VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00312 Package ID: USCOURTS-cofc-1_20-vv-00312 Petitioner: Franklin Kuczarski Filed: 2020-03-19 Decided: 2023-12-15 Vaccine: influenza Vaccination date: 2018-12-15 Condition: right shoulder injury Outcome: dismissed Award amount USD: AI-assisted case summary: Franklin Kuczarski filed a petition alleging a right shoulder injury following an influenza vaccination on December 15, 2018. He claimed the injury was caused-in-fact by the vaccination. The case was initially dismissed as a Table claim by the Chief Special Master because the evidence preponderated in favor of an onset of shoulder pain one week after vaccination, which is outside the 48-hour window for a Table SIRVA. The case was reassigned to allow Mr. Kuczarski to pursue an off-Table, cause-in-fact claim. Despite opportunities to present further evidence, including an expert opinion, Mr. Kuczarski did not provide new evidence to support his claim. The court found that the evidence still preponderated in favor of a one-week onset, which is not compatible with the medical theory underlying SIRVA. The orthopedist's opinion was not given significant weight as its basis was not indicated and it did not clearly reflect the one-week onset. Therefore, Mr. Kuczarski failed to establish entitlement to compensation, and the petition was dismissed. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00312-0 Date issued/filed: 2023-02-06 Pages: 6 Docket text: PUBLIC ORDER/RULING (Originally filed: 01/05/2023) regarding 37 Findings of Fact & Conclusions of Law, Signed by Chief Special Master Brian H. Corcoran. (nh) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0312V UNPUBLISHED FRANKLIN KUCZARSKI, Chief Special Master Corcoran Petitioner, v. Filed: January 5, 2023 SECRETARY OF HEALTH AND Special Processing Unit (SPU); HUMAN SERVICES, Findings of Fact; Onset; Influenza (Flu); Shoulder Injury Related to Respondent. Vaccine Administration (SIRVA); Table Claim Dismissal. Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for Petitioner. Andrew Henning, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1 On March 19, 2020, Franklin Kuczarski filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that he suffered a shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccination he received on December 15, 2018. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”). 1 Because this unpublished Ruling contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the Ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 2 of 6 For the reasons discussed below, I find that Petitioner’s Table SIRVA claim must be dismissed, because the evidentiary record does not support the conclusion that the onset of his pain occurred within 48 hours following administration of the flu vaccine. This leaves, however, a possibly-meritorious causation-in-fact claim to be adjudicated. I. Relevant Procedural History This case was assigned to the SPU in April 2020. ECF No. 8. From May 2021 through November 2021, the parties attempted to settle the case informally, but reached an impasse. ECR No. 31. On January 24, 2022, Respondent filed his Rule 4(c) Report in which he argued that Petitioner has not provided preponderant evidence that his shoulder pain began within 48 hours of his flu vaccination. Rule 4(c) Report at 6. Rather, Respondent noted that Petitioner reported that his shoulder pain began one week after his vaccination in his most contemporaneous records. Id. After a review of the records, I determined that a hearing to resolve the disputed issues would be unnecessary. See ECF No. 33. I then directed the parties to file briefs and any other evidence in support of their positions. Id. Petitioner filed a Brief in Support of a Fact Ruling on the Issue of Onset (“Br.”) on July 11, 2022, to which Respondent filed a response (“Op.”) on November 12, 2021. ECF No. 35, 36. This matter is now ripe for adjudication. II. Authority Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, test result, report, or summary concerning the nature, causation, and aggravation of petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where medical records are clear, consistent, and complete, they should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always apply. In Lowrie, the special master wrote that “written records which 2 Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 3 of 6 are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” Lowrie, at *19. And the Federal Circuit recently “reject[ed] as incorrect the presumption that medical records are accurate and complete as to all the patient’s physical conditions.” Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). The United States Court of Federal Claims has recognized that “medical records may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998). The Court later outlined four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014). The Court has also said that medical records may be outweighed by testimony that is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed. Cl. at 391 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must also be determined. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). A special master may find that the first symptom or manifestation of onset of an injury occurred “within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset [of the injury] ... did in fact occur within the time period described in the Vaccine Injury Table.” Id. The special master is obligated to fully consider and compare the medical records, testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110 Fed. Cl. at 204 (citing § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master's discretion to determine whether to afford greater weight to medical records or to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is rational). 3 Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 4 of 6 III. Findings of Fact I have fully reviewed the evidence pertaining to the onset question, including all medical records, Respondent’s Rule 4(c) Report, and the parties’ briefs. I find the following facts most relevant: • Petitioner’s pre-vaccination record reveals no injuries, inflammation, or dysfunction in either shoulder or arm. • Petitioner received a flu vaccine in his right shoulder at a Walgreens Pharmacy in Springfield, MA, on December 15, 2018. Ex.1 at 2. Petitioner described “normal, residual pain” after his vaccination, but explained that the “pain never subsided” and “continued for weeks.” Ex. 11 at ¶4. • On January 8, 2019 (24 days after his vaccination), Petitioner presented to urgent care with shoulder pain for two weeks. Ex. 3 at 2. The record notes that “3 weeks ago flu shot R arm. 2 weeks developed R shoulder pain “frozen” with painful ROM.” Id. The record also noted that Petitioner reported working on a lawn mower “for an extended period of time” 3-4 weeks ago. Id. Petitioner was diagnosed with a right shoulder sprain, advised to take over-the-counter pain medications, and was referred to physical therapy. Id. at 3. • Two days later, on January 10, 2019, Petitioner presented to physical therapy for a shoulder evaluation. Ex. 4 at 171. Petitioner reported that “about two weeks ago, [he] began to have tightness in [his] right shoulder and it felt like it was going to lock up.” Id. He stated that he had returned to the gym, but felt pain during his exercise. Id. Finally, Petitioner stated that he “got the flu shot about a week before the pain began” and that he “was not sure if it might have caused pain.” Id. (emphasis added). Petitioner was discharged from physical therapy on August 20, 2019, after 42 sessions, having “reached maximum benefit from therapy.” Id. at 58. • On April 30, 2019, Petitioner returned to urgent care to follow up on his right shoulder pain, as well as right hand weakness for the past 2-3 weeks. Ex. 5 at 14. The record notes onset four months previously and that Petitioner reported some relief from physical therapy. Id. Petitioner was diagnosed with cervical radiculopathy and paresthesias, prescribed medications, and instructed to continue physical therapy and follow up with his primary care physician. Id. at 15-16. 4 Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 5 of 6 • On May 24, 2019, Petitioner presented to orthopedic physician assistant, Henry Casagrande, for evaluation of his right shoulder. Ex. 6 at 2. Petitioner reported that his had had shoulder symptoms for approximately five months which were “induced when he received a tetanus vaccination into the right deltoid.” Id. PA Casagrande’s impression was “post vaccination inducted adhesive capsulitis.” Id. He administered a cortisone injection and recommended that Petitioner continue physical therapy. Id. • Petitioner returned to PA Casagrande on August 23, 2019 to follow up on his right shoulder pain. Ex. 6 at 6. Petitioner reported “significant improvements with near resolution” of his symptoms. Id. Petitioner was advised to continue physical therapy with more aggressive strengthening. Id. • Petitioner retuned to physical therapy on August 28, 2019. Ex. 4 at 20. He was discharged on October 3, 2019, after five additional sessions. Id. at 9. While I acknowledge that the standard applied to resolving onset for an alleged Table SIRVA is liberal, and will often permit a determination in a petitioner’s favor, especially in the absence of fairly contemporaneous and direct statements within the petitioner’s medical records to the contrary, not every case can be so preponderantly established. Ultimately, the resolution of such fact issues involves weighing different items of evidence against the overall record. Here, Petitioner’s onset claims are offset against a record created very near-in- time to vaccination in which Petitioner reported the onset of his right shoulder pain as beginning approximately one week after his vaccination. Although Petitioner states that he had “normal, residual pain following administration” of his flu shot, there is no record or sworn statement from Petitioner or any other witness indicating that the pain occurred within 48 hours. And the two medical records closest in time to Petitioner’s vaccination (the January 8, 2019 urgent care visit and the January 10, 2019 physical therapy evaluation) specifically contradict onset as having occurred within the required period. Rather, both of those records place onset approximately one week after vaccination. Ex. 3 at 2; Ex. 4 at 171. These records, both created within the first month after vaccination, consistently place onset of Petitioner’s shoulder pain outside of the 48 hours required to establish a Table SIRVA. Petitioner argues that “it is not a requirement that a petitioner specify the exact date of vaccination when reporting onset of pain to a provider or a third party, nor is it a 5 Case 1:20-vv-00312-UNJ Document 38 Filed 02/06/23 Page 6 of 6 requirement that a petitioner accurately recall the month or day of their vaccination.” Br. at 3. Petitioner further notes that “though Petitioner’s medical records from January 8, 2019 state that his shoulder pain began ‘two weeks ago,’ we cannot assume that his pain began exactly on December 25, 2018.” Id. But the records suggesting an onset of a week post-vaccination (and not sooner) remain. And there is no reference in any record, including Petitioner’s affidavit, to an onset specifically occurring within the 48 period after vaccination. Thus, although he consistently linked his pain to his flu shot, Petitioner has not provided a credible explanation as to why he reported the onset of his pain as one week after his vaccination during the first two medical appointments to address his condition. Accordingly, I find Petitioner has not preponderantly established that onset of his pain occurred within 48 hours of vaccination – meaning that he cannot proceed in this action with a Table SIRVA claim. But a causation-in-fact injury claim might still be tenable, based on an onset occurring a week after vaccination. I urge the parties to make one final brief attempt at settlement before transferring the case so that a non-Table version of the claim can be adjudicated. Conclusion Petitioner’s Table SIRVA claim is dismissed, for the reasons set forth above. Petitioner shall file a joint status report addressing his conveyance of a revised settlement demand for an off-Table claim, and the parties’ efforts towards informal resolution, by no later than Tuesday, February 14, 2023. If the parties do not report progress in their efforts, the matter will likely be transferred out of the SPU. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 6 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00312-1 Date issued/filed: 2023-12-15 Pages: 10 Docket text: PUBLIC DECISION (Originally filed: 11/17/2023) regarding 50 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 1 of 10 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-312V Filed: November 17, 2023 Special Master Horner FRANKLIN KUCZARSKI, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Leigh Finfer, Muller Brazil, LLP, Dresher, PA, for petitioner. Andrew Henning, U.S. Department of Justice, Washington, DC, for respondent. DECISION1 On March 19, 2020, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2012),2 alleging that he suffered a right shoulder injury following an influenza (“flu”) vaccination that he received on December 15, 2018. (ECF No. 1.) Petitioner alleged his injury was caused-in-fact by his vaccination. (Id. at 3.) For the reasons set forth below, I conclude that petitioner is not entitled to compensation and the petition is dismissed. I. Applicable Statutory Scheme Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In 1 Because this document contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the document will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C. § 300aa-10, et seq. 1 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 2 of 10 general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. § 300aa-11(c). Finally – and the key question in most cases under the Program – the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to the vaccination in question, within an applicable time period following the vaccination, which is also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. See § 300aa- 13(a)(1); § 300 aa-11(c)(1)(C)(i); § 300aa-14(a). As relevant here, the Vaccine Injury Table lists a SIRVA as a compensable injury if it occurs within 48 hours of vaccine administration. See § 300aa-14(a), amended by 42 CFR § 100.3. Table Injury cases are guided by statutory “Qualifications and aids in interpretation” (“QAIs”), which provide more detailed explanation of what should be considered when determining whether a petitioner has actually suffered an injury listed on the Vaccine Injury Table. 42 CFR § 100.3(c). To be considered a “Table SIRVA,” petitioner must show that her injury fits within the following definition: SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis . . . . A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 2 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 3 of 10 42 CFR § 100.3(c)(10). Alternatively, if no injury falling within the Table can be shown, the petitioner may still demonstrate entitlement to an award by showing that the vaccine recipient’s injury or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must show that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). In particular, a petitioner must show by preponderant evidence: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury in order to prove causation-in-fact. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). For both Table and Non–Table claims, Vaccine Program petitioners must establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a petitioner must present evidence sufficient to show “that the existence of a fact is more probable than its nonexistence . . . .” 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). However, a petitioner may not receive a Vaccine Program award based solely on her assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 300aa-13(a)(1). Once a petitioner has established their prima facie case, the burden then shifts to respondent to prove, also by preponderant evidence, that the alleged injury was caused by a factor unrelated to vaccination. Althen, 418 F.3d at 1278; § 300aa-13(a)(1)(B). II. Procedural History Petitioner’s case was initially assigned to the Chief Special Master as part of the Special Processing Unit. (ECF Nos. 8-9.) As of May 21, 2021, respondent agreed to entertain settlement discussions (ECF No. 23); however, the parties were unable to reach agreement. Accordingly, the Chief Special Master advised that the issue of onset of petitioner’s shoulder condition was ripe for adjudication and required the parties to brief the issue. (ECF No. 33.) Subsequently, petitioner moved for a ruling on the written record seeking a finding that petitioner suffered onset of shoulder pain within 48 hours of vaccination. (ECF No. 35.) Petitioner’s motion did not object to the Chief Special Master ruling as to onset and, in fact, requested that the Chief Master do so, arguing that the finding should be that onset occurred within 48 hours of vaccination, consistent with the timeframe required for a Table SIRVA. (Id.) On January 5, 2023, the Chief Special Master issued “Findings of Fact and Conclusions of Law Dismissing Table Claim.” (ECF No. 37; see also 2023 WL 1777208.) The Chief Special Master concluded that there is not preponderant evidence that petitioner suffered onset of shoulder pain within 48 hours of his vaccination, thereby precluding the availability of any Table Injury claim. (Id. at 6.) In so concluding, the 3 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 4 of 10 Chief Special Master weighed more heavily the contemporaneous medical records that indicated onset was one-week post-vaccination. (Id.) Thereafter, the parties attempted settlement again, but reached an impasse. (ECF No. 40.) In light of the impasse, petitioner indicated that he “seeks an entitlement decision for an off-Table claim and awaits further instruction from the Court.” (ECF No. 40.) Shortly thereafter, the case was reassigned to the undersigned. (ECF No. 41-42.) The case was reassigned to allow petitioner to pursue his cause-in-fact claim. (ECF No. 41.) On March 21, 2023, I held a status conference with the parties. I advised the parties that “although the Chief Special Master’s onset ruling is not binding on me, I am unlikely to disagree with the finding absent compelling new evidence. If petitioner does not wish to pursue settlement, he will likely need to provide an expert opinion that provides more detailed evidence on timing beyond what is traditionally seen in SIRVA cases and/or provide additional evidence sufficient to prompt reevaluation of the Chief Special Master’s prior finding as to onset.” (ECF No. 43, pp. 1-2.) I expressed doubt that it will be possible for petitioner to substantiate that a one-week post-vaccination latency (as reflected in the medical records) is appropriate to support a cause-in-fact claim and instructed petitioner to file a status report indicating how he intends to proceed. (Id. at 2.) Initially, petitioner did indicate he would seek an expert report to support a cause- in-fact claim reflective of “timing beyond traditional SIRVA claims.” (ECF No. 44.) However, on August 14, 2023, petitioner instead filed a supplemental affidavit. (ECF No. 46; Ex. 10.) Thereafter, on September 11, 2023, petitioner filed a status report in which he further advised that “[a]lthough Special Master Horner advised Petitioner of the likely need for an expert report to support any cause-in-fact claim, Petitioner is seeking reevaluation of the Chief Special Master’s prior finding as to onset.” (ECF No. 47.) Petitioner asserted that, “[a]n expert report in support of onset timing beyond 48 hours would be in direct contradiction to Petitioner’s assertions in both his supplemental declaration (Exhibit 10) and several medical records.” (Id.) Petitioner’s status report did not indicate any intention of filing further evidence. On September 6, 2023, I issued an Order to Show Cause why the case should not be dismissed. (ECF No. 48.) I explained the standard for revisiting prior rulings and explained that I have already advised petitioner that based on my review of the case I am unlikely to disagree with the Chief Special Master’s fact finding absent a material change in the record evidence. However, petitioner has not presented any significant or compelling new evidence nor pointed to supervening law. Petitioner also fails to describe any way in which the prior finding was erroneous. Instead, petitioner indicates without supporting explanation that he is seeking a reevaluation of the Chief Special Master’s prior fact finding, despite having had a full and fair opportunity to litigate 4 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 5 of 10 onset of his condition before the Chief Special Master and despite having offered only the barest of additional evidence. (Id. at 4 (citation omitted).) I concluded that “petitioner has failed to muster meaningful support for his suggestion that the Chief Special Master’s dismissal of the Table claim should be revisited. Yet, he has also failed up to this point to prosecute his remaining cause-in- fact claim.” (ECF No. 48, p. 5.) I provided petitioner sixty days to file any additional evidence he wishes to have considered along with a written submission pursuant to Vaccine Rule 8(d). (Id.) I cautioned that “[w]hile the undersigned will consider any and all arguments presented in petitioner’s written submission, petitioner should anticipate that additional evidence will likely be necessary to avoid dismissal.” (Id.) On November 13, 2023, petitioner filed a response to my Order to Show Cause. (ECF No. 49.) Petitioner did not submit any additional evidence, and instead summarized the current record and asked the court again to find that his “pain began within forty-eight (48) hours of flu vaccination.” (Id. at 8.) In light of the above, I have determined that the parties have had a full and fair opportunity to present their cases and that it is appropriate to resolve entitlement on the existing record. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2); see also Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must determine that the record is comprehensive and fully developed before ruling on the record”). Accordingly, this matter is now ripe for resolution. III. Factual History and Prior Analysis of Onset The factual history at issue is set forth in the Chief Special Master’s Finding of Fact. (ECF No. 37; see also 2023 WL 1777208.) It is not necessary to repeat that history in full for purposes of this decision and it is instead incorporated by reference. In short, petitioner was vaccinated on December 15, 2018. (Ex. 1, p. 2.) Three weeks later he presented to an urgent care clinic with a complaint of two weeks of left shoulder pain. (Ex. 3, p. 2.) The record specifies that petitioner reported having had a flu vaccine “1 week prior” to onset. (Id.) Two days later petitioner presented for physical therapy. (Ex. 4, p. 171.) At that encounter he explained that “I got the flu shot about a week before the pain began so I am not sure if it might have caused pain.” (Id.) On May 24, 2019, petitioner presented to an orthopedist. (Ex. 6, p. 2.) He associated his pain to his vaccination and reported a five-month history of shoulder pain. (Id.) The orthopedist diagnosed “post vaccination induced adhesive capsulitis.” (Id.) Later, at an unrelated medical appointment, petitioner reported to his primary care physician he was experiencing shoulder pain he believed was secondary to his flu shot. (Ex. 2, p. 5.) In addition to evaluating the medical records, the Chief Special Master took note of the fact that Petitioner’s affidavit described “normal residual pain” after his vaccination that “never subsided” and “continued for weeks.” (ECF No. 37, p. 4 (quoting Ex. 11, ¶ 5 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 6 of 10 4).) However, the Chief Special Master explained that petitioner’s first treatment record for that shoulder pain specified that petitioner reported that “3 weeks ago flu shot R arm. 2 weeks developed R shoulder pain ‘frozen’ with painful ROM.” (Id. (quoting Ex. 3, p. 2).) Two days later, petitioner’s physical therapy evaluation recorded that petitioner reported “about two weeks ago, [he] began to have tightness in [his] right shoulder and it felt like it was going to lock up.” (Id. (quoting Ex. 4, p. 171).) The record further specifies that petitioner “got the flu shot about a week before the pain began” and that he “was not sure if it might have caused pain.” (Id.) The Chief Special Master considered petitioner’s affidavit as evidence suggesting onset occurred within 48 hours of vaccination, but found it outweighed by the medical records for two reasons. (ECF No. 37, pp. 5-6.) First, nothing in the record, including petitioner’s affidavit, actually specified onset occurring within 48 hours of vaccination. (ECF No. 37, p. 6.) Second, petitioner’s two most contemporaneous medical records contradict the idea of pain beginning around the time of vaccination by explicitly placing onset at one-week post-vaccination. (Id. at 5.) The Chief considered petitioner’s arguments, but concluded that petitioner “has not provided a credible explanation as to why he reported the onset of his pain as one week after his vaccination during the first two medical appointments to address his condition.” (Id. at 6.) Subsequently, on August 14, 2023, petitioner filed a supplemental affidavit. (Ex. 10.) Petitioner’s supplemental affidavit specifies that the post-vaccination pain he experienced began “immediately following” receipt of the vaccination at issue. (Id. at ¶ 3.) He adds that “[a]fter one (1) week, I realized the pain was not going to subside.” (Id.) Apart from this affidavit, the record of the case otherwise remains the same as when reviewed by the Chief Special Master when he dismissed petitioner’s Table claim. IV. Petitioner’s Show Cause Response Although petitioner did not file any additional evidence in response to my show cause order, he did file a brief explaining why he believes his case should not be dismissed based on the existing record. (ECF No. 49.) Petitioner acknowledges that the Chief Special Master found onset of shoulder pain occurred beyond 48 hours post vaccination based in large part on the contemporaneous medical records placing onset one full week post-vaccination. (Id. at 3.) However, petitioner declines to pursue a cause-in-fact claim based on a one-week post-vaccination onset because that would be inconsistent with his sworn statements and some of his other medical records. (Id.) Instead, petitioner’s show cause response urges reevaluation of the Chief Special Master’s dismissal of his Table claim. (Id.) Petitioner argues in effect that his later filed supplemental affidavit confirms that the Chief Special Master misconstrued his first affidavit. (ECF No. 49, p. 4.) Petitioner argues that the purpose of affidavits under the Vaccine Rules is only to explain the substance of a witness’s testimony relating to the elements of petitioner’s claim. (Id. at 4-5.) It does not require petitioner to delineate his specific allegations, i.e. to explicitly 6 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 7 of 10 state onset occurred within 48 hours of vaccination. (Id.) Further to this, petitioner argues that the Chief Special Master over weighed the contemporaneous medical records. (Id. at 5-6.) Petitioner cites the Federal Circuit decision in Kirby v. Secretary of Health & Human Services for the proposition that “[a]lthough a patient has a ‘strong motivation to be truthful’ when speaking to his physician, that does not mean he will report every ailment he is experiencing, or that the physician will accurately record everything he observes.” (Id. at 5 (quoting 997 F.3d 1378, 1383 (Fed. Cir. 2021).) Petitioner argues that he should not be burdened with differentiating normal residual post-vaccination pain from what would prove to be pain due to a shoulder injury. (Id.) Petitioner further argues that prior program experience indicates that petitioners need not be precise in reporting onset to their physicians and that patient reports of symptoms associated to vaccination should be understood in context. (ECF No. 49 at 5-6.) Regardless of the limitations of his understanding of the relationship between his vaccinations and symptoms, petitioner’s records show that he consistently felt his vaccination was an important aspect of his history of shoulder pain. (Id. at 6.) Petitioner stresses that based on these repeated histories, his orthopedist diagnosed a post-vaccination induced adhesive capsulitis. (Id. at 6-7 (citing Ex. 6, pp. 2, 6).) Petitioner urges a “lenient” standard in assessing onset for SIRVA. (Id. at 7-8.) V. Discussion a. Table Injury I have considered petitioner’s arguments; however, I am not persuaded that petitioner has provided any basis for reopening the Chief Special Master’s dismissal of his Table Injury claim. Generally, special masters may change or revisit any ruling until judgment enters, even if the case has been transferred. See McGowan v. Sec'y of Health & Human Servs., 31 Fed. Cl. 734, 737–38 (1994). In most cases, however, a judicial officer such as a special master departs from previously decided issues only in the event of “new evidence, supervening law, or a clearly erroneous decision.” Id. at 737; see also Sullivan v. Sec'y of Health & Human Servs., No. 10–398V, 2015 WL 1404957, at *20, n.36 (Fed. Cl. Spec. Mstr. Feb. 13, 2015). Petitioner had a full and fair opportunity to litigate his Table injury claim prior to issuance of the Chief Special Master’s finding of fact and the record is substantially the same as it was when the Chief Special Master rendered his finding. Only petitioner’s supplemental affidavit has been added to the record; however, that supplemental affidavit provides basically no new evidence despite petitioner urging otherwise. Petitioner’s first affidavit indicated that he experienced residual post-vaccination pain that never subsided and eventually prompted him to seek medical attention. (Ex. 8, ¶ 4.) Petitioner’s supplemental affidavit offers the same assertion, adding only by implication that the pain was not actually “normal” post-vaccination pain after all and more explicitly stating that onset was immediate. (Ex. 10, ¶ 3.) In fact, the affidavit explicitly confirms it is merely a restatement of the initial affidavit, prefacing the key point with “as I previously stated.” (Id.) 7 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 8 of 10 As with many cases reassigned from the SPU, this case was reassigned for the specific purpose of allowing petitioner an opportunity to prosecute any remaining cause- in-fact claim after his Table claim was dismissed. As discussed in the procedural history above, as long as a case continues to be litigated there is always a possibility that further record development will necessitate revisiting a prior finding based on newly discovered evidence. However, petitioners should not view reassignment of a case out of the SPU as a second bite at the apple regarding what has already been decided. When examining the record as a whole, petitioner’s argument that his supplemental affidavit warrants reevaluation of his Table claim is specious. Indeed, petitioner himself characterizes his newly filed evidence as “miniscule.” (ECF No. 49, p. 4.) b. Onset In dismissing the Table claim, the Chief Special Master previously concluded that the onset of shoulder pain in this case was outside the requisite 48-hour period for a Table SIRVA. Based on my review of the medical records, I further specifically conclude for purposes of assessing causation-in-fact that the evidence preponderates in favor of a finding that onset of petitioner’s shoulder pain began one week post vaccination for many of the same reasons discussed by the Chief Special Master when he dismissed the Table claim. It is true, as petitioner argues, that medical records can be incorrect, that many petitioners report difficulty in determining that the initial symptoms of SIRVA are not typical post-vaccination pain, and that petitioners cannot necessarily be expected to always report onset of their symptoms with precision. In this case, however, petitioner specified to two different medical providers during the course of his treatment that his shoulder pain began one full week post-vaccination. (Ex. 3, p. 2; Ex. 4, p. 171.) Especially because the same report was recorded by two different medical providers, this is very weighty evidence. “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec'y of Dep't of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Petitioner stresses these are not the only reports of symptoms contained in the records and that petitioners often associate their symptoms to vaccination by noting they occurred “following” or “after” vaccination. In this particular case, petitioner stresses his report to another physician that his shoulder condition was “secondary to” his flu shot. (ECF No. 49, p. 6-7.) However, such notations are not actually inconsistent with symptoms beginning one-week post-vaccination as indicated by those medical records that were specific as to onset. Petitioner’s physical therapy records explicitly confirm that petitioner was suspicious that shoulder pain beginning one-week post-vaccination might be related to his vaccination. (Ex. 4, p. 171.) Moreover, those records that specify a one-week post-vaccination onset are more contemporaneous to 8 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 9 of 10 onset than the later orthopedic records petitioner otherwise cites. See e.g., R.K. v. Sec’y of Health & Human Servs., No. 03-632V, 2015 WL 10936124, at *76 (Fed. Cl. Spec. Mstr. Sept. 28, 2015) (holding that more remote histories of illness do not have sufficient indicia of reliability to be credited over conflicting contemporaneous medical records and earlier reported histories), mot. rev. denied, 125 Fed Cl. 57 (2016), aff’d 671 Fed.Appx. 792 (Fed. Cir. 2016); see also e.g., Vergara v. Sec’y of Health & Human Servs., 08-882V, 2014 WL 2795491, *4 (Fed. Cl. Spec. Mstr May 15, 2014) (“Special Masters frequently accord more weight to contemporaneously-recorded medical symptoms than those recorded in later medical histories, affidavits, or trial testimony” (emphasis added).). Finally, while cogent testimonial evidence can sometimes outweigh contemporaneous medical records, petitioner’s affidavits are insufficient to outweigh the medical records in this case. Petitioner’s affidavits are sparse with regard to any description of events that would support his specific recollection of onset. (Exs. 8, 10.) Moreover, petitioner offers no attempt to explain how two of his medical providers came to report a one-week post-vaccination onset despite his understanding of events as stated in the affidavits. (Id.) Contrary to what petitioner argues in his briefing, both affidavits clearly state that by the time petitioner sought medical care he had resolved any confusion regarding the nature of his symptoms and concluded that the pain he had experienced from the time of his vaccination was more than merely normal residual injection pain. (Ex. 8, ¶ 4; Ex. 10, ¶ 3.) Indeed, that is precisely why he sought medical care. While petitioner does challenge some notations in his medical records, he conspicuously does not dispute that he reported a one-week onset at both urgent care and physical therapy. (Id.) c. Causation-in-fact With regard to causation in fact, petitioner cites the opinion of his orthopedist noting petitioner to have suffered vaccine induced adhesive capsulitis. (ECF No. 49, pp. 6-7 (citing Ex. 6, pp. 2, 6).) However, the basis for the orthopedist’s opinion is not indicated. The Federal Circuit has explained that “[a]lthough probative, neither a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation.” Althen, 418 F.3d at 1278 (citing Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1149 (Fed. Cir. 1992)). Thus, “[a] treating physician’s recognition of a temporal relationship does not advance the analysis of causation.” Isaac v. Sec’y of Health and Human Servs., No. 08-601V, 2012 WL 3609993, at *26 (Fed. Cl. Spec. Mstr. July 30, 2012). Accordingly, an expert report would be critical to a cause-in-fact claim in this case, because the orthopedist’s opinion is inadequate without more to address the showings required under the three Althen prongs. Moreover, the history petitioner provided his orthopedist over five months post- vaccination was less detailed than the earlier history he provided at urgent care and physical therapy. (Ex. 3, p. 2; Ex. 4, p. 171.) Accordingly, it is not clear whether the 9 Case 1:20-vv-00312-UNJ Document 54 Filed 12/15/23 Page 10 of 10 orthopedic opinion reflects the one-week post-vaccination onset that I have determined is preponderantly evidenced on this record. This greatly reduces the weight due this medical opinion as to causation. See, e.g. Garner v. Sec’y of Health & Human Servs., No. 15-63V, 2017 WL 1713184, at *11 (Fed. Cl. Spec. Mstr. Mar. 24, 2017) (explaining that “the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals.”), mot. rev. denied, 133 Fed. Cl. 140 (2017); Anderson v. Sec’y of Health & Human Servs., No. 20-195V, 2023 WL 2237320, at *13 (Fed. Cl. Spec. Mstr. Feb. 2, 2023) (finding that an orthopedist’s vaccine causation opinion was entitled to less weight where earlier records contradicted petitioner’s report to the physician that the vaccine at issue and been administered in the affected shoulder). Prior experience also suggests that a one-week post-vaccination onset is not compatible with the type of medical theory underlying SIRVA. Pitts v. Sec'y of Health & Human Servs., No. 18-1512V, 2023 WL 2770943 (Fed. Cl. Spec. Mstr. Apr. 4, 2023); Gruszka v. Sec'y of Health & Human Servs., No. 18-1736V, 2023 WL 2583390 (Fed. Cl. Spec. Mstr. Feb. 24, 2023). Petitioner acknowledges this point. (ECF No. 49, p. 3.) Accordingly, a more detailed explanation substantiating that a one-week onset is appropriate to infer causation would be critical in order for petitioner to meet his burden of proof under Althen prongs two and especially three. Petitioner was provided an opportunity to provide an expert opinion substantiating that a one-week onset is appropriate for a SIRVA-like injury, but declined to do so. Petitioner suggests that it would be disingenuous to pursue a cause-in-fact claim based on a one-week onset, because this would be inconsistent with his sworn statements. (Id.) This is not so. Petitioner need not agree that onset was one-week post-vaccination in order to substantiate that it would be medically reasonable to infer causation based on such a latency. VI. Conclusion After weighing the evidence of record within the context of this program, and for all the reasons discussed herein, petitioner has neither demonstrated that his right shoulder injury constitutes a Table Injury of SIRVA nor an injury caused-in-fact by his vaccination. Accordingly, this case is dismissed.3 IT IS SO ORDERED. s/Daniel T. Horner Daniel T. Horner Special Master 3 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment accordingly. 10