Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin exfoliation, Therapeutic response shortened, X-ray
Clinical narrative: Immunosuppression; Ligament tear; Meniscus tear; Psoriasis flare-up; Flaking scalp; Wearing off effect; This spontaneous case was reported by a physician and describes the occurrence of IMMUNOSUPPRESSION (Immunosuppression) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025120-2A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    The patient's past medical history included Meniscus tear (Worsened over the years) in 2020 and Knee surgery NOS (Continued to be on brace.) on 16-Feb-2021. Concurrent medical conditions included Blood pressure high, Cholesterol and Macular degeneration. Concomitant products included AMLODIPINE for Blood pressure high, METOPROLOL for Blood pressure management, ATORVASTATIN for Cholesterol, ASCORBIC ACID, CUPRIC OXIDE, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (MACULAR SHIELD AREDS 2) for Macular degeneration, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Prophylaxis NOS.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage form. On 13-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 an unknown date, the patient experienced IMMUNOSUPPRESSION (Immunosuppression) (seriousness criterion medically significant), LIGAMENT RUPTURE (Ligament tear), MENISCUS INJURY (Meniscus tear), PSORIASIS (Psoriasis flare-up), SKIN EXFOLIATION (Flaking scalp) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, IMMUNOSUPPRESSION (Immunosuppression) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown, LIGAMENT RUPTURE (Ligament tear) and MENISCUS INJURY (Meniscus tear) was resolving and PSORIASIS (Psoriasis flare-up) and SKIN EXFOLIATION (Flaking scalp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: abnormal (Inconclusive) Worsened torn meniscus and medial collateral ligament popped.. In 2021, X-ray: abnormal (Inconclusive) Worsened torn meniscus and medial collateral ligament popped..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In Feb-2021, on an unspecified date, the patient developed a breakout with plaque psoriasis in head. She clarified  that after the second dose of vaccine on 23-Feb-2021 and the Skyrizi shot due on 18-Feb-2021, she developed a breakout of heavy flakes in the head, for 12 weeks. She reported that  the covid-19 vaccine seemed to have an effect on her immune system. Covid-19 was considered as the alternate etiology. It was reported that she took Skyrizi shot on 12-May-2021 and was doing better.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.