Age: 87.0
Sex: U
Vaccine: COVID19, COVID19-2
Symptoms: Lung cancer metastatic
Clinical narrative: metastatic lung cancer; This spontaneous case was reported by a patient and describes the occurrence of LUNG CANCER METASTATIC (metastatic lung cancer) in an 87-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product POVIDONE-IODINE (COVIDON) for an unknown indication.    Patient don't have information about previous COVID-19 vaccination doses.  The patient's past medical history included Melanoma (was diagnosed with skin cancer on his left arm 5 to 7 years ago as a lesion. There was no evidence of spread to his sentinel node) and Surgery (lesion was removed through a Mhos surgery).   In October 2022, the patient received 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, the patient started POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose. In December 2022, the patient experienced LUNG CANCER METASTATIC (metastatic lung cancer) (seriousness criterion medically significant). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) for Melanoma and Lung cancer metastatic, at an unspecified dose and frequency. At the time of the report, LUNG CANCER METASTATIC (metastatic lung cancer) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered LUNG CANCER METASTATIC (metastatic lung cancer) to be not related.    No concomitant medication was reported.  In December of 2022 the patient was diagnosed with a metastatic lung cancer from his arm to his lungs in December 2022 The lung cancer was ongoing still and the patient was receiving Keytruda infusion It was reported that the patient and his team of Physicians do not believe that the patient lung cancer was related to his October Moderna bivalent whatsoever. It was also reported that the patient received his first Moderna Covid-19 vaccine and the patient had received all of his Covid-19 vaccines as Moderna Covid-19 vaccines. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 87-year-old patient with relevant medical history of melanoma with surgery 5-7 years ago, who experienced the unexpected serious (medically significant) event of Lung cancer metastatic. The event occurred after a dose of mRNA-1273.222 vaccine. The patient was receiving Keytruda infusion for treatment. No information disclosed about diagnostic tests performed or treatments received. The medical history remains as a confounder. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.; Reporter's Comments: This is a spontaneous case concerning a 87-year-old patient with relevant medical history of melanoma with surgery 5-7 years ago, who experienced the unexpected serious (medically significant) event of Lung carcinoma metastatic. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The medical history remains as a confounder. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.