Pub. L. No. 99-660

The Act creates an alternative no-fault vaccine-injury compensation program while leaving state tort and contract remedies available, as modified by the Act.

Abbot v. American Cyanamid Co. · filed 1988-04-20

Congress, when it addressed vaccines in 1986 and 1987, did not preempt state law. Further, to the extent that the Acts state congressional views about the preemptive effect of earlier legislation, the Acts and their legislative history assume that earlier legislation was of no preemptive effect.

Under the Act, attorneys’ fees are compensation and cannot be paid from Program funds until the petitioner elects to receive compensation under § 21(a).

Ashe-Cline v. Secretary of Department of Health & Human Services · filed 1993-10-29

The court concludes, based on the plain language of the statute, that the term “compensation” means all forms of compensation to a petitioner authorized by the Act, ie., all forms of compensation listed in § 15 (“Compensation”), including attorneys’ fees, which are authorized in § 15(e) (“Attorneys’ fees”). If “compensation” includes “attorneys’ fees,” the § 15(f)(1) prohibition on the payment of “compensation” until a petitioner has elected “to receive compensation” under § 21(a) also bars the payment of attorneys’ fees until such an election is made. Because petitioner indisputably has not elected to receive “compensation” under § 21(a), but, instead, has elected the alternative of filing a civil action, the court holds that petitioner’s attorneys’ fees may not be paid from funds authorized under the Program.

The Act does not completely preempt state tort remedies for vaccine-related injuries; in some circumstances claimants must first complete the federal compensation proceeding.

Patten v. Lederle Laboratories · filed 1987-02-12

It is clear to the court that the scheme established by the language of the Act itself demonstrates that Congress contemplated that civil tort remedies for vaccine-related injuries have been available, are now available, and will continue to be available under certain circumstances, even after the effective date of the Act.

The Act permits state tort remedies for vaccine-related injuries despite compliance with federal vaccine regulations.

Graham Ex Rel. Graham v. Wyeth Laboratories · filed 1987-07-22

The NCVIA further evinces a congressional intent that civil tort actions were— and are — permissible despite compliance with the FDA regulations.

Section 11113 allows a substantially prevailing defendant to seek attorney fees when the professional review action met § 11112(a) standards, even if the defendant prevailed on another defense and did not obtain immunity.

Addis v. Holy Cross Health System Corporation · filed 1996-07-08

In the latter case, where the final disposition is not related to immunity, defendants may still file postjudgment motions for attorney fees under the Health Care Act. The text of § 11113 explicitly states that an award of fees may be appropriate "to the extent that a defendant has met the standards set forth under [sec. 11112(a) ]." It does not link an award of fees to immunity, as might be the case were § 11113 written along the lines of, "to the extent that a defendant has acquired immunity from damages liability as provided for in § 11111(a)." Nothing in § 11112 confers immunity; that section only describes the criteria for a qualifying review action. The plain meaning of § 11113 demonstrates that Congress did not intend immunity to be a prerequisite to an award of attorney fees. The fact that § 11113 is not part of the section conferring immunity reinforces the conclusion that they are indeed independent questions.

The Act requires a Vaccine Program claimant to prove actual causation by preponderant evidence based on the record as a whole, and bars entitlement based solely on unsubstantiated personal claims.

Sullivan v. Secretary of Health and Human Services · filed 2015-03-27(a)(1)

Petitioners bear the burden of demonstrating actual causation by preponderant evidence. Cedillo v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); § 300aa-13(a)(1). ... To determine if the petitioner has carried her burden, I must assess “the record as a whole” and may not make an entitlement decision in her favor based solely on her own claims “unsubstantiated by medical records or by medical opinion.” § 300aa-13(a)(1).

The Act requires an off-Table Vaccine Program claimant to prove by a preponderance of the evidence that a listed vaccine received in the United States caused a condition that persisted for more than six months.

Morgan v. Secretary of Health and Human Services · filed 2016-01-12(a)(1)(A)

An “off-Table” injury is initially established when the petitioner demonstrates by a preponderance of the evidence: (1) she received a vaccine set forth on the Vaccine Injury Table; (2) she received the vaccine in the United States; (3) she sustained or had significantly aggravated an illness, disease, disability, or condition caused by the vaccine; and (4) the condition has persisted for more than six months. § 13(a)(1)(A).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Bell v. Secretary of Health and Human Services · filed 2017-01-31(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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. Section 13(a)(1).

The Act requires a vaccine-compensation claimant to prove causation by a preponderance of the evidence and bars an award based solely on unsupported personal claims.

Harmon v. Secretary of Health and Human Services · filed 2017-07-06(a)(1)

Petitioner bears the burden of demonstrating actual causation by a preponderance of the evidence. See Cedillo v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); § 300aa-13(a)(1). ... The undersigned must consider the record “as a whole” and may not rule in petitioner’s favor solely based on petitioner’s own claims “unsubstantiated by medical records or medical opinion.” § 13(a)(1).

The Act requires an off-Table Vaccine Program claimant to prove by a preponderance of the evidence that the vaccine caused the injury, but the vaccine need not be the sole or predominant cause; showing that it was a substantial factor and a but-for cause is sufficient.

Rodriguez v. Secretary of Health and Human Services · filed 2017-11-20(a)(1)

The Vaccine Act provides two avenues for petitioners to receive compensation. First, a petitioner may demonstrate a “Table” injury—i.e., an injury listed on the Vaccine Injury Table that occurred within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed on the Vaccine Injury Table, a petitioner may demonstrate an “off-Table” injury, which requires that the petitioner “prove by a preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at 1320; see § 11(c)(1)(C)(ii). A petitioner need not show that the vaccination was the sole cause, or even the predominant cause, of the alleged injury; showing that the vaccination was a “substantial factor” and a “but for” cause of the injury is sufficient for recovery.

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Carda v. Secretary of Health and Human Services · filed 2018-01-11(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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. Section 13(a)(1).

The Act permits a special master to find a Table injury’s onset period satisfied despite an unrecorded or incorrectly recorded onset, on a preponderance of the evidence.

Schoonover v. Secretary of Health and Human Services · filed 2019-03-05(b)(2)

In that regard, the undersigned notes that respondent’s argument is inconsistent with the Vaccine Act insofar as the statute instructs – at least with regard to Table injuries – that the special master may find the time period for the first symptom or manifestation of onset required for a Table injury is satisfied “even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such a period.” § 13(b)(2). “Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset . . . occured within the time period described in the Vaccine Injury Table.” Id.

The Act requires Vaccine Program petitioners to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Yalacki v. Secretary of Health and Human Services · filed 2019-03-06(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program petitioners to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Guzman v. Secretary of Health and Human Services · filed 2019-07-01(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

McKown v. Secretary of Health and Human Services · filed 2019-08-29(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires a Vaccine Program claimant to prove vaccine causation by a preponderance of the evidence based on the record as a whole.

Contino v. Secretary of Health and Human Services · filed 2019-10-08(a)(1)

Pursuant to Section 300aa-13(a)(1), in order to reach my conclusion, I have considered the entire record including all of the medical records, statements, expert reports, and medical literature submitted by the parties. This opinion discusses the elements of the record I found most relevant to the outcome. ... To satisfy the burden of proving causation-in-fact, petitioner must “show by preponderant evidence that the vaccination brought about the injury by providing 1) a medical theory connecting the vaccination and 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.” ... Petitioner’s must establish each Althen prong by the preponderance of the evidence. ... After a review of the entire record, I conclude that petitioner has established a reliable theory that the flu vaccination G.C. received on December 3, 2013 was the cause-in-fact of her urticarial vasculitis. Accordingly, petitioner is entitled to compensation.

The Act requires Vaccine Program claimants to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Schultz v. Secretary of Health and Human Services · filed 2020-03-03(a)(1)

For both Table and Non–Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove either a Table injury or an injury caused by a covered vaccine, and bars compensation based solely on unsupported claims.

Antolick v. Secretary of Health and Human Services · filed 2020-03-24(a)(1)

To receive compensation in the Vaccine Program, petitioners have the burden of proving either: (1) that the vaccinee suffered a “Table Injury,” i.e., an injury beginning within a specified period of time following receipt of a corresponding vaccine listed on the Vaccine Injury Table (a “Table injury”) or (2) that the vaccinee suffered an injury that was caused-in-fact by a covered vaccine. §§ 13(a)(1)(A); 11(c)(1). ... Moreover, under the Vaccine Act, the Vaccine Program may not award compensation based on the petitioner’s claims alone. Rather, the petitioner must support the claim with either medical records or the opinion of a competent medical expert. § 13(a)(1).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

N. v. Secretary of Health and Human Services · filed 2020-05-19(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Perekotiy v. Secretary of Health and Human Services · filed 2020-05-20(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program petitioners to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Samuels v. Secretary of Health and Human Services · filed 2020-06-02(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. ... 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).

The Act requires Vaccine Program claimants to prove entitlement by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Kern v. Secretary of Health and Human Services · filed 2020-10-06(a)(1)

Under the Vaccine Act, a petitioner may not receive a Vaccine Program award based solely on his claims alone. In this case, there is insufficient evidence in the record for Petitioner to meet his burden of proof, and insufficient reliable scientific proof offered in support of his causation theory. Therefore, Petitioner's claim cannot succeed and must be dismissed. Section 11(c)(1)(A).

The Act requires Vaccine Program claimants to prove entitlement by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Hock v. Secretary of Health and Human Services · filed 2020-11-02(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Hughes v. Secretary of Health and Human Services · filed 2021-03-05(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act permits a special master to find that a Table injury's onset occurred within the required period despite an unrecorded or incorrectly recorded onset, when the evidence proves that timing by a preponderance.

Meagher v. Secretary of Health and Human Services · filed 2021-04-07(b)(2)

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.” § 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. ... Accordingly, I find there is preponderant evidence to establish the onset of Petitioner’s pain occurred within 48 hours of the October 15, 2015 vaccination.

The Act requires an off-Table Vaccine Program claimant to prove by a preponderance of the evidence that the vaccine caused the injury, but the vaccine need not be the sole or predominant cause; it must be a but-for cause and a substantial factor.

Nifakos v. Secretary of Health and Human Services · filed 2021-04-12(a)(1)

If, however, a petitioner suffered an injury that either is not listed in the Table or did not occur within the prescribed time frame, she must prove that the administered vaccine caused injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or [an] off-Table” claim and to prevail, a petitioner must prove her claim by preponderant evidence. § 13(a)(1)(A). This standard is “one of . . . simple preponderance, or ‘more probable than not’ causation.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v. Sec’y of Health & Hum. Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal Circuit has held that to establish an off-Table injury, a petitioner must “prove . . . that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1351 (Fed Cir 1999). Id. at 1352. The received vaccine, however, need not be the predominant cause of the injury. Id. at 1351.

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Keja v. Secretary of Health and Human Services · filed 2021-05-03(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Loyd v. Secretary of Health and Human Services · filed 2021-07-01(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires a Vaccine Program decision-maker to assess entitlement using the entire record, including medical records, expert testimony, and literature.

Davis v. Secretary of Health and Human Services · filed 2021-09-01(a)(1)

Pursuant to Section 13(a)(1), in order to reach my decision, I have considered the entire record, including all of the medical records, expert testimony, and literature submitted by the parties.

The Act permits a special master to find that a Table injury's onset occurred within the required period despite an unrecorded or incorrectly recorded onset, when the evidence proves that timing by a preponderance.

Drumm v. Secretary of Health and Human Services · filed 2021-10-13(b)(2)

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. ... Accordingly, I find there is preponderant evidence to establish the onset of Petitioner’s pain occurred within 48 hours of vaccination.

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Kelly v. Secretary of Health and Human Services · filed 2021-11-12(a)(1)

For both Table and Non–Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. ... 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).

The Act allows a special master to find that a Table injury began within the required period even when the onset was not recorded then or was recorded as outside the period, if a preponderance of evidence proves timely onset.

Mahan v. Secretary of Health and Human Services · filed 2022-01-19(b)(2)

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 Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Sanchez v. Secretary of Health and Human Services · filed 2022-04-05(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act bars compensation when the injury was caused by factors unrelated to vaccine administration, and the respondent must prove that alternative causation by a preponderance of the evidence.

Maloney v. Secretary of Health and Human Services · filed 2022-04-11(a)(1)(B)

Because the undersigned concludes that petitioner has established a prima facie case, petitioner is entitled to compensation unless respondent can put forth preponderant evidence “that [petitioner’s] injury was in fact caused by factors unrelated to the vaccine.” ... Thus, respondent did not prove by a preponderance of evidence that petitioner’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B).

The Act requires a Vaccine Program petitioner to establish by a preponderance of the evidence the matters required for compensation, with allegations supported by medical records or medical opinion.

Clavio v. Secretary of Health and Human Services · filed 2022-04-11(a)(1)(A)

Before compensation can be awarded under the Vaccine Act, a petitioner must demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1). § 13(a)(1)(A). In making this determination, the special master or court should consider the record as a whole. § 13(a)(1). Petitioner’s allegations must be supported by medical records or by medical opinion. Id.

The Act places on a Vaccine Program petitioner the burden to show at least one defined and recognized injury.

Davis v. Secretary of Health and Human Services · filed 2022-05-24(a)(1)

As the Federal Circuit has made clear, “the statute places the burden on petitioner to make a showing of at least one defined and recognized injury.”

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Fantini v. Secretary of Health and Human Services · filed 2022-05-31(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act allows a special master to find that a Table injury began within the required period even when the onset was not recorded then or was recorded as outside the period, if a preponderance of the evidence proves timely onset.

Ortiz v. Secretary of Health and Human Services · filed 2022-08-04(b)(2)

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.” § 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. ... After a careful review of the record, I find that the evidence preponderates (albeit barely) in Petitioner’s favor on the disputed onset issue. ... Subsequent records in this case, however, all corroborate the injury and onset, and the Vaccine Act expressly does not obligate claimants to prove onset issues with evidence from within the alleged timeframe in any event. Section 13(b)(2).

The Act requires Vaccine Program claimants to prove either a Table injury or a non-Table injury caused by a vaccine, by a preponderance of the evidence, and bars awards based solely on unsupported assertions.

Chambers v. Secretary of Health and Human Services · filed 2022-08-16(a)(1)

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). ... For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act permits a special master to find that a Table injury's onset occurred within the required period despite an unrecorded or incorrectly recorded onset, when the evidence proves that timing by a preponderance.

Jones v. Secretary of Health and Human Services · filed 2022-08-23(b)(2)

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.” § 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. ... At bottom, the evidence preponderates, although just barely, in favor of a determination that onset began in 48 hours of vaccination.

The Act requires Vaccine Program petitioners to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Martinez v. Secretary of Health and Human Services · filed 2022-10-04(a)(1)

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). ... For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove either a Table injury within the prescribed period or a non-Table injury actually caused by a vaccine.

Howard v. Secretary of Health and Human Services · filed 2022-10-04(a)(1)

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Weaver v. Secretary of Health and Human Services · filed 2022-10-21(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Porch v. Secretary of Health and Human Services · filed 2023-01-03(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program petitioners to prove causation by a preponderance of the evidence and bars an award based solely on unsupported assertions.

F. v. Secretary of Health and Human Services · filed 2023-01-18(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Trollinger v. Secretary of Health and Human Services · filed 2023-03-15(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Nieves v. Secretary of Health and Human Services · filed 2023-05-22(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires a Vaccine Program claimant with a non-Table injury to prove by a preponderance of the evidence that the administered vaccine caused the injury.

Walters v. Secretary of Health and Human Services · filed 2023-06-01(a)(1)(A)

If, however, a petitioner suffered an injury that either is not listed in the Table or did not occur within the prescribed time frame, she must prove that the administered vaccine caused injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or [an] off-Table” claim and to prevail, a petitioner must prove her claim by preponderant evidence. § 13(a)(1)(A).

The Act requires Vaccine Program claimants to prove their claims by a preponderance of the evidence and bars awards based solely on unsupported assertions, requiring medical records or a competent physician’s opinion.

BECHEL v. SECRETARY OF HEALTH AND HUMAN SERVICES · filed 2023-12-11(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence.

Brancheau v. Secretary of Health and Human Services · filed 2024-04-15(a)(1)

Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence, showing that the vaccine was a but-for cause and a substantial factor, and bars awards based solely on unsupported assertions.

Garris v. Secretary of Health and Human Services · filed 2025-08-19(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). ... In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” ... 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).

The Act requires Vaccine Program claimants to prove entitlement by a preponderance of the evidence and bars awards based solely on their assertions; the petition must be supported by medical records or a competent physician's opinion.

Kaczerowski v. Secretary of Health and Human Services · filed 2025-09-30(a)(1)

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. ... 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).

The Act requires Vaccine Program claimants to prove either a Table injury corresponding to their vaccination or an injury actually caused by a vaccine, and requires support from medical records or a competent physician's opinion.

Derrick v. Secretary of Health and Human Services · filed 2026-01-02(a)(1)

To receive compensation under the Program, petitioner must prove either 1) that she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to her vaccination, or 2) that she suffered an injury that was actually caused by a vaccine. See §§ 13(a)(1)(A) and 11(c)(1). ... Under the Act, a petitioner may not be given a Program award based solely on the petitioner’s claims alone. Rather, the petition must be supported by either medical records or by the opinion of a competent physician. § 13(a)(1).

The Act requires Vaccine Program claimants to prove either a Table injury or a non-Table injury actually caused by a vaccine, by a preponderance of the evidence, and to support the claim with medical records or a competent physician's opinion.

Bickel v. Secretary of Health and Human Services · filed 2026-02-17(a)(1)

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). ... For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. ... 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.

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

Bickel v. Secretary of Health and Human Services · filed 2026-02-23(a)(1)

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.” ... 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).

The Act requires Vaccine Program claimants to prove causation by a preponderance of the evidence and bars awards based solely on unsupported assertions.

S. v. Secretary of Health and Human Services · filed 2026-02-24(a)(1)

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.” ... 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).

The Act requires Vaccine Program claimants to prove either a Table injury or a non-Table injury actually caused by a vaccine, by a preponderance of the evidence, and to support the claim with medical records or a competent physician's opinion.

Wyble v. Secretary of Health and Human Services · filed 2026-03-24(a)(1)

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). ... For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. ... 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).

The Act requires an off-Table Vaccine Program claimant to prove by a preponderance of the evidence that the vaccine caused the injury, but the vaccine need not be the sole or predominant cause; it must be a but-for cause and a substantial factor.

Rudzki v. Secretary of Health and Human Services · filed 2026-06-15(a)(1)

The second avenue for petitioners to receive compensation, where the alleged injury is not listed on the Vaccine Injury Table, is an “off-Table” injury, which requires that the petitioner “prove by a preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at 1320; see § 11(c)(1)(C)(ii). ... A petitioner need not show that the vaccination was the sole cause, or even the predominant cause, of the alleged injury; showing that the vaccination was a “substantial factor” and a “but for” cause of the injury is sufficient for recovery. See Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006); Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999).

The Act bars filing a compensation petition more than 36 months after the first symptom or manifestation of onset or significant aggravation of the injury.

Thomann v. Secretary of Health and Human Services · filed 2016-03-21(a)(2)

Pursuant to 42 U.S.C. § 300aa-16(a)(2), the Vaccine Act provides that “no petition may be filed for compensation . . . after the expiration of thirty-six months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury.”

the Act's look-back provision can make a non-table, causation-in-fact claim timely when a Table revision significantly increases the claimant's likelihood of obtaining compensation.

Simpson v. Secretary of Health and Human Services · filed 2021-03-08(b)

Thus, having reviewed the petition, the parties’ respective filings, the Vaccine Act, and the relevant case law and legislative history, the undersigned holds that § 16(b) applies to petitioner’s non-table GBS claim as alleged in the petition.

Section 15(e) permits an award of reasonable attorneys’ fees and costs in a Vaccine Act proceeding.

Turner v. Secretary of Health and Human Services · filed 2016-05-16(e)

The Vaccine Act permits an award of reasonable attorneys’ fees and costs.

Section 15(e)(1) requires a Vaccine Act fee award to be reasonable and permits the special master to determine and reduce the requested amount.

Atnip v. Secretary of Health and Human Services · filed 2016-08-15(e)(1)

Whether a fee award is made on an interim basis or after a case’s conclusion, the requested sum must be “reasonable.” Section 15(e)(1).

Section 15(e)(1) entitles Vaccine Program petitioners to reasonable attorneys’ fees and costs even if they do not prevail, provided the claim was brought in good faith and had a reasonable basis.

Rojas v. Secretary of Health and Human Services · filed 2017-12-06(e)(1)

First, each of these cases involved a fee-shifting regime that included a prevailing party requirement. It is well established in this Program that direct comparisons between Vaccine Act cases and other fee-shifting schemes are not appropriate because petitioners in this Program are entitled to reasonable attorneys’ fees and costs – win or lose – provided that the claim is brought in good faith and there is a reasonable basis for the claim. See § 15(e)(1). For this reason, rates outside the Vaccine Program must be adjusted before they can be directly compared.

Section 15(e) permits an award of reasonable attorneys’ fees and costs.

Kramer v. Secretary of Health and Human Services · filed 2018-05-09(e)

The Vaccine Act permits an award of reasonable attorneys’ fees and costs. § 15(e).

The Act permits a special master to award reasonable attorneys’ fees and costs when a Vaccine Act petition is filed in good faith and supported by a reasonable basis, and compensation awarded by stipulation supports entitlement to those fees and costs.

Rosso v. Secretary of Health and Human Services · filed 2025-05-20(e)(1)

Under the Vaccine Act, the special master may award reasonable attorneys’ fees and costs for a petition that does not result in an award of compensation but was filed in good faith and supported by a reasonable basis. § 300aa–15(e)(1). Here, because Petitioner was awarded compensation pursuant to a stipulation, he is entitled to an award of reasonable attorneys’ fees and costs.

The Act permits an award of reasonable attorneys’ fees and costs under the Vaccine Act, based on the reasonableness of the billing records and costs submitted.

Lungaro v. Secretary of Health and Human Services · filed 2025-05-20(e)

The Vaccine Act permits an award of reasonable attorneys’ fees and costs. § 15(e). ... In accordance with the Vaccine Act, 42 U.S.C. § 300aa-15(e) (2012), I have reviewed the billing records and costs in this case and finds that petitioner’s request for fees and costs is reasonable.

For a claimant injured by a vaccine before age 18, the Vaccine Act does not require an average work-life expectancy; the special master may determine a reasonable figure from the record.

A. v. Secretary of Health and Human Services · filed 2021-10-12(a)(3)(B)

I agree that the determination of an appropriate work-life expectancy is within each special master’s discretion. ... I am not persuaded that the Vaccine Act requires applying an average work-life expectancy (e.g., for all women, all women and men generally, or all women and men weighted by their participation in the work force) to the particular petitioner before me, particularly where she was close to reaching the age of majority when she sustained the vaccine injury and there is credible, relevant evidence about her likely educational attainment.

The Act prohibits a Vaccine Program claimant from filing a petition while a civil action for the same vaccine-related injury or death is pending, and the special master lacks jurisdiction over the prohibited petition.

Williams v. Secretary of Health and Human Services · filed 2022-08-15(a)(5)(B)

If an individual has a pending civil action for a vaccine-related injury or death, such an individual may not file a petition for such injury or death in Vaccine Program. § 300aa-11(a)(5)(B). ... Succinctly stated, petitioner filed her petition while a civil action was pending for her vaccine related injury. Applying a plain reading of Section 300aa-11(a)(5)(B) of the Vaccine Act, petitioner’s filing of her claim was prohibited. Under these circumstances, the undersigned lacks jurisdiction over petitioner’s claim and her claim in the Vaccine Program must be dismissed.

The Act bars a claimant from filing a Vaccine Program petition for a vaccine-related injury while a civil action for the same injury is pending, and the court lacks jurisdiction over the barred petition.

Williams v. Secretary of Health and Human Services · filed 2024-09-03(a)(5)(B)

An analysis of reasonable basis is therefore unnecessary because the statute is clear that where a civil action is filed, this Court lacks jurisdiction over the claim. ... Petitioner’s filing of her petition with a civil action pending for the same claim falls squarely within the statute. §300aa-11(a)(5)(B).

The Act makes the Vaccine Program a secondary payer only for payments from the funding sources expressly listed in the statute, including payments made under an insurance policy, so payments by an indemnity company are not offset absent proof they were made under an insurance policy.

R. v. Secretary of Health and Human Services · filed 2023-01-23(g)

Moreover, the settlement proceeds were paid by “Indemnity, LLC.” Section 15(g) of the Vaccine Act states that “[p]ayment of compensation under the Program shall not be made for any item or service to the extent that payment has been made . . . with respect to such item or service . . . under an insurance policy.” No evidence has been filed to show Indemnity, LLC made the payment at issue “under an insurance policy.” While the purpose of Indemnity, LLC may have been to “insure the risks of its Parent,” this alone is not evidence that the payment at issue was made “under an insurance policy.” If Congress had wanted the Vaccine Program to be a secondary payer as to payments made by indemnity companies, it could have included such language in the statute. But it did not. The language of § 15(g) specifically enumerates the types of funding sources that may offset compensation awards. These include payments made “(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program . . . , or (2) by an entity which provides health services on a prepaid basis.” Payment “by an indemnity company” is not included. Payments by any source not expressly identified in the statute may not be used to offset awards of compensation. The statute provides that any sources not expressly identified may not be used to offset awards. Thus, it appears that Congress intended the secondary payor provision to be very narrowly construed.

The Act requires a Table-injury claimant to show that the first medically recognized symptom or manifestation of onset occurred within the Vaccine Injury Table’s specified period after vaccination.

Le v. Secretary of Health and Human Services · filed 2023-04-24(c)(1)(C)(i)

The Vaccine Act does not define the meaning of the phrase, “the first symptom or manifestation of the onset.” § (c)(1)(C)(i). The Vaccine Injury Table does not provide guidance either. 42 C.F.R. § 100.3(a) (noting “time period in which the first symptom or manifestation of onset . . . after vaccine administration”). However, there is some guidance from case law. “‘[T]he first symptom or manifestation of onset’ . . . is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large.” Markovich v. Sec’y of Health & Hum. Servs., 477 F.3d 1353, 1360 (Fed. Cir. 2007). Further, the Federal Circuit held “the statute of limitations of the Vaccine Act begins to run on the calendar date of the occurrence of the first medically recognized symptom or manifestation of onset of the injury.” Cloer v. Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1324-25 (Fed. Cir. 2011) (en banc). Following this guidance, it is appropriate to place onset at the time of a “medically recognized symptom.”