Sex: F
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Limb injury, Vaccination complication
Clinical narrative: STEPPED ON GLASS AND HAD TO HAVE SURGERY TO REPAIR; BASAL CELL CANCER ON NOSE; HAD ALL THREE COVID VACCINES AND FELT CRUMMY; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (STEPPED ON GLASS AND HAD TO HAVE SURGERY TO REPAIR) and BASAL CELL CARCINOMA (BASAL CELL CANCER ON NOSE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LIMB INJURY (STEPPED ON GLASS AND HAD TO HAVE SURGERY TO REPAIR) (seriousness criterion medically significant), BASAL CELL CARCINOMA (BASAL CELL CANCER ON NOSE) (seriousness criterion medically significant) and VACCINATION COMPLICATION (HAD ALL THREE COVID VACCINES AND FELT CRUMMY). At the time of the report, LIMB INJURY (STEPPED ON GLASS AND HAD TO HAVE SURGERY TO REPAIR) outcome was unknown and BASAL CELL CARCINOMA (BASAL CELL CANCER ON NOSE) and VACCINATION COMPLICATION (HAD ALL THREE COVID VACCINES AND FELT CRUMMY) had resolved.            Company comment: This is a spontaneous case concerning an adult female patient with Plaque psoriasis and psoriatic arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events limb injury and basal cell carcinoma on nose, on an unknown date after the second dose of mRNA-1273. It was reported that patient stepped on glass and had to have surgery to repair foot injury. Additional clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  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.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant product use was reported.  The patient received all doses one in once. Humira (Adalimumab) was citrate free.  No treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the event of stepped on glass and had to have surgery to repair was not provided. The reporter's causality for the events of basal cell cancer on nose and had all three covid vaccines and felt crummy with Humira (Adalimumab) was no reasonable possibility.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient with Plaque psoriasis and psoriatic arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events limb injury and basal cell carcinoma on nose, on an unknown date after the second dose of mRNA-1273. It was reported that patient stepped on glass and had to have surgery to repair foot injury. Additional clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.