Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Inflammatory pseudotumour, Joint range of motion measurement, Magnetic resonance imaging, Pain assessment
Clinical narrative: Right Biceps Pseudo-Tumor/inflammatory pseudo-tumor; viral syndrome; transient injection site soreness; This literature-non-study case was reported in a literature article and describes the occurrence of INFLAMMATORY PSEUDOTUMOUR (Right Biceps Pseudo-Tumor/inflammatory pseudo-tumor) and VIRAL INFECTION (viral syndrome) in a 49-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.        No known drug allergies. No major medical, oncologic, rheumatologic, or orthopedic conditions.  Concurrent medical conditions included Lipoma (Two lipomas in the right forearm that had remained unchanged for over 10 years.).   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATORY PSEUDOTUMOUR (Right Biceps Pseudo-Tumor/inflammatory pseudo-tumor) (seriousness criterion medically significant), VIRAL INFECTION (viral syndrome) (seriousness criterion medically significant) and VACCINATION SITE PAIN (transient injection site soreness). The patient was treated with IBUPROFEN for Viral syndrome and Pseudotumor, at an unspecified dose and frequency; ACETAMINOPHEN for Pseudotumor, at an unspecified dose and frequency and Surgery (complete excision of the mas) for Inflammatory pseudotumour. At the time of the report, INFLAMMATORY PSEUDOTUMOUR (Right Biceps Pseudo-Tumor/inflammatory pseudo-tumor) and VACCINATION SITE PAIN (transient injection site soreness) had resolved and VIRAL INFECTION (viral syndrome) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: showed fibromuscular tissue with a chronic lymphoplasmacytic inflammatory infiltrate comprised of lymphocytes, plasm cells, and eosinophils.. On an unknown date, Joint range of motion measurement: attributed to a feeling of heaviness., Right shoulder active range of motion (ROM) was within the normal range, but passive range of motion was decreased. and full passive ROM was restored.. On an unknown date, Magnetic resonance imaging: Multiplanar MRI of the right upper arm taken five days after identifying the mass and six months after receiving booster dose:  Axial T2 and coronal T1W FS images show an ill-defined fluid signal within the short head, right biceps muscle belly. The area involved extended from the muscle belly to the proximal humeral cortex, measuring approximately 7.4 × 3.7 × 2.6 cm (arrows), Multiplanar MRI of the right upper arm taken one month after identifying the mass and seven months after receiving booster dose (MRI taken two weeks after the needle aspiration): Axial fast spin gradient echo postcontrast and coronal STIR images show an ill-defined central fluid signal measuring 10 × 3.1 × 1.9 cm with prominent peripheral enhancement (arrows) in the proximal right biceps in the same location as on the first MRI and showed no residual mass or edema.. On an unknown date, Pain assessment: 3-out-of-10 pain in right arm. On an unknown date, Pathology test: Low-power view shows soft tissue and skeletal muscle with mild fibrosis and aggregates of inflammatory cells, consisting mostly of lymphocytes arranged in serpentine and nodular patterns and granulation tissue (blue arrows in the skeletal muscle; black arrows in the fibrous soft tissue). High-power views show the inflammatory infiltrates consisting mostly of lymphocytes, plasma cells, and histiocytes. The cells show no atypia or cytological features of malignancy. Multiple special immunohistochemical studies were performed; EpsteinBarr virus in situ hybridization, Grocott methenamine silver, acid-fast bacillus, and human herpesvirus-8 were negative, ruling out viral and fungal-associated conditions. Lymphoid markers and CyclinD1 were performed and were negative, ruling out hematopoietic or histiocytic neoplasms. Histocytologic findings are most consistent with deep chronic inflammatory tumefaction or inflammatory pseudo-tumor.. On an unknown date, Physical examination: firm, clinically circumscribed, nontender mass in the right upper arm..     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered INFLAMMATORY PSEUDOTUMOUR (Right Biceps Pseudo-Tumor/inflammatory pseudo-tumor) to be related. No further causality assessments were provided for VIRAL INFECTION (viral syndrome) and VACCINATION SITE PAIN (transient injection site soreness).   Company Comment: This is a literature non-study case concerning a 49-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Inflammatory pseudotumour and viral infection. The events occurred after the administration of the booster dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. Immediately after receiving the booster dose, the patient experienced a viral syndrome with symptoms of diaphragmatic breathing, fatigue, and reduced exercise tolerance. These symptoms persisted over the following several months. Six months after the booster, the patient discovered a mass in the anteromedial aspect of the right upper arm, accompanied by a limited range of motion attributed to a feeling of 'heaviness'. Magnetic resonance imaging (MRI) of his right arm revealed a 7.4 × 3.7 × 2.6 cm mass in the short head of the right biceps, with mild hemorrhagic fluid abutting the humerus but with no evidence of cortical erosion or bone marrow signal change. Needle aspiration yielded 30 mL of turbid brown fluid, and a biopsy showed fibromuscular tissue with a chronic lymphoplasmacytic inflammatory infiltrate comprised of lymphocytes, plasma cells, and eosinophils. A new MRI was performed, and given the persistent MRI findings and unclear diagnosis, a complete excision of the mass was accomplished the following week. The pathology showed soft tissue and skeletal muscle with mild fibrosis and aggregates of inflammatory cells, consisting mostly of lymphocytes, plasma cells, and histiocytes. The cells showed no atypia or cytological features of malignancy. two weeks after the removal of the mass, the systemic symptoms of diaphragmatic breathing, fatigue, and reduced exercise tolerance had finally resolved. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS Vaccine is not affected by this report. No concomitant medications were reported.  The patient presented to physician with a four-day history (6 months after receiving the booster dose) of a firm mass in the proximal-medial short-head of the right biceps muscle.   Eight months after completing the primary series, he received a booster dose of the Moderna vaccine. The patient revealed that the needle was inserted below the bulk of the deltoid muscle, approximately one finger breadth above the deltoid tuberosity. The patient developed constitutional symptoms, including diaphragmatic breathing, fatigue, and reduced exercise tolerance. After one week, he was diagnosed with viral syndrome and recommended ibuprofen, fluids, and rest. However, these symptoms persisted over the next several months despite following the treatment protocol.  Six months after the booster, he discovered a mass in the anteromedial right upper arm. The lump was described as a solid, golf-ball-sized mass without induration, warmth, discoloration, or urticaria.   Given the MRI findings of an indeterminate mass, the orthopedic surgeon elected for a needle aspiration. An ultrasound-guided needle aspiration yielded 30 mL of turbid brown fluid.  Immediately after the aspiration, there was a subjective improvement in the size of the swelling; as he stated, the mass was not a golf-ball anymore.  During follow-up, there was no palpable mass, the pain improved, and his full passive ROM was restored. However, his systemic symptoms of diaphragmatic breathing, fatigue, and reduced exercise intolerance had finally resolved around the time of this final follow-up two weeks following removal of the mass.  Non-operative conservative treatment modalities, including heating pads, ice packs failed to improve the patient's mass.; Sender's Comments: This is a literature non-study case concerning a 49-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Inflammatory pseudotumour and viral infection. The events occurred after the administration of the booster dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. Immediately after receiving the booster dose, the patient experienced a viral syndrome with symptoms of diaphragmatic breathing, fatigue, and reduced exercise tolerance. These symptoms persisted over the following several months. Six months after the booster, the patient discovered a mass in the anteromedial aspect of the right upper arm, accompanied by a limited range of motion attributed to a feeling of 'heaviness'. Magnetic resonance imaging (MRI) of his right arm revealed a 7.4 × 3.7 × 2.6 cm mass in the short head of the right biceps, with mild hemorrhagic fluid abutting the humerus but with no evidence of cortical erosion or bone marrow signal change. Needle aspiration yielded 30 mL of turbid brown fluid, and a biopsy showed fibromuscular tissue with a chronic lymphoplasmacytic inflammatory infiltrate comprised of lymphocytes, plasma cells, and eosinophils. A new MRI was performed, and given the persistent MRI findings and unclear diagnosis, a complete excision of the mass was accomplished the following week. The pathology showed soft tissue and skeletal muscle with mild fibrosis and aggregates of inflammatory cells, consisting mostly of lymphocytes, plasma cells, and histiocytes. The cells showed no atypia or cytological features of malignancy. two weeks after the removal of the mass, the systemic symptoms of diaphragmatic breathing, fatigue, and reduced exercise tolerance had finally resolved. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS Vaccine is not affected by this report.