Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Rheumatoid arthritis flare up/ Achiness from weather; Anxiety disorder; Sleep apnea; Obstructive sleep apnoea syndrome; Panic attacks; Fatigue; Shoulder pain after Moderna Vaccine; Headache after first Moderna vaccine; Arm pain after first Moderna Vaccine; Chills after first Moderna Vaccine; Achiness and pain after first Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ Achiness from weather) in a 59-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 flare up.   On 26-Mar-2020, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Achiness and pain after first Moderna Vaccine), HEADACHE (Headache after first Moderna vaccine), VACCINATION SITE PAIN (Arm pain after first Moderna Vaccine) and CHILLS (Chills after first Moderna Vaccine). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ Achiness from weather) (seriousness criterion medically significant), ANXIETY DISORDER (Anxiety disorder), SLEEP APNOEA SYNDROME (Sleep apnea), OBSTRUCTIVE SLEEP APNOEA SYNDROME (Obstructive sleep apnoea syndrome), PANIC ATTACK (Panic attacks), FATIGUE (Fatigue) and ARTHRALGIA (Shoulder pain after Moderna Vaccine). In 2021, PAIN (Achiness and pain after first Moderna Vaccine), HEADACHE (Headache after first Moderna vaccine), VACCINATION SITE PAIN (Arm pain after first Moderna Vaccine) and CHILLS (Chills after first Moderna Vaccine) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/ Achiness from weather), ANXIETY DISORDER (Anxiety disorder), SLEEP APNOEA SYNDROME (Sleep apnea) and PANIC ATTACK (Panic attacks) had not resolved and OBSTRUCTIVE SLEEP APNOEA SYNDROME (Obstructive sleep apnoea syndrome), FATIGUE (Fatigue) and ARTHRALGIA (Shoulder pain after Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  The patient on an unknown date, experienced anxiety disorder, sleep apnea, obstructive sleep disorder, panic attacks and rheumatoid arthritis flare up. In Mar-2021, the patient experienced headache after first Moderna vaccine, arm pain after first Moderna vaccine, chills after first Moderna vaccine and achiness and pains after first Moderna vaccine. The rheumatoid arthritis flare up with Rinvoq (Upadacitinib). In 2021, the headache after first Moderna vaccine, arm pain after first Moderna vaccine, chills after first Moderna vaccine and achiness and pains after first Moderna vaccine resolved.  It was also reported that the patient had fatigue. The patient had shoulder pain after Moderna vaccine and Rheumatoid arthritis flare up/achiness from weather with RINVOQ (UPADACITINIB).  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  The causality of events with respect to drug RINVOQ - Anxiety disorder, Sleep apnea, Obstructive sleep apnea syndrome, Panic attacks, Headache after first Moderna vaccine, Arm pain after first Moderna Vaccine, Chills after first Moderna Vaccine, Arm pain after first Moderna Vaccine was reported as no reasonable possibility.  The reporter's causality for the event of RHEUMATOID ARTHRITIS FLARE UP/ACHINESS FROM WEATHER with RINVOQ (UPADACITINIB) was reported as a reasonable possibility.  There were no medical history reported.  Company comment : This spontaneous case concerns a 59-year-old female patient, with no medical history of Rheumatoid arthritis and intake of Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis flare up, the unexpected events of Pain, Anxiety disorder, Sleep apnea syndrome, Obstructive sleep apnea syndrome, and Panic attacks, and the expected events of Headache, Vaccination site pain, Chills, Fatigue and Arthralgia. The events occurred on an unspecified date after receiving the first dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for Pain, Headache, Vaccination site pain, and Chills; not resolved for Rheumatoid arthritis, Anxiety disorder, Sleep apnea syndrome and Panic attack; and unknown for Obstructive sleep apnea syndrome, Fatigue and Arthralgia. Treatment information was not provided. The patient's medical history of Rheumatoid arthritis and intake of Upadacitinib remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  No treatment medication was provided   This case was linked to MOD-2022-582662 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Significant live follow-up information was received: Updated the co-suspect start date, Event verbatim for Rheumatoid arthritis flare up changed to Rheumatoid arthritis flare up/achiness from weather. New event Shoulder pain was added.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient, with no medical history of Rheumatoid arthritis and intake of Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis flare up, the unexpected events of Pain, Anxiety disorder, Sleep apnea syndrome, Obstructive sleep apnea syndrome, and Panic attacks, and the expected events of Headache, Vaccination site pain, Chills, Fatigue and Arthralgia. The events occurred on an unspecified date after receiving the first dose of mRNA-1273 Vaccine. The outcome of the events was reported as resolved for Pain, Headache, Vaccination site pain, and Chills; not resolved for Rheumatoid arthritis, Anxiety disorder, Sleep apnea syndrome and Panic attack; and unknown for Obstructive sleep apnea syndrome, Fatigue and Arthralgia. Treatment information was not provided. The patient's medical history of Rheumatoid arthritis and intake of Upadacitinib remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.