Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscle twitching, Oedema peripheral, Pain in extremity, Peripheral coldness, Urinary tract infection
Clinical narrative: UTI; uti; He experienced swollen legs, filled with water, and required draining/swollen legs; twitching in legs; coldness to the lower legs; Pain in leg; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (uti) and URINARY TRACT INFECTION (UTI) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (Dose 4 left arm) on 23-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine. Concurrent medical conditions included Arthritis since 2004 and Allergy to nuts since 2006. Concomitant products included HYALURONATE SODIUM (ORTHOVISC) for an unknown indication.    On 26-Dec-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. On 05-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced URINARY TRACT INFECTION (uti) (seriousness criterion hospitalization). On 01-May-2023, the patient experienced MUSCLE TWITCHING (twitching in legs), PERIPHERAL COLDNESS (coldness to the lower legs) and PAIN IN EXTREMITY (Pain in leg). On 05-Sep-2023, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criterion hospitalization). On an unknown date, the patient experienced OEDEMA PERIPHERAL (He experienced swollen legs, filled with water, and required draining/swollen legs). The patient was hospitalized on 05-Sep-2023 due to URINARY TRACT INFECTION, and then for 19 days due to URINARY TRACT INFECTION. The patient was treated with Rehabilitation therapy (Was catheterized and admitted to rehab from 24-APR-2023 to 27-MAY-2023) for Urinary tract infection. At the time of the report, URINARY TRACT INFECTION (uti), MUSCLE TWITCHING (twitching in legs), PERIPHERAL COLDNESS (coldness to the lower legs) and PAIN IN EXTREMITY (Pain in leg) had not resolved and URINARY TRACT INFECTION (UTI) and OEDEMA PERIPHERAL (He experienced swollen legs, filled with water, and required draining/swollen legs) outcome was unknown.            The right heel felt like there was a vise pressing on it. Patient woke up at morning and legs felt like they were in a vat of ice. This began back in May 2023 and had gotten worse in the fall of 2023.On 05-SEP-2023 patient required a heart valve replacement and was hospitalized for another UTI.   Patient will be signing up for cardio rehab this month. During the hospitalization and rehab stay patient took several antibiotics and decided against the COVID-19 booster.  Company comment: This spontaneous case concerns an-84-year-old male patient with concomitant condition of arthritis in legs, who experienced the unexpected serious (hospitalization) event urinary tract infection along with the non-serious unexpected events of twitching, peripheral coldness, pain in extremity and oedema peripheral. The event urinary tract infection occurred approximately 3 months after a dose of mRNA-1273.222 vaccine, given as a fifth dose of COVID vaccine schedule, was administered. It was reported patient started to experience twitching in legs, coldness to the lower legs and pain, especially in the right lower leg. The right heel feels like there is a vise pressing on it. He woke up one morning and his legs felt they were in a vat of ice. This began four months after vaccination and had gotten worse. Three months after vaccine was given, he was hospitalized post-prostate flushing (for possible prostate Cancer) for 19 days for a UTI. He was catheterized and admitted to rehabilitation. During the hospitalization and rehabilitation stay he took several antibiotics. He experienced swollen legs, filled with water, and required draining. A couple of months after he required a heart valve replacement and was hospitalized for another UTI. The event UTI was assessed as not related to mRNA-1273.222 vaccine due to nature of the event and due to lack of temporal association, while the events twitching, peripheral coldness, pain in extremity were also assessed as not related due to lack of temporal association. Concomitant condition of arthritis in legs remains as a confounder for the non-serious events of twitching, peripheral coldness, pain in extremity and oedema peripheral. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.