Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia sepsis, Urinary tract infection
Clinical narrative: Serious UTI; Sepsis due to E. coli; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (Serious UTI) and ESCHERICHIA SEPSIS (Sepsis due to E. coli) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lupus syndrome (had lupus).    In April 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2022, the patient experienced URINARY TRACT INFECTION (Serious UTI) (seriousness criterion hospitalization) and ESCHERICHIA SEPSIS (Sepsis due to E. coli) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-Jul-2022 to 15-Jul-2022 due to ESCHERICHIA SEPSIS and URINARY TRACT INFECTION. On 15-Jul-2022, URINARY TRACT INFECTION (Serious UTI) and ESCHERICHIA SEPSIS (Sepsis due to E. coli) outcome was unknown.            It was reported that the patient was under a lot of unspecified concomitant and regular medications like antibiotics because of fluids in her lungs.  Event Escherichia coli are subsume under event Escherichia sepsis  It was unknown if patient had any allergies. It was unknown if the condition of lupus began before or after vaccine.  The patient did not remember treatment given for her symptoms after getting the Moderna booster.  Company comment-This spontaneous case concerns a female patient aged 63 years with relevant medical history of lupus reported, who experienced the unexpected serious (hospitalization/Medically significant) event of Escherichia sepsis, unexpected serious (hospitalization)event of Urinary tract infection which occurred unspecified days after receiving first Booster dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. Patient was hospitalized on 12Jul2022 due to a serious UTI and sepsis due to E.coli. and was discharged on 15Jul2022. Outcome of the events was unknown at the time of report. No further details on initial vaccination details, clinical course, lab results and treatment given were reported. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-610674 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient aged 63 years with relevant medical history of lupus reported, who experienced the unexpected serious (hospitalization/Medically significant) event of Escherichia sepsis, unexpected serious (hospitalization)event of Urinary tract infection which occurred unspecified days after receiving first Booster dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. Patient was hospitalized on 12Jul2022 due to a serious UTI and sepsis due to E.coli. and was discharged on 15Jul2022. Outcome of the events was unknown at the time of report. No further details on initial vaccination details, clinical course, lab results and treatment given were reported. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.