Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Prostatomegaly
Clinical narrative: he has had difficulty with his bowel movements; his prostate had swollen extensively/He has a had a long standing prostate problem but that night he got up to urinate 10 times with an urgency, but he couldn't pee; This spontaneous case was reported by a consumer and describes the occurrence of FUNCTIONAL GASTROINTESTINAL DISORDER (he has had difficulty with his bowel movements) and PROSTATOMEGALY (his prostate had swollen extensively/He has a had a long standing prostate problem but that night he got up to urinate 10 times with an urgency, but he couldn't pee) in an 81-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.     Concurrent medical conditions included Prostate infection (Long standing history of prostate issues, patient says it was steady and bothered him on and off but it was never this bad.).    In September 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 01-Sep-2022, the patient experienced FUNCTIONAL GASTROINTESTINAL DISORDER (he has had difficulty with his bowel movements) (seriousness criterion medically significant) and PROSTATOMEGALY (his prostate had swollen extensively/He has a had a long standing prostate problem but that night he got up to urinate 10 times with an urgency, but he couldn't pee) (seriousness criterion medically significant). At the time of the report, FUNCTIONAL GASTROINTESTINAL DISORDER (he has had difficulty with his bowel movements) and PROSTATOMEGALY (his prostate had swollen extensively/He has a had a long standing prostate problem but that night he got up to urinate 10 times with an urgency, but he couldn't pee) had not resolved.        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. There was no history of a previous COVID-19 diagnosis reported.  Patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient got the shot at about 4 in the afternoon and has a had a long-standing prostate problem, but that night got up to urinate 10 times with an urgency but couldn't pee. Finally, later in the morning the following day, patient needed to go for a bowel movement. At this time patient was able to urinate as well. It was reported that that this was kind of an extreme reaction of the prostate and had difficulty with bowel movements as well. This issue mainly started 2-3 weeks ago. Patient had to go to the ER, and they said that prostate had swollen extensively. This was plugging the bladder, which in turn was plugging his colon. They had to put patient on a catheter. The doctor wants to do a surgery on the prostate to reduce it, but patient was not sure if wants to go that route. Patient didn't have the vaccination records at this time and could not provide any vaccination information. Patient was remembered that getting the most updated booster that had only been out for a couple of weeks at that time in SEP2022. Patient was also mentioned that the 1st booster dose had only given a mild tired feeling in the shoulder and some tiredness at night, nothing like what happened with the 2nd booster. No treatment medications were reported.  Company Comment: This spontaneous case report concerns an 81-year-old male patient, with medical history of Long-standing history of prostate issues, who experienced serious (medically significant) unexpected event of Prostatomegaly and the serious (medically significant) unexpected event of Functional gastrointestinal disorder, which occurred on the same month after the patient had received a dose of mRNA-1273.222 (BA.4/BA.5) given as the second booster dose. It was reported that the same night after the vaccine, the patient got up to urinate 10 times with urgency but couldn't urinate. In the morning on the following day, patient was able to urinate and needed to go for a bowel movement. This issue mainly started 2-3 weeks ago. Patient had to go to the ER, and they said that prostate had swollen extensively. This was disturbing the bladder, and thus colon, bringing difficulty in bowel movements. The doctor put a cathether to the patient and wanted to do a surgery on the prostate to reduce it, but he was not sure. He could not provide any vaccination information but mentioned that the first booster dose had only gave him a mild tired feeling in the shoulder and some tiredness at night, nothing like what happened with the 2nd booster. The patient's age and medical history of previous prostate issues could be a confounder for the events. The event Functional gastrointestinal disorder could be associated with prostatomegaly. 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-2022-691711 (Patient Link).; Sender's Comments: This spontaneous case report concerns an 81-year-old male patient, with medical history of Long-standing history of prostate issues, who experienced serious (medically significant) unexpected event of Prostatomegaly and the serious (medically significant) unexpected event of Functional gastrointestinal disorder, which occurred on the same month after the patient had received a dose of mRNA-1273.222 (BA.4/BA.5) given as the second booster dose. It was reported that the same night after the vaccine, the patient got up to urinate 10 times with urgency but couldn't urinate. In the morning on the following day, patient was able to urinate and needed to go for a bowel movement. This issue mainly started 2-3 weeks ago. Patient had to go to the ER, and they said that prostate had swollen extensively. This was disturbing the bladder, and thus colon, bringing difficulty in bowel movements. The doctor put a cathether to the patient and wanted to do a surgery on the prostate to reduce it, but he was not sure. He could not provide any vaccination information but mentioned that the first booster dose had only gave him a mild tired feeling in the shoulder and some tiredness at night, nothing like what happened with the 2nd booster. The patient's age and medical history of previous prostate issues could be a confounder for the events. The event Functional gastrointestinal disorder could be associated with prostatomegaly. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.