Age: 82.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Neoplasm malignant, Single functional kidney
Clinical narrative: Single kidney(loss to cancer); Single kidney(loss to cancer); This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Single kidney(loss to cancer)) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Chronic kidney disease.   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. and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Single kidney(loss to cancer)) (seriousness criterion medically significant) and SINGLE FUNCTIONAL KIDNEY (Single kidney(loss to cancer)). At the time of the report, NEOPLASM MALIGNANT (Single kidney(loss to cancer)) and SINGLE FUNCTIONAL KIDNEY (Single kidney(loss to cancer)) outcome was unknown.        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 medication was reported. It was reported that the patient had 3 Moderna shots and 1 shot for Season's Flue. No treatment information was reported.  Company comment:  This spontaneous case report concerns an 82-year-old male patient with medical history of Chronic kidney disease, who experienced serious (medically significant) unexpected event of Neoplasm malignant and non serious unexpected event of Single functional kidney. According to current available information, it was only provided that the patient had cancer and that due to cancer the patient had only single kidney. It remained unclear when the reported cancer occurred and whether it was actually part of the patient's medical history or it occurred after vaccination, since no dates were provided. At the time of this report, the company causality for the event of Neoplasm malignant and Single functional kidney is assessed as not related to the mRNA-1273.222 vaccine, having in mind that until this date, there is no evidence to suggest that mRNA-1273.222 vaccine had oncological potential. In addition, as per provided information due to cancer, the patient had single kidney due to cancer loss. The patient's elderly age remains a confounder. Case will be re-assessed upon receipt of additional information. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live followup received contains No new Information.