Sex: M
Vaccine: COVID19
Symptoms: Biopsy, T-cell lymphoma
Clinical narrative: Red thumb-print sized bump on his left arm/ lump was diagnosed as a patch stage T-Cell Lymphoma/ indurated, inflamed, and painful; This spontaneous case was reported by a physician and describes the occurrence of T-CELL LYMPHOMA (Red thumb-print sized bump on his left arm/ lump was diagnosed as a patch stage T-Cell Lymphoma/ indurated, inflamed, and painful) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: DTAP, PNEUMOCOCCAL VACCINES and INFLUENZA. Past adverse reactions to the above products included No adverse event with DTAP, INFLUENZA and PNEUMOCOCCAL VACCINES. Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced T-CELL LYMPHOMA (Red thumb-print sized bump on his left arm/ lump was diagnosed as a patch stage T-Cell Lymphoma/ indurated, inflamed, and painful) (seriousness criterion medically significant). At the time of the report, T-CELL LYMPHOMA (Red thumb-print sized bump on his left arm/ lump was diagnosed as a patch stage T-Cell Lymphoma/ indurated, inflamed, and painful) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: lump was diagnosed as a patch stage T-Cell Lymphoma.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported The patient previously received 5 doses of COVID19 vaccination He received other vaccines in the 4 weeks prior to COVID19 vaccine His red thumbprint sized bump on his left arm became more indurated inflamed and painful after an additional 2 booster doses of the vaccine He had tried antiinflammatories topical steroids oral steroids and antifungals with minimal improvement He had received 5 doses of the Moderna COVID19 vaccines in total all to the left arm  Treatment information was not provided Company comment This is a spontaneous case concerning a male patient of an unknown age, with no relevant medical history reported, who experienced the serious (medically significant) event of T-Cell Lymphoma, which occurred in the context of the fifth dose of mRNA-1273.222 (BA.4/BA.5) (BIVALENT ORIGINAL AND OMICRON BA.4/BA.5). The vaccination date and the exact event onset date were unknown, thus, exact latency between vaccination and onset of the event could not be assessed. The event was described as a red thumb-print sized bump on his left arm; this indurated, inflamed, and painful lump was diagnosed as a patch stage T-Cell Lymphoma. It was reported that the patient received 5 doses of Moderna COVID-19 vaccines in total all in the left arm. He received other vaccines in the 4 weeks prior to COVID-19 vaccine. His red thumbprint sized bump on his left arm became more indurated inflamed and painful after an additional 2 booster doses of the vaccine. He had tried anti-inflammatories, topical steroids, oral steroids and antifungals with minimal improvement. No further clinical information such as the course of the event, studies performed, treatment details were available for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   This case was linked to MOD-2023-696151.