Michael J. Sayles v. HHS - Influenza, shoulder injury and/or an acute complication or sequella [sic] of an illness, disability, injury, or condition (2024)

Michael J. Sayles, a 69-year-old nursing home resident, filed a petition under the National Vaccine Injury Compensation Program on December 2, 2020, alleging that an influenza vaccine administered on January 10, 2020, caused him to suffer a shoulder injury related to vaccine administration (SIRVA) or an aggravation of a medical condition.

Petitioner was hospitalized for chest pain and dizziness when he received the flu vaccine in his left deltoid. He immediately complained of left shoulder pain, which worsened the next day.

Medical records from his hospitalization noted swelling, induration, rubor, hypertonicity, tenderness, and limited range of motion in his left shoulder. Differential diagnoses considered by his treaters included tendonitis rupture, subdeltoid bursitis secondary to vaccination, acute infection, or Reiter's syndrome.

Petitioner was discharged to a skilled nursing facility, Harbor Lakes, on January 14, 2020, where his decreased range of motion in his left shoulder was noted. His medical records at Harbor Lakes, however, began to focus on other issues.

On April 29, 2020, he complained of bilateral elbow pain and swelling, diagnosed as olecranon bursitis. He later presented to orthopedics on May 7, 2020, with a two-week history of bilateral elbow pain and swelling, with numbness and tingling in his left hand.

X-rays showed mild degenerative changes in his right elbow and a small spur with soft tissue calcifications and swelling in his left elbow. He was diagnosed with spontaneous onset bilateral olecranon bursitis.

In October 2020, he complained of right elbow pain with bruising extending from his right elbow to his shoulder. Petitioner's own affidavit described immediate, painful swelling and burning in both arms after vaccination, with his right arm swelling significantly and developing a large bruise.

He stated his injuries were "on again, off again" and that prostate surgery was cancelled due to bilateral arm swelling. He reported still experiencing pain and swelling at times as of May 25, 2021.

A nurse at Harbor Lakes also observed swelling and a bump on his right elbow, which grew, and noted similar effects on his left arm and elbow, including purple bruising on his right arm. Photographs submitted by Petitioner showed extensive redness and bruising on his arms and elbows, but not on his shoulders.

Respondent moved to dismiss, arguing that Petitioner did not meet the criteria for a Table SIRVA because his symptoms were not limited to the shoulder and his medical records shifted focus to elbow issues. Respondent also argued that Petitioner failed to provide evidence of the injury's duration (at least six months without surgery or hospitalization) or a causation theory for an off-Table claim.

Petitioner responded by asserting that both arms reacted violently with painful swelling and bruising, causing overall weakness and pain in his shoulders and body. He claimed to have suffered residual effects for more than six months and requiring future medical care.

Special Master Herbrina D. Sanders reviewed the evidence and applicable law.

The Special Master found that Petitioner did not meet the criteria for a Table SIRVA because his symptoms were not limited to the shoulder, with significant focus shifting to elbow pain and swelling. The Special Master also found that Petitioner did not provide preponderant evidence of a shoulder injury lasting more than six months, nor did he provide a sufficient causation theory for an off-Table claim, particularly regarding the elbow injuries which were not alleged as the primary injury.

The public decision does not describe specific medical experts, detailed clinical findings beyond pain and swelling, or specific diagnostic tests beyond X-rays. The Special Master concluded that Petitioner had not established by preponderant evidence that he suffered from a Table SIRVA, an off-Table shoulder injury, or any other condition caused-in-fact by the vaccination.

Consequently, the petition was dismissed.