Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Illness, Psoriasis, Restless legs syndrome, Spondylitis
Clinical narrative: arthritis in back and neck; BURSITIS IN HIP; psoriasis returns on elbows about a week before her next Skyrizi injection; RESTLESS LEGS; SICK; Wearing off effect; This spontaneous case was reported by a patient and describes the occurrence of SPONDYLITIS (arthritis in back and neck), BURSITIS (BURSITIS IN HIP), PSORIASIS (psoriasis returns on elbows about a week before her next Skyrizi injection), RESTLESS LEGS SYNDROME (RESTLESS LEGS) and ILLNESS (SICK) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis and COVID-19 VACCINE for COVID-19 vaccination.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SPONDYLITIS (arthritis in back and neck), BURSITIS (BURSITIS IN HIP), PSORIASIS (psoriasis returns on elbows about a week before her next Skyrizi injection), RESTLESS LEGS SYNDROME (RESTLESS LEGS), ILLNESS (SICK) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). The patient was treated with PRAMIPEXOLE for Restless legs, at a dose of 1 milligram twice a day. At the time of the report, SPONDYLITIS (arthritis in back and neck), BURSITIS (BURSITIS IN HIP) and PSORIASIS (psoriasis returns on elbows about a week before her next Skyrizi injection) had not resolved, RESTLESS LEGS SYNDROME (RESTLESS LEGS) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown and ILLNESS (SICK) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial The reporter's causality for the events spondylitis, bursitis, restless legs syndrome and illness was not provided, and therapeutic response shortened was unknown and for psoriasis was probable for the cosuspect SKYRIZI (risankizumab) and possible for illness and not provided for rest all was not provided for COVID-19 VACCINE.  Company comment: This spontaneous case concerns an adult female patient with no relevant medical history who experienced the unexpected non-serious AESI of Spondylitis (arthritis in back and neck) which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Further details regarding number and specifics of COVID 19 vaccines, therapy dates, concomitant medications, investigations, and treatment are not provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with no relevant medical history who experienced the unexpected non-serious AESI of Spondylitis (arthritis in back and neck) which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Further details regarding number and specifics of COVID 19 vaccines, therapy dates, concomitant medications, investigations, and treatment are not provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report.