Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin exfoliation, Therapeutic response shortened
Clinical narrative: Itchy scalp; Flaking scalp; Wearing off effect; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy scalp), SKIN EXFOLIATION (Flaking scalp), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and PAIN IN EXTREMITY (Pain in arm) in a 68-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 Psoriasis.    No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2022, received second dose of RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 12-Apr-2022, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced PRURITUS (Itchy scalp), SKIN EXFOLIATION (Flaking scalp) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PRURITUS (Itchy scalp) and PAIN IN EXTREMITY (Pain in arm) had resolved and SKIN EXFOLIATION (Flaking scalp) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved.            The event of pain in arm  recovered in the year of 2022.  The patient reported that she was having some symptoms of flaking and itching on scalp returned four weeks prior to next dose being due.   She had already talked to her physician and that she wanted to take Skyrizi every two months, which he gave her a sample to take for two months to try and itching immediately went away and took the next injection five weeks later. Patient would like Adverse event department to reach out to her.   She would like to know why it was only a 12-week regimen instead of 8-week regimen. She took her injection on 26 May 2022.   On 12 Apr 2022, fourth dose of COVID-19 vaccine received and all she felt was that her arm was hurt. Causality for SKYRIZI(RISANKIZUMAB) .   The reporter's causality for the events of SOME SYMPTOMS OF FLAKING AND ITCHING ON SCALP RETURN FOUR WEEKS PRIOR TO NEXT DOSE BEING DUE unknown onset, SOME SYMPTOMS OF FLAKING AND ITCHING ON SCALP RETURN FOUR WEEKS PRIOR TO NEXT DOSE BEING DUE unknown onset and SOME SYMPTOMS OF FLAKING AND ITCHING ON SCALP RETURN FOUR WEEKS PRIOR TO NEXT DOSE BEING DUE unknown onset with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.  The reporter's causality for the event of ARM HURT with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  Concomitant drugs were not reported.  Treatment details were not given. COMPANY COMMENT: This is an spontaneous case concerning a 68-year-old female patient with medical history of Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis, Moderna COVID-19 Vaccine on 2/13, 3/13, 11/4 2021 and 4/12 2022 who experienced the unexpected events of PRURITUS, PAIN IN EXTREMITY, SKIN EXFOLIATION and THERAPEUTIC RESPONSE SHORTENED the same day after 4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 68-year-old female patient with medical history of Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis, Moderna COVID-19 Vaccine on 2/13, 3/13, 11/4 2021 and 4/12 2022 who experienced the unexpected events of PRURITUS, PAIN IN EXTREMITY, SKIN EXFOLIATION and THERAPEUTIC RESPONSE SHORTENED the same day after 4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.