Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, COVID-19, Pain in extremity, Pruritus
Clinical narrative: COVID-19; anxiety disorder; Pain in arm/sore arm; itchiness/Itching; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PRURITUS (itchiness/Itching), ANXIETY DISORDER (anxiety disorder) and PAIN IN EXTREMITY (Pain in arm/sore arm) in a 69-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.    The patient's past medical history included Plaque psoriasis.   On 02-Oct-2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itchiness/Itching) and PAIN IN EXTREMITY (Pain in arm/sore arm). On an unknown date, the patient experienced COVID-19 (COVID-19) and ANXIETY DISORDER (anxiety disorder). At the time of the report, COVID-19 (COVID-19) and ANXIETY DISORDER (anxiety disorder) had not resolved and PRURITUS (itchiness/Itching) and PAIN IN EXTREMITY (Pain in arm/sore arm) outcome was unknown.     Concomitant Drugs Not Reported. Information provided by patient not related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19, ANXIETY DISORDER, SORE ARM and ITCHINESS with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Patient reported Covid-19 with symptoms of fever, fatigue, and headache. No treatment details were reported.  Company comment: This spontaneous case concerns a 69 year old female with prior medication of risankizumab (Skyrizi) indicated for plaque psoriasis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the third dose of mRNA1273. Additional non-serious events of pruritus, anxiety disorder and pain in extremity were reported in the case. The patient reported she had COVID-19 at an unknown date post vaccination with symptoms of fever, fatigue and headache. Further details regarding the clinical course,  diagnostic or imaging test done and treatment were not provided. The patient's elderly age along with the impaired immunity of the patient due to psoriasis (indicated by the use of risankizumab) may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female with prior medication of risankizumab (Skyrizi) indicated for plaque psoriasis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the third dose of mRNA1273. Additional non-serious events of pruritus, anxiety disorder and pain in extremity were reported in the case. The patient reported she had COVID-19 at an unknown date post vaccination with symptoms of fever, fatigue and headache. Further details regarding the clinical course,  diagnostic or imaging test done and treatment were not provided. The patient's elderly age along with the impaired immunity of the patient due to psoriasis (indicated by the use of risankizumab) may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.