Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaesthetic complication, Anal incontinence, Anxiety, Drug ineffective, Feeling abnormal
Clinical narrative: Foggy feeling in head; Pelvic floor dysfunction; Anxiety; Vision peripheral decreased; Anesthetic complication; Psoriatic arthritis aggravated; Sinus infection; Swelling; Lack of drug effect; Urinary incontinence; Bowel incontinence; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 53-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 products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and PREDNISONE for an unknown indication.    The patient's past medical history included Hysterectomy, Eye operation (Eye surgery) in September 2021 and Brow lift in September 2021. Concurrent medical conditions included Psoriatic arthritis and Anxiety.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In September 2021, the patient started PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2019, the patient experienced URINARY INCONTINENCE (Urinary incontinence) and ANAL INCONTINENCE (Bowel incontinence). In 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). In September 2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant), SINUSITIS (Sinus infection), SWELLING (Swelling) and ANAESTHETIC COMPLICATION (Anesthetic complication). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head), PELVIC FLOOR DYSFUNCTION (Pelvic floor dysfunction), ANXIETY (Anxiety) and VISUAL FIELD DEFECT (Vision peripheral decreased). The patient was treated with ETANERCEPT (ENBREL) in September 2021 at an unspecified dose and frequency. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), SINUSITIS (Sinus infection), FEELING ABNORMAL (Foggy feeling in head), PELVIC FLOOR DYSFUNCTION (Pelvic floor dysfunction) and ANXIETY (Anxiety) had not resolved, URINARY INCONTINENCE (Urinary incontinence), ANAL INCONTINENCE (Bowel incontinence), SWELLING (Swelling) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and VISUAL FIELD DEFECT (Vision peripheral decreased) and ANAESTHETIC COMPLICATION (Anesthetic complication) had resolved.            No concomitant medications was reported.  Patient had issues with HUMIRA keeping her symptoms under control in 2021. Patient experienced bad reaction to Anesthesia and developed significant swelling and triggered a flare of psoriatic arthritis. Patient was started on Prednisone and developed a bad reaction to prednisone which led to more swelling. Patient started on Enbrel and had been on it since Sep 2021 and her symptoms had not improved. In Oct-2021, patient was significant fatigued since she stopped taking HUMIRA. Her Psoriatic Arthritis symptoms had gotten worse since her second COVID vaccine and developed brain fog.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company comment: This spontaneous case concerns a 53-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy an unknown time after the booster dose of mRNA-1273. The patient states that she stopped taking adalimumab due to eye surgery, which along with the disease's natural history of relapses, could be a confounder. Prednisone and etanercept were given as treatment, although the patient reported no improvement. Outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy an unknown time after the booster dose of mRNA-1273. The patient states that she stopped taking adalimumab due to eye surgery, which along with the disease's natural history of relapses, could be a confounder. Prednisone and etanercept were given as treatment, although the patient reported no improvement. Outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.