Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, Menopause, Psoriasis, Therapeutic response shortened
Clinical narrative: Difficulty sleeping; Menopause; Psoriasis flare-up; Wearing off effect; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), INSOMNIA (Difficulty sleeping), MENOPAUSE (Menopause), PSORIASIS (Psoriasis flare-up) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping), MENOPAUSE (Menopause), PSORIASIS (Psoriasis flare-up) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, COVID-19 (COVID-19) had resolved, INSOMNIA (Difficulty sleeping) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved, MENOPAUSE (Menopause) outcome was unknown and PSORIASIS (Psoriasis flare-up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of covid-19, difficulty sleeping and Menopause was not provided. The reporter's causality for the events of psoriasis flare up and wearing off effect with skyrizi(risankizumab) was a reasonable possibility.  No treatment medication were provided.  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 patient, concerning a 59-year-old female patient with relevant medical condition of moderate to severe Chronic plaque Psoriasis treated with Risankizumab (Skyrizi), who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred on the same month of the first mRNA-1273 vaccination. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 32 days which falls within the recommended vaccine dosing schedule. Additionally, Therapeutic response shortened, described as wearing off effect, was also reported. Patient reported she missed her last Skyrizi injection which resulted to breakout on her knees and elbows. After taking another Skyraizi injection, the spots went away and only dry patches were left. Patient had trouble sleeping through the night since going through menopause and also stated she also worked in the night shift, which interfered with her sleeping through the night. No further details about the diagnostic procedures and treatments were provided. It was reported that the event COVID-19 was resolved. The medical condition of moderate to severe Chronic plaque Psoriasis remains as a confounders for the Psoriasis flare-up. Furthermore, co-suspect drug Risankizumab; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 59-year-old female patient with relevant medical condition of moderate to severe Chronic plaque Psoriasis treated with Risankizumab (Skyrizi), who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred on the same month of the first mRNA-1273 vaccination. Latency cannot be properly assessed since the exact event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 32 days which falls within the recommended vaccine dosing schedule. Additionally, Therapeutic response shortened, described as wearing off effect, was also reported. Patient reported she missed her last Skyrizi injection which resulted to breakout on her knees and elbows. After taking another Skyraizi injection, the spots went away and only dry patches were left. Patient had trouble sleeping through the night since going through menopause and also stated she also worked in the night shift, which interfered with her sleeping through the night. No further details about the diagnostic procedures and treatments were provided. It was reported that the event COVID-19 was resolved. The medical condition of moderate to severe Chronic plaque Psoriasis remains as a confounders for the Psoriasis flare-up. Furthermore, co-suspect drug Risankizumab, which is an immunosuppressant, could increased the patient's susceptibility to have COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.