Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, Skin exfoliation, Therapeutic product effect decreased
Clinical narrative: Flaking scalp; CONTRACTED COVID-19; SKYRIZI WAS NOT WORKING/STOPPED WORKING; SORE ARM; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Flaking scalp), THERAPEUTIC PRODUCT EFFECT DECREASED (SKYRIZI WAS NOT WORKING/STOPPED WORKING), PAIN IN EXTREMITY (SORE ARM), FATIGUE (fatigued) and COVID-19 (CONTRACTED COVID-19) in a 32-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.    No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COVID-19 (CONTRACTED COVID-19). In 2021, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (SKYRIZI WAS NOT WORKING/STOPPED WORKING), PAIN IN EXTREMITY (SORE ARM) and FATIGUE (fatigued). On an unknown date, the patient experienced SKIN EXFOLIATION (Flaking scalp). In 2021, THERAPEUTIC PRODUCT EFFECT DECREASED (SKYRIZI WAS NOT WORKING/STOPPED WORKING), PAIN IN EXTREMITY (SORE ARM) and COVID-19 (CONTRACTED COVID-19) had resolved. At the time of the report, SKIN EXFOLIATION (Flaking scalp) had not resolved and FATIGUE (fatigued) outcome was unknown.            Concomitant drugs were not reported.  On an unknown date, the patient experienced FLAKING SCALP. In 2021, the patient experienced SORE ARM and SKYRIZI WAS NOT WORKING/STOPPED WORKING. In January 2021, the patient experienced CONTRACTED COVID-19. In 2021, the CONTRACTED COVID-19, SORE ARM and SKYRIZI WAS NOT WORKING/STOPPED WORKING resolved. No treatment medication was reported.  The patient felt like Skyrizi not working since she contracted Covid-19 in Jan 2021. She had scalp was lot of flaking. After contracting covid had to stop taking skyrizi when she started back said it stopped working now as of In 2021 on new medication. She had sore arm and fatigued after vaccination.   It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of FLAKING SCALP, CONTRACTED COVID-19 and SKYRIZI WAS NOT WORKING/STOPPED WORKING was not provided. The reporter's causality for the event(s) of SORE ARM with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  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 32-year-old, female patient with history of co-suspect administration of Skyrizi (risankizumab) for Chronic Plaque Psoriasis, who experienced the unexpected, non-serious AESI of COVID-19 and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving Skyrizi. Of note, the administration date of Skyrizi was reported as unspecified date in 2021 and the event onset date was reported as unspecified date in Jan2021, hence, the onset latency could not be assessed. The event occurred approximately 3 to 4 months before receiving the first dose of the mRNA-1273 vaccine. No symptoms and treatment were reported. On an unspecified date in 2021, the event had resolved. The events therapeutic product effect decreased, pain in extremity and fatigue occurred unknown number of days after receiving Skyrizi. Of note, the administration date of Skyrizi and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start date of the event skin exfoliation was not provided, hence, the onset latency could not be assessed. On an unknown date, the patient experienced that her scalp had a lot of flaking. It was also reported that the patient felt like Skyrizi was not working since she contracted COVID-19 in Jan2021. The patient had to stop receiving Skyrizi when she started back and said it stopped working. As of an unspecified date in 2021, she was on a new medication (unspecified). The patient also had sore arm and was fatigued after vaccination. Treatment Information was not provided. The history of co-suspect administration of Skyrizi remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old, female patient with history of co-suspect administration of Skyrizi (risankizumab) for Chronic Plaque Psoriasis, who experienced the unexpected, non-serious AESI of COVID-19 and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving Skyrizi. Of note, the administration date of Skyrizi was reported as unspecified date in 2021 and the event onset date was reported as unspecified date in Jan2021, hence, the onset latency could not be assessed. The event occurred approximately 3 to 4 months before receiving the first dose of the mRNA-1273 vaccine. No symptoms and treatment were reported. On an unspecified date in 2021, the event had resolved. The events therapeutic product effect decreased, pain in extremity and fatigue occurred unknown number of days after receiving Skyrizi. Of note, the administration date of Skyrizi and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start date of the event skin exfoliation was not provided, hence, the onset latency could not be assessed. On an unknown date, the patient experienced that her scalp had a lot of flaking. It was also reported that the patient felt like Skyrizi was not working since she contracted COVID-19 in Jan2021. The patient had to stop receiving Skyrizi when she started back and said it stopped working. As of an unspecified date in 2021, she was on a new medication (unspecified). The patient also had sore arm and was fatigued after vaccination. Treatment Information was not provided. The history of co-suspect administration of Skyrizi remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.