Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dry skin, Hepatic pain, Influenza, Renal haemorrhage
Clinical narrative: eventually he had solid blood from the kidney; his mouth is dry; his mouth is dry and his skin too; liver started hurt; urinary tract infection; a year later the renal pain came back; feeling pain in the right kidney; like he had flu/ he felt sick during around 4 days/ dizzy; This spontaneous case was reported by a patient and describes the occurrence of RENAL HAEMORRHAGE (eventually he had solid blood from the kidney), DRY MOUTH (his mouth is dry), DRY SKIN (his mouth is dry and his skin too), HEPATIC PAIN (liver started hurt), RENAL PAIN (a year later the renal pain came back) and URINARY TRACT INFECTION (urinary tract infection) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 029K20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not knew if ever had COVID-19  and did not had diseases or  medications. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient does not drink or smoke or use drugs. Patient states that he does not have hepatitis.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA (like he had flu/ he felt sick during around 4 days/ dizzy). In December 2021, the patient experienced RENAL PAIN (feeling pain in the right kidney). In 2022, the patient experienced RENAL PAIN (a year later the renal pain came back) (seriousness criterion medically significant). In February 2023, the patient experienced URINARY TRACT INFECTION (urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced RENAL HAEMORRHAGE (eventually he had solid blood from the kidney) (seriousness criteria hospitalization and medically significant), DRY MOUTH (his mouth is dry) (seriousness criterion hospitalization), DRY SKIN (his mouth is dry and his skin too) (seriousness criterion hospitalization) and HEPATIC PAIN (liver started hurt) (seriousness criterion hospitalization). At the time of the report, RENAL HAEMORRHAGE (eventually he had solid blood from the kidney), DRY MOUTH (his mouth is dry), DRY SKIN (his mouth is dry and his skin too), HEPATIC PAIN (liver started hurt), RENAL PAIN (a year later the renal pain came back) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown, RENAL PAIN (feeling pain in the right kidney) had resolved and INFLUENZA (like he had flu/ he felt sick during around 4 days/ dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  It was reported that patient did not experienced any adverse events after first dose.  After the second dose he felt sick during around 4 days, he felt dizzy, like he had flu, but he did not have COVID-19 because got tested. About 1 week after the booster dose, patient started feeling pain in the right kidney, and it was coming and going and then it stopped out of nowhere, but approximately a year later the pain came back and patient needed to go to the hospital several times and about 3 months ago he was diagnosed with an urinary tract infection, but he did not even have sex. Patient liver started hurt but does not drink or smoke or use drugs, and patient did not had hepatitis, spent 3 or 4 days in the hospital and doctors had gave him  intravenous several times but eventually he had solid blood from the kidney. The doctors can't find a cause for all these symptoms, but the only thing that changed is that he received the Moderna COVID-19 Vaccines.  Company Comment: This is a spontaneous case regarding a 63-year-old male patient with no relevant medical history, who experienced unexpected-serious (medically significant) event of renal pain, unexpected-serious (hospitalization) events of urinary tract infection, dry mouth, dry skin, hepatic pain, and unexpected-serious (hospitalization and medically significant) event of renal bleeding after receiving the third dose of mRNA-1273 vaccine. According to the report, about 1 week after the booster dose patient started feeling intermittent pain in the right kidney that stopped out of nowhere. Approximately a year later the pain came back and patient needed to go to the hospital several times. Approximately 14 months after vaccination he was diagnosed with urinary tract infection. Patient stated that recently, a few times, his mouth is dry and his skin too and his liver started to hurt.  He spent 3 or 4 days in the hospital and was treated with unspecified IV treatment several times but eventually he had solid blood from the kidney. Patient stated that  doctors can't find a cause for all these symptoms. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.