Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Therapeutic response shortened
Clinical narrative: Itches on inside week before Skyrizi injection and about a week after; Wearing off effect; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches on inside week before Skyrizi injection and about a week after), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and NAUSEA (Nausea) in a 70-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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, 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 NAUSEA (Nausea). On an unknown date, the patient experienced PRURITUS (Itches on inside week before Skyrizi injection and about a week after) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PRURITUS (Itches on inside week before Skyrizi injection and about a week after), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.   The reporter's causality for the event(s) of Itches on inside week before Skyrizi injection and about a week after unknown onset, Nausea with first COVID vaccine and Itches on inside week before Skyrizi injection and about a week after unknown onset was not 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 spontaneous case concerns a female patient aged 70 years with relevant medical history of plaque psoriasis on RISANKIZUMAB reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of one month and third dose 10 months later. Patient also had non serious events of nausea and pruritis. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 70 years with relevant medical history of plaque psoriasis on RISANKIZUMAB reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of one month and third dose 10 months later. Patient also had non serious events of nausea and pruritis. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.