key: cord-0900646-wpbwd5sp
authors: Elkousy, Hussein A.; Khoriaty, Justin D.; Vidal, Emily A.; Vincent, Sara J.; Buras, Bridget A.; Laughlin, Mitzi S.
title: Adverse events following mRNA vaccine administration from a busy orthopedic practice: A series of four cases
date: 2022-01-13
journal: JSES Rev Rep Tech
DOI: 10.1016/j.xrrt.2021.12.003
sha: dbb4c7705f22560c309d6f308e3a370766b4244d
doc_id: 900646
cord_uid: wpbwd5sp

MRNA technology is not new, but with the COVID-19 pandemic, it is the first time it has been utilized on a large-scale basis in humans. Because of this widespread use, novel side effects have been noted in several organ systems. However, there are no publications to date documenting musculoskeletal side effects. This paper presents 4 cases of potential side effects of the mRNA vaccine noted in a busy shoulder practice.

Abstract 1 MRNA technology is not new, but with the COVID-19 pandemic, it is the first time it has been utilized on 2 a large-scale basis in humans. Because of this widespread use, novel side effects have been noted in 3 several organ systems. However, there are no publications to date documenting musculoskeletal side 4 effects. This paper presents 4 cases of potential side effects of the mRNA vaccine noted in a busy 5 shoulder practice. To date, there have been no publications describing musculoskeletal side effects. In this paper, we 18 present 4 shoulder cases that may have been impacted by mRNA vaccine administration. Of the 4 cases, 19

The first patient was a 58-year-old right-hand-dominant male who initially presented to our clinic 4.5 23 years prior with a left shoulder rotator cuff tear. This injury was treated conservatively for 3.5 years until 24 he underwent arthroscopic rotator cuff repair by the primary surgeon in March 2020, just prior to the 25 COVID-19 pandemic. A double row transosseous equivalent technique was used with 4.5 mm PEEK 26 anchors in the medial row and 4.75 mm PEEK anchors in the lateral row. His postoperative course was 27 unremarkable, and he had an excellent functional recovery. 28

The patient presented with right shoulder pain in February 2021, which had worsened after a recent fall. shoulder. He stated that soon after the vaccination, he started feeling fatigued and malaise with fever. 37

He also noticed a significant increase of pain in the right arm, with redness and streaking distal to his 38 right shoulder within two days of the vaccination. The malaise subsided after a few days, but the 39 shoulder pain and discoloration symptoms worsened during this time. 40

The patient returned to the clinic on POD 47. Peripheral labs were drawn to assess for infection (Table  41 1). He was sent for both an MRI and a fluoroscopically guided aspiration of the shoulder joint. The 42 aspirate yielded little fluid, mainly blood, but was still sent for analysis. The MRI demonstrated a large 43 loculated fluid collection in the subacromial space with disruption of the rotator cuff repair and lucency 44 around the previously placed anchors (Figure 2 ).

On POD 49, he underwent arthroscopic débridement with hardware removal. Operative findings 46 included a failure of the rotator cuff repair. The anchors were loose due to the surrounding destruction 47 of bone but were not displaced. There was moderate reactive bursitis, and the arthroscopy fluid was 48 initially cloudy, but there was no gross purulence or efflux of fluid with placement of the trochar and 49 cannula or with the initial visual assessment. During the procedure, cultures were obtained from the 50 reactive bursitis. The sutures and anchors were removed and sent along with the cultures. Antibiotic 51 treatment was not initiated until all cultures were obtained. 52

A repeat arthroscopy and débridement were performed 2 days later. A PICC line was placed, and the 53 patient was started on empiric antibiotics. The final gram stain was negative. The cultures were held for 54 21 days and also remained negative. The patient was treated with 8 weeks of intravenous antibiotics for 55 presumed Cutibacterium acnes. At 4 months post débridement and 8 weeks after conclusion of IV 56 antibiotics, the patient underwent a revision rotator cuff repair and postoperative recovery was 57 unremarkable. The patient currently has little to no pain at has 160 degrees of active elevation. 58

The second case was a 68-year-old right-hand-dominant male with controlled type 2 diabetes. He has 60 been followed by the primary surgeon for over 10 years for bilateral shoulder osteoarthritis. He 61 underwent a right shoulder arthroscopic débridement with biceps surgery after 6 years of conservative 62 treatment. He continued to have pain and presented for definitive shoulder arthroplasty 4 years later. 63

He had not received any prior cortisone injections nor invasive treatment to the shoulder since the 64 arthroscopic procedure. A preoperative CT scan was obtained to confirm the diagnosis and allow for 65 templating for shoulder arthroplasty. 66

He underwent routine right shoulder anatomic total shoulder arthroplasty in early March of 2021. His 67 postoperative course initially was unremarkable. Prophylactic Clindamycin had been given. He was also given 2 more doses while in the hospital. His serum glucose levels were well controlled while in the 69 hospital. He was discharged home on POD 1. 70

At his first postoperative visit on POD 14, he commented that his pain was surprisingly better than he 71 thought it would be. He had some initial issues with constipation that had resolved, but otherwise 72 unremarkable. 73

The patient then called on POD 50, stating that he had developed some redness surrounding his incision. 74

He explained that he was doing well until POD 25 when he received his second mRNA-1273 injection in 75 his left (non-operative) shoulder. He stated that he felt significant malaise after the injection for several 76 days. He also noticed an almost immediate increase in his right shoulder pain at that time which had 77 persisted. He had not been taking narcotics for several weeks, but he now needed narcotics to manage 78 the pain. 79

Examination of his wound demonstrated an apparent central abscess. A CT scan was obtained looking 80 for a deep abscess which was not identified. A fluoroscopically guided aspiration was also performed. 81

Only 1 mL of bloody fluid was aspirated and was sent for culture and gram stain. The peripheral lab 82 values are in Table 2 . She had no atrophy on physical examination but was hypersensitive to light touch over the arm and 123 forearm. Active forward elevation was to 60 degrees. An EMG was performed which was consistent with 124 left neuralgic amyotrophy (brachial plexitis or Parsonage-Turner Syndrome). She is being treated 125 currently with physical therapy. 126

Comorbidities for Case #1 are hypercholesterolemia and hypertension, but otherwise, the patient is 133 healthy. He had undergone a prior rotator cuff repair of his left shoulder 1 year prior with no 134 complications. On the day of his right shoulder surgery, another patient with more comorbidities 135 including diabetes also had a rotator cuff repair and has had no complications. The primary surgeon has 136 had one prior rotator cuff repair infection in 18.5 years. This infection can certainly be explained 137 statistically based on an expected infection rate of rotator cuff repair. However, the temporal 138 association with the second vaccination is difficult to ignore. 139

The risk of infection in primary shoulder arthroplasty is approximately 1%. 12 The most common 140 organism causing infection in total shoulder arthroplasty is Cutibacterium acnes, which accounts for 141 approximately 39% of infections in shoulder arthroplasty. 9 The risk factors of shoulder prosthetic joint 142 infections include male sex, higher BMI, and younger age at the time of the index procedure. 9 143

Our Case #2 has a history of well-controlled type 2 diabetes and no other risk factors. He had not 144 received prior injections in the shoulder. Similar to the patient in Case #1, he had little to no pain 145

initially, but the pain significantly increased after a second mRNA injection for COVID-19. Another 146 patient had a reverse shoulder arthroplasty the same day as the index surgery and has had no 147 complications. Additionally, the primary surgeon has only had two primary arthroplasty infections in 148 18.5 years, which were both reverse arthroplasty for fracture cases. This is the first primary anatomic 149 shoulder arthroplasty to present with infection. Similar to Case #1, the temporal association with the 150 second vaccination is difficult to ignore when evaluating Case #2. 151

The third case in this series developed shingles following mRNA vaccination. This adverse event has 152 been reported by Furer et al in patients with autoimmune inflammatory rheumatic disease. 5 Case #3 is 153 unique in that shingles resulted in profound loss of function in the shoulder that underwent arthroplasty 154 over 2.5 years prior. The patient has known severe glenohumeral osteoarthritis on the contralateral this patient has other comorbidities and has undergone prior chemotherapy and radiation therapy on 157 the surgical shoulder, possibly adding to the increased risk for right-side involvement. In this case, the 158 shingles occurred on the extremity that had prior radiation therapy. Nevertheless, this case illustrates 159 that the mRNA vaccine may cause some type of modulation of the immune system that allows 160 previously suppressed pathology to manifest itself. 161

Patient #4 was diagnosed with neuralgic amyotrophy and had significant comorbidity with uncontrolled 162 insulin-dependent diabetes mellitus. It is not clear if this played a role in her reaction to the vaccine, as 163 uncontrolled diabetes is well known to adversely impact several other organ systems including the 164 kidney, eyes, vascular system, and peripheral nervous system. 6 Additionally, this type of nervous system 165 reaction is not necessarily specific to mRNA vaccines, but her presentation illustrates the concept that 166 an mRNA vaccine can have an impact on the immune system, leading to complications. 167

The 4 cases presented here represent possible musculoskeletal adverse events that will be evaluated in experience only minor and/or well-documented side effects. The cases presented here represent 183 possible musculoskeletal adverse events that will be evaluated in orthopedic clinics. Fortunately, these 184 cases are rare, but orthopedic surgeons need to be aware of this possibility to better treat their patients. 185 

Journal of 188 Shoulder and Elbow Surgery

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