Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, White blood cell count
Clinical narrative: Acute kidney injury; ACUTE RESPIRATORY FAILURE; CARDIAC ARREST; CONFUSIONAL STATE; COVID-19; EMBOLISM VENOUS; HYPERNATREMIA; HYPOPHAGIA / Poor oral intake; MENTAL STATUS CHANGES; MYDRIASIS; PUPIL FIXED; RESPIRATORY ARREST; STAPHYLOCOCCAL BACTERAEMIA; UNRESPONSIVE TO STIMULI; received 3d dose of Pfizer BioNTech vaccine; received 3d dose of Pfizer BioNTech vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE RESPIRATORY FAILURE (ACUTE RESPIRATORY FAILURE), CARDIAC ARREST (CARDIAC ARREST), CONFUSIONAL STATE (CONFUSIONAL STATE), COVID-19 (COVID-19), EMBOLISM VENOUS (EMBOLISM VENOUS), HYPERNATRAEMIA (HYPERNATREMIA), HYPOPHAGIA (HYPOPHAGIA / Poor oral intake), MENTAL STATUS CHANGES (MENTAL STATUS CHANGES), MYDRIASIS (MYDRIASIS), PUPIL FIXED (PUPIL FIXED), RESPIRATORY ARREST (RESPIRATORY ARREST), STAPHYLOCOCCAL BACTERAEMIA (STAPHYLOCOCCAL BACTERAEMIA) and UNRESPONSIVE TO STIMULI (UNRESPONSIVE TO STIMULI) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 040A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Dementia.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria death, hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (ACUTE RESPIRATORY FAILURE) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (CARDIAC ARREST) (seriousness criteria death, hospitalization and medically significant), CONFUSIONAL STATE (CONFUSIONAL STATE) (seriousness criteria death and hospitalization), COVID-19 (COVID-19) (seriousness criteria death and hospitalization), EMBOLISM VENOUS (EMBOLISM VENOUS) (seriousness criteria death, hospitalization and medically significant), HYPERNATRAEMIA (HYPERNATREMIA) (seriousness criteria death and hospitalization), HYPOPHAGIA (HYPOPHAGIA / Poor oral intake) (seriousness criteria death and hospitalization), MENTAL STATUS CHANGES (MENTAL STATUS CHANGES) (seriousness criteria death and hospitalization), MYDRIASIS (MYDRIASIS) (seriousness criteria death and hospitalization), PUPIL FIXED (PUPIL FIXED) (seriousness criteria death, hospitalization and medically significant), RESPIRATORY ARREST (RESPIRATORY ARREST) (seriousness criteria death, hospitalization and medically significant), STAPHYLOCOCCAL BACTERAEMIA (STAPHYLOCOCCAL BACTERAEMIA) (seriousness criteria death, hospitalization and medically significant), UNRESPONSIVE TO STIMULI (UNRESPONSIVE TO STIMULI) (seriousness criteria death, hospitalization and medically significant), INTERCHANGE OF VACCINE PRODUCTS (received 3d dose of Pfizer BioNTech vaccine) and COVID-19 IMMUNISATION (received 3d dose of Pfizer BioNTech vaccine). The patient was hospitalized for 7 days due to ACUTE KIDNEY INJURY, ACUTE RESPIRATORY FAILURE, CARDIAC ARREST, CONFUSIONAL STATE, COVID-19, EMBOLISM VENOUS, HYPERNATRAEMIA, HYPOPHAGIA, MENTAL STATUS CHANGES, MYDRIASIS, PUPIL FIXED, RESPIRATORY ARREST, STAPHYLOCOCCAL BACTERAEMIA and UNRESPONSIVE TO STIMULI. The patient died on 31-Aug-2022. The reported cause of death was Acute kidney injury, Acute respiratory failure, Cardiac arrest, Confusional state, covid-19, Embolism venous, Hypernatremia, Hypophagia, Mental status changes, Mydriasis, Pupil fixed, Respiratory arrest, Staphylococcal bacteraemia and Unresponsive to stimuli. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (received 3d dose of Pfizer BioNTech vaccine) and COVID-19 IMMUNISATION (received 3d dose of Pfizer BioNTech vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2022, SARS-CoV-1 test: (Positive) Positive. On 23-Aug-2022, SARS-CoV-1 test: detected. On an unknown date, Blood creatinine: INCREASED, 3.07. On an unknown date, Blood pressure measurement: 168/104. On an unknown date, Blood sodium: INCREASED, 162. On an unknown date, Body temperature: INCREASED, 102 deg/F. On an unknown date, Heart rate: absent, 134. On an unknown date, Laboratory test: Abnormal. On an unknown date, Oxygen saturation: 89 %. On an unknown date, Respiratory rate: 36. On an unknown date, SARS-CoV-1 test: (Positive) Positive. On an unknown date, Troponin: increased, 0.11. On an unknown date, White blood cell count: increased, 19.6.         No concomitant medication were reported. Patient presented with altered mental status, patient was at nursing with advanced dementia, not conversational at baseline. A few weeks ago, started having oral intake and worsening confusion. Patient found to be in acute hypoxic respiratory failure due to (Covid, MSSA bacteremia, VTE, AKI and hypernatremia.) Patient assessed and unresponsive to verbal and tactile stimuli, pulseless, respirations and heartsounds absent. pupils dilated, fixed, and unresponsive to light.  No treatment medication were reported.  Company comment: This is a spontaneous case concerning a 79-year-old male patient with relevant medical history of dementia, who experienced the unexpected and serious (due to death and hospitalization) events of Acute kidney injury, Acute respiratory failure, Cardiac arrest, Confusional state, Covid-19, Embolism venous, Hypernatremia, Hypophagia, Mental state changes, Mydriasis, Pupil fixed, respiratory arrest, Staphylococcal bacteriemia, Unresponsive to stimuli, which occurred unknown days after a second dose of mRNA-1273. Primary vaccination was with 2 doses of Moderna vaccine and the third dose with Comirnaty. It is reported that patient started having poor oral intake and worsening confusion. Laboratory tests showed positive Covid-19 virus test, high temperature, Heart rate 134/min, blood pressure 168/104, respiratory rate 36, saturation of 89 % of 6 l of oxygen of nasal canula, sodium, troponin, creatinine and white blood cells were increased. Patient was admitted for hospital care. He was assessed as unresponsive to stimuli, pulseless and with absents of respiration and heart sound. No further information disclosed about diagnostic tests performed or treatments received. The outcome of the events were fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.; Sender's Comments: This is a spontaneous case concerning a 79-year-old male patient with relevant medical history of dementia, who experienced the unexpected and serious (due to death and hospitalization) events of Acute kidney injury, Acute respiratory failure, Cardiac arrest, Confusional state, Covid-19, Embolism venous, Hypernatremia, Hypophagia, Mental state changes, Mydriasis, Pupil fixed, respiratory arrest, Staphylococcal bacteriemia, Unresponsive to stimuli, which occurred unknown days after a second dose of mRNA-1273. Primary vaccination was with 2 doses of Moderna vaccine and the third dose with Comirnaty. It is reported that patient started having poor oral intake and worsening confusion. Laboratory tests showed positive Covid-19 virus test, high temperature, Heart rate 134/min, blood pressure 168/104, respiratory rate 36, saturation of 89 % of 6 l of oxygen of nasal canula, sodium, troponin, creatinine and white blood cells were increased. Patient was admitted for hospital care. He was assessed as unresponsive to stimuli, pulseless and with absents of respiration and heart sound. No further information disclosed about diagnostic tests performed or treatments received. The outcome of the events were fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.; Reported Cause(s) of Death: Acute kidney injury; ACUTE RESPIRATORY FAILURE; CARDIAC ARREST; Confusional state; COVID-19; Embolism venous; HYPERNATREMIA; HYPOPHAGIA; Mental status changes; MYDRIASIS; Pupil fixed; RESPIRATORY ARREST; Staphylococcal bacteraemia; UNRESPONSIVE TO ST