Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Fatigue, Hypercholesterolaemia, Pain in extremity, Temporomandibular joint syndrome
Clinical narrative: TMJ syndrome/ Temporomandibular joint issue; Elevated cholesterol which was steadily increasing; sore arm following the Moderna vaccine; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2022 and was forwarded to Moderna on 09-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of TEMPOROMANDIBULAR JOINT SYNDROME (TMJ syndrome/ Temporomandibular joint issue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (TMJ syndrome/ Temporomandibular joint issue) (seriousness criterion medically significant), HYPERCHOLESTEROLAEMIA (Elevated cholesterol which was steadily increasing), PAIN IN EXTREMITY (sore arm following the Moderna vaccine) and FATIGUE (Fatigue). The patient was treated with PRAVASTATIN at an unspecified dose and frequency and Surgery (TMJ surgery on 27-APR-2022) for Temporomandibular joint syndrome. At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (TMJ syndrome/ Temporomandibular joint issue) had not resolved and HYPERCHOLESTEROLAEMIA (Elevated cholesterol which was steadily increasing), PAIN IN EXTREMITY (sore arm following the Moderna vaccine) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: elevated cholesterol which was steadily increasing Elevated cholesterol which was steadily increasing.         No concomitant medication was reported. It was reported that the patient had temporomandibular joint issue and on 27-Apr-2022, she underwent temporomandibular joint surgery. She was unable to open her mouth properly, had fatigue. She had elevated cholesterol which was steadily increasing. Her physician had prescribed Pravastatin. She had sore arm and fatigue following the Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This spontaneous case reported by a consumer concerns a 62-year-old female patient, with relevant concurrent condition rheumatoid arthritis for which she takes Upadacitinib, who experienced unexpected, serious (medically significant) AESI temporomandibular joint syndrome, after receiving three doses of mRNA-1273.  The onset date of the event was unknown; she underwent temporomandibular joint surgery approximately 5 ½ months after her third dose of the vaccine.  The concurrent rheumatoid arthritis could be a risk factor for temporomandibular joint syndrome.  Non-serious event hypercholesterolaemia was also reported; the use of Upadacitinib could be a confounding factor for this event.  Hypercholesterolaemia was treated with Pravastatin.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 62-year-old female patient, with relevant concurrent condition rheumatoid arthritis for which she takes Upadacitinib, who experienced unexpected, serious (medically significant) AESI temporomandibular joint syndrome, after receiving three doses of mRNA-1273.  The onset date of the event was unknown; she underwent temporomandibular joint surgery approximately 5 ½ months after her third dose of the vaccine.  The concurrent rheumatoid arthritis could be a risk factor for temporomandibular joint syndrome.  Non-serious event hypercholesterolaemia was also reported; the use of Upadacitinib could be a confounding factor for this event.  Hypercholesterolaemia was treated with Pravastatin.  The benefit risk relationship of mRNA-1273 is not affected by this report.