Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: diagnosed with basal cell carcinoma after a biopsy; soreness on arm after receiving all previous doses of the Moderna COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of BASAL CELL CARCINOMA (diagnosed with basal cell carcinoma after a biopsy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots. Concurrent medical conditions included Penicillin allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced BASAL CELL CARCINOMA (diagnosed with basal cell carcinoma after a biopsy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (soreness on arm after receiving all previous doses of the Moderna COVID-19 vaccines). At the time of the report, BASAL CELL CARCINOMA (diagnosed with basal cell carcinoma after a biopsy) was resolving and PAIN IN EXTREMITY (soreness on arm after receiving all previous doses of the Moderna COVID-19 vaccines) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: diagnosed with basal cell carcinoma.         No concomitant and treatment drug was reported. Patient never had COVID positive test or diagnosis. There was a red circle about a quarter inch from where the injection was given to patient. That never went away and when he went for his second shot of Moderna, nobody knew why he had the red circle at the injection site. He ended up receiving his second dose, but the redness never went away. He finally went to see a dermatologist and was diagnosed with basal cell carcinoma after a biopsy. Patient stated that the redness had nothing to do with the Moderna. He had an outpatient procedure to treat the carcinoma, after which the redness finally went away. He did not seek medical care for the event soreness on arm. The soreness only lasted for a day.  Company comment: This spontaneous case concerns an 80-years-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of Basal cell carcinoma that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. It was reported that there was a red circle about a quarter inch from where the injection was given to patient. That never went away and when patient went for his second shot of Moderna, nobody knew why patient had the red circle at the injection site. Patient ended up receiving his second dose, but the redness never went away. Patient finally went to see a dermatologist and was diagnosed with basal cell carcinoma after a biopsy as on unknown date. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was resolving. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-645576, MOD-2022-645573 (Patient Link).; Sender's Comments: This spontaneous case concerns an 80-years-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of Basal cell carcinoma that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. It was reported that there was a red circle about a quarter inch from where the injection was given to patient. That never went away and when patient went for his second shot of Moderna, nobody knew why patient had the red circle at the injection site. Patient ended up receiving his second dose, but the redness never went away. Patient finally went to see a dermatologist and was diagnosed with basal cell carcinoma after a biopsy as on unknown date. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was resolving. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.