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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
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its interpretation of these injuries.
Moreover, the Department has concluded that there are strong policy reasons for now removing SIRVA from the Table.
Response: As discussed above, it is the Departments belief that vasovagal syncope is not a vaccine-related injury and therefore should not be included on the Table or compensable under the VICP. 42 U.S.C. 300aa11, 300aa14e, and the inclusion of the injury in 2017 was incorrect.
Comment: Many commenters believe that SIRVA should remain on the table because No evidence has been presented by DHHS justifying the removal of these injuries.
Response: The scientific literature indicates that SIRVA likely results from poor vaccination technique, rather than the vaccine or its components alone.
The notice of proposed rulemaking that preceded the Final Rule characterized SIRVA as an adverse event following vaccination thought to be related to the technique of intramuscular percutaneous injection the procedure where access to a muscle is obtained by using a needle to puncture the skin into an arm resulting in trauma from the needle and/or the unintentional injection of a vaccine into tissues and structures lying underneath the deltoid muscle of the shoulder. 20 The IOM
similarly concluded that the injection, and not the contents of the vaccine, contributed to the development of deltoid bursitis. 21 Indeed, the primary case series relied upon by the Department in promulgating the proposed rule and Final Rule found that the medical literature supports the possibility that SIRVA may result from inappropriate needle length and/or injection technique.22 There is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself.23 Since the 20 National Vaccine Injury Compensation:
Revision to the Vaccine Injury Table 2015
Proposed Rule, 80 FR 45132, 45136 July 29, 2015 emphasis supplied; see also Adverse Effects of Vaccines: Evidence and Causality IOM
Report, at 620, available at https www.nap.edu/
catalog/13164/adverse-effects-of-vaccines-evidenceand-causality.
21 IOM Report at 620. SIRVA is a medicolegal term, not a medical diagnosis, that is meant to capture a broad array of potential shoulder injuries.
However the IOM only made findings concerning deltoid bursitis.
22 Atanasoff S, Ryan T, Lightfoot R, and Johann Liang R, 2010, Shoulder injury related to vaccine administration SIRVA, Vaccine 2851: 804952
recommending that injections avoid the top third of the deltoid muscle to avoid shoulder injury.
23 See Barnes MG, Ledford C, Hogan K. A
needling problem: Shoulder injury related to vaccine administration. J Am Board Fam Med. 2012

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Final Rule was promulgated, additional scientific research concluded that subdeltoid or subacromial bursitis and other shoulder lesions are more likely to be the consequence of a poor injection technique site, angle, needle size, and failure to take into account a patients characteristics, i.e., sex, body weight, and physical constitution, rather than antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. 24
Comment: Some commenters stated that HHSs justification for removing SIRVA from the VICP does not comport with best available science, because, although HHS correctly states that SIRVA and syncope are considered to be adverse injuries following direct trauma from an injection point, negligent administration and poor vaccination technique are not exclusively connected with the onset of SIRVA and Nov-Dec; 256:91922; Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Dont aim too high:
Avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016 May;
455:3036.
24 Mart n Arias, K.H., Fadrique, R., Sainz Gil, M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations, Vaccine, 2017; 35: 4870
4876. See also Bancsi A, Houle SKD, Grindrod KA.
Shoulder injury related to vaccine administration and other injection site events. Can. Fam.
Physician. 2019 Jan; 651: 4042 explaining that SIRVA is a preventable occurrence caused by the injection of a vaccine into the shoulder capsule rather than the deltoid muscle; Macomb CV, Evans MO, Dockstater JE, Montgomery JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections: A Case Series. Mil Med. 2019 Oct 17
noting that SIRVA does not occur unless the vaccine is mistakenly given in the shoulder capsule. Another recent study reviewed the Vaccine Adverse Event Reporting System VAERS
database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine IIV. See B.F. Hibbs, C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System VAERS, 20102017, Vaccine. The review found that, of the 266 reports where contributing factors for the injury were reported, 216 81.2% described the vaccination as being given too high on the arm. Other reports described improper or poor administration technique e.g., bone strikes, administered in tendon, uneven position between vaccinator and the patient e.g., vaccinator standing while patient sitting, vaccination needle too long, and others e.g., difficulty injecting vaccine. A small minority of reports also indicated the patient had a history of thyroid dysfunction or diabetes. It is possible that certain injuries characterized as SIRVA occur when an immunologically active substance designed to trigger an inflammatory response i.e., the vaccine antigen is injected into an area where the inflammatory response can cause joint damage i.e., the bursa or tendons as opposed to an area where the inflammatory response will not cause joint damage or permanent harm i.e., the deltoid muscle. Such injuries are fairly characterized as resulting from the vaccination technique, since they would not have occurred if the injection occurred in the proper part of the body.

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syncope-related injuries. Commenters stated that the agency did not consider that serious injuries may occur following the onset of SIRVA or a syncope-related event.
Response: It is possible that serious injuries may occur following the onset of SIRVA or a syncope-related event, but the scientific literature suggests such injuries generally result from the act of injection, rather than the vaccine or its components. That negligent administration or poor vaccination technique may also be connected with other injuries does not change the Departments conclusions.
Comment: Some commenters stated that SIRVA injuries are not as rare as the Department states. They state that due to lack of information, many SIRVA
injuries are not recognized or reported.
Response: The Department did not state that SIRVA injuries are rare.
Comment: Some commenters argue that medical literature supports that SIRVA alone cannot result from negligent administration of a vaccine, because these injuries are a combination of both 1 the needle placed into the subacromial bursa and 2 the vaccine components that are needed to cause the immune response, resulting in SIRVA.
Response: It is possible that certain injuries characterized as SIRVA occur when an immunologically active substance designed to trigger an inflammatory response i.e., the vaccine antigen is injected into an area where the inflammatory response can cause joint damage i.e., the bursa or tendons as opposed to an area where the inflammatory response will not cause joint damage or permanent harm i.e., the deltoid muscle. Such injuries are fairly characterized as resulting from the vaccination technique, since they would not have occurred if the injection occurred in the proper part of the body.
Section VI: Vasovagal Syncope Specific Concerns Comment: Some commenters shared their negative experiences with vasovagal syncope. One commenter said he was left alone after receiving a vaccine, which resulted in severe injuries to his face and causing him to need extensive medical treatment. He stated that the VICP is the only recourse to financial compensation for pain and suffering, since Texas malpractice laws make it difficult to obtain compensation.
Response: The Department sympathizes with those who suffered an injury, but it is the Departments belief that Congress intended for the Vaccine Acts compensation system to be used for unavoidable injuries and illnesses
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