Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bladder cancer, Prostatic disorder
Clinical narrative: they also went to do some surgery in the prostate; diagnosed to have bladder cancer in Dec2022; This spontaneous case was reported by a patient and describes the occurrence of BLADDER CANCER (diagnosed to have bladder cancer in Dec2022) and PROSTATIC DISORDER (they also went to do some surgery in the prostate) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE]. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concurrent medical conditions included Hypertension, Overweight and Mood disorder.    On 30-Nov-2022, 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. In December 2022, the patient experienced BLADDER CANCER (diagnosed to have bladder cancer in Dec2022) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PROSTATIC DISORDER (they also went to do some surgery in the prostate) (seriousness criterion hospitalization). The patient was treated with Surgery for Bladder cancer and Surgery for Prostatic disorder. At the time of the report, BLADDER CANCER (diagnosed to have bladder cancer in Dec2022) and PROSTATIC DISORDER (they also went to do some surgery in the prostate) was resolving.        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.   The concomitant medications included 3 medications for mood.  Patient vaccination details were as follows: Moderna COVID-19 vaccine 1st dose on 15-Jan-2021 (lot number 013L20A), 2nd dose on 15-Feb-2021 (lot number 030M20A), next (third) must have been a booster on 30-Oct-2021 (lot number: unknown), fourth dose on 20-May-2022 (lot number 049L21A).  Patient had a surgery in end of Dec-2022 to remove the cancer and they also went to do some surgery in the prostate. Patient was told that it was too raw to be able to tell that it was gone. They did a chemo within the bladder after the surgery once and he was currently on 4 medications for his bladder cancer. Patient mentioned that he might have gotten the cancer form the spray that was used in the vegetation while they were still out of the country. Patient learned that this was one of the outcomes of the spray.  Company Comment: This spontaneous case concerns a 78-year-old male patient with no relevant medical history reported, who experienced unexpected serious (hospitalization, medically significant) event of bladder cancer and unexpected serious (hospitalization) event of prostatic disorder which occurred after receiving a dose of mRNA-1273.222, which was the patient's 5th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to lack of exact events onset date, but it was not longer than app. 1 month. Primary series of COVID-19 vaccination with 1 dose and 2 dose (administered 30 days apart) with consecutive 3rd and 4th doses were performed with mRNA-1273; 4th dose administered approximately 6 months before the current vaccination. It was described that "the patient had a surgery in end of Dec-2022 to remove the cancer and they also went to do some surgery in the prostate". It is not clear what kind of surgery was performed as well as the type of prostate disorder. It was reported that the patient was administered chemotherapy within the bladder which could suggest that the surgery did not involve cystectomy. The patient explained that the probable cause of bladder cancer could be some kind of vegetation spray used during the time the patient was there. Patient elderly age could be considered as an additional risk factor for both events. None further details regarding exact dates of events, clinical course, relevant risk factors, diagnostic work-up and treatment details, investigations performed are available in the report. Events' outcome was resolving at the time of the report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old male patient with no relevant medical history reported, who experienced unexpected serious (hospitalization, medically significant) event of bladder cancer and unexpected serious (hospitalization) event of prostatic disorder which occurred after receiving a dose of mRNA-1273.222, which was the patient's 5th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to lack of exact events onset date, but it was not longer than app. 1 month. Primary series of COVID-19 vaccination with 1 dose and 2 dose (administered 30 days apart) with consecutive 3rd and 4th doses were performed with mRNA-1273; 4th dose administered approximately 6 months before the current vaccination. It was described that "the patient had a surgery in end of Dec-2022 to remove the cancer and they also went to do some surgery in the prostate". It is not clear what kind of surgery was performed as well as the type of prostate disorder. It was reported that the patient was administered chemotherapy within the bladder which could suggest that the surgery did not involve cystectomy. The patient explained that the probable cause of bladder cancer could be some kind of vegetation spray used during the time the patient was there. Patient elderly age could be considered as an additional risk factor for both events. None further details regarding exact dates of events, clinical course, relevant risk factors, diagnostic work-up and treatment details, investigations performed are available in the report. Events' outcome was resolving at the time of the report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.