscitate" order. The petitioner did not provide an expert report. Her own review of the record mentioned Acute Respiratory Distress Syndrome (ARDS) and Guillain-Barre Syndrome (GBS) as potential vaccine-related conditions, but the medical records did not support GBS as a diagnosis, and the information provided did not establish a causal link between the flu vaccine and Jessica's specific symptoms or death. The respondent argued that the petitioner failed to meet the burden of proof under the Althen standard, asserting that no treating physician linked the vaccine to the injuries, Jessica's underlying diabetes was the more likely cause of her conditions, and the temporal relationship between the vaccination and her death was not medically acceptable. The Special Master found that the petitioner failed to establish a medical theory connecting the flu vaccine to Jessica's injuries, a logical sequence of cause and effect, or a proximate temporal relationship. The Special Master noted that none of Jessica's treating physicians connected her illness or death to the flu vaccine and that her underlying health issues, particularly her diabetes, were the more likely cause of her symptoms and death. The petition was denied, and the case was dismissed. Petitioner's counsel was Sheila Graffeo, pro se. Respondent's counsel was Gordon E. Shemin. Special Master Brian H. Corcoran issued the decision on April 20, 2016.

Theory of causation field:
Petitioner Sheila Graffeo, on behalf of her deceased daughter Jessica Graffeo, alleged that a December 14, 2011, influenza vaccine caused acute respiratory failure, pneumonia, coma, and death. The petitioner did not provide an expert report or a clear medical theory linking the vaccine to the injuries, instead submitting information on ARDS and GBS. The Special Master found that the petitioner failed to establish a medically acceptable theory of causation, a logical sequence of cause and effect, or a proximate temporal relationship, noting that none of Jessica's treating physicians connected her illness or death to the vaccine and that her pre-existing, poorly controlled diabetes was the more likely cause of her progressive decline and death on November 2, 2013, nearly two years after vaccination. The claim was denied. Petitioner was represented by Sheila Graffeo, pro se, and Respondent by Gordon E. Shemin. Special Master Brian H. Corcoran issued the decision on April 20, 2016. This was an Off-Table claim.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_13-vv-00997-0
Date issued/filed: 2016-04-20
Pages: 9
Docket text: PUBLIC DECISION (Originally filed: 10/13/2015) Regarding 33 DECISION of Special Master Signed by Special Master Brian H. Corcoran. (ay) Copy to parties. Modified on 5/18/2016 - corrected pdf (jt1).
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Case 1:13-vv-00997-UNJ Document 35 Filed 04/20/16 Page 1 of 9
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-997V
(Not to be Published)
* * * * * * * * * * * * * * * * * * * * * * * * *
SHEILA GRAFFEO, on behalf of the *
Estate of JESSICA GRAFFEO, * Filed: October 13, 2015
*
Petitioner, *
* Entitlement; Ruling on the Record;
v. * Influenza (“Flu”) Vaccine; Acute
* Respiratory Failure; Pneumonia; Coma;
SECRETARY OF HEALTH AND * Death.
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Sheila Graffeo, Metairie, LA, pro se Petitioner.
Gordon E. Shemin, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT AWARD1
On December 17, 2013, Sheila Graffeo filed a petition on behalf of the estate of her deceased
daughter, Jessica, seeking compensation under the National Vaccine Injury Compensation Program
(“Vaccine Program”).2 Petitioner alleges that Jessica’s acute respiratory failure, pneumonia, coma,
and ultimate death were caused-in-fact by her receipt of the Pneumovax 233 and influenza (“flu”)
1 Because this decision contains a reasoned explanation for my actions in this case, I will post it on the United States
Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116
Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As provided by 42 U.S.C. § 300aa-
12(d)(4)(B), however, the parties may object to the published decisions inclusion of certain kinds of confidential
information. Specifically, under Vaccine Rule 18(b), each party has 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. 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, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”].
Individual section references hereafter will be to § 300aa of the Act.
3 Section 11(c)(1) of the Vaccine Act requires that the injured person have “received a vaccine set forth in the Vaccine
Injury Table . . ..” The Pneumovax vaccine, however, is not a vaccine listed on the Vaccine Injury Table (see, e.g., Amin
v. Sec’y of Health & Human Servs., No. 13-300V, 2013 WL 3994322, at *2 (Fed. Cl. Spec. Mstr. July 29, 2013)), so
Petitioner cannot prevail with a claim regarding Pneumovax vaccine having caused her daughter’s alleged injuries and

Case 1:13-vv-00997-UNJ Document 35 Filed 04/20/16 Page 2 of 9
vaccines on December 14, 2011. Pet. at 1 (ECF No. 1). Petitioner has now requested that I rule on her
claim based solely on the record as it currently exists. See Order, dated July 29, 2015. For the reasons
set forth below, and based on my review of the record4 filed in this matter, I find that the evidence
offered is insufficient to meet Petitioner’s burden to establish entitlement to compensation, and
therefore her claim warrants dismissal.
I. BACKGROUND
A. Factual History
As noted above, Ms. Graffeo filed her petition in December of 2013, and spent the ensuing
fourteen months obtaining and filing medical records.5 Pet’r’s Exs. 1-7. The filed records plainly
establish that Jessica (then 26 years old) received a flu vaccine on December 14, 2011, and that she
became extremely ill thereafter, dying a little less than two years later, on November 2, 2013. See
Iberia Medical Center, records dated Jan. 8, 2013 at 7-9, 52-53; Dauterive Hospital, records dated
2008 through 2013 at 119-20. The crux of the parties’ dispute is whether the symptoms she suffered
in 2011 through 2013 were caused by the flu vaccine, or were unrelated and/or simply reflected her
pre-vaccination poor health.
The record establishes that at the time she received the flu vaccine, Jessica had a history of
insulin-dependent diabetes (which was poorly controlled). Iberia Medical Center, records dated Jan.
8, 2013 at 7-9, 53-54. Jessica had been dealing with insulin-dependent diabetes (and associated
complications) since she was seven years old. Iberia Medical Center, dated Dec. 11, 2011 through
Mar. 6, 2012 at 11. Thus, when Jessica was admitted to a hospital in New Iberia, Louisiana through
the emergency room on December 13, 2011 (the day prior to the vaccination at issue) after reporting
that she had been experiencing nausea and vomiting over the last few days,6 her principal diagnosis
ultimate death. Accordingly, I will only provide further review going forward in my decision with regards to Petitioner’s
claim with that the flu vaccination was responsible for her daughter’s injuries and ultimately her death.
4 Ms. Graffeo’s petition is not supported by an affidavit, as the Vaccine Act requires. § 300aa-11(c)(1). Petitioner did,
however, file medical records which themselves contain proof of vaccination, and also corroborate the facts pertaining to
Jessica’s alleged illness and its course in considerable detail. I therefore find that the failure to include an affidavit was a
de minimis omission not prejudicial to the Petitioner. See also Vaccine Rule 2(B) (describing circumstances in which
affidavits are required to supplement existing medical record).
5 The individual exhibits filed by Petitioner do not contain exhibit numbers (on the actual documents) or page numbers.
Accordingly, the exhibits are referred to by the naming conventions utilized by Petitioner when filing the compact disks
in this case, and the page numbers cited correspond to the page number of the actual PDF document (as reflected in the
PDF reader).
6 This was not the first time Jessica had presented to the emergency department in 2011. On August 15, 2011, Jessica
noted that she had been experiencing nausea for the past three to four days and expressed concerns that she was pregnant.
Iberia Medical Center, records dated Jan. 8, 2013, at 19-20, 24. On August 19, 2011, Jessica went to the hospital reporting
that she had been experiencing body aches for two months and that she thought her blood sugar was low, and also repeated
her pregnancy concern. Id. at 30. Id. Then, on November 2, 2011, Jessica went back to the emergency room complaining
of a rash, hives, and itching that had occurred for the last two weeks. Id. at 41.
2

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was uncontrolled diabetes mellitus (“DM”) with ketoacidosis. Id. at 7-9, 49, 51.
Jessica’s symptoms responded well to treatment during the time that she was in the hospital.
Iberia Medical Center, records dated May 15, 2012 at 12. Because it was noted that the flu and
pneumococcal vaccinations were indicated for Jessica, she received both vaccinations prior to being
discharged from the hospital on December 14, 2011. Iberia Medical Center, records dated Dec. 11,
2011 through Mar. 6, 2012 at 23, 53, 78. Four days later, however, on December 18, 2011, Jessica
returned to the emergency room with complaints of dyspnea (shortness of breath), as well as a fever.
Iberia Medical Center, records dated May 15, 2015 at 89, 109. While at Iberia Medical Center, Jessica
was intubated and received manual ventilation. Id. A chest x-ray revealed “bilateral patchy infiltrates
throughout much of the lung fields.” Id. at 108. Under clinical impressions, pneumonia, diabetic
ketoacidosis (“DKA”), hypotension, and uncontrolled DM were listed. Iberia Medical Center, records
dated Jan. 8, 2013, at 133. She was subsequently transferred to Regional Medical Center in Lafayette,
Louisiana for admission because they could provide her with a higher level of care. Iberia Medical
Center, records dated May 15, 2015 at 78-83, 117; Iberia Medical Center, records dated Jan. 8, 2013
at 132.
At that time, the following were listed under the assessment of Jessica’s condition: (1) DKA;
(2) acute respiratory failure with acute lung injury, and possible acute respiratory distress syndrome
(“ARDS”); (3) possible healthcare acquired pneumonia with sepsis; (4) acute renal failure likely
prerenal in organ; (5) shock of multifactorial origin, primarily metabolic at this point; (6) iatrogenic
hypokalemia; (7) shock liver; (8) systemic inflammatory response syndrome (“SIRS”) (due to DKA
and probable infection); (9) diabetes mellitus type 1; (10) volume overload; and (11) elevated liver
function test consistent with liver shock. Regional Medical Center, records dated Aug. 16, 2012 at
3011-12. Although the contemporaneous medical records record the fact of Jessica’s receipt of the
flu vaccine days before, no connection between Jessica’s receipt of vaccination and present condition
was made by her treaters. Id. at 3012.
Jessica remained hospitalized through February 6, 2012, and upon discharge her diagnoses
were “acute respiratory failure, resolved; Type 1 diabetes; and hypothyroidism.” Regional Medical
Center, records dated Aug. 16, 2012 at 3009. She was thereafter transferred to inpatient rehabilitation
at Regional Medical Center of Acadiana. Id. at 2007, 3009. Her diagnosis in rehabilitation was listed
as “[d]ebilitation following diabetic ketoacidosis resulting [in] an ICU stay and mechanical
ventilation due to respiratory failure,” with the contributing factor of a “[l]ong history of poorly
controlled type 1 diabetes resulting in above and decreased ADL function endurance and strength
secondary to recent illness.” Id. at 2015. No mention of her flu vaccine as having had any role in her
symptoms or illness is set forth in these contemporaneous records, however. She remained an
inpatient at the transfer medical facility through February 23, 2012. Id. at 2015-16.
Jessica’s subsequent medical history for the remainder of 2012 through 2013 is characterized
by repeated visits to hospital emergency rooms, complaining of symptoms similar to those she had
3

Case 1:13-vv-00997-UNJ Document 35 Filed 04/20/16 Page 4 of 9
previously reported as reflected in the medical history, as well as increasingly severe medical
problems.7 When Jessica came into the emergency room on June 4, 2012, she reported a three-week
history of left breast access and was at that time was noted to be suffering from uncontrolled Type I
diabetes, resulting in nearly a three week long hospitalization during which she developed renal
failure. Regional Medical Center, records dated Aug. 16, 2012 at 36-39. Upon discharge, it was noted
that Jessica would likely require dialysis. Id.8
As per orders from her treaters, Jessica was thereafter to undergo dialysis treatments three
times per week for three hours each time at a facility in Acadiana, Louisiana. Kidney Care of
Acadiana, records dated Apr. 18, 2014 at 171. Jessica did initially do so, but thereafter often failed to
show up for appointments or terminated treatment early against the advice of her treaters (despite
having been repeatedly warned about the risk associated with doing so). See, e.g., Kidney Care of
Acadiana, records dated Apr. 18, 2014 at 37, 76; Kidney Care of Acadiana, records dated Apr. 28,
2014 at 325-29. Because of the above, Jessica received the dialysis she required only after new
inpatient admissions, often in connection with additional emergency room visits.9 By the summer of
2013, Jessica had informed the Acadiana facility that she would no longer receive dialysis treatments
there because she was moving, and signed a formal waiver indicating her awareness of the risks she
ran in abandoning regular treatment. Kidney Care of Acadiana, records dated Apr. 28, 2014 at 323.
Jessica returned to yet another hospital emergency room on October 17, 2013, complaining of
chest pain and shortness of breath. Dauterive Hospital, records dated 2008 through 2013 at 266.
During her hospitalization, despite having the importance of compliance with her medical therapy
repeatedly reinforced, Jessica “continued to refuse inpatient hemodialysis and oftentimes refused her
insulin.” Id. at 266. Jessica was encourage to remain in the hospital until her glucose levels were
closer to the goal, but she decided to leave against medical advice on October 21, 2013. Id. at 266-
67.
7 For instance, she visited the emergency room on February 25, 2012, complaining of a three day history of chest pain
and shortness of breath, but let the hospital on her own accord against her treater’s advice. Regional Medical Center,
records dated Aug. 16, 2012 at 1992, 1981.
8 On July 10, 2012, Jessica was admitted to Dauterive Hospital in New Iberia, Louisiana after presenting to the emergency
room “with generalized weakness,” and “was lethargic and oriented to person only.” Kidney Care of Acadiana, records
dated Apr. 28, 2014 at 286-87. She remained hospitalized until August 4, 2012, and at the time of discharge her diagnoses
included “[e]nd-stage renal disease, on hemodialysis, hyperkalemia secondary to end-stage renal disease, uncontrolled
type 1 diabetes mellitus secondary to noncompliance, hyperphosphatemia, heart failure systolic with an ejection fraction
of 10%, noncompliance with medications and diet, and mildly elevated liver function tests.” Id.
9 For instance, on January 24, 2013, Jessica was admitted to Dauterive Hospital because of “altered mental state.” Id. at
268. At that time, it was noted that she was “very acidotic and sugar is very high, and also [Jessica] did not show up for
dialysis the past week, so [she] was admitted to the hospital for dialysis and also treatment of DKA.” Id. at 268. Similarly,
on April 9, 2013, Jessica was admitted to Dauterive Hospital due to complaints of chest pain. Id. at 262. After initially
refusing to undergo hemodialysis upon admission to the hospital, Jessica underwent hemodialysis the next morning. Id.
at 262.
4

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Jessica had her final visit to an emergency room a little over a week later, on October 25,
2013, complaining of symptoms very similar to those she had reported in the past. Dauterive Hospital,
records dated 2008 through 2013 at 119. After examination and testing, she was diagnosed with acute
DKA and admitted to an intensive care unit. Id. During her hospitalization, Jessica’s condition
progressively worsened, requiring intubation, and she subsequently developed hypotension and
sepsis. Id. She ultimately worsened to the point where she became unresponsive even without
sedation. Id. at 120. Jessica had signed a “do not resuscitate” order, and she passed away on November
2, 2013. Id. at 119-20.
B. Procedural History
As noted above, Petitioner filed a number of medical records in the summer of 2014, and then
filed her statement of completion in September of 2014 (ECF No. 15). I thereafter provided Ms.
Graffeo the opportunity to locate and file additional medical records after Respondent indicated her
belief that relevant materials were missing from the record. Order, dated Nov. 13, 2014 (ECF No.
21). Eventually, Respondent deemed the record sufficiently complete to address the merits of
Petitioner’s claim. Thus, on April 8, 2015, Respondent filed her Rule 4(c) report denying that
Petitioner was entitled to compensation. Rule 4(c) Report (ECF No. 25).
Following the filing of Respondent’s Rule 4(c) report, I urged Petitioner to consider what
other proof she might offer to support her claim that the vaccines in question caused her daughter’s
alleged injuries and death – and in particular observed that an expert report might assist her in proving
her case. See Status Conference Order, dated Apr. 23, 2015 (ECF No. 27). Despite being provided
with an opportunity to do so (see Scheduling Order, dated Apr. 23, 2015 (ECF No. 27); Scheduling
Order, dated June 24, 2015) (ECF No. 30)), however, Petitioner was unable to locate an expert to
support her claim. Accordingly, on July 29, 2015, Ms. Graffeo contacted my chambers and orally
requested a ruling on the record in this case as it then existed, foregoing the opportunity to present
additional evidence in support of her claim. See Order, dated July 29, 2015 (ECF No. 31). I provided
Respondent with an opportunity to reply to Petitioner’s request for a ruling on the record, and she did
so on August 8, 2015 (Response to Pet’r’s Request for a Ruling on the Record (ECF No. 32)).
The parties’ respective positions on the viability of Ms. Graffeo’s claim were largely set forth
prior to her request for a ruling on the record in this case.10 Petitioner had filed (on June 1, 2015) a
document with six pages of information essentially consisting of her own review of available
information regarding vaccine causation. See ECF No. 28. In it, Petitioner outlined information
regarding two different medical conditions that could be attributable to the flu vaccine Jessica
received. First, Petitioner provided information apparently copied from an unidentified internet
source and pasted into a word document regarding ARDS, indicating that it “usually develops within
10 Indeed, in opposing Ms. Graffeo’s request, Respondent simply referenced the arguments set forth in the earlier Rule
4(c) report. Resp. to Pet’r’s Request for a Ruling on the Record (ECF No. 32).
5

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a few hours to a few days after the original disease or trauma” and alleging that in this case, ARDS
“[o]ccured after Jessica received the two ordered vaccines.” Pet’r’s Statement of Additional Medical
Information (ECF No. 28) at 2. However, as Petitioner also acknowledged, the most common
underlying causes of ARDS are sepsis; inhalation of harmful substances; severe pneumonia; and head,
chest, or other major injury (id.), and her report cited no other medical proof or literature causally
connecting any vaccines to ARDS. Second, Petitioner provided information regarding Guillain-Barre
syndrome (“GBS”), noting that it can be triggered by “recent surgery or immunization,” including
“[r]arely, influenza vaccinations or childhood vaccinations,” and can result in death. Id. at 5.
Petitioner, however, does not allege that Jessica suffered from GBS, nor do the medical records make
any mention of it as a proposed or actual diagnosis for Jessica’s symptoms.
Respondent’s Rule 4(c) report contended that Ms. Graffeo could not establish her burden of
proof by preponderant evidence, referencing the Federal Circuit’s conception of a vaccine injury
claimant’s burden as stated in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed.
Cir. 2005). In support of this argument, Respondent observed that no treater had identified the flu
vaccine as the cause of Jessica’s death, and deduced from the record that Jessica’s pneumonia and
respiratory failure in late 2011 was more likely attributed to a respiratory infection. ECF No. 25 at 7.
Moreover, Respondent proposed that Jessica’s uncontrolled diabetes was the trigger for her
intervening infections, episodes of diabetic ketoacidosis, and renal failure.11 Id. at 7-8.
Respondent also asserted that Ms. Graffeo lacked a reliable medical or scientific theory
explaining how the flu vaccine could cause Jessica’s sickness and death. ECF No. 25 at 6-8. And
Respondent disputed whether Petitioner had satisfied the third Althen prong, arguing that to the extent
Petitioner is alleging that Jessica’s shortness of breath in October of 2013, the time period
immediately preceding her death, was caused by the flu vaccine, the nearly two years from when she
received the flu vaccine in December of 2011 was too long a period to allow the inference that such
a temporal period was medically acceptable. Id. at 7-8.
II. Analysis
To receive compensation under the Vaccine Program, a petitioner must prove either: (1) that
she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding
to one of the vaccinations in question, or (2) that her illnesses were actually caused by a vaccine (a
category of claim often referred to as a “Non-Table Injury”). See §§ 13(a)(1)(A), 11(c)(1), 14(a), and
11(c)(1)(C)(ii)(I); 42 C.F.R. § 100.3; see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320
11 Respondent also questioned whether Petitioner met the six-month requirement (see 42 U.S.C. § 300aa-11(c)(1)(D)
(requiring that the injured individual “suffered the residual effects or complications of such illness, disability, injury, or
condition for more than 6 months after the administration of the vaccine”)), because the medical records suggest that
“following her discharge from Regional Medical Center in February 2012, Jessica likely returned to the baseline health
status she had [experienced] prior to receiving the flu vaccine.” ECF No. 25 at 7, n. 8.
6

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(Fed. Cir. 2006).12 Ms. Graffeo has not alleged a Table Injury in this case (and in fact there are no
Table Injuries specified for the flu vaccine, although the vaccine itself can be the basis for a claim).
I must therefore consider the requirements needed to prove a Non-Table Injury. Under such
circumstances, the petitioner bears the burden of demonstrating actual causation by preponderant
evidence. Cedillo v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); §
13(a)(1). To do so, a petitioner must provide: “(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 a proximate temporal relationship between
vaccination and injury.” Althen, 418 F.3d at 1278. Under this evidentiary standard, a petitioner must
demonstrate that the injury claimed was “more likely than not” caused by the alleged vaccine.
Moberly, 592 F.3d at 1322 n.2. Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner who successfully does so is entitled
to compensation, unless the Respondent can then demonstrate by a preponderance of the evidence
that the injury was caused by factors unrelated to the vaccination. Althen, 418 F.3d at 1278.
Petitioners may be awarded Vaccine Program compensation based on “medical records or . .
. medical opinion.” Section 13(a)(1) (emphasis added); see also Althen, 418 F.3d at 1279-80.
Although expert testimony may be helpful and may be considered, there are no “hard and fast per se
scientific or medical rules” for finding causation under the Vaccine Act, and thus no requirement that
a petitioner offer expert testimony to prevail. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Indeed, a special master may determine that a petitioner has carried his or
her burden of proof sufficient to receive a Vaccine Program award even where the claim is not
supported with conclusive medical literature, epidemiological studies, and/or theories enjoying
general acceptance in the scientific or medical communities. See Andreu v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009). Often, however, establishing a sound and reliable
medical theory requires that the parties present expert testimony in support of their claims. Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000).
I have reviewed the entire record as required by the Vaccine Act (§ 300aa-13(a)(1)). Based
upon that review, I find that Petitioner has failed to meet her burden of proof under any of the Althen
prongs. Under its first prong, Petitioner was required to set forth a medical theory explaining how the
flu vaccination that her daughter received could have caused her alleged injuries. Pafford v. Sec'y of
Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006). Petitioner did not offer an expert
report, but she has submitted information regarding various medical conditions (ADRS and GBS), as
well as potential causes of and complications associated with those medical conditions. However,
12 In this decision, I reference published decisions of other special masters, which constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). I also cite Federal Circuit decisions,
which are binding on special masters. Guillory v. Sec’y of Health & Human 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 & Human Servs., No. 13-159V, 2014 WL 504728,
at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
7

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even if such information supports the conclusion that in certain cases vaccinations (including the flu
vaccine) can result in illness, it does not bulwark her argument that the flu vaccine could cause the
kinds of symptoms Jessica experienced in the almost two years following her receipt of that vaccine.
She has not offered sufficient reliable scientific or medical evidence pertinent to the circumstances
herein (for example, literature dealing with the effects of vaccination on individuals suffering from
diabetes, or proposing some other theory by which the flu vaccine could cause the cascade of
problems Jessica evidently experienced). Ms. Graffeo was not obligated to obtain an expert opinion
to make her case, but given the nature of Jessica’s overall health as reflected in the records, and lack
of a treating physician that Jessica’s vaccination was related to her symptoms, such support would
have greatly assisted her in carrying her burden of proof. I find that she has not demonstrated how the
flu vaccine could cause her daughter’s alleged injuries (and ultimately her death).
I similarly find (even if the showing she made with respect to her theory of causation was
deemed sufficient) that Ms. Graffeo has not established with preponderant evidence that the flu
vaccine did cause Jessica’s illness and/or death. Under the second prong of Althen, Petitioner is
required to establish “a logical sequence of cause and effect showing that the vaccination was the
reason for the injury,” 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 Dep't
of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). Here, however, none of Jessica’s
treaters speculated as to any connection (beyond the temporal) between her receipt of a flu vaccine
and subsequent complications. Moberly, 592 F.3d at 1325 (although evidence from a treating
physician regarding causation is not required, such evidence can be probative with regards to
causation).
The record far more likely suggests that Jessica’s underlying health problems (in particular,
her diabetes) were the instigating factor for her symptoms. Jessica had a long history of diabetes,
dating back to her childhood that predates administration of the flu vaccination at issue in this case.
And Petitioner has not offered a more persuasive, contrary reading of the medical record (whether
based on her own analysis or that of a competent medical expert). Accordingly, Petitioner has also
failed to offer sufficient evidence to satisfy the second Althen prong.
I conclude the same with respect to the third component of a petitioner’s burden under Althen,
which requires a petitioner to show that there was a proximate temporal relationship13 between the
vaccination and injury. Althen, 418 F.3d at 1279, 1281. To the extent Petitioner is alleging that
13 That term has been equated to the phrase “medically-acceptable temporal relationship.” Althen, 418 F.3d at 1279, 1281.
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
& Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what constitutes a medically acceptable
timeframe must also coincide with the theory of how the relevant vaccine can cause an injury set forth by the petitioner
(Althen prong one’s requirement). Id.; Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (Fed. Cl. 2011),
recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of
Health & Human Servs., No. 11-355V, 2013 WL 3214877, at *27 (Fed. Cl. Spec. Mstr. May 30, 2013), aff’d, No. 2014-
5054, 2014 WL 6804880 (Fed. Cir. Dec. 4, 2014).
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Case 1:13-vv-00997-UNJ Document 35 Filed 04/20/16 Page 9 of 9
Jessica’s shortness of breath in October of 2013 (the time period immediately preceding her death)
was caused by the flu vaccine, the nearly two years from when she received the flu vaccine in
December of 2011 is too long to be medically appropriate to infer vaccine causation, and Ms. Graffeo
has not offered any scientific or medical explanation for how this could have occurred. Nor has Ms.
Graffeo offered an explanation for how the flu vaccine could have resulted in the symptoms that led
to her daughter seeking medical intervention on December 18, 2011 (four days after receipt of
vaccination). At bottom, she seems to be relying on the fact that her daughter became ill subsequent
to receipt of the vaccination – but a temporal association alone is insufficient to establish entitlement
to compensation. Moberly, 592 F.3d at 1323.
CONCLUSION
I have great sympathy for Ms. Graffeo’s suffering at the loss of her daughter, and have no
doubt this action has been pursued in a good faith desire to seek redress for that tragedy. However, I
must make entitlement decisions on the basis of the legal standards applicable in the Vaccine Program
regardless of the sympathy I have for petitioners. Having considered the evidence in the record in its
totality, I am persuaded that despite her best efforts Ms. Graffeo has failed to offer sufficient evidence
to meet her burden of proof. Accordingly, Petitioner is not entitled to an award of compensation under
the Vaccine Program, and this case is hereby DISMISSED.
IT IS SO ORDERED.
Brian H. Corcoran
Special Master
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