Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Escherichia urinary tract infection, Inappropriate schedule of product administration, Oxygen saturation, Pneumonia
Clinical narrative: Pneumonia; Caller reports still having diarrhea a month after they got out; The patient received her first Moderna Covid-19 vaccine in November 2021 lot number 012F21A expiration date is not available. The patient received her second Moderna Covid-19 vaccine May 20,2022 lot number 049L21A expiration date is not known; The E. Coli traveled into her kidneys/Patient had E. coli recently between 20Oct2023 and 30Oct2023; nearly died from it; This spontaneous case was reported by a patient and describes the occurrence of ESCHERICHIA URINARY TRACT INFECTION (The E. Coli traveled into her kidneys/Patient had E. coli recently between 20Oct2023 and 30Oct2023; nearly died from it) and PNEUMONIA (Pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 049L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacterial pyelonephritis and Oxygen therapy. Previously administered products included for Drug use for unknown indication: Johnson and Johnson vaccine (The patient was hospitalized and placed on antibiotics and Oxygen.). Past adverse reactions to the above products included No adverse reaction with Johnson and Johnson vaccine.   On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ESCHERICHIA URINARY TRACT INFECTION (The E. Coli traveled into her kidneys/Patient had E. coli recently between 20Oct2023 and 30Oct2023; nearly died from it) (seriousness criterion life threatening). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DIARRHOEA (Caller reports still having diarrhea a month after they got out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first Moderna Covid-19 vaccine in November 2021 lot number 012F21A expiration date is not available. The patient received her second Moderna Covid-19 vaccine May 20,2022 lot number 049L21A expiration date is not known). At the time of the report, ESCHERICHIA URINARY TRACT INFECTION (The E. Coli traveled into her kidneys/Patient had E. coli recently between 20Oct2023 and 30Oct2023; nearly died from it), PNEUMONIA (Pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first Moderna Covid-19 vaccine in November 2021 lot number 012F21A expiration date is not available. The patient received her second Moderna Covid-19 vaccine May 20,2022 lot number 049L21A expiration date is not known) outcome was unknown and DIARRHOEA (Caller reports still having diarrhea a month after they got out) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 82, 83, 84 something.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient had pneumonia a few years back for which she was treated with some antibiotics.  The patient did not remember which arm she received the Moderna vaccine in. The patient said that she had a Covid-19 vaccine at her assisted living facility, but she did not know if that was a Moderna Covid-19 vaccine, but she had not gotten Covid-19 since receiving the Moderna vaccines and that she like Moderna. Patient's immune system was fading somewhat. Patient had E. Coli recently between 20Oct2023 and 30Oct2023; nearly died from E. coli infection so patient was being careful with the vaccine she was getting. Patient reported that E. coli infection was probably because of the assisted living facility she lives in and not the vaccine. Her personal physician said if she had been 12 hours late to arriving to the hospital she would not have lived. Caller reports still having diarrhea a month after they got out. Patient's urine was liquid for over a month.  Company Comment: This spontaneous case concerns a 75-year-old female patient, with medical history of bacterial pyelonephritis, who experienced the unexpected and serious (life threatening) event of Escherichia urinary tract infection and the unexpected and serious (medically significant) event of pneumonia, among other non-serious events. The Escherichia urinary tract infection occurred approximately a year and a half after vaccination with the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. Since the exact onset dates of the other events were not reported, latency could not be properly assessed. She was hospitalized for pneumonia and was diagnosed with an E. Coli infection in her kidneys and diarrhea. Her oxygen saturation level was reported of 82,83 and 84, and she was treated with antibiotics and oxygen. No information disclosed about diagnostic tests performed. Diarrhea continued at the time of report. Inappropriate schedule of product administration was also reported since she received the first and the second doses six months apart. The company causality for the event Escherichia urinary tract infection was assessed as not related, due to long latency and lack of biologic plausibility. Patient´s medical history of bacterial pyelonephritis could be a risk factor for Escherichia urinary tract infection. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2024: Follow-up received and added lab test, new events (Escherichia urinary tract infection, Pneumonia and Diarrhea).