Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Injection site swelling, Vaccination site pain
Clinical narrative: Second dose on 10-sep-2021 and Booster dose on 01-Oct-2021; Vaccination site pain/Covid vaccine caused Sore arm; Injection site redness/recurring injection site redness; Injection site swelling/Injection site swollen; Injection site pain/recurring injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/Covid vaccine caused Sore arm), INJECTION SITE ERYTHEMA (Injection site redness/recurring injection site redness), INJECTION SITE SWELLING (Injection site swelling/Injection site swollen), INJECTION SITE PAIN (Injection site pain/recurring injection site soreness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-sep-2021 and Booster dose on 01-Oct-2021) in a 31-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) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (MODERATE TO SEVERE).   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 wk, First dose. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/Covid vaccine caused Sore arm), INJECTION SITE ERYTHEMA (Injection site redness/recurring injection site redness), INJECTION SITE SWELLING (Injection site swelling/Injection site swollen) and INJECTION SITE PAIN (Injection site pain/recurring injection site soreness). On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-sep-2021 and Booster dose on 01-Oct-2021). In 2021, VACCINATION SITE PAIN (Vaccination site pain/Covid vaccine caused Sore arm) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness/recurring injection site redness), INJECTION SITE SWELLING (Injection site swelling/Injection site swollen) and INJECTION SITE PAIN (Injection site pain/recurring injection site soreness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-sep-2021 and Booster dose on 01-Oct-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The reporter Causality for humira(adalimumab) with the event(s) of covid vaccine caused sore arm and injection site swollen was not provided. And for recurring injection site redness and  injection site soreness was a reasonable possibility. Action taken with Humira with response to the event Vaccination site pain was reported as Not applicable. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment details were reported.  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.   Reporter did not allow further contact