Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: COVID-19 vaccination injection site became red; COVID-19 vaccination injection site became hard; COVID-19 vaccination injection site increased in swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling) in a 57-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]) injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram once a day. On 31-Jan-2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram every three months. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, the patient experienced VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling). At the time of the report, VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling) was resolving.            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.  No concomitant medication was reported.  The patient experienced the events over a three days period till it was softball sized on patients arm. It stopped getting bigger on 16-Apr-2022 and was not currently back to normal skin color and size.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication was reported.  The reporter's causality for the event(s) of COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022, COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022 and COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022 was not provided for co-suspect Skyrizi.