VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00381 Package ID: USCOURTS-cofc-1_20-vv-00381 Petitioner: Sharon Campbell Filed: 2020-04-03 Decided: 2023-02-03 Vaccine: influenza Vaccination date: 2018-09-17 Condition: vasovagal presyncope leading to a fall and subsequent fracture of her tibia and fibula Outcome: compensated Award amount USD: 190000 AI-assisted case summary: Sharon Campbell, a 64-year-old histology specialist, filed a petition for compensation under the National Vaccine Injury Compensation Program on April 3, 2020. She alleged that on September 17, 2018, after receiving an influenza vaccine, she experienced a vasovagal presyncopal episode, leading to a fall down stairs and subsequent fractures of her tibia and fibula. Initially, she sought compensation for a Table injury of vasovagal syncope. However, the public decision does not describe the specific medical records or expert opinions presented to support this claim, other than noting that the Table injury requires loss of consciousness, which Ms. Campbell did not experience. Consequently, her Table claim was dismissed. Ms. Campbell also pursued an off-Table claim, alleging a vasovagal reaction caused by the vaccine that led to her fall and injuries. The Special Master reviewed the medical records, which indicated that approximately fifteen minutes after vaccination, Ms. Campbell felt dizzy while walking down stairs, causing her to fall. She was evaluated by emergency room physicians and an orthopedic surgeon, who diagnosed a fractured left tibial plateau and attributed the fall to vasovagal presyncope. She underwent surgery for open reduction and internal fixation, followed by physical therapy. Over the subsequent months, she experienced persistent pain, decreased range of motion, and hardware issues, leading to further surgical interventions, including a debridement, removal of hardware, implantation of a bone cement spacer, and ultimately a total knee arthroplasty. The medical records detail multiple surgeries, hospitalizations, and extensive physical therapy over an extended period. The Special Master found that the evidence established that the influenza vaccination could cause a vasovagal response, that this response led to dizziness, wooziness, and weakness causing the fall, that the onset of symptoms occurred within minutes of vaccination, and that her injury resulted in inpatient hospitalization and surgical intervention, satisfying the Vaccine Act's severity requirement. The case proceeded to a damages award. On February 3, 2023, Chief Special Master Brian H. Corcoran awarded Ms. Campbell $190,000.00 for actual pain and suffering. The decision noted that while the initial injury was transient, its impact was uncommonly severe, justifying the award, which compensated for actual pain and suffering and did not require reduction to present value. Petitioner was represented by John Robert Howie of Howie Law, PC, and Respondent was represented by Amanda Pasciuto of the U.S. Department of Justice. Theory of causation field: Sharon Campbell, age 64, received an influenza vaccine on September 17, 2018. She alleged a vasovagal presyncopal episode approximately 15 minutes post-vaccination, leading to a fall and fracture of her tibia and fibula. The Special Master dismissed the Table claim for vasovagal syncope due to the absence of loss of consciousness. For the off-Table claim, the Special Master found entitlement based on a medical theory supported by literature (e.g., Braun, Crawford, Graham, Centeno, Whitledge) and the Institute of Medicine's conclusion that a causal relationship exists between vaccine injection and vasovagal syncope. The theory posited that the vaccine could elicit a vasovagal reaction, characterized by presyncope (dizziness, wooziness, weakness) even without loss of consciousness, which precipitated a fall and subsequent severe injuries requiring multiple surgeries (open reduction and internal fixation, debridement, hardware removal, total knee arthroplasty) and extensive physical therapy. The medical records, including those from treating physicians, supported a logical sequence of cause and effect, with symptoms occurring within minutes of vaccination and leading directly to the fall and subsequent complications. The injury met the severity requirement due to hospitalization and surgical intervention. Chief Special Master Brian H. Corcoran issued the Entitlement Ruling on March 9, 2022, finding entitlement, and the Damages Decision on February 3, 2023, awarding $190,000.00 for actual pain and suffering. Petitioner was represented by John Robert Howie (Howie Law, PC), and Respondent by Sarah Christina Duncan (initially) and Amanda Pasciuto (U.S. Department of Justice). Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00381-0 Date issued/filed: 2022-04-08 Pages: 17 Docket text: PUBLIC ORDER/RULING (Originally filed: 03/09/2022) regarding 40 Ruling on Entitlement,, Damages Order,, Order on Motion for Summary Judgment, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 1 of 17 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0381V UNPUBLISHED SHARON CAMPBELL, Chief Special Master Corcoran Petitioner, Filed: March 9, 2022 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Ruling on Entitlement; Uncontested; HUMAN SERVICES, Causation-In-Fact; Influenza (Flu) Vaccine; Vasovagal Syncope Respondent. John Robert Howie, Howie Law, PC, Dallas, TX, for Petitioner. Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On April 3, 2020, Sharon Campbell filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that she “suffer[ed] a syncopal episode resulting in a fall and subsequent fracture of her tibia and fibula” after receiving an influenza (“flu”) vaccine on September 17, 2018. Petition at 1. Petitioner later filed an amended petition alleging both a Table syncope injury and, in the alternative, a cause-in-fact injury of vasovagal reaction triggered by the flu vaccine and leading to the fall and subsequent lower extremity fractures. ECF 35 at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. 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-00381-UNJ Document 43 Filed 04/08/22 Page 2 of 17 I. Procedural History After an initial status conference, Petitioner was provided with the opportunity to file additional medical records, which she did over the next several months. On September 28, 2020, Respondent filed a status report indicating interest in pursuing settlement negotiations. ECF 26. However, on January 6, 2021, Petitioner filed a status report indicating that “settlement in this case is [not] feasible” and requesting permission to retain an expert to address causation. ECF 32. I subsequently issued an order setting a deadline for Respondent’s Rule 4(c) Report, but I found the request for medical experts premature. ECF 33. On February 22, 2021, Respondent filed his Rule 4(c) Report recommending that entitlement to compensation be denied because Petitioner could not establish that she suffered a Table injury of vasovagal syncope.3 ECF 34 at 7-8. Respondent also argued that Petitioner had not established a causation-in-fact claim. Id. at 8-9. Petitioner then filed an amended petition alleging both a Table syncope injury and, in the alternative, a causation-in-fact injury of “vasovagal reaction.” ECF 35. The same day, Petitioner also filed a Motion for Summary Judgment with accompanying medical literature. ECF 36-37. On May 21, 2021, Respondent filed an Amended Rule 4(c) Report and Response to Petitioner’s Motion for Summary Judgment. ECF 39. In it, Respondent stated, [i]n light of [P]etitioner’s Motion and the evidence filed therewith, and while maintaining his position that [P]etitioner’s medical records do not establish that she lost consciousness as required by the QAI, . . . he will not continue to defend this case during further proceedings on entitlement before the Office of Special Masters. Id. at 3. Respondent also requested a ruling on the record regarding Petitioner’s entitlement to compensation. Id. Therefore, this matter is now ripe for adjudication. 3 Specifically, Respondent noted that Petitioner’s medical records consistently reflect that she did not lose consciousness after receiving the flu vaccine, which the Qualifications and Aids to Interpretation (QAI) require for a Table injury of vasovagal syncope. ECF 34 at 8. Respondent further argued that Petitioner’s medical providers diagnosed her as having experienced a presyncopal or vasovagal event rather than an episode of syncope. Id. at 8. 2 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 3 of 17 II. Relevant Factual History A. Medical Records Petitioner was a 64-year-old histology specialist when she received the flu vaccine on September 17, 2018, during an outdoor flu clinic at her place of employment, Massachusetts General Hospital (“MGH”). Ex 2 at 1. Fifteen minutes after vaccination, Petitioner arrived in the MGH emergency room (“ER”) reporting a “pre-syncopal episode” with “a fall down stairs after receiving her influenza vaccine.” Ex 5c at 111-12. The ER physician initially assessed Petitioner with “dislocation of proximal tibia/fibula after a fall which sounds to be vaso-vagal after her influenza shot.” Id. at 113. Petitioner was subsequently evaluated by Dr. Marilyn Heng, an orthopedic surgeon. Ex 5c at 117. Dr. Heng’s notes reflect that after Petitioner received her flu shot, she “began feeling weak while she was ambulating downstairs and she stumbled to the ground.” Id. Dr. Heng diagnosed Petitioner with a “displaced, closed, acute fracture of the left tibial plateau” caused by “vasovagal pre-syncope leading to a fall onto her left lower extremity.” Id. at 116-17. On September 19, 2018, Petitioner underwent surgical open reduction and internal fixation of her left tibial plateau fracture and lateral meniscus repair. Ex 5c at 138-39. She was discharged from the hospital three days later. Id. at 89. Three months after surgery, Petitioner was released to WBAT,4 and she underwent physical therapy evaluation during which she reported that “she got dizzy for a bit and fell down a flight of stairs” after receiving a flu shot. Ex 5d at 632; Ex 5e at 9. B. Affidavits & Other Documentation In her affidavit, Petitioner reports that she received the flu vaccine through her employer on September 17, 2018. Ex 1 at ¶ 4. With regard to her fall, Petitioner avers: Immediately after [vaccine] administration, I stood up, walked out of the tent, and walked approximately ten feet toward a nearby, concrete stairwell in the lawn.5 Upon arriving at the top of the stairwell, I began to feel dizzy, and everything went black. The next thing I knew, I was laying on the ground at the bottom of the stairs. 4 Weight bearing as tolerated. 5 Petitioner’s employer had erected a tent outside where employees could receive their flu vaccines. Ex 1 at ¶ 4. 3 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 4 of 17 Id. The record also reflects that approximately four hours after her fall, Petitioner called MGH Occupational Health Service and reported that after receiving her flu shot, she “fel[t] a little dizzy walking down the stairs to the lawn area” and fell. Ex 7 at 187. III. Summary Judgment vs Ruling on the Record Pursuant to Vaccine Rule 3(b)(2), special masters are responsible for “mak[ing] the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case and creating a record sufficient to allow review of the special master’s decision.” Under Vaccine Rule 8(d), a special master “may decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgement, in which event the procedures set forth in RCFC 566 will apply.” As I have previously observed (relying on controlling Federal Circuit precedent), “a special master’s ability to decide a case based upon written submissions without a hearing is not limited to a motion for summary judgement.” Smallwood v. Sec’y of Health & Human Servs., No. 18-0291V, 2020 WL 2954958, at *7 (Fed. Cl. Spec. Mstr. Apr. 29, 2020) (citing Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020)). Rather, special masters may rule on the record after affording each party “a full and fair opportunity to present its case.” Kreizenbeck, 945 F.3d at 1366 (citing Vaccine Rule 3(b)(2)). Although Petitioner styles her present motion as one for summary judgment, I find at this stage in the proceedings (and given the extensive factual materials filed) that it is best treated as requesting a ruling on the record. The record in this case with regard to entitlement is fully developed, and the parties have been afforded a full and fair opportunity to present their evidence and arguments. In order to resolve the motion and determine if in fact Petitioner should receive a damages award, I must weigh the evidence – a task I am empowered to perform without hearing, but which goes beyond the more limited judicial determinations implicit to the summary judgment process. Accordingly, I treat Petitioner’s motion as one requesting a ruling on the record, and shall evaluate the parties’ positions accordingly. 6 RCFC 56 sets forth the rules governing summary judgment. The Vaccine Rules “govern all proceedings before the United States Court of Federal Claims.” Vaccine Rule 1(a). Pursuant to the Vaccine Rules, “[t]he RCFC apply only to the extent they are consistent with the Vaccine Rules.” Vaccine Rule 1(c). Vaccine Rule 8(d) specifically incorporates the procedures set forth in RCFC 56 when a motion for summary judgment is filed. 4 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 5 of 17 IV. Applicable Law A. Standards for Vaccine Claims To receive compensation in the Vaccine Program, a petitioner must prove that: (1) they suffered an injury falling within the Vaccine Injury Table (i.e., a “Table Injury”); or (2) they suffered an injury actually caused by a vaccine (i.e., a “Non-Table Injury). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). To bring a successful Table claim, the petitioner must make a precise factual showing sufficient to meet the Table's relevant definitions, as set forth in the Table's “Qualifications and aids to interpretation” (“QAIs”). Section 14(b). If successful, the petitioner need not establish vaccine causation, as it is presumed if the Table requirements for a particular claim are met. Section 14(a). In this case, Petitioner asserts both a Table and non-Table claim. For both Table and Non–Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a preponderance standard). On one hand, proof of medical certainty is not required. Bunting v. Sec'y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). But on the other hand, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec'y of Health & 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). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal 5 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 6 of 17 relationship between vaccination and injury.” Each Althen prong requires a different showing and is discussed in turn along with the parties’ arguments and my findings. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner's theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. However, the Federal Circuit has repeatedly stated that the first prong requires a preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (“[w]e have consistently rejected theories that the vaccine only “likely caused” the injury and reiterated that a “plausible” or “possible” causal theory does not satisfy the standard”); see also Moberly, 592 F.3d at 1321; Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). This is consistent with the petitioner’s ultimate burden to establish his overall entitlement to damages by preponderant evidence. W.C. v. Sec'y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted). If a claimant must overall meet the preponderance standard, it is logical that they be required also to meet each individual prong with the same degree of evidentiary showing (even if the type of evidence offered for each is different). Petitioners may offer a variety of individual items of evidence in support of the first Althen prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one “type” of evidence is required. Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence standard.” Andreu, 569 F.3d at 1380. But even though “scientific certainty” is not required to prevail, the individual items of proof offered for the “can cause” prong must each reflect or arise from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at 1359–60. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a 6 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 7 of 17 vaccine “did cause” injury, the opinions and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician's views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). Instead, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014). B. Law Governing Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [ ] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or 7 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 8 of 17 autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such findings are supported by a rational determination). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Human Servs., No. 11- 685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras, 993 F.2d at 1525. Accordingly, if the medical records are clear, consistent, and complete, then 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). Indeed, contemporaneous medical records are often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face to other forms of evidence. Kirby v. 8 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 9 of 17 Sec’y of Health & Human Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). C. Consideration of Medical Literature While I have reviewed all the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec'y of Health & Human Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec'y of Health & Human Servs., 527 F. App’x 875 (Fed. Cir. 2013). V. Analysis A. The Parties’ Arguments Respondent argues that Petitioner has not established that she experienced syncope as defined by the QAI after her flu vaccine because she did not lose consciousness (although he rests his argument on the record without additional elaboration). ECF 39 at 9, 10. Petitioner maintains in response that regardless of whether she lost consciousness, “the evidence conclusively demonstrates that [she] experienced a vasovagal episode that was caused by her influenza vaccination and that resulted in a fall with permanent injuries.” ECF 37 at 1. 9 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 10 of 17 B. Syncope Under the Vaccine Injury Table Vasovagal syncope is a Table injury for the flu vaccine when it occurs within one hour of vaccine administration.7 42 C.F.R. § 100.3(a)XIV.C. The QAI criteria define vasovagal syncope as: [L]oss of consciousness (fainting) and postural tone caused by a transient decrease in blood flow to the brain occurring after the administration of an injected vaccine. Vasovagal syncope is usually a benign condition but may result in falling and injury with significant sequela. Vasovagal syncope may be preceded by symptoms such as nausea, lightheadedness, diaphoresis, and/or pallor. Vasovagal syncope may be associated with transient seizure-like activity, but recovery of orientation and consciousness generally occurs simultaneously with vasovagal syncope. Loss of consciousness resulting from the following conditions will not be considered vasovagal syncope: organic heart disease, cardiac arrhythmias, transient ischemic attacks, hyperventilation, metabolic conditions, neurological conditions, and seizures. Episodes of recurrent syncope occurring after the applicable time period are not considered to be sequela of an episode of syncope meeting the Table requirements. 42 C.F.R. § 100.3(c)(13). It is thus clear from the QAI description that proof of loss of consciousness is a fundamental factual element that must be established to meet the Table requirements. Petitioner cannot meet these strict requirements for her Table claim, as the record clearly demonstrates that she did not experience loss of consciousness (“LOC”) after vaccination. Records from the emergency department reflect that Petitioner presented with “dizziness without [LOC] leading to a mechanical fall.” Ex 5c at 120, 123. Petitioner also denied LOC when she was evaluated by Dr. Heng and when she phoned Occupational Health to report her fall. Id. at 117; Ex 7 at 187. The notes from Petitioner’s perioperative risk evaluation also reflect “[t]here appears to be no sign of actual LOC.” Ex 5c at 120-21. Furthermore, Petitioner asserts in her affidavit that “[u]pon arrival in the emergency department, [she] explained to the nursing staff that [she] had received an influenza vaccination that morning, and afterwards, [she] felt woozy . . . and fell.” Ex 1 at ¶ 5. Petitioner also avers she “began feeling weak” and “developed dizziness” while walking down the stairs after vaccination. Id. at ¶¶ 6-7, 14. In the absence of any evidence 7 Respondent does not contest that Petitioner’s fall occurred within one hour of vaccination. ECF 39 at 8 n.5. 10 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 11 of 17 of LOC, Petitioner’s cannot establish by preponderant evidence that she suffered a Table injury of vasovagal syncope.8 Accordingly, Petitioner’s Table claim is dismissed. C. Causation-in-Fact In her amended petition, Petitioner also alleges a “vasovagal reaction” caused-in- fact by her flu vaccine resulting in her fall and left lower extremity injuries. ECF 35 at 1. Because a “vasovagal reaction” is not a Table injury, there is no causal presumption available for this alternative claim. However, when alleging a non-Table injury, a petitioner is also not bound by the narrow criteria enumerated in the QAI. 1. Althen Prong 1 Petitioner’s burden under the first Althen prong is to provide “a medical theory causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278. In this case, Petitioner argues that the flu vaccination could cause a vasovagal event that, even if it did not itself involve a loss of consciousness, could impact an individual sufficiently to precipitate a fall (as is alleged to have occurred here). ECF 37 at 8. In making this assertion, Petitioner relies on medical literature describing the pathophysiology of vasovagal syncope, which results from a loss of blood perfusion in the brain that can be brought about by nervous system stimulation, often in a setting of fear or emotional stress. M. Braun et al., Syncope After Immunization, 151 Archives Pediatric Adolescent Med. 255 (1997), filed as Ex 16 on April 19, 2021 (ECF 36-3) (“Braun”). Vasovagal reactions are “known to be elicited by a variety of stimuli including simple venipuncture.” Braun at 255. Furthermore, “syncopal episode[s] (vasovagal, faint) [can] occur due to a . . . painful stimulus (e.g., vaccination),” a common and well-described trigger. N. Crawford et al., Syncope & Seizures Following Human Papillomavirus Vaccination: A Retrospective Case Series, 194 Med. J. Austl. 16 (2011), filed as Ex 20 on April 19, 2021 (ECF 36-7) (“Crawford”). More specifically, in the initial phase (during the response to the “threat”), stimulation of the sympathetic nervous system causes anxiety, accompanied by a rapid heart rate and rising blood pressure. D. Graham et al., Vasovagal Fainting: A Diphasic Response, XXIII:6 Psychosomatic Med. 493 (1961), filed as Ex 18 on April 19, 2021 (ECF 36-5) (“Graham”); P. Gilchrist & B. Ditto, The Effects of Blood-Draw & Injection Stimuli on the Vasovagal Response, 49:6 Psychophysiology 815 (2012), filed as Ex 19 on April 19, 8 Accord Kidwell v. Sec’y of Health & Human Servs., No. 17-0651V, 2021 WL 4203056, at *13-14 (Fed. Cl. Spec. Mstr. Aug. 19, 2021) (finding that the petitioner could not satisfy the Table syncope injury requirements because she did not lose consciousness). 11 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 12 of 17 2021 (ECF 36-6); Braun at 255; Crawford at 16. In the second phase (after cessation of the “threat”), there is relief from the anxiety accompanied by a fall in heart rate and blood pressure, which can result in vasovagal fainting. Id. Presyncope, also known as “near syncope,” is the prodrome9 of syncope without the loss of consciousness. E. Centeno et al., Syncope, Clev. Clinic Ctr. for Continuing Educ. (2018), filed as Ex 22 on April 19, 2021 (ECF 36-9) (“Centeno”). Data suggest that the pathophysiology, causes, and outcomes of near syncope mimic those of syncope. J. Whitledge, Presyncope, Nat’l Ctr. for Biotechnology Infor. Bookshelf (2021), filed as Ex 21 on April 19, 2021 (ECF 36-8) (“Whitledge”) (defining presyncope as a “feeling like one was going to pass out but without actual loss of consciousness”). Symptoms common to both presyncope and syncope include lightheadedness, weakness, nausea, palpitations, and blurry vision. Whitledge at 1. In fact, some researchers do not even require evidence of LOC when classifying a syncopal episode. In Graham, for example, it was noted that it is “unrealistic to insist on complete loss of consciousness as a criterion of fainting, since it is clear . . . that the vasovagal faint is not an all-or-nothing reaction but occurs in various degrees.” Graham at 494. Instead, for purposes of the study, a vasovagal faint was defined as “a sudden drop in blood pressure and pulse rate, accompanied by a report [from the study participant] of some disturbance of consciousness, expressed in such words as ‘dizzy,’ light-headed,’ and ‘woozy.’” Id. (emphasis added); see also Crawford at 17 (defining syncope as an “episode of pallor and unresponsiveness or reduced responsiveness or feeling light-headed and occurring while vaccine being administered or shortly thereafter (usually within 5 minutes)” (emphasis added). Furthermore, the Institute of Medicine has concluded that evidence convincingly supports a causal relationship between injection of a vaccine and vasovagal syncope. ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY 615, 623-24 (2012), filed as Ex 14 on April 19, 2021 (ECF 36-1). In fact, pursuant to the reports of syncopal episodes from VAERS10 and the NVICP,11 “the predominant cause [of syncope after vaccination] [i]s vasovagal reaction.” Braun at 258. As a result, the Centers for Disease Control (CDC) recommends that “to prevent syncope-related injuries, vaccine providers should follow 9 A premonitory symptom or precursor; a symptom indicating the onset of a disease. DORLAND’S MEDICAL DICTIONARY Online, https://www.dorlandsonline.com/dorland/definition?id=41089&searchterm=prodrome (last visited November 24, 2021). 10 Vaccine Adverse Event Reporting System. 11 National Vaccine Injury Compensation Program. 12 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 13 of 17 the ACIP12 recommendations to strongly consider observing patients for 15 minutes after vaccination.” A. Sutherland et al., Syncope After Vaccination, 57 Morbidity & Mortality Wkly. Rep. 457 (2008), filed as Ex 17 on April 19, 2021 (ECF 36-4) (“Sutherland”). And I take notice of the fact that the incorporation of vasovagal response in the Table definition of syncope serves as tacit acknowledgement by Respondent of a causal link between the two conditions.13 Accordingly, I find there is preponderant evidence to establish that influenza vaccination can cause a presyncopal vasovagal reaction, even in the absence of LOC. This determination is consistent with prior findings in other persuasively-reasoned decisions. See, e.g., Kidwell v. Sec’y of Health & Human Servs., No. 17-0651V, 2021 WL 4203056, at *14 (Fed. Cl. Spec. Mstr. Aug. 19, 2021) (finding that the flu vaccine can cause presyncope under Althen prong 1).14 2. Althen Prong 2 Petitioner has also preponderantly satisfied the second, “did cause,” Althen prong. Althen, 418 F.3d at 1278. As discussed above, the QAI recognize that vasovagal syncope may be preceded by lightheadedness,15 a symptom reported by Petitioner as occurring only minutes after vaccination. Ex 5c at 107, 113, 119, 120, 123-24, 129. The QAI also indicate that while vasovagal episodes are usually benign, they can “result in falling and injury with significant sequela.” 42 C.F.R. § 100.3(c)(13). While I reiterate the fact that this 12 Advisory Committee on Immunization Practices. 13 See C.C. v. Sec’y of Health & Hum. Servs., No. 17-0708V, 2021 WL 2182817, at *21 (Fed. Cl. Spec. Mstr. Mar. 31, 2021) (citing Doe 21 v. Sec'y of Health & Hum. Servs., 88 Fed. Cl. 178, 199 (2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013)) (in non-Table cases, “a link to a Table injury can support a petitioner's ability to fulfill Althen's first prong”); Lesher v. Sec’y of Health & Hum. Servs., No. 17- 1076V, 2020 WL 4522381, at *11 (Fed. Cl. Spec. Mstr. July 2, 2020) (citing Doe 21, 88 Fed. Cl. at 193) (a “recognition of the causal link between vaccine and injury has been held to support the establishment of the theory require[d] by the first Althen prong, since it suggests the existence of reliable medical or scientific evidence supporting the ‘can cause’ prong”). 14 In reaching a decision in this case, I have considered other decisions issued by special masters involving similar injuries, vaccines, or circumstances. There is no error in doing so. Although only Federal Circuit decisions control the outcome herein (Boatmon, 941 F.3d at 1358-59; Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998)), special masters reasonably draw upon their experience in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338-39 (2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and experience to know the type of information that is most probative of a claim”). I would therefore be remiss in ignoring prior cases presenting similar theories or factual circumstances, along with the reasoning employed in reaching such decisions. 15 42 C.F.R. § 100.3(c)(13). 13 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 14 of 17 is not a Table claim, the QAI description of a comparable injury has relevance to understanding these circumstances. In this case, the records reflect that approximately five minutes after vaccination, Petitioner was descending a flight of stairs when she felt dizzy and “took a mis-step and fell on the concrete floor.” Ex 5c at 121; Ex 7 at 172. Furthermore, Petitioner’s treating physicians consistently classified her episode as a vasovagal presyncopal response to the flu vaccination. See, e.g., Ex 5c at 111, 113, 117, 119, 120, 123, 167. For example, the ER records reflect that Petitioner presented with a “syncopal episode leading to LLE16 injury” after receiving her flu vaccine. Ex 5c at 107. Dr. Heng, the orthopedic surgeon, also attributed Petitioner’s fall to a “pre-syncope (likely vasovagal)” episode. Ex 5c at 119. Finally, Petitioner’s discharge summary further reflects that she “had a vaso-vagal fall” causing a left tibial plateau fracture. Ex 5c at 89. In determining whether the flu vaccination caused Petitioner’s injury, I have also considered whether the records demonstrate evidence of any other condition that could have resulted in her vasovagal episode.17 Petitioner’s past medical history includes hypertension; however, on her initial presentation to the ER, the evaluating physician noted there was low concern for a cardiac cause of her fall. Ex 5c at 111. Additionally, the treatment records reflect that Petitioner denied chest pain, shortness of breath, palpitations, and focal neurological changes preceding her fall, and there was “[l]ow suspicion for cardiogenic or neurologic etiology of [her] near syncope.” Ex 5c at 117, 119. As a precaution, Petitioner was referred for perioperative risk evaluation, which found that Petitioner’s history of “feeling well prior to getting [the] flu shot then [getting dizzy] a few minutes after . . . strongly suggests a vasovagal response to her shot.” Id. at 119-20, 123. As Petitioner had no cardiac history and a “normal cardiac exam . . . and . . . ECG,” Petitioner was determined to be at low risk of developing cardiac and pulmonary complications during surgery. Id. at 120-23.18 Overall, the evidence establishes that Petitioner experienced a “painful stimulus” (vaccination), which activated her central nervous system. Once vaccination was 16 Left lower extremity. 17 See Kidwell, 2021 WL 4203056, at *16-18. 18 In contrast to the present case, treaters who contemporaneously evaluated the petitioner in Kidwell after her “episode” concluded that no syncopal (or presyncopal) process was implicated. 2021 WL 4203056, at *16-17. The Kidwell petitioner’s ER discharge records also listed a transient ischemic attack as the most likely explanation for her symptoms. Id. The special master’s decision further notes that the Kidwell petitioner’s symptoms were also consistent with additional other disorders for which she had established diagnoses (e.g., bradycardia, vertigo, and a disorder of the inner ear). Id. at 17-18. The Kidwell petitioner also had a pre-existing history of syncopal episodes unrelated to vaccination. Id. at 18. 14 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 15 of 17 complete and Petitioner was released to return to work, she experienced relief from her anxiety (likely accompanied by decreased heart rate and lowered blood pressure), causing her to feel woozy, dizzy, and weak. Petitioner’s treating physicians universally attributed her symptoms of wooziness, dizziness, and weakness and her subsequent fall to a presyncopal, or near syncopal, vasovagal reaction to vaccination. Ex 5c at 89, 107, 111, 113, 117, 119, 120, 123-24, 129, 167. And as noted above, presyncope occurs through the same physiologic process as syncope, with common symptoms between the two conditions. Centeno at 2-3; Whitledge at 1. There is also no other competing explanation for Petitioner’s vasovagal response. Preponderant evidence supports the conclusion that the vaccine likely caused her presyncopal reaction. 3. Althen Prong 3 Petitioner has also provided preponderant evidence showing a proximate temporal relationship between the vaccination and injury. Petitioner fell within 15 minutes of vaccination – receiving the flu vaccine at 9:30am and then arriving at the ER by 9:45am. The medical records further document that Petitioner felt woozy, dizzy, and weak immediately preceding her fall. Given this timeline, these symptoms, which resulted in her fall, must have occurred within minutes of vaccination. As discussed above, presyncope is a prodrome of syncope and occurs through the same pathophysiologic process as syncope, which most commonly occurs within 15 minutes of vaccination. Sutherland at 3; Centeno at 2-3; Whitledge at 1. Therefore, I find there is preponderant evidence to conclude that Petitioner’s influenza vaccination resulted in a vasovagal episode only minutes after vaccination, and that such a timeframe between vaccination and onset is medically acceptable. 4. Other Entitlement Issues Petitioner must also establish that her injuries satisfy the Vaccine Act’s severity requirement. § 300aa-11(c)(1)(D). In relevant part, the Vaccine Act requires a petitioner to demonstrate that the residual effects of her injury persisted for at least six months or that her injury resulted in inpatient hospitalization and surgical intervention. Id. As discussed above, the medical records show that Petitioner was hospitalized for five days and underwent surgery to treat her left lower extremity fractures after her fall. Ex 5c at 89, 138-39. Petitioner also continued to suffer the residual effects of her injury for more than six months, as she underwent a third surgical revision procedure on May 29, 2019, eight months after vaccination. Ex 5g at 284-87. Accordingly, this requirement is satisfied. 15 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 16 of 17 5. Comment on Table’s LOC requirement Respondent often reasonably “polices” the requirements of a Table claim, since such a claim relieves petitioners of the obligation to establish causation. Thus, Respondent not only requires strict satisfaction of Table requirements (for example, refusing to concede SIRVA claims where a 48-hour onset is not established), but also resists arguments that a claimant’s showing that falls just short of a Table element is nevertheless “close” enough to enjoy the Table’s protective benefits. See, e.g., Greene v. Sec’y of Health & Human Servs., No. 11-0631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019) (denying entitlement when the petitioner’s brachial neuritis symptoms arose 41 days after vaccination and thus outside of the 28-day limit for a brachial neuritis Table claim), review denied, 164 Fed. Cl. 655 (2020), aff’d, 841 Fed. Appx. 195 (2020). Here, it might appear that my determination effectively stretches the terms of a Table syncope claim, permitting Petitioner to recover despite her inability to prove LOC. But that view, while understandable, would be incorrect. Because in this case Petitioner has preponderantly demonstrated, with citation to persuasive items of literature, that she experienced a different form of syncope that is not dependent on LOC. In other matters, by contrast, the inability to meet the Table claim elements is fatal, where the existing science so plainly supports a particular element that falling “closely” outside of it means the facts of the case presented are not likely to establish what in other circumstances might be a legitimate vaccine injury. See, e.g., Rowan v. Sec’y of Health & Human Servs., No. 17-0760V, 2020 WL 2954954, at *19 (Fed. Cl. Spec. Mstr. Apr. 28, 2020) (petitioner’s claim dismissed because she had not demonstrated that the flu vaccine could cause GBS in a 30 to 36-hour timeframe); see also Orton v. Sec’y of Health & Human Servs., No. 13- 631V, 2015 WL 1275459 (Fed. Cl. Spec. Mstr. Feb. 23, 2015) (claim with a one-day onset of GBS after flu vaccine dismissed). However, the inability to meet Table elements will not always mean a non-Table version of the same claim could succeed – as I have found here. VI. Conclusion Petitioner has preponderantly demonstrated that (1) flu vaccination can cause a vasovagal response; (2) this vasovagal response resulted in dizziness, wooziness, and weakness, causing Petitioner’s fall; (3) the onset of her symptoms occurred within minutes of vaccination; and (4) her injury resulted in inpatient hospitalization and surgical intervention. Therefore, I find that Petitioner is entitled to compensation. 16 Case 1:20-vv-00381-UNJ Document 43 Filed 04/08/22 Page 17 of 17 VII. Scheduling Order Petitioner shall file a status report updating me on the progress made toward informally resolving the issue of damages by no later than Friday, April 8, 2022.19 The status report shall indicate the date by which Petitioner provided, or intends to provide, a demand for damages to Respondent. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 19 The parties are reminded that they should not retain a medical expert, life care planner, or other expert without consulting each other and the Chief Special Master. If counsel retains an expert without so consulting in advance, reimbursement of those costs may be affected. 17 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00381-1 Date issued/filed: 2023-02-03 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 01/04/2023) regarding 55 DECISION of Special Master ( Signed by Chief Special Master Brian H. Corcoran. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0381V UNPUBLISHED SHARON CAMPBELL, Chief Special Master Corcoran Petitioner, January 4, 2023 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Decision Awarding Damages; Pain HUMAN SERVICES, and Suffering; Influenza (Flu) Vaccine; Presyncope; Vasovagal Respondent. Response. John Robert Howie, Howie Law, PC, Dallas, TX, for Petitioner. Amanda Pasciuto, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On April 3, 2020, Sharon Campbell filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). The case was assigned to the Special Processing Unit (“SPU”) of the Office of Special Masters. On March 9, 2022, I determined that Petitioner established causation-in-fact based upon an influenza (“flu”) vaccine received on September 17, 2018. See generally Entitlement Ruling (ECF No. 40). I specifically found that Petitioner had carried her burden of establishing off-Table injuries including a presyncope vasovagal 1 Because this unpublished opinion 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 opinion 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-00381-UNJ Document 62 Filed 02/03/23 Page 2 of 11 response, leading to inpatient hospitalization and surgical interventions on her left knee. Entitlement Ruling at 16.3, 4 However, the parties could not resolve the quantum of damages (solely pain and suffering) to be awarded, and therefore have briefed their dispute for my resolution. Petitioner’s Damages Brief filed July 13, 2022 (ECF No. 49); Respondent’s Brief filed August 4, 2022 (ECF No. 51); Petitioner’s Reply filed August 23, 2022 (ECF No. 52). For the following reasons, I find that Petitioner is entitled to an award of $190,000.00 (representing actual pain and suffering). I. Relevant Factual History I have reviewed all of the evidence filed to date. This ruling, however, is limited to determining facts pertaining to Petitioner’s pain and suffering. Accordingly, I will only summarize or discuss evidence that directly pertains to this issue. A. Contemporaneous Medical Records Petitioner was 64 years old and employed full-time as a histology specialist at Massachusetts General Hospital (“MGH”), where she received the subject flu vaccine during an outdoor clinic on September 17, 2018. Ex. 2 at 1; Ex. 7 at 187.5 Upon walking away, she became “woozy,” fell down several stairs, and was transported on a stretcher into the MGH emergency room (“ER”). Ex. 5c at 95. She rated her initial pain at 9-10/10, received IV Dilaudid (hydromorphone), and was admitted for a likely fracture of the left tibia and fibula. Id. at 96-98, 102, 111-13; see also id. at 237-38 (CT scan). On September 19, 2018, orthopedic surgeon R. Malcolm Smith, M.D., performed the first surgical intervention, which involved an open reduction – involving a 20 cm (7.9 inch) incision to expose the lower femur, knee, tibia, and fibula – followed by internal 3 Petitioner could not establish a Table claim of vasovagal syncope because she did not lose consciousness after the vaccination. Entitlement Ruling at 10 (citing 42 C.F.R. § 100.3(c)(13)). “Presyncope, also known as ‘near-syncope,’ is the prodrome of syncope without the loss of consciousness.” Entitlement Ruling at 12 (internal citations omitted). 4 The Entitlement Ruling’s prior summary of the procedural history and facts is fully incorporated and relied upon herein. This Decision expands upon aspects that are relevant to the parties’ arguments, as well as my ultimate determination, of the appropriate damages award. 5 Petitioner contacted occupational health about her injury that same day. Ex. 7 at 187, 801-03. She initiated a workers’ compensation claim, which was approved later that month. Id. at 41-43. 2 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 3 of 11 fixation of a metal plate and several screws to stabilize the left tibial plateau fracture. Dr. Smith also repaired a lateral meniscus tear. He stapled the incision closed. Ex. 5c at 138- 39, 477; see also Ex. 25a (x-rays). He assessed that Petitioner also had “very poor bone quality,” putting her at risk for further fractures. Ex. 5c at 129. An endocrinologist concurred that Petitioner “may have” previously untreated osteoporosis, for which daily supplemental vitamin D and calcium was recommended. Id. at 129-33. Id.6 On September 22, 2018, Petitioner was discharged home. She was given a knee immobilizing brace to wear for 8 –12 weeks; prescription-strength Tylenol (acetaminophen), and oxycodone (to take as needed). Ex. 5c at 93. On September 24, 2018, Petitioner underwent a home-based PT evaluation. Ex. 5c at 522. She also had six home health visits. Ex. 5c at 547, 601; Ex. 5d at 22, 61, 96, 125. Her pain ranged from 2 – 10/10 and she required assistance to ambulate. Id. At the October 9, 2018, orthopedics follow-up, the surgical wound was healing well. Ex. 5d at 173. The knee’s range of motion was improving, but there was still “aching discomfort.” Id. The knee displayed “a little bit of valgus.”7 Id. If the valgus progressed, she might require a knee replacement. Id. That same week, Petitioner was discharged from home health care. Ex. 5d at 226-27. During four further home-based PT sessions, Petitioner expressed concern about the prospect of further surgeries and further time away from work. Ex. 5d at 263-64, 294, 409, 468. At the next orthopedics follow-up on December 11, 2018, Petitioner was “feeling well” without “much pain.” Ex. 5d at 632. Repeat x-rays (id. at 611) reflected that the fracture was healing. Id. at 632. However, due to her poor bone quality, there was some “some subsidence and subsequent valgus alignment.” Consequently, one of the surgically inserted screws was “backing out,” which (the orthopedist explained) “might cause some pain while ambulating.” Id. at 632. However, Petitioner was cleared to remove the brace, bear weight on her leg as tolerated, start out-patient PT, and return to 6 Dr. Weil also recommended additional testing to confirm the suspicion of osteoporosis and to determine whether pharmacotherapy was warranted. Ex. 5c at 133. Subsequent medical records reflect that Petitioner’s primary care provider planned to schedule a DXA scan; “If it is abnormal to the point of requiring treatment… Dr. Weil will be the one to follow her since she consulted on [Petitioner’s] case.” Ex. 5c at 438. However, no further work-up for osteoporosis or follow-ups with Dr. Weil occurred. 7 Valgus is defined as “bent or twisted outward; denoting a deformity in which the angulation of the part is away from the midline of the body.” Dorland’s Medical Dictionary Online, www.dorlandsonline.com (hereinafter “Dorland’s”) (definition of “valgus”). 3 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 4 of 11 work 20 hours per week. Ex. 5d at 611; see also Ex. 7 at 107-08 (work approval letter); Ex. 5e at 9-13. 26 (first two PT sessions, reflecting pain rating of 5/10). On January 9, 2019, Petitioner reported increased pain and decreased range of motion. Ex. 5e at 78 (reflecting pain rating of 6/10). A repeat x-ray confirmed the same subsidence, valgus, and hardware instability. Id. at 91. Petitioner’s care was then transferred to another orthopedic surgeon, John Guido Esposito, M.D. Id. at 122-23. In the interim, Petitioner rated her pain on average as 4/10; ambulated with a cane; and worked part-time. However, her activities remained limited (e.g., she was unable to walk more than a mile, bend, kneel, or stoop). Ex. 5e at 201-02, 260, 285-87, 295-296, 404-05. On March 6, 2019, Dr. Esposito surgically opened the previous incision; removed the existing hardware; debrided and irrigated the knee; implanted antibiotic bone cement spacer at the proximal tibial defect; and closed the incision with staples. Ex. 5e at 526 (operative note);8 Ex. 26 (post-operative x-ray images). Petitioner was hospitalized for this procedure and discharged three days later – again, with a knee brace and prescription pain medication. Ex. 5e at 221-683 (hospitalization records). She also started another full-time leave of absence from work. She followed with Dr. Esposito and underwent home health and home-based PT treatment. Her pain ranged from 4 – 8/10 for the first few weeks, then decreased to 4 – 5/10. She ambulated with a rolling walker and used the left leg only for balance (touch-down weight bearing, or “TDWB”). Ex.5f at 76, 97, 149, 193, 208, 222, 284, 322, 352, 426, 460, 483, 536, 558; Ex. 5g at 88. On May 29, 2019, Dr. Esposito surgically opened the previous incision; performed a total knee arthroplasty (replacement); and again closed the incision with staples. Ex. 5g at 284-87 (operative note); see also Ex. 26 (post-operative x-ray images). She was discharged the following day. Ex. 5g at 290. During approximately one month of home health and home-based PT sessions, Petitioner rated her pain at 5-10/10. Ex. 5g at 440, 476, 536-37, 552; Ex. 5h at 31, 93, 122, 258, 262. On June 13, 2019, the surgical staples were removed. Ex. 5h at 154-55. Her pain was “well-controlled and appropriate for her level of recovery,” and she was transitioned from oxycodone to tramadol. Id. at 154, 164. 8 The operative note inadvertently states, “right knee,” but there is no dispute that the March 6, 2019, surgery was on Petitioner’s left knee. 4 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 5 of 11 At a June 25, 2019, initial outpatient PT evaluation, Petitioner rated her pain at 6- 8/10. She had decreased ROM and strength in the left knee, pelvic instability, and deviated gait. She would work to “eliminate or reduce” these symptoms in formal sessions, tentatively twice a week for four months. After the symptoms “subside[d],” Petitioner would progress to a home exercise program. Ex. 8 at 2-3. At a July 11, 2019, orthopedics follow up, Petitioner was doing well and making progress with swelling and range of motion. She had no pain with gentle motion of the knee, and good stability, strength, alignment, and sensation. She was taking prescription acetaminophen and ambulating with a cane. The orthopedic surgeon, Dr. Esposito, noted their “detailed” discussion about the “rehab plan and prognosis.” Ex. 5h at 523-24. On August 9, 2019, he authorized a return to work part-time (4 hours per day). Ex. 7 at 178. On August 10, 2019, Petitioner submitted to a different orthopedic surgeon’s independent medical examination (“IME”) for her workers’ compensation claim. Ex. 7 at 171-77. The IME concluded that the post-vaccine fall was the “the major contributing cause of her left knee condition by causing a comminuted tibial plateau fracture, which then developed a malunion and hardware failure, and an eventual total knee replacement.” Id. at 175-76. She was not a candidate for any further surgery. Id. at 176. She required additional PT and a home exercise program, and she would not reach maximum medical improvement “until at least” the following spring. Id. at 176; see also Ex. 8 at 4-25 (PT sessions). On August 23, 2019, the treating orthopedic surgeon recorded that Petitioner’s knee range of motion was further increased (“0 to 90 degrees of flexion”) and she was no longer using a cane to ambulate. The rehab plan and prognosis were again discussed, but not recorded. Petitioner would follow up again in approximately one year. Ex. 5h at 595-96. One month later, Petitioner was authorized to work full-time with restrictions on repetitive bending, squatting, kneeling, stair climbing, and walking. Ex. 7 at 800. By December 23, 2019, Petitioner had completed a total of 37 PT sessions. Her activities of daily living and ambulation tolerance were “improving.” She had improved strength on break tests, but easy fatigue; improved mechanics of gait with verbal cues; and continued functional limitations including ambulation endurance, navigating stairs, bed mobility, and driving. She would “continue [a home exercise program] independently and contact clinic and MD if progress [did] not continue as expected.” Ex. 8 at 62-63. There are no further medical records pertaining to Petitioner’s left knee for over six months. Then, on July 2, 2020, a repeat x-ray visualized that the total knee replacement was aligned normally, intact, and showed no evidence of loosening. Ex. 13 at 95. 5 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 6 of 11 However, the left leg had a “mild residual valgus angulation.” Id. Petitioner reported an “occasional knee ache which [was] tolerable.” Id. at 132. Her range of motion was further increased (“0 to 100 degrees of flexion”). Id. The orthopedic surgeon assessed that she was “doing well” and had “made progress with therapy”; he did not plan any further treatment. Id. at 133. Petitioner would follow up with repeat x-rays in one year. Id. The next medical records are from March 21, 2022, when Petitioner returned to the same PT practice. She reported that her chronic left knee pain had worsened over the last two months and was currently rated at 3 – 8/10. Ex. 24 at 2. She had abnormal gait; difficulty climbing stairs; left knee flexion deficits (80 degrees, compared to 130 degrees); and decreased muscle strength (with pain and spasms). Id. The therapist appeared to recommend additional formal PT, id. at 3, but there are no further records. B. Affidavits Before her injury, Petitioner reports, she had enjoyed an active lifestyle featuring daily walks as well as skiing and bowling. Since the September 2018 injury, however, she has suffered from persistent weight gain; diminished stamina, balance, and range of motion; knee swelling over the course of the day; a limp by the end of the work week; disrupted sleep; and less independence in her daily life. Ex. 1; see also Ex. 27 at ¶¶ 1-3 (her supplemental affidavit); accord Ex. 28 (affidavit of her older son). Petitioner averred that in July 2020, her orthopedic surgeon did not offer any further treatment for her ongoing pain, swelling, and impairments. Ex. 27 at ¶ 4.9 She acquiesced to merely following up in a year – but missed that appointment after her younger son passed away suddenly and unexpectedly in April 2021. Id. at ¶ 5. At that point, she received extended bereavement leave from work and deferred further evaluations of her knee, especially in light of the prior explanations that “nothing more could be done.” Id. at ¶ 6. II. Authority Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” Section 15(a)(4). Additionally, a petitioner may recover “actual unreimbursable expenses incurred before the date of judgment award such expenses which (i) resulted from the vaccine-related injury for which petitioner seeks 9 Ex. 27 at ¶ 6 states that Petitioner last saw the orthopedic surgeon “in July of 2021.” This is a typo. The last appointment was in July 2020. See Ex. 13 at 132-33. 6 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 7 of 11 compensation, (ii) were incurred by or on behalf of the person who suffered such injury, and (iii) were for diagnosis, medical or other remedial care, rehabilitation . . . determined to be reasonably necessary.” Section 15(a)(1)(B). The petitioner bears the burden of proof with respect to each element of compensation requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). There is no mathematic formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“[a]wards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula”); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective evaluation”). Factors to be considered when determining an award for pain and suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister v. Sec’y of Health & Hum. Servs., No 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). I may also consider prior pain and suffering awards to aid my resolution of the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Hum. Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in determining the proper amount of damages in this case.”). And, of course, I may rely on my own experience (along with my predecessor Chief Special Masters) adjudicating similar claims.10 Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). Although pain and suffering in the past was often determined based on a continuum, as Respondent argues, that practice was cast into doubt by the Court several years ago. Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579 (2013). In Graves, the Court maintained that to do so resulted in “the forcing of all suffering awards into a global comparative scale in which the individual petitioner’s suffering is compared to the most extreme cases and reduced accordingly.” Id. at 590. Instead, Graves assessed pain and suffering by looking to the record evidence, prior pain and suffering awards within the 10 From July 2014 until September 2015, the SPU was overseen by former Chief Special Master Vowell. For the next four years, until September 30, 2019, all SPU cases, including the majority of SIRVA claims, were assigned to former Chief Special Master Dorsey, now Special Master Dorsey. In early October 2019, the majority of SPU cases were reassigned to me as the current Chief Special Master. 7 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 8 of 11 Vaccine Program, and a survey of similar injury claims outside of the Vaccine Program. Id. at 595. Under this alternative approach, the statutory cap merely cuts off higher pain and suffering awards – it does not shrink the magnitude of all possible awards as falling within a spectrum that ends at the cap. Although Graves is not controlling of how pain and suffering is to be calculated herein, it makes sound points about the functioning of the statutory cap. III. Appropriate Compensation for Petitioner’s Pain and Suffering In this case, awareness of the injury is not disputed. The record reflects that at all times, Petitioner was a competent adult with no impairments that would impact her awareness of her injury. Therefore, I analyze principally the severity and duration of her injury. Petitioner averred that she should be compensated $250,000.00 – whether that figure is designated solely for her actual pain and suffering or involves some future component. Brief at 2. In reaction, Respondent stated that the evidence supported only actual pain and suffering, and a lesser award of $150,000.00. Response at 1.11 In performing this analysis, I have reviewed the record as a whole, including all medical records, affidavits, declarations, and all other filed evidence, plus the parties’ briefs and other pleadings. My ultimate determination is based on the specific circumstances of this case. In addition, in any case in which the parties cannot agree to a damages component, I have considered my experience adjudicating damages generally – including the fact that even the most self-limiting and transient of vaccine injuries from an immediate-impact stance can have “significant treatment consequences.” Hietpas v. Sec’y of Health & Hum. Servs., No. 19-1702V, 2021 WL 688620, at *5 (Fed. Cl. Spec. Mstr. Jan. 15, 2021) (recognizing that intussusception can necessitate surgical intervention). Because most vaccine injury claims involving syncope, presyncope, and vasovagal response are resolved informally, there are few reasoned decisions that can guide this outcome. Petitioner urged comparison to past damages decisions concerning shoulder injuries related to vaccine administration (“SIRVA”) – and specifically those resulting in between two to three (most often arthroscopic) surgeries, with awards of 11 Respondent has again argued for a pain and suffering “continuum” – on the basis that Congress created the $250,000.00 statutory cap while contemplating “very serious” injuries – such as paralysis, encephalopathy, and seizure disorders – “involv[ing] severe neurological and other complications that would require lifelong medical care.” Response at 11-18. Here, Respondent averred that Petitioner’s injury is comparatively less severe, and thus, should not receive the statutory maximum. Id. at 18. Nevertheless, Respondent accepted Graves “to the extent it calls for an individualized assessment of damages based on the specific facts of a petitioner’s case,” Id. at 11 - which is in fact the proper the focus of the analysis. 8 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 9 of 11 between $200,000.00 - $210,000.00 for actual pain and suffering. Brief at 19-20.12 Respondent agreed that such cases “may be helpful in consideration of surgical treatment for a vaccine injury,” even though the specific injuries differed. Response at 19. And it is certainly true that SIRVA cases requiring surgery typically are associated with higher awards. However, the existing case law has not (to date) drawn a distinction based on whether surgical intervention is arthroscopic or more invasive, as Petitioner has argued for here. Moreover, any damages award takes into account multiple factors – including the scope and extent of other treatment efforts. For example, Meirndorf (full citation at note 12, supra) involved surgery plus “three steroid injections, five laser treatments, two joint injections…” Meirndorf, 2022 WL 1055475, at *2. And in Lawson, the injured party received seven cortisone injections, and then started platelet-rich plasma (“PRP”) injections four years into the course of treatment. Lawson, 2021 WL 688560, at *1-3. The damages awards took into account these additional interventions – making clear that surgery is not the only relevant factor (even if it supports a higher-than-average award otherwise). In adjudicating damages for a given injury, a more helpful benchmark will generally be past decisions on similar injuries with similar potential symptoms, treatment interventions, and outcomes. See Gunter v. Sec’y of Health & Hum. Servs., No. 17- 1941V, 2020 WL 662141, *4 (Fed. Cl. Spec. Mstr. Oct. 13, 2020) (declining to consider a past damages award for syncope, upon awarding damages for SIRVA). But as already noted, such on-point cases specific to syncopal, presyncopal, and vasovagal injuries and their sequelae are hard to come by. Thus (and as I have done in other cases where necessary), settled matters also give some guidance. See, e.g., Hietpas, 2021 WL 688620, at *5.13 12 Citing Elmakky v. Sec’y of Health & Hum. Servs., No. 17-2032V, 2021 WL 6285619 (Fed. Cl. Spec. Mstr. Dec. 3, 2021) (awarding $205,000.00 for actual pain and suffering); Lawson v. Sec’y of Health & Hum. Servs., No. 18-0882V, 2021 WL 688560 (Fed. Cl. Spec. Mstr. Jan. 5, 2021) ($205,000.00); Welch v. Sec’y of Health & Hum. Servs., No. 18-0074V, 2021 WL 1795205 (Fed. Cl. Spec. Mstr. Apr. 5, 2021) ($210,000.00); Meirndorf v. Sec’y of Health & Hum. Servs., No. 19-1876V, 2022 WL 1055475 (Fed. Cl. Spec. Mstr. Mar. 7, 2022) ($200,000.00). 13 Citing Edwards v. Sec’y of Health & Hum. Servs., No. 18-0138V, 2019 WL 7597444 (Fed. Cl. Spec. Mstr. Dec. 13, 2019) (awarding $100,000.00 for actual pain and suffering for syncope, fractured jaw, ruptured eardrum, chin laceration, and fractured teeth); Hoelzel v. Sec’y of Health & Hum. Servs., No. 17-1987V, 2018 WL 7220754 (Fed. Cl. Spec. Mstr. Dec. 19, 2018) ($100,000.00 for actual and projected pain and suffering for syncope, concussion, dental fractures, and permanent facial scarring); and Aholt v. Sec’y of Health & Hum. Servs., No. 12-0055V, 2012 WL 2866119 (Fed. Cl. Spec. Mstr. June 18, 2012) ($100,000.00 for actual and projected pain and suffering for syncope and various injuries to face, jaw, and teeth). For 9 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 10 of 11 In Hietpas, a syncope followed by facial bone fractures, suturing, surgery, physical therapy, and a splint warranted an award of $140,000.00 for actual pain and suffering. Id. at * 5-6. In the present case, Ms. Campbell alleged that her own treatment course was “considerably longer and considerably more involved,” therefore supporting a significantly higher award. Brief at 19. Respondent contended that Hietpas was in fact roughly comparable, based on his characterization hat the Hietpas petitioner “underwent multiple jaw surgeries.” Response at n. 8. This may be due to an inadvertent reading of Hietpas – potentially, an interpretation of the initial suturing as surgery, when it in fact seemed like a preliminary and less invasive measure - meaning Hietpas in fact involved only one surgery. I find that the present case warrants a higher award than in Hietpas. Petitioner’s initial course was more severe - including three surgeries each resulting in a brief hospitalization, prescription pain medication, and limited range of motion and weightbearing. This case also reflects more significant life disruptions – namely, medically excused extended absences, totaling approximately one year, from Petitioner’s employment. In contrast, Hietpas involved a teenager without extended absences from school (although she described foregoing certain extracurricular activities such as volleyball). This case also documents a greater number of PT sessions – 37, compared to only seven in Hietpas.14 After approximately one year, in September 2019, Petitioner was permitted to return to work full-time but with restrictions. The subsequent medical records also support that she had reduced but persistent pain, weakness, and motion deficits. The December 2019 PT record notes these residual symptoms and does not explain the discharge to a home exercise program – e.g., whether that was Petitioner or the therapist’s decision. I recognize Petitioner’s recollection that in July 2020, her orthopedist explained that she would always have some residual deficits even with additional treatment. However, the orthopedist’s records are imperfect and do not address the PT’s suggestion of additional formal sessions “if progress [did] not continue as expected.” There is also no evidence that Petitioner sought pain medications or additional accommodations at work prior to the loss of her son in April 2021. I accept that such an event could reasonably have reduced an individual’s capacity to seek medical treatment for a chronic injury. The March 2022 PT reevaluation also reflects objective, ongoing deficits with no clear evidence of any each case, the medical details were alleged in the petition and subsequently in the decision approving the parties’ agreed-upon proffer. 14 Petitioner also asserted emotional suffering as a result of post-surgical permanent and significant scarring on her leg. Brief at 19. I find that such scarring is roughly equivalent to the “permanent scarring on [the vaccinee’s] chin” in Hietpas, 2021 WL 688620, at *6. 10 Case 1:20-vv-00381-UNJ Document 62 Filed 02/03/23 Page 11 of 11 alternative cause.15 Thus, Petitioner’s ongoing deficits, however mild, are substantially attributable to the vaccine injury – consistent with the conclusions of her treating providers and an IME. Overall, I conclude that Petitioner’s pain and suffering was severe to moderate for nearly one year. Her pain and suffering have since persisted, albeit at a more mild level, to date – but they are not sufficiently documented to support a separate award for future pain and suffering. She is thus entitled to an actual pain and suffering award of $190,000.00.16 While the initial injury itself at issue was transient and seemingly minor, the impact of that event was uncommonly severe – justifying a fairly high pain and suffering award. Conclusion Based on the record as a whole and the parties’ arguments, I award Petitioner a lump sum payment of $190,000.00 (for actual pain and suffering). This amount represents compensation for all damages that would be available under Section 15(a). The Clerk of the Court is directed to enter judgment in accordance with this Decision.17 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 15 Likewise, I do not find sufficient objective evidence that Petitioner’s condition worsened in early 2022. 16 Since this amount is being awarded for actual, rather than projected, pain and suffering, no reduction to net present value is required. See § 15(f)(4)(A); Childers v. Sec’y of Health & Hum. Servs., No. 96-0194V, 1999 WL 159844, at *1 (Fed. Cl. Spec. Mstr. Mar. 5, 1999) (citing Youngblood v. Sec’y of Health & Hum. Servs., 32 F.3d 552 (Fed. Cir. 1994)). 17 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 11