Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Disturbance in attention, Psoriatic arthropathy, Stress, Vaccination failure
Clinical narrative: Had trouble concentrating; Dose 1 on 15Jan2021, dose 2 on 15Feb2021 and COVID-19 occurred on Nov2021; Had COVID; Psoriatic arthritis flare up; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 46-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 ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    The patient's past medical history included Psoriatic arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 UNK, Citrate Free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate Free. In 2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant) and STRESS (Stress). In November 2021, the patient experienced COVID-19 (Had COVID). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Had trouble concentrating) and VACCINATION FAILURE (Dose 1 on 15Jan2021, dose 2 on 15Feb2021 and COVID-19 occurred on Nov2021). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up), DISTURBANCE IN ATTENTION (Had trouble concentrating), STRESS (Stress) and VACCINATION FAILURE (Dose 1 on 15Jan2021, dose 2 on 15Feb2021 and COVID-19 occurred on Nov2021) outcome was unknown and COVID-19 (Had COVID) had not resolved.            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.  On 15-Dec-2021, the patient was administered with Moderna booster dose, route of administration was reported as intramuscular with no batch number. No concomitant medication was reported.  The patient reported general body pain and joint disorder.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of had trouble concentrating, depressed/patient was down all weekend, inflammation, stress, stiffness, had covid and this has caused some long term effect joints onset in November 2021, had covid and this has caused some long term effect joints onset in November 2021, hurting/pain all over, headache, psoriatic arthritis flare up and Humira was not helping as much as it was before was not provided.  This spontaneous case concerns a 46-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Psoriatic arthritis aggravated and an unexpected, non-serious COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at an interval of 31 days apart, followed by a 3rd dose. Exact onset latency of the event Psoriatic arthritis aggravated relative to vaccination cannot be determined with unknown event's onset date. Event COVID-19 occurred approximately 8 months after her 2nd vaccination. Reportedly, patient had COVID-19 related long term effect on her joints. On unknown dates, she experienced stress and impaired concentration. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Live follow up information was added: Suspect drug information and narrative description was updated. The event of COVID was amended to had COVID and this has caused some long term effect joints. Sender's Comments: This spontaneous case concerns a 46-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Psoriatic arthritis aggravated and an unexpected, non-serious COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at an interval of 31 days apart, followed by a 3rd dose. Exact onset latency of the event Psoriatic arthritis aggravated relative to vaccination cannot be determined with unknown event's onset date. Event COVID-19 occurred approximately 8 months after her 2nd vaccination. Reportedly, patient had COVID-19 related long term effect on her joints. On unknown dates, she experienced stress and impaired concentration. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.