Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site induration, Injection site mass, Injection site papule, Injection site rash, Injection site warmth
Clinical narrative: Injection site induration/reaction at injection site with a hard bump; Injection site rash/reaction at injection site with rash; Injection site papule/Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised; Injection site lump/reaction at injection site with lumps on leg which was warm to touch and raised; Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised), INJECTION SITE INDURATION (Injection site induration/reaction at injection site with a hard bump), INJECTION SITE MASS (Injection site lump/reaction at injection site with lumps on leg which was warm to touch and raised), INJECTION SITE RASH (Injection site rash/reaction at injection site with rash) and INJECTION SITE PAPULE (Injection site papule/Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Sep-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised), INJECTION SITE MASS (Injection site lump/reaction at injection site with lumps on leg which was warm to touch and raised) and INJECTION SITE PAPULE (Injection site papule/Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised). On 24-Sep-2021, the patient experienced INJECTION SITE INDURATION (Injection site induration/reaction at injection site with a hard bump) and INJECTION SITE RASH (Injection site rash/reaction at injection site with rash). At the time of the report, INJECTION SITE WARMTH (Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised), INJECTION SITE MASS (Injection site lump/reaction at injection site with lumps on leg which was warm to touch and raised) and INJECTION SITE PAPULE (Injection site papule/Injection site warmth/reaction at injection site with lumps on leg which was warm to touch and raised) had not resolved and INJECTION SITE INDURATION (Injection site induration/reaction at injection site with a hard bump) and INJECTION SITE RASH (Injection site rash/reaction at injection site with rash) was resolving.            Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a covid-19 vaccine trial Treatment information was not provided. 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