Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Cartilage injury, Magnetic resonance imaging, Periarthritis, Tendonitis
Clinical narrative: Superior labral tear anterior to posterior; ADHESIVE CAPSULITIS; BURSITIS; Tendonitis; This spontaneous case was reported by a consumer and describes the occurrence of CARTILAGE INJURY (Superior labral tear anterior to posterior), PERIARTHRITIS (ADHESIVE CAPSULITIS), BURSITIS (BURSITIS) and TENDONITIS (Tendonitis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Previously administered products included for Product used for unknown indication: CYMBALTA, PLAQUENIL, TOPIRAMATE, GABAPENTIN, ALENDRONATE, MELOXICAM and TRAMADOL. Past adverse reactions to the above products included No adverse event with ALENDRONATE, CYMBALTA, GABAPENTIN, MELOXICAM, PLAQUENIL, TOPIRAMATE and TRAMADOL. Concurrent medical conditions included Asthma, Non-smoker, Abstains from alcohol, Chronic obstructive pulmonary disease, Drug allergy (MANIFESTED BY BLOOD PRESSURE WENT UP/HEART POUNDING/DEPRESSION), Drug allergy (MANIFESTED BY SEVERE DEPRESSION AND WANTED TO DIE), Drug allergy (MANIFESTED BY SEVERE CONSTIPATION/NO PAIN RELIEF/DEPRESSION), Drug allergy (MANIFESTED BY GASTRITIS AND INFLAMMATION IN STOMACH), Drug allergy (MANIFESTED BY DID NOT RELIEVE ANY PAIN AND DEPRESSION), Drug allergy (MANIFESTED BY DEPRESSION AND NO PAIN RELIEF) and Drug allergy (MANIFESTED BY BLOOD PRESSURE WENT UP/ ECZEMA/ BLOOD VESSELS ON TOP OF FEET BROKE/ LOOKED LIKE  THEY WERE BRUISED/DEPRESSION). Concomitant products included MONTELUKAST, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, VENLAFAXINE for Depression, DENOSUMAB (PROLIA) for Osteoporosis, PREDNISONE for Pain and Arthritis, METHOTREXATE and FOLIC ACID for Rheumatoid arthritis.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In July 2021, the patient experienced CARTILAGE INJURY (Superior labral tear anterior to posterior) (seriousness criterion medically significant), PERIARTHRITIS (ADHESIVE CAPSULITIS) (seriousness criterion medically significant), BURSITIS (BURSITIS) (seriousness criterion medically significant) and TENDONITIS (Tendonitis) (seriousness criterion medically significant). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, CARTILAGE INJURY (Superior labral tear anterior to posterior), PERIARTHRITIS (ADHESIVE CAPSULITIS), BURSITIS (BURSITIS) and TENDONITIS (Tendonitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Magnetic resonance imaging: SLAP (Superior Labrum Anterior and Posterior) tear, adhesive capsulitis, bursitis, tendonosis on left shoulder.         The reporter's causality for the events of delirious, superior labrum Anterior and posterior tear, adhesive capsulitis, bursitis, tendonosis, with Humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  Opinion is that there is no reasonable possibility that the events of superior labrum anterior and posterior tear, adhesive capsulitis, tendonosis are related to humira 40mg/0.4ml(adalimumab).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of CARTILAGE INJURY (Superior labral tear anterior to posterior), event of PERIARTHRITIS (ADHESIVE CAPSULITIS), BURSITIS (BURSITIS) and TENDONITIS (Tendonitis) unknown days after receiving 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  Patient had also received on an unknown date in 2017, ADALIMUMAB (HUMIRA) injection for an unknown indication and METHOTREXATE for Rheumatoid arthritis, which remain as  confounder for the events. Magnetic resonance imaging showed, SLAP (Superior Labrum Anterior and Posterior) tear, adhesive capsulitis, bursitis, tendonosis on left shoulder. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The events were not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.     This case was linked to MOD-2021-624442 (Patient Link).; Sender's Comments: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of CARTILAGE INJURY (Superior labral tear anterior to posterior), event of PERIARTHRITIS (ADHESIVE CAPSULITIS), BURSITIS (BURSITIS) and TENDONITIS (Tendonitis) unknown days after receiving 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  Patient had also received on an unknown date in 2017, ADALIMUMAB (HUMIRA) injection for an unknown indication and METHOTREXATE for Rheumatoid arthritis, which remain as  confounder for the events. Magnetic resonance imaging showed, SLAP (Superior Labrum Anterior and Posterior) tear, adhesive capsulitis, bursitis, tendonosis on left shoulder. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The events were not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.