Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza, Neck pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 54-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 Plaque psoriasis. The patient's past medical history included Foot fracture (LEFT FOOT BROKE) in 1997. Concurrent medical conditions included Plaque psoriasis (Moderate to Severe). Concomitant products included METHOTREXATE for an unknown indication. 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In October 2021, the patient experienced WEIGHT INCREASED (Weight gain). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant), GAIT DISTURBANCE (Walking difficulty), NECK PAIN (Neck pain), INFLUENZA (Flu), PAIN (General body pain) and PAIN IN EXTREMITY (Foot pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) and PAIN IN EXTREMITY (Foot pain) was resolving and GAIT DISTURBANCE (Walking difficulty), WEIGHT INCREASED (Weight gain), NECK PAIN (Neck pain), INFLUENZA (Flu) and PAIN (General body pain) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. 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 is a Spontaneous case reported by a consumer, concerning a 54-year-old female patient, with relevant medical condition of plaque psoriasis, who experienced the unexpected and serious (due to medically significant) event of Psoriatic arthropathy (reported as psoriatic arthritis aggravated), which occurred related to the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for plaque psoriasis. No information disclosed about diagnostic tests performed. Patient was treated with ibuprofen and cortisone. At the time of the report, the event was resolving. Psoriasis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Significant Follow up received - patient demographics, medical history, event information added. Suspect drug information, treatment drug information and narrative description updated. The event of LEFT FOOT PAIN was added. Outcome of Psoriatic arthritis aggravated updated. Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 54-year-old female patient, with relevant medical condition of plaque psoriasis, who experienced the unexpected and serious (due to medically significant) event of Psoriatic arthropathy (reported as psoriatic arthritis aggravated), which occurred related to the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for plaque psoriasis. No information disclosed about diagnostic tests performed. Patient was treated with ibuprofen and cortisone. At the time of the report, the event was resolving. Psoriasis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.