Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, COVID-19, Insomnia, Joint range of motion decreased, Pharyngitis streptococcal
Clinical narrative: Psoriatic arthritis/COVID vaccine effected psoriatic arthritis; Sinus infection; Joint range of motion decreased/Could not bend knees; Unspecified disorder of joint of shoulder region/Shoulders had problems; Difficulty sleeping/had problems sleeping; COVID-19; Streptococcal sore throat/Strep throat; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis/COVID vaccine effected psoriatic arthritis) in a 56-year-old female patient who received mRNA-1273 (Spikevax) 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 relevant medical history was not reported.  Concomitant products included AZITHROMYCIN (Z-PAK) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily Dose: CF, Solution for injection in prefilled pen. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat/Strep throat). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis/COVID vaccine effected psoriatic arthritis) (seriousness criterion medically significant), SINUSITIS (Sinus infection), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not bend knees), ARTHROPATHY (Unspecified disorder of joint of shoulder region/Shoulders had problems), INSOMNIA (Difficulty sleeping/had problems sleeping) and COVID-19 (COVID-19). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis/COVID vaccine effected psoriatic arthritis), SINUSITIS (Sinus infection), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not bend knees), ARTHROPATHY (Unspecified disorder of joint of shoulder region/Shoulders had problems) and INSOMNIA (Difficulty sleeping/had problems sleeping) outcome was unknown, PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat/Strep throat) was resolving and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient had other concomitant therapy of Z pack.   The reporter's causality of events with respect to drug HUMIRA(Adalimumab): Could not bend knees, Shoulders had problems, Sinus infection, COVID vaccine effected psoriatic arthritis, COVID and had problems sleeping was not provided and the reporter's causality for the events of strep throat with HUMIRA(Adalimumab) was no reasonable possibility.  Treatment medication were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment: This spontaneous case concerns a 56-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Psoriatic arthropathy and unexpected, non-serious AESI of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 and exact onset of events was not specified, hence latency could not be assessed. The patient has history of chronic administration of the drug Adalimumab. It has been reported that the patient experienced inability to mobilize her knees and shoulders and claimed that the vaccine affected her psoriatic arthritis. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Psoriatic arthropathy and unexpected, non-serious AESI of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 and exact onset of events was not specified, hence latency could not be assessed. The patient has history of chronic administration of the drug Adalimumab. It has been reported that the patient experienced inability to mobilize her knees and shoulders and claimed that the vaccine affected her psoriatic arthritis. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.