Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site inflammation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine; Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine; Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine; Fatigue after first dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE INFLAMMATION (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE SWELLING (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine) and FATIGUE (Fatigue after first dose of Moderna vaccine) in a 49-year-old male 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 (Moderate to severe chronic plaque psoriasis).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE WARMTH (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE INFLAMMATION (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE SWELLING (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine) and FATIGUE (Fatigue after first dose of Moderna vaccine). At the time of the report, VACCINATION SITE WARMTH (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE INFLAMMATION (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine), VACCINATION SITE SWELLING (Inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine) and FATIGUE (Fatigue after first dose of Moderna vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. No treatment medication was reported.  In 2021, the patient had inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine and fatigue after first dose of Moderna vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of inflamed with hot feeling and swelling in arm caused by first dose of Moderna COVID vaccine, fatigue after first dose of Moderna vaccine 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.   This case was linked to MOD-2022-630475, MOD-2022-630551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up was received: Suspect start date, event start date and additional event of "Fatigue after first dose of Moderna vaccine" was added.