# In the United States Court of Federal Claims

DONNA BALDWIN, Petitioner,

v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. No. 13

- 957 V Filed: December 2 , 202 0 ∗ Reissued for Public Availability: December 17, 2020

For Petitioner : F. John Caldwell, Jr., Maglio Christopher & Toale, P.A., Sarasota, FL For Defendant : Lisa A. Watts, Senior Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, D.C.

MEMORANDUM AND ORDER Petitioner , Donna Baldwin , seeks review of a decision issued by Special Master Daniel T. Horner , wh o concluded that Petitioner is not entitled to an award of compensation. See Baldwin v. HHS , No. 13

- 957V, slip op. (Fed. Cl. Spec. Mstr. June 4, 2020) (ECF No. 104) (Dec. or Decision) . Petitioner alleges that the S pecial M aster erred in finding that Petit ioner did not meet her burden under Althen prongs one and two. Pet ’ r’s Mot

. for Review (ECF No. 106) ; see also Pet’r’s Mem. of Objs. in Support of Mot. for Review (ECF No. 107) (Pet ’r’s Br .). Respondent requests this Court affirm the Special Master’s decision. Resp ’ t’s Mem

. in Resp

. to Pet ’ r’s Mot

. for Review at 7 (ECF No. 109) (Resp ’t’s Br

. )

. Respondent argues that

∗ Pursuant to Rule 18(b) of the Vaccine Rules of the United States Court of Federal Claims (Appendix B to the Rules of the United States Court of Fed eral Claims), the Court filed this Memorandum and Order on December 2, 2020, and provided the parties fourteen (14) days to propose redactions. The parties did not propose redactions. Accordingly, th e Court is publicly reissuing its Memorandum and Order in its original form for publication.2 Petitioner failed to provide a reliable medical theory causally connecting th e influenza (flu) vaccine to her ventricular fibrillation and failed to identify objective evidence in her contemporaneous medical records to support her experts’ proffered theories of causation . Resp ’t’s Br. at 1

- 2

. For the reasons stated below, Petitioner's Motion for Review is DENIED , and the Special Master's Decision denying entitlement is SUSTAINED

.

Factual and Procedural Background

On December 5, 2013, P etitioner filed a p etition for compensation with the Nation al Vaccine Injury Compensation Program (Vaccine Program), under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa

- 1

– 300aa

- 34 (2012) (Vaccine Act), for an off

- t able injury. Petition ¶ 1 (ECF No. 1) (Pet.)

. Specifically, P etitioner alle ged that six days after her flu vaccination , under the Fluvirin brand, P etitioner experienced a ventricular fibrillation and cardiac
arrest. Pet. at ¶ ¶ 2

- 3 ; see also Pet’r’s Ex. 9 at 21

. To support her position, s he provided various medical records 1 and expert reports 2

. Respondent filed competing expert opinions 3 to support its position that P etitioner’s cardiac event was caused by factors other than her vaccine

. P etitioner’s medical records and the parties’ expert opinions are summarized in detail below.

1 Petitioner initially filed medical records marked as Exhibits 1

- 21 (ECF No. 4) and Exhibits 22

- 23 (ECF No. 8). She later filed additional medical records marked as Exhibit 24 and a Statement of Completion on April 14, 2014. (ECF Nos. 9

- 10). However, after filing her Statement of Completion, Petitioner filed medical records again on May 28, 2015 (ECF No. 35) (Exhibits 30

- 34) and August 30, 2018 (ECF No. 79) (Exhibits 44

- 48). See also ECF Nos. 81, 83, 89, 90, 96. 2 Petitioner filed reports by two experts: Dr

. Robert A. Waugh (ECF Nos. 18, 19, 32, 38, 44) and Dr. Robert M. Stark (ECF No. 74). 3 Respondent filed reports by two experts: Dr. Laurence Sperling (ECF Nos. 41, 50) an d Dr. Shane LaRue (ECF Nos. 72, 75, 77).3 I. Petitioner’s Medical Records At the time of the flu vaccin ation at issue, P etitioner was fifty

- four (54) years old , and had several pre - existing conditions. See Pet’r’s Ex. 21 at 19 (listing Petitioner’s date of birth and date of vaccination). Based on P etitioner’s m edical records, the S pecial M aster found that prior to receiving the vaccination at issue, “ [p] etitioner [ had ] a history of various medical issues including muscle spasm, chronic fatigue syndrome, obesity, anemia, hypothyroidism, hyperlipidemia and dyslipidemia, hypertension, anxiety, depression, and diabetes.” Dec. at 5 (citing Pet ’r ’s Ex. 2 at 25; Pet ’r ’s Ex. 3 at 3; Pet ’r ’s Ex. 5 at 2; Pet ’r ’s Ex. 6 at 2, 8; Pet ’r ’s Ex. 9 at 3, 14; Pet ’r ’s Ex. 14
at 2). On September 8, 2009, P etitioner visited a primary care doctor and complain ed of dizziness and heart palpitations characterized by a rapid heartbeat that had been occurring for an uncertain time period

. Pet ’r ’s Ex. 6 at 30. She was noted to be morbidly obese, with a history of type II diabetes, abnormal thyroid findings, iron deficiency anemia, arthralgias, and fatigue. Id. at 30

- 31. Petitioner’s medical records reveal that she visited Dr. Jeffrey Howard, a cardiologist, in late 2009, after she complained of palpitations, dyspnea, and chest pain. Pet ’ r’s Ex. 5 at 8

. Dr. Howard interpreted Petitioner’s echocardiogram as indicating tha t Petitioner had “concentric LV hypertrophy” and “minimal to mild mitral regurgitation,” but his overall impression was that Petitioner’s echocardiogram was normal and “no stress induced regional wall motion abnormalities” were detected. Id

. at 10

- 11

. Fo r these and other reasons, Dr. Howard concluded further diagnostic testing was unwarranted. Id at 12

. Throughout 2010, P etitioner sought treatment at Healing Innovations and frequently had visits to address various medical issues including elevated blo od pressure, heart palpitations, rapid heart beating, and/or chest pain or pressure. See Pet ’r ’s Ex. 6 at 2

- 29 ; Pet ’r ’s Ex. 12 at 3

. Additionally, Petitioner went to the hospital emergency room for dizziness and chest pain on June4 1 , 2010 and June 9 , 2010. Pet ’ r’s Ex. 13 at 90

- 9 6 , 128

- 33 . At both visits, Petitioner received an electrocardiogram (ECG). Notably, Petitioner’s ECG on Jun e 9, 2010 was abnormal as compared to her June 1, 2010 ECG, an abnormality that her treating physician believed indicated “possible anterior infarct.” Dec. at 6 (quoting Pet’r’s Ex 13 at 98, 128)

. Moreover , in early 2011, after P etitioner underwent left knee surgery and suffered an episode of laryngospasm , id . (citations omitted) , s he complained to Dr. Roger S. Blair of shortness of breath and heart palpitation s . Id . (citing Pet’r’s Ex. 1 2)

. A month later, P etitioner also underwent a neur ological evaluation from Dr. Hung Huy Nguyen. Id. (citing Pet ’ r’s Ex. 11 at 2

- 4 )

. During that visit, P etitioner reported family history of myocardial infarction, but tests showed P etitioner’s heart had regular rhythm and no murmur. Id

. Against this backdrop, o n October 13, 2011, Petitioner received the i nfluenza vaccine at the Walgreen s p harmacy, located at 2253 Central Drive, Bedford, Texas. Pet. ¶ 1 (citing Pet ’ r’s Ex. 21 at 19. 4 Six days later, Petitioner experienced sudden chest pain after sitting down from “rushing around the house for towels to clean up [ a water leak ]

. ” Pet ’ r’s Ex. 24 at 195. An ambulance was called ; while en route to the hospital, Petitioner suffered ventricular fibrillation

. Id. Petitioner was admitted to Texas Health Harris Methodist Hospital Hurst

- Euless

- Bedford for ventricular fibrillation cardiac arrest. Id

. at 170. On the same day she was admitted to the h ospital, Petitioner consulted cardiologist, Dr. Srinivas Paranandi. Pet ’ r’s Ex. 9 at 13

- 20. She informed Dr. Paranandi that immediately prior to her ventricular fibrillation , she was “ emotionally quite upset ” by t he events surrounding a water leak

. Id

. at 13. She later explained to other treating physicians that immediately prior to her ventricular fibrillation she had an “emotional argument

4 Although no t mentioned in the S pecial M aster’s D ecision, the Court notes that Petitioner received flu vaccines on September 25, 2009, and November 2, 2010, without incident. Pet ’ r’s Ex. 6 at 36 , 41

- 42

.5 with her husband” and was “rushing around the house for towels ” while “ helping her husband with repair of some bathroom parts, where there was significant leakage.” Pet ’ r’s Ex. 15 at 3, 17; Pet ’ r’s Ex. 19 at 12, 20, 29, 38, 57, 72 ; Pet ’ r’s Ex. 22 at 76, 98, 104, 123; Pet ’ r’s Ex. 24 at 195

. It was during these events that Petitioner began to experience tightness in her chest, which she described as feeling like “ an expanding balloon in her chest. ” Pet ’ r’s Ex. 9 at 13 P etitioner also told Dr. Paranandi that during a cardiac assessment two years prior, P etitioner was told that one of her heart valves “may not be closing well.” Id

. at 1 4

. Dr. Paranandi also assessed that P etitioner’s diagnostic testing on the day of her cardiac episode showed the following :

• “[c]hest x

- ray showed some patchy infiltrates, possibly due to aspiration,”
• “[c]ardiac enzymes are negative for myocardial injury so far,”
• “ [ e ] chocardiogram showed ejection fraction of 70 percent and mo derate left ventricular hypertrophy , ”
• “EKG was nonacute and no significant ST segment deviations were noted,”
• “CT angiography study

. . . was nonacute , ” and
• no significant valvular or wall

- motion abnormalities

. Id

. at 14, 16. Petitioner underwent a diagnostic cardiac catheterization which yielded unremarkable results. Pet ’ r’s Ex s . 2 at 20; 9 at 18

- 23 ; 24 at 209

- 213

. U pon evaluating coronary risk factors, Dr. Paranandi noted P etitioner as being morbidly obese with a histo ry of hypertension, hyperglycemia, and hyperlipidemia but did not note that P etitioner had a prior documented history of coronary disease or peripheral vascular disease

. Pet ’ r’s Ex. 9 at 1 4 . Ultimately, Dr. Paranandi was uncertain as to the exact reason for P etitioner’s cardiac event , in part , because P etitioner had normal left ventricular function

. Id

. at 16. Petitioner was referred to Dr. Scott L. Greenberg, who also noted that the cause of Petitioner’s ventricular fibrillation was unclear but that P etitioner “ d[id] not have significant electrolyte disorder, cardiomyopathy, or obstructive coronary artery disease.” Pet ’ r’s Ex. 24 at6 207. Additionally, Dr. Greenberg indicated that P etitioner had “mild elevation of he r troponin,” which he attributed to the rapid heartbeat and cardiac arrest, “as opposed to a primary myocardial infarction.” Id

. On Dr. Greenberg ’s recommendation, Petitioner had a defibrillator implanted

. Pet ’ r’s Ex. 9 at 21. On O ctober 21, 2011, Petitioner was discharged from the hospital in stable condition. Pet ’ r’s Ex. 2 at 20

. Throughout 2011 and 2012 , P etitioner met with Drs. Paranandi and Greenberg for various follow

- up appointments. Notably on a December 5, 2011 visit , Dr . Paranandi indicated as part of P etitioner’s history that “ [ s ] he had a[n] emotional argument with her husband prior to [ cardiac arrest] and it was felt that she probably had a coronary spasm event, since there was a small area of mild focal disease in the mid anterior region.” Pet ’ r’s Ex s . 15 at 3; 19 at 57. Additionally, in many of these appointments, Petitioner complained of chest pain related to her implant ed defibrillator , as well as various other ailments

. Pet ’ r’s Ex s . 9 at 3 ; 15 at 6 ; 19 at 57. But after each of these appointments , her treating physicians concluded the defibrillator was functioning well and P etitioner ’ s heart condition was stable. See e.g. , Pet ’ r’s Ex s . 14 at 2

- 3; 15 at 3

- 4; 19 at 40. However, Dr. Paranandi, recommended that Petitioner should be assessed for obstructive sleep apnea. Pet ’ r’s Ex s . 15 at 4; 19 at 40. On April 6, 2012, Petitioner had an ECG performed during a visit to the emergency room which showed that P etitioner had poor R

- wave progress across the precordium ; and , “[c]ompared with prior ECG, T wave amplitude in anterior leads has decreased, NS T wave changes laterally no longer present.” Pet ’ r’s Ex. 22 at 134. O n April 10, 2012, Petitioner was evaluated by Dr. Paranandi who fou nd that P etitioner was “positive for chest pain, palpitations and leg swelling , ” Pet’r’s Ex. 19 at 31, and that Petitioner’s ECG showed “sinus rhythm, no acute changes or prior infarctions, left posterior fascicular block pattern.” Id. at 28. Dr. Paranandi reiterated his7 recommendation that P etitioner needed an assessment for obstructive sleep apnea but again concluded that P etitioner ’s heart condition was stable

. Id

. at 2 9

. On June 12, 2012, Petitioner met with Dr. Paranandi again and reported that she had been experiencing mild chronic shortness of breath and occasional brief palpitations and emotional distress for various reasons. Pet ’ r’s Ex. 16 at 2

. During this visit, Petitioner took another E C G which showed “sinus rhythm, poor R

- wave pro gression through precordial leads, and no acute changes or definite prior infarction.” Id

. Petitioner’s follow

- up visit was otherwise unremarkable

. Id

. at 5. On October 2 4, 2012, after participating in a nocturnal polysomnogram study and a h ome sleep test, P etitioner was diagnosed with obstructive sleep apnea

. Pet ’ r’s Ex. 17 at 8

- 1 3

. On July 19, 2013, Petitioner again met with Dr. Paranandi to discuss a June 29, 2013 ECG which sh owed that P etitioner had mild left ventricular hypertrophy with normal chamber dimensions. Pet ’ r’s Ex. 22 at 87

- 88. On June 5, 2014, after Petitioner had brought this action, P etitioner visited Dr. Stevan Cordas, D.O, M.P.H. Pet ’ r’s Ex. 30 at 1

- 2. Petitioner reported “ that in October 2011 she had [been] incorrectly provided influenza injection at Walgreens and then she developed a flu

- like syndrome almost immediately

. . .” Id

. at 1

. Dr. Cordas was aware that P etitioner was pursuing a vaccine

- injury related claim. Id

. at 1

- 2. Dr. Cordas stated, “[n]o symptoms typical of anaphylactic or anaphylactoid reactions related to the vaccine, so I cannot directly link the cardiac arrest to the flu shot.” Id

. at 2. On November 10, 2014 , Petiti oner visited Dr. Paranandi again for an outpatient follow

- up and reported that she went to the emergency room on September 27, 2014 for chest pain

. Pet ’ r’s Ex. 45 at 65

- 72. However, testing revealed that Petitioner’s heart was stable. Id

.8 Throughout 2 015 to 2018, P etitioner continued visiting Dr. Paranandi for follow

- ups and defibrillator evaluations. See generally Pet ’ r’s Ex s . 44; Ex. 45 at 168

- 75 , 181

- 201, 355

- 62. Overall, P etitioner was stable from a cardiovascular standpoint. Pet ’ r’s Ex s . 44 at 122; Ex. 45 at 141. During that period, P etitioner received a stress test with results that were considered unremarkable and an ECG that showed mild left ventricular hypertrophy wi th ejection fraction of 60

- 65% and grade II diastolic dysfunction. Pet ’ r’s Ex. 44 at 96. In sum, the undisputed record shows that following her 2011 cardiac event, Petitioner experienced numer ous ailments, but her heart function remained stable.

II. Expert Opinions Given that Petitioner’s medical records showed considerable risk factors, the S pecial M aster informed P etitioner that it would be difficult for her to prove causation without retaining

an expert to provide a legally probable theory of ca usation. See ECF Nos. 7, 11. The S pecial M aster reviewed a total of eleven expert reports that were filed by four different cardiology experts over a span of six years. A . Dr. Waugh’s Initial Opinion P etitioner initially filed a report by Dr. Robert A. Waugh , who exchanged views with R espondent’s initial expert, Dr. Sperling. See generally Pet ’ r’s Ex. 25 (Waugh initial report) (ECF No. 18

- 1) ; Ex. 29 (Waugh First Supplement) (ECF No. 32

- 1) ; 5 Ex. 35 (Waugh S econd S upplement ) (ECF No. 38

- 1)

. In his initial report , Dr. Waugh opined that “[g]iven the proximate temporal sequence of events . . . and an episode of significant emotional distress shortly thereafter . . . in combination with the absence of significant coronary artery disease by coronary angiography

5 Dr. Waugh’s unsigned supplemental opinion was initially filed as Pet itioner’s Ex. 27, and later refiled with a signature as Pet it ioner’s Ex. 29.9 . . .it is plausible that [petitioner ] suffered an episode of coronary spasm

. . . . ” Pet ’ r’s Ex. 25 at 3 ( emphasis added)

. H owever, Dr. Waugh could not tie the vaccination to his theorized coronary spasm because “[ t ] he exact pathophysiologic sequence at the cellular lev e l between vaccination, coronary artery spasm , [ and Petitioner’s ] emotional distress remains to be elucidated. Id

. The Special Master found Dr. Waugh’s initial opinion inadequate and ordered P etitioner to file a supplemental opinion comporting with the Althen factors and specifically addressing: ( 1)

“ a medical theory of how the flu vaccine causes cardiovascular spasm; ” ( 2) “ a medical theory explaining why six days [ would be ] an appropriate onset interval to link cardiovascular spasm in a vaccine recipient ; ” and ( 3) explaining the basis for his opinion that the flu vaccine caused P etitioner’s cardiovascular spasm as opposed to her multitude of cardiac risk factors (inter alia morbid obesity, diabetes, hypertension, hypothyroidism, hyperlipidemia, and a family histo ry of heart disease). Order filed August 22, 2014 (ECF No. 20)

. In his first supplement to his report, Dr. Waugh attempted to further elucidate on “a plausible mechanism to explain how a vaccine could have caused the cardiac event [ P etitioner] suffered.” Pet ’ r’s Ex. 29 at 2. T o develop a plausible theory, Dr. Waugh relied in significant part on a study by Lanza et al., which discussed vaccine

- induced changes in platelet activity leading to a transient increase in the risk of cardiovascular events. Pet ’ r ’s Ex. 29 (citing Pet ’ r’s Ex. 28 ( Gaetano A. Lanza et al., Inflammation

- Related Effects of Adjuvant Influenza A Vaccination on Platelet Activation and Cardiac Autonomic Function, 269 J. INTERNAL MEDICINE 118 (2011) ( Lanza et al. ) (ECF No. 29

- 2) )

. The Lanza study examined twenty

- eight patients with type II diabetes over the course of three days. Lanza et al

. at 1

- 2. On day one, patients underwent a twenty

- four

- hour ambulatory electrocardiogram monitoring and had a blood sample c ollected. Id . at 1

- 2. On day two, the10 patients were administered an influenza A vaccination. Id

. On day three, patients had a second twenty

- four

- hour ECG recording. Id

. Additional blood samples were drawn twenty

- four and forty

- eight hours after the v accination. Id

. C

- reactive protein, interleukin

- 6 levels, monocyte

platelet aggregates and monocyte/platelet receptor expression were measured. Id . at 1. A control group of twelve patients underwent the same testing but did not receive any vaccination. Id . at 3. T he Lanza authors concluded that: influenza A vaccination in patients with type II diabetes in duces , together with the expected inflammatory re action, an increase in platelet activation and a cardiac sympathovagal imbalance. Overall, the vaccine

- induced changes in platelet activity and autonomic nervous activity may transiently increase the risk of cardiovascular events in vaccinated patients. Id

. at 7. Dr. Waugh opined that “[t]his suggests a pathophysiological link between inflammation and cardiac autonomic dysregulation which, in turn, increases the risk of cardiovascular events.” Pet ’ r’s Ex. 29 at 2

. Dr. Waugh readily acknowledged that P etitioner had ongoing cardiac risk factors , but stated she had no notable findings on angiography or ventriculography following her cardiac event. Id

. For these reasons, he concluded that a transient heart rate variab ility brought on by inflammation “to a reasonable degree of medical probability , the flu vaccine was a substantial factor in bringing about [ P etitioner’s ] cardiac event

. . . . ” Id

. T he Special Master ordered P etitioner to file a second supplemental opinion from Dr. Waugh explaining: “ ( 1) how the Lanz a article, [ showing ] inflammation up to two days after [ flu ] vaccination , supports the timing of [ P ] etitioner’s alleged reaction six days after [flu] vaccination; and, ( 2) how the [ article’s ] authors’ finding of increased risk of a clot up to two days [ after ] vaccination relates to [ P ] etitioner’s case, [since P] etitioner had atrial fibrillation , not a clot , six days after [ receiving the flu vaccine ]

. Order filed February 23, 2015 (ECF No. 30)

.11 In his second supplemental report , Dr. Waugh clarified that he was relying on the Lanza study’s findings with respect to sympathovagal imbalance

. Pet’r’s Ex. 35. Dr. Waugh explained that the Lanza study found that inflammation as indicat ed by increased C

- reactive protein , effect s heart rate variability, which in turn can lead to cardiac events

. Id

. B . Dr. Sperling’s Responsive Opinion Respondent provided a competing opinion from Dr. Laurence S. Sperling , who believed it was more likely that P etitioner ’s ventricular fibrillation arrest “ was due to uncharacteristic physical exertion and profound emotional distress

. ” Resp ’ t’s Ex. A at 5 (ECF No. 41)

. Dr. Sperling believed that P etitioner’s pre

- existing conditions, such as “ her morbid obesity, type II diabetes and hypertension already predisposed her to having [an] acute cardiovascular event and underlying endothelial dysfunction. ” Id

. at 3. Dr. Sperling opined that these risk factors coupled with “[t]he elevated pulse secondary to physical exertion and emotional distress provided an extra cardiac burden that may have resulted in coronary artery spasm and then an unstable cardiac rhythm.” Id

. Dr. Sperling also took issue with Dr

. Waugh’s reliance on the Lanza article because according to D r . Sperling, “the overwhelming preponderance of scientific data supports the influenza vaccine as being cardioprotective.” Id. at 4. Dr. Sperling cited t wo studies that involved over 26,000 patients in total, showing no adverse cardiovascular effect following a flu vaccination. Id. Dr. Sperling highlighted that the Udell article noted a significant decrease in cardiovascular events in patients that were considered of high cardiovascular risk and that the Smeeth article concluded that the “mild transient inflammation induced by vaccination does not appear to translate into a detectable increase in the risk of vascular events.” Id . (citing Resp ’ t’s Ex. C ( Jacob A. Udell et al., Association Between Influenza Vaccination and Cardiovascular Outcomes in High

Risk Patients: A Meta

- Analysis , 310 (16) JAMA 1711 (2013) ) ( Udell et a l. ) ) (ECF No. 41

- 3) ;12 Resp ’ t’s Ex. D ( Liam Smeeth et al., Risk of Myocardial Infraction and Stroke After Acute Infection or Vaccination , 351 N. ENG. J. MED. 2611 (2004) ( Smeeth et al .) ) (ECF No. 41

- 4)

. For these reasons, Dr. Sperling concluded that it was highly unlikely that her cardiac arrest was related to her vaccine. Resp ’ t’s Ex. A at 5. C . Dr. Waugh’s Response Dr. Waugh retorted that he believed that Dr. Sperling’s theory placed too much weight on P eti ti oner’s pre

- existing condition s because “[a]lthough she has multiple putative cardiac risk factors, none has proved to have caused her any harm

. ” Pet ’ r’s Ex. 36 at 1 (ECF No. 44

- 1)

. Dr Waugh believed that “there was nothing wrong with [ P etitioner’s] heart,” and therefore deduced that on the day of her cardiac event, “the only variable not previously p resent was the influenza vaccine

. . . .” Id

. at 1

- 2. Dr. Waugh further criticized Dr. Sperling’s reliance on articles that found flu vaccines to be cardiovascular protection overly generalized as to apply to P etitioner’s specific factors in this case. Id

. at 2. D . Dr. Sperling’s Second Response Dr. Sperling responded to these criticisms by acknowledging that “a definitive etiology in regard to [ P etitioner’s] acute cardiovascular event is not possible to determine .” Resp ’ t’s Ex. E at 1 (ECF No. 50

- 1)

. However, Dr. Sperling noted that the re is evidence in P etitioner’s medical records that she experienced stress shortly before the onset of her cardiac event and the Sharkey article , originally cited by Dr. Waugh , also found “it is not understood why a specific stressful event will on one occasion trigger this condition whereas at another time a similar circumstance (even more stressful) does not.” Id

. at 4 (citing Pet ’ r’s E x . 38 (Sc ott W. Sharkey, John R. Lesser & Barry J. Maron, Cardiology Patient Page: Takotsubo (Stress) Cardiomyopathy , 124:18 CIRCULATION e460 (2011) at 3 ) ( Sharkey, Lesser & Maron ) (ECF No. 44

- 3) ) (quotations13 omitted)

. Accordingly, Dr. Sperling maintained that the c ombination of stress and pre

- existing conditions is still the most likely cause of P etitioner’s cardiac event

. Resp ’ t’s Ex. E at 3

- 4. An entitlement hearing was subsequently set, but then cancelled due to Dr. Waugh’s retirement. (ECF Nos. 51

- 53.) Petitioner was ordered to file a report by a different expert or dismiss the case. Order , dated June 22, 2017 (ECF No. 54)

. However, P etiti oner’s counsel ( Franklin John Caldwell, Jr. ) withdrew from the case before any expert report was filed. (ECF Nos. 54

- 61.) Subsequently, both experts ceased participating in the case and additional cardiology experts, Dr. Robert M. Stark (for P etitioner) and Dr. Shane R. LaRue (for R espondent), were retained to offer further opinions and to be available for a potential entitlement hearing. Pet ’ r’s Notice of Filing (ECF No. 69) (announcing Dr. Stark’s opinion ); Resp ’ t’s Notice of Filing (ECF No. 72) (announcing Dr. LaRue’s opinion). On September 12, 2017, Special Master Millman held a status conference with Respondent and P etitioner, now proceeding pro se . (ECF No. 63)

. Petitioner indicated that she was seeking anothe r attorney, but also indicated that she wished to change her theory of the case. Id

. Petitioner wished to allege vaccine

- caused peripheral neuropathy, Guillain

- Barre syndrome, and positive findings of cytomegalovirus and Epstein Barr virus. Id. Special Master Millman indicated that additional medical records substantiating these allegations would be needed but that P etitioner should first determine whether she will proceed with different counsel. Id. E . Dr. Stark’s Initial Opinion Dr. Stark’s basis for opining in the case differed from Dr. Waugh’s opinion

. Unlike Dr. Waugh, who explicitly rejected increased platelet activation as the cause of P etitioner ’ s cardiac arrest, Dr. Stark theorized that P etitioner’s flu vaccination triggered an antige n - antibody reaction that inflamed the arteries and could have “ cause [d] the platelets in smaller blood vessels to clump14 together and stick to the vessel wall , ” which in turn le d to P etitioner’s cardiac arrest. Pet ’ r ’s Ex. 39 at 2

- 3 (ECF No. 69

- 1)

. Dr. Stark ruled out other causes such as artery disease and any pre

existing arrhythmogenic focus based on the P etitioner’s negative stress test, normal cardiac catherization, and lack of any previous cardiac problems (arrythmias, coronar y artery lesions, fainting)

. Id

. Like Dr. Waugh , Dr

. Stark concluded that the flu vaccination caused P eti ti oner’s cardiac arrest because it was “[n]ot until [ P etitioner] received a flu vaccine (six days before) did she have her first episode of chest pai n, collapse and cardiac arrest.” Id

. at 2

. F . Dr. LaRue’s Responsive Opinion Dr. LaRue filed reports responsive to both Dr. Stark and Dr. Waugh. Resp ’ t’s Ex. H (ECF No. 72

- 1)

. Like Dr. Sperling, Dr. LaRue opined that “it is far more likely that [ P etitioner] experienced [ventricular fibrillization] arrest due to her underlying risk and acute trigger

. . . ” Resp ’ t’s Ex. H at 5. To support this conclusion , h e noted that both P etitioner’s pre

- and post

cardiac arrest electrocardiograms indicated poor R

- wave progression in the precordial leads, and this suggests that P etitioner has left ventricular hypertrophy (LVH) or an abnormality in the mid

anterior wall of her left ventricle. Id . at 4. Dr. LaRue ad ditionally emphasized that P etitioner’s ECG indeed documented that P etitioner has LVH and “LVH has a well

- established association with ventricular arrhythmias.” Id

. He cited to the McClenaghan and Haider articles which found hypertensive individuals with LVH experienced higher frequencies of ventricular premature contractions and that LVH was a risk factor for sudden death, respectively. Id

. (citing Resp ’ t’s Ex

. K ( James M. McLenachan et al., Ventricular Arrythmias in Patients with Hypertensive Ventricular Hypertrophy , 317 N. ENGLAND J. MED. 787 (1987) )) (McLenachan et al.) (ECF No. 75

- 2) ; Resp ’ t’s Ex. L ( Agha Haider et al., Increased Left Ventricular Mass and Hypertrophy are Associated with Increased Risk for Sudden De ath , 3 2:5 J. AM. COLLEGE Cardiology 145415 (1998) ) (Haider et al.) (ECF No. 75

- 3)

. Additionally, Dr. LaRue opined, citing to the Gami study, that P etitioner’s obstructive sleep apnea increased her risk for ventricular arrythmia and sudden cardiac death. Resp ’ t’s Ex. H at 4

- 5 (citing Resp ’ t’s Ex. M ( Apoor S. Gami et al., Obstructive Sleep Apnea and the Risk of Sudden Cardiac Death: A Longitudinal Stu dy of 10,701 Adults , 62 :7 J. AM. COLLEGE CARDIOLOGY 610 (2013) ) ( Gami et al.) (ECF No. 75

- 4)

. Lastly, he opined that the emotional and physical stress significantly contributed to P etitioner’s cardiac event. Resp ’ t ’s Ex. H at 5. Dr. LaRue cited to the L ampert study that found elevated levels of anger and anxiety and mild

- to

- moderate physical activity significantly preceded defibrillator shocks. Id

. (citing Respondent’s Ex. N ( Rachel Lampert et al. , Emotional and Physical Precipitants of Ventricular Arrythmia , 106 CIRCULATION 1 8 00 (2002) ( Lampert ) (ECF No. 75

- 5))

. Dr. LaRue suggested that Dr. Waugh’s reports contained contradictions and further emphasized that Dr. Waugh had previously opined that coronary artery spasm and emotional
stres s, both unrelated to flu vaccine, explained ventricular arrhythmias. Resp’t’s Ex. H . at 6. Dr. LaRue also explained that the “influenza vaccine has been studied in numerous trials, in hundreds of thousands of people, and no reports of associated ventricu lar arrythmias have been made .” Id

. at 7 (citing Respondent’s Ex. P (Rohit S. Loomba et al., Influenza Vaccination and Cardiovascular Morbidity and Mortality: Analysis of 292 383 Patients , 17 J. CARDIOVASCULAR & THERAPEUTICS 277 (2012) ) (Loomba et al.) (ECF No. 75

- 7) )

. Dr. LaRue also disagreed with Dr. Waugh’s opinion that “there was nothing wrong with [ P etitioner’s] heart.” Resp ’ t ’s Ex. H at 8. Addressing the medical record, Dr. LaRue noted that P etitioner’s ECG demonstrated mild LVH and that P etitioner “experienced at least 13 episodes of ventricular tachycardia or non

- sustained ventricular tachycardia

. . . over the 11 months immediately following her arrest

. . . ” Id

. T he continued nature of these arrhythmias undermines Responde nt’s theory that transitory16 inflammation caused P etitioner’s arrythmia which le d to her cardiac arrest

. Id

. Dr. LaRue also rebutted Dr. Stark’s opinion, emphasizing that P etitioner’s cardiac catherization report did not “suggest [ P etitioner] had an acute myocardial infarction of a small vessel such as slow coronary flow or a vessel that was occluded.” Id . at 4. He again pointed to P etitioner’s poor R

- wave progression and post arrest ventricular arrhythmias which he believed indica ted “[ P etitioner ] may well have had an arrhythmogenic focus that had not yet manifest, and finally did so in the setting of the catecholamine surge of her stressful situation.” Id

. at 9. Further, Dr. LaRue relied on the Posthouwer study, which showed C

- reactive protein and thrombin activation to return to baseline at day four and five post

- vaccination, to rule out the possibility of P etitioner’s cardiac arrest being caused by clotting due to vaccine

- induced inflammation. Id

. at 8

- 9 (citing Resp ’ t’s Ex. R ( Dirk Posthouwer et al., Influenza and Pneumococcal Vaccination as a Model to Assess C

- Reactive Protein Response to Mild Inflammation , 23 VACCINE 362 (2004) ( Posthouwer et al. ) (ECF No. 75

- 9) )

. Ultimately, Dr. LaRue concluded that , considering the lack of reported cases relating flu vaccine to ventricular arrhythmias or sudden cardiac death, P etitioner’s flu vaccine, “ more likely than not, ” did not contribute to P etitioner’s cardiac arrest. Resp ’ t ’s Ex. H at 10. Conversely , there substantial support showing that cardiac arrest can be caused by the combination of underlying hypertensive heart disease and obstructive sleep apnea

. Id

. G . Dr. Stark’s Response Dr. Stark responded refut ing Dr. LaRue’s suggestion that P etitioner’s sleep apnea was a causal factor because “ [ s ] leep apnea patients face their greatest risk for arrhythmia when their blood oxygen levels decline to low levels during night time sleep ; ” whereas , P etitioner had her cardiac arrest when she was not asleep and during the day. Pet ’ r’s Ex. 43 at 1

- 2 (ECF No. 74

- 1)

.17 Dr. Stark also refuted Dr. La Rue’s suggestion that hypertension played a rule in P etitioner’s cardiac event because “ [ v ] irtually all patients with hypertension have some degree of left ventricular hypertrophy ; ” but , according to Dr. Stark, P etitioner’s mild left ventricular hypertroph y “is a negligible contributor to potential ventricular fibrillation or cardiac arrest.” Id . at 2. He continued that “poor R

- wave progression . . . can be, and is, a normal variant in an individual’s EKG. ” Id

. (internal quotation s omitted). Regarding P etitioner’s post

- vaccination arrhythmias, Dr. Stark posited that these arrythmias could indicate that there was an arrhythmogenic focus, but most likely, the focus came from the area that was damaged when P etitioner had her cardiac a rrest and thus could not disprove that the flu vaccine caused the arrythmia which lead to P etitioner’s cardiac
arrest

. Id . at 3. H . Dr. LaRue’s Second Response In his response, Dr. LaRue noted that there is an increased risk of obstructive sleep apnea induced arrythmias during the daytime due to the “increase in sympathetic drive,” although the greatest risk remained during nighttime. Resp ’ t’s Ex. S at 1 (ECF No. 77

- 1) . He als o disagreed with Dr. Stark’s suggestion that mild LVH has negligible arrhythmic risk, because neither the McLenachan trial or Haider study, which found higher incidence of ventricular arrythmias to be associated with LVH , a t tributed an y significan ce to LVH severity. Id

. at 1

- 2

. Regarding P etitioner’s post

- arrest ventricular tachycardia, Dr. LaRue disagreed with Dr. Stark that the focus originated from the area damaged from P etitioner’s cardiac arrest because such damage would be evident in an electrocardi ogram, but P etitioner’s ECG both pre

- and post

- arrest were essentially undifferentiated. Id . at 3. Regarding inflammation, Dr. LaRue agreed with Dr. Stark that inflammatory mediators exert an effect on vascular endothelium ; but , in this case, there is no evidence indicating that P etitioner experienced significant inflammation six days post

- vaccination.18 Id . at 2. Regarding clotting, Dr. LaRue agreed that many measures of clotting ability exist; however, “[t]hrombin is required both for the initiation and the propagation of the clotting cascade and thus elevation in prothrombin fragment is seen in a hypercoagulable state,” showing that the Posthouwer article is indeed relevant to this case. Id . at 2

- 3 (footnote omit ted)

. I. Dr. Stark’s Final Response On September 23, 2019, P etitione r filed a Motion for Decision on the Record. (ECF No. 92)

. On February 5, 2020 , Petitioner filed a limited second supplemental expert report from Dr. Stark

. See Pet’r’s Ex. 54 ( ECF No. 96

- 1 )

. I n his final response, Dr. Stark opined that “[ t ] he absence of significant coronary disease makes the alternative of coronary inflammation far more likely” and that P etitioner’s known diabetes predisposes her to small vessel inflam mation and
spasm. Id

. at 1

. Dr. Stark emphasized that systemic inflammation from recent flu immunization can cause a cardiac event, where the mechanism is “virtually identical to that for influenza infection.” Id

. Again, Dr. Stark highlighted the Lanza study, showing that for diabetic patients, there were “significant rises in inflammatory markers as well as platelet activation and adrenergic activation which are known to predispose to heart attack.” Id . at 2. He conclude d that he believed to a “reaso nable degree of medical certainty” that Petitioner’s cardiac arrest was caused by systemic inflammation from her flu vaccine. Id. III. Special Master’s Decision On June 4, 2020 , the Special Master issued his Decision d enying e ntitlement

. ( ECF No. 104. ) Based on the medical records and expert opinions, the S pecial M aster found that P etitioner had failed to meet the requirements of Althen prongs one and two. With respect to prong one, the S pecial M aster found that neither Dr. Waugh ’s nor Dr. Stark’s theories of causation were legal ly plausible because neither expert persuasively expla ined how inflammation from the vaccine , and19 specifically the brand Fluvirin , can lead to ventricular fibrillation and/or cardiac arrest. Dec. at 22

- 28. With respect to Althen p rong two , the S pecial M aster held that P etitioner had failed to show, by prepo nderance of the evidence , that the flu vaccine caused P etitioner’s ventricular fibrillation. Dec. at 28

- 3 1 . The Special M aster explained that none of P etitioner’s treating physicians noted any concerns of inflammation as a factor for petitioner’s ventricular fibrillation. Dec. at 28. Moreover, P etitioner’s experts were unable to consistently articulate what effect inflammation had on P etitioner’s heart

. Dec. at 29. Conversely, the S pecial M aster found that P etitioner’s contemporaneous medical records supported R espondent’s theory that P etitioner’s ventricular fibrillation was caused by a combination of pre

- existing risk factors and stress. Dec. at 30

- 31. On July 6, 2020 , P etitioner filed a M otion for R eview of the Special Master’s D ecision denying her claim pursuant to Rule 23 of the Vaccine Rules of the United States Court of Federal Claims (Vaccine Rules). (ECF No. 106). Petitioner argues that the Special Master’s determinations with regard to Althen p rong s one and two were arbitrary and capricious

. Id

. Under Althen p rong one , Petitioner takes issue with the probative weight the S pecial M aster assigned to the Lanza study and the Fluzone post

- marketing information. Pet ’r’s Br. at 16

- 17 ; Pet ’r’s Reply Br. at 2

- 3 (ECF No. 115) . She argues that her position is supported by Halverson v. Sec’y of Health & Human Servs. , where a s pecial master found entitlement for cardiac injuries cause d by a Fluzone vaccination. Pet ’ r ’s Br. at 17 (citing Halverson v. Sec’y of Health & Human Servs. , No. 15

- 227 V, 2020 WL 992588, *21 (Fed. Cl. Spec. Mstr. Feb. 4, 2020)); Pet ’r’s Reply Br. at 1

- 2. Under Althen
p rong two , Petitioner argues that the Special Master erroneously interpreted the medical record s to suggest that Dr. Paranandi opined at a medical visit that her ventricular fibrillation was due to20 stress. Pet ’r’s Br. at 6

- 7. S he also argues that the Special Master subjected her to an elevated burden of proof because “[t]here is no requirement under Althen p rong 2 for Petitioner to demonst rate results from tests that are not routinely administered

. . . ” Pet ’r’s Br. at 7. She argues that the causal theories put forth by her experts are sufficient to meet her burden of proof under Althen p rong two

. Pet ‘r’s Br. at 9

- 14, 18

- 19. As explained below, these contentions are without merit.

APPLICABLE STANDARD OF REVIEW T he National Childhood Vaccine Injury Act of 1986 (Vaccine Act) created the National Vaccine Injury Compensation Program , 42 U.S.C. § 300aa

– 10 et seq

. , to provide compensation to people found to be injured by certain vaccines. Congress established the Vaccine Act after lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates. See Bruesewitz v. Wyeth LLC , 562 U.S. 223, 227

- 28 (2011)

. Petitions alleging injuries caused by a vaccine must be filed in the United States Court of Federal Claims, and a s pecial m aster initially reviews and issues a decision on the petition. Id

. at 228 (ci ting 42 U.S.C. § 300aa

– 11(a)(1). Under the Vaccine Act, the United States Court of Federal Claims reviews the special master's decision upon the filing of a Motion for Review of Decision of Special Master

. 42 U.S.C. § 300aa

– 12(e)

. Upon such review of the special master’s decision, the Court may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master's decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or21 (C) remand the petition to the special master for further action in accordance with the court's direction. 42 U.S.C. § 300aa

- 12(e)(2); accord Vaccine Rule 27(c). The standards set forth in 42 U.S.C. § 300aa

- 12(e)(2)(B), “vary in application as well as degree of deference” as each “standard applies to a different aspect of the judgment.” Munn v. Sec'y of Health & Human Servs. , 970 F.2d 863, 870 n.10 (Fed. Cir. 1992 ). “Thus, the [ United States Court of Federal Claims ] judge reviews the special master's decision essentially for legal error or factual arbitrariness.” Bradley v. Sec'y of Health & Human Servs. , 991 F.2d 1570, 1574 (Fed. Cir. 1993). “[ S] pecial masters have broad discretion to weigh evidence and make factual determinations.” Dougherty v. Sec’y of Health & Human Servs ., 141 Fed. Cl. 223, 229 (2018)

. W hen reviewing the special master’s fact ual findings, the court does “not reweigh the factual

ev idence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses

— these are all matters within the purview of the fact finder.” Porter v. Sec'y of Health & Human Servs. , 663 F.3d 1242, 1249 (Fed. Cir. 2011) . This Court should not “second guess the Special Master[']s fact

- intensive conclusions particularly in cases in which the medical evidence of causation is in dispute.” Cedillo v. Sec'y of Health & Human Servs. , 617 F.3d 1328, 1338 (Fed. Cir. 2010) (quoting Hodges v. Sec'y of Health & Human Servs. , 9 F.3d 958, 961 (Fed. Cir. 1993) ) (quotations omitted)

.

DISCUSSION Under the Vaccine Act, P etitioner may demonstrate eligibility for an award in two ways

. See Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 865 (Fed.Cir.1992). Petitioner may either show that she suffered an injury listed on the Vaccine Injury Table within the requisite time period, in which causation is presumed (table injury) , or she may demonstrate that her condition22 was caused

- in

- fact by the flu vaccine (of f

- table injury)

. Capizzano , 440 F.3d at 1320

- 21 (citing Munn , 970 F.2d at 865; 42 U.S.C. § § 300aa

- 1 3 ( a )(1) , - 11(c)(1)(C)(ii)(I))

. It is undisputed that n either ventricular fibrillation nor cardiac arrest is a presumptive injury following receipt of the flu vaccine. See 42 U.S.C. § 300aa

- 14(a) (Vaccine Injury Table) see also Resp ’t’s Br. at 11. Therefore, Petitioner alleges is an off

- t able injury, and Petitioner must prove by a preponderan ce of the evidence that her vaccine was “not only a but

- for cause of the injury but also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health & Human Servs ., 165 F.3d 1344, 1352 (Fed. Cir. 1999). In m aking this showing “that the vaccination brought about her injury , ” P etitioner 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; see Boatmon v. Sec'y of Health & Human Servs. , 941 F.3d 1351, 135 4

- 55 (Fed. Cir. 2019)

. A petitioner must prove all three Althen pr ongs by a preponderance of the evidence. See Boatmon , 941 F.3d at 1355 ; Althen , 418 F.3d at 1278

. “ Once a petitioner establishes a prima facie case, the government then bears the burden of establishing alternative causation by a preponderance of the evid ence. ” Cedillo , 617 F.3d at 1335 (citation omitted) ; see Althen, 418 F.3d at 1278 (Petitioner is recovers unless Defendant shows “also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine”) (quotation omitted)

. However, if the petitioner fails to establish a prima facie case, then , of course, th is burden does not shift to respondent. S ee Deribeaux v. Sec’y of Health & Human Servs. , 105 Fed. Cl. 583, 587 (2012), aff'd , 717 F.3d 1363 (Fed. Cir. 2013); see also Doe v. Sec’y of Health & Human Servs. , 601 F.3d 1349, 1358 (Fed. Cir. 2010). Nevertheless , regardless of whether the burden of proof23 ever shifts to the respondent, the special master may consider such evidence presented by the respondent in determining whether the petiti oner has established a prima facie case , as the special master is to consider the record as a whole in determining causation

. See Stone v. Sec’y of Health & Human Servs. , 676 F.3d 1373, 1380 (Fed. Cir. 2012) (citing Doe , 601 F.3d at 1356

- 58; de Bazan v. Sec'y of Health & Human Servs. , 539 F.3d 1347, 1353 (Fed. Cir. 2008); Shyface , 165 F.3d at 1352).

I. Althen Prong One

“ Under the first [ Althen ] prong , a petitioner must demonstrate that the vaccine at issue can cause the injury alleged. ” Greene v. Sec'y of Health & Human Servs. , 146 Fed. Cl. 655, 663 (2020) (citing Pafford v. Sec'y of Health & Human Servs. , 451 F.3d 1352, 1355

- 56 (Fed. Cir. 2006) )

. To make this showing, “a petitioner must provide a reputable me dical or scientific explanation that pertains specifically to the petitioner ’ s case, although the explanation need only be ‘legally probable, not medically or scientifically certain.’” Broekelschen v. Sec'y of Heatlh & Human Servs. , 618 F.3d 1339, 1345 (F ed. Cir. 2010) ( quoting Knudsen v. Sec'y of Health & Human Servs. , 35 F.3d 543, 548

– 49 (Fed. Cir. 1994)). Petitioner’s experts proposed two different avenues by which inflammation could theoretically result in cardiac arrest

. Dr. Waugh suggested that in flammation from a vaccination can destabilize cardiac autonomic function leading to an arrhythmia brought on by a “chemical

electrical instability” in the heart. Dec. at 13

- 17, 23

- 25. P etitioner’s second expert, Dr. Stark, proposed that inflammation from a vaccination can lead to increased clotting (a prothrombotic state) leading to small blockages in microcirculation and cardiac arrest. Id . at 18, 21, 23. The Special Master found P etitioner failed to establish a legally probable theory that vaccine

- induced inflammation can cause a cardiac arrest , and this Court concurs with the Special Master’s findings

.24 Id. at 23

- 27. A. Lanza Study The Special Master found that neither Dr. Waugh’ s nor Dr. Stark’s reliance on the L anza study sufficiently supported their respective theories for multiple reason s. Dec. at 24. In grappling with the Lanza findings , the S pecial M aster concluded that Lanza did not completely support P etitioner’s theory that the flu vaccine can lead to a pro

- thrombotic state

. Id

. Specifically, the S pecial M aster noted that: the Lanza study failed to find any correlation between increased platelet activation (as measured by [ monocyte

- platelet aggregates ] ) and either [ C

- reactive protein ] levels or [heart rate variability (HRV)] variables

. [ Lanza et al. at 4 ]

. The authors expl ained that “[t]he increase in [ monocyte

- platelet aggregates ] , however, did not show any significant correlation with HRV changes, suggesting that the acute cell

mediated inflammatory response to viral vaccine did not result in appreciable effects on cardia c autonomic activity. Accordingly, no significant relation was found between HRV changes and platelet activation in this context. ( Id. at 7. ) Dec. at 24. The Special M aster also noted the study’s shortcoming s with respect to Dr. W augh’s “chemical

- electrical instability” causation theory. Dec. at 24

. Specifically, the S pecial M aster noted that the L anza study “ shows only a correlation between elevated [ C

- reactive protein ] and reduced [ heart rate variability ] and not a causal relat ionship. ” Id. Notwithstanding these shortcomings , t he Special M aster explained , and this Court concurs, that he was troubled by the novelty of the study stating that the Lanza study was “intriguing as a piece of preliminary investigation” but fell “ well short of supporting [ P ] etitioner’s theory that post

vaccination inflammation can lead to ventricular fibrillation and/or cardiac arrest. ” Id

. Moreover , the Special Master foun d that the Lanza study was not generalizable because the Lanza study included only twenty

- eight patients

. Id . at 25. The small scale of the Lanza study is particularly notable when juxtaposed with the larger scale studies that Respondent presented, finding that the flu vaccine is likely to be cardio protective. See Smeeth et al. (study involving 20,486 patients);25 Udell et al. ( study involving 6,735 patients ) ; Loomba et al. ( meta

- analysis involving 292,383 patients)

. The S pecial M aster stated while “[these] findings do not negate the Lanza study, . . . they do suggest . . . that the [Lanza study’s] results should be interpreted with caution.” Dec. at 25. A special master's determination regarding the persuasiveness of exp ert testimony is afforded considerable deference. Broekelschen , 618 F.3d at 1347 (“ [T]he special master’s credibility findings , [concerning medical expert testimony,] ‘are virtually unchallengeable on appeal’”) (quoting Lampe , 219 F.3d at 1362)

. The Special Master was entitled to weigh the evidence from multiple sources and find that the novel Lanza study findings were less persua sive than multiple larger scale studies. See Moberly ex rel. Moberly v. Sec'y of Health & Human Servs. , 592 F.3d 1315, 1326 (Fed. Cir. 2010) ( “ F inders of fact are entitled

— indeed, expected

— to make determinations as to the reliability of the evidence prese nted to them . . .” )

. Accordingly, t his C ourt cannot say that the S pecial M aster acted arbitrarily in favoring large scale studies over the small scale and novel Lanza study, especially when P etitioner’s own experts relied on the Lanza study to support somewhat contradictory theories of causation. B. Fluzone P ost - M arketing I nformation Likewise, the Special Master did not err in find ing that Dr. Waugh’s theory of causation was not sufficiently supported by post

- marketing information from the high dose Fluzone brand of vaccine. To support his theory of causation, Dr. Stark relied on post

- marketing information from the high dose Fluzone vaccine , as well as a clinical trial examining the immunogenicity of high dose vaccines to standard dose vaccines as evidence of “an antigen

- antibody mediated inflammatory response [] ” capable of acting on the endothelium of blood vessels. Pet ’ r’s Ex. 43 at 2

- 3 (citing Pet’r’s Exs. 55

- 5 7 (ECF No. 96) ).26 The S pecial M aster provided several reasons for finding that this data was inapposite. First, the high dose Fluzone vaccine is a diff erent vaccine from what P etitioner received , which was the Fluvirin brand vaccine

. Dec. at 27

. Additionally, the S pecial M aster noted that the clinical trial examining the immunogenicity of high dose vaccines to standard dose vaccines was unpersuasive because although the authors concluded that the high dose flu vaccine induced a greater antibody response than the standard dose flu vaccine, there was no co rrelative increase in adverse reactions. Dec. at 27. The S pecial M aster believed , and this Court agrees, that “[s]uch a conclusion would seem to weigh against any suggestion of a correlation between the antigen

- antibody mediated inflammatory re sponse . . . ” Id

. This C ourt cannot find that t he S pecial M aster acted arbitrarily and capriciously in concluding the logical leap between the studies of high dose Fluzone , which Petitioner did not receive, and the lower dose Fluvirin , which Petitioner received, was too great

. See McCollum v. Sec’y of Health & Human Servs. , 760 F. App’x 1003, 1008

- 09 (Fed. Cir. 2019) ( affirming as permissible the special master’s finding that a study involving a different vaccine than what the petitioner rece ived was unpersuasive); D’Tiole v. Sec’y of Health & Human Servs. , 726 F. App ’ x. 809 , 811 (Fed. Cir. 2018) (affirming special master’s rejection of a medical theory , which was based largely upon literature concerning a vaccine with a distinct formulation a nd manufacturing process from the vaccine at issue ). C. Halverson Finally, the S pecial M aster did not err in concluding P eti ti oner’s case was distinguishable from the petitioner in Halverson

. In Halverson , another special master ruled that a high dose flu vaccine caused that petitioner’s cardiac arrest and death. Halverson , 2020 WL 992588 at *32

. A s the Special Master noted, and this Court agrees, Halverson is distinguishable because the petitioner27 in that case received a different vaccine and P etitioner ’s expert relied on studies involving the
exact vaccine that the petitioner received

. Dec. at 27 n.18. The S pecial M aster found that the high dose vaccine in Halverson is materially different from the vaccine Petitioner received , because the high dose vaccine contained four times the amount of hemagglutinin , which is known to cause blood clotting, than the vaccine Petitioner received in this case

. Id

. It was not unrea sonable for the S pecial M aster to conclude that because of this difference in the amount of hemagglutinin , studies relating to high dose vaccines are not relevant for predicting the effects of low dose vaccine s

— such as the vaccine Petitioner received

. Mor eover, the S pecial M aster is not bound by decisions of other special masters. See Boatmon , 941 F.3d at 1358

- 59 (“To the extent the Court of Federal Claims required that special masters cite and distinguish the decisions of other special masters, it was incorrect.”); Hanlon v. Sec’y of Health & Human Servs. , 40 Fed. Cl. 625, 630 (1998) , aff’d , 191 F.3d 1344 (Fed. Cir. 1999) (“Special masters are neither bound by their own decisions nor by cases from the Court of Federal Claims, except, of course, in the same case on remand.”)

. For these reasons , Petitioner has failed to show that the S pecial M aster erred or acte d in an arbitrary or capricious manner in finding that Petitioner did not meet the first Althen prong .

II. Althen Prong Two The second prong of the Althen test requires the petitioner to demonstrate “a logical sequence of cause and effect showing that the vaccination was the reason for the injury” by a preponderance of the evidence. Althen , 418 F.3d at 1278 (citing Grant v. Sec’y of Health & Human Servs. , 956 F.2d 1144, 1148 (Fed. Cir. 1992)) (quotations omitted)

. In order to prevail, the petitioner must show “that the vaccine was not only a but

- for cause of the injury but also a28 substantial factor in bringing about the injury.” Althen , 418 F.3d at 1278 (quoting Shyface , 165 F.3d at 1352

- 53 ). Testimony from treating physicians “is ‘quite probative’ since ‘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.’” Andreu v. Sec’y of Health & Hum an Servs. , 569 F.3d 1367, 1375 (Fed. Cir. 2009) ( quoting Capizzano , 440 F.3d at 132 6 ) ; see also Paluck v. Sec'y of Health & Human Servs. , 786 F.3d 1373, 1385 (Fed. Cir. 2015) (finding “the special master erred in disregarding contemporaneous statements from [petitioners’ minor child ’s ] treating physicians regarding the cause of his neurodegeneration”)

. Petitioner argues that the Special Master erroneously interpreted Petitioner’s medical record s as not supporting P etitioner’s theory of causation. Pet ‘r’s Br. at 6

- 14

. Th is Court disagrees. The S pecial Master did not err in interpre ting P etitioner’s medical records as supporting R espondent ’ s rather than P etitioner’s medical theory. As discussed above, P etitioner’s experts theorized that the Fluvirin vaccine can induce various inflammatory responses which can lead to cardiac arrest . Dec. at 27. Consequently, P etitioner was required to prove by a preponderance of the evidence that one of her expert’s theories actually occurred

. Broekelschen , 618 F.3d at 1339 (holding the special master’s determination that petitioner failed to provide a reliable medical explanation sufficiently link ing the flu vaccine to petitioner’s injury alleged was not arbitrary or capricious). P etitioner did not identify anything in her medical records to support any of her experts ’ various theories by a preponderance of the evidence

. Dec. at 27. N one of the treating physicians who contemporaneously examined Petitioner drew a connection from the cardiac event to the vaccine. Dec. at 7

- 8, 28

- 29. Indeed, the S pecial M aster noted that even though Dr. Co rdas was aware that Petitioner was pursuing a vaccine

- injury claim, he nevertheless could not “directly link” P etitioner’s flu vaccination to her October 19, 2011 cardiac arrest, because “ ‘ [n]o symptoms29 typical of anaphylactic or anaphylactoid reactions [w ere] related to the vaccine . . . ’ ” Dec. at 11 ( c iting Pet ’ r’s Ex. 30 at 2 (ECF No. 35

- 1) )

. Petitioner attempts to sidestep this absence of causation evidence by arguing that the treating physicians did not test P etitioner’s inflammatory process because these tests are not routinely administered after a cardiac event

. Pet ’r’s Br. at 7 (citing Dec. at 28

- 29). This argument is unavailing because , as not ed , P etitioner did receive medical test s which could have confirmed P etitioner’s theory. For instance, P etitioner’s prothrombin time was measured shortly after Petitioner’s cardiac arrest but was found to be within the normal limits. Dec. at 29 (citing P et ’ r’s Ex. 24 at 190, 218)

. As the Special Master stated, this evidence undermines Dr. Stark’s
pro thrombotic theory. Id

. Additionally , P etitioner’s cardiac catheterization report , which was done shortly after her cardiac arrest , did not show “an acute myocardial infarc tion of a small vessel such as slow coronary flow or vessel that was occluded.” Dec. at 20 (quoting Resp’t’s Ex. H . at 4)

. The S pecial M aster found , and this Court agrees, that these results weighed against Dr. St ark’s proposition of a vaccine

- induced prothrombotic state leading to cardiac arrest in Petitioner’s case. Dec. at 20 , 26

. Moreover, under the arbitrary and capricious standard, i f a special master’s “conclusion [is] based on evidence in the record that was not wholly implausible, [the Court is] compelled to uphold that finding as not being arbitrary or capricious.” Lampe , 219 F.3d at 136 3

. It is not enough for an appellant to poi nt to alternative conclusions the special master could have drawn or to point to inferential steps the special master might have taken

. See i d

. Thus, i n the absence of any objective evidence to support P etitioner’s theory and taking into account her own expert’s statement that he could not “directly link the cardiac arrest to the flu shot,” see Dec. at 11 (citation omitted) , this Court cannot find that the S pecial M aster acted arbitrarily in declining to conclude30 that the vaccine caused Petitioner’s cardiac arrest

. See Moberly ex rel. Moberly , 592 F.3d at 1323

- 24 (holding that the special master did not err in rejecting the expert's theory of causation when no treating physician ever drew a causal link between petitioner’s injury ) ; see also Burns by Burns v. Sec'y of Health & Human Servs. , 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that the decision of whether to accord greater weight to contemporaneous medical records or later given testimony is “uniquely within the purview of the special master.”) (citations omitted)

. For these reasons , the Court concludes that the S pecial M aster did not err or act in an arbitrary or capricious manner in determining that Petitioner failed to satisfy Althen prong two.

CONCLUSION This Court holds that the findings of the Special Master are not arbitrary and capricious. The Special Master properly found that Petitioner failed to show by preponderant evidence that the vaccination at issue brought about her injury under either Althen prongs I and II

. Althen , 418 F.3d at 1278. Therefore, the C ourt DENIES Petitioner's Motion for Review (ECF No. 106 ) and SUSTAINS the Decision of the Special Master. The parties shall separately file any proposed redaction to this Memorandum and Order, with the text to be redacted clearly blacked out, by December 16, 2020. The Clerk of Court is directed to enter judgment accordingly. IT IS SO ORDERED.

s/ Eleni M. Roume l ELENI M. ROUMEL Chi ef Judge Dated: December 2 , 2020 Reissued for Public Availability: December 17, 2020 Washington, D.C.