Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left knee replaced/had knee replacement surgery; Plaque psoriasis breaking out had small flare ups; Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache; Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache; Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache; Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Left knee replaced/had knee replacement surgery) in a 74-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache), PYREXIA (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache), CHILLS (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache) and HEADACHE (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache). On an unknown date, the patient experienced KNEE ARTHROPLASTY (Left knee replaced/had knee replacement surgery) (seriousness criterion medically significant) and PSORIASIS (Plaque psoriasis breaking out had small flare ups). In 2021, PAIN IN EXTREMITY (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache), PYREXIA (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache), CHILLS (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache) and HEADACHE (Fever/chills/sore arm after vaccine/fever/chills/sore arm after vaccine/first vaccine caused chills and headache) had resolved. At the time of the report, KNEE ARTHROPLASTY (Left knee replaced/had knee replacement surgery) was resolving and PSORIASIS (Plaque psoriasis breaking out had small flare ups) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for all events with co-suspect Skyrizi was not provided.  Company Comment: This spontaneous case concerns a 74-year-old, female patient with medical history of Moderate-to-severe Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab), who experienced the unexpected, serious (medically significant) event of knee arthroplasty, the unexpected, non-serious event of psoriasis flare-up, and other unexpected and expected, non-serious events. The events knee arthroplasty and psoriasis flare-up occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi and the event onset dates were not provided, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, administration date of Skyrizi and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient had knee replacement surgery (unknown indication). The patient also experienced fever, chills, sore arm, headache and plaque psoriasis breaking out with small flare-ups. Treatment information was not provided. Of note, the reporter assessed the event knee arthroplasty as not related to the mRNA-1273 vaccine. The medical history of Plaque Psoriasis, a chronic autoimmune disease characterized by flares and remission, remains a confounder for the event psoriasis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow up includes new event (Plaque psoriasis breaking out had small flare ups) added and event verbatim updated.; Sender's Comments: This spontaneous case concerns a 74-year-old, female patient with medical history of Moderate-to-severe Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab), who experienced the unexpected, serious (medically significant) event of knee arthroplasty, the unexpected, non-serious event of psoriasis flare-up, and other unexpected and expected, non-serious events. The events knee arthroplasty and psoriasis flare-up occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi and the event onset dates were not provided, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, administration date of Skyrizi and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient had knee replacement surgery (unknown indication). The patient also experienced fever, chills, sore arm, headache and plaque psoriasis breaking out with small flare-ups. Treatment information was not provided. Of note, the reporter assessed the event knee arthroplasty as not related to the mRNA-1273 vaccine. The medical history of Plaque Psoriasis, a chronic autoimmune disease characterized by flares and remission, remains a confounder for the event psoriasis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.