Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate
Clinical narrative: Drug ineffective; Can't keep fluids down; Severe dehydration; Bilateral covid pneumonia in his lungs/ Dehydration COVID Pneumonia; Altered level of consciousness; very weak; Unable to eat / Drink; hepatic enzymes abnormal; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs/ Dehydration COVID Pneumonia), ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness), HEPATIC ENZYME ABNORMAL (hepatic enzymes abnormal), DEHYDRATION (Severe dehydration) and VOMITING (Can't keep fluids down) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU Vaccine (Flu vaccine and Intramuscular) on 14-Sep-2021. Past adverse reactions to the above products included No adverse event with FLU Vaccine. Concurrent medical conditions included Bradycardia (Cardiovascular disease), Type 2 diabetes mellitus (Type 2 Diabetes) since 1997 and Obesity (Obesity).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced HEPATIC ENZYME ABNORMAL (hepatic enzymes abnormal) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) (seriousness criterion medically significant), ASTHENIA (very weak) and FEEDING DISORDER (Unable to eat / Drink). On 28-Nov-2021, the patient experienced COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs/ Dehydration COVID Pneumonia) (seriousness criterion medically significant). On 01-Dec-2021, the patient experienced DEHYDRATION (Severe dehydration) (seriousness criterion medically significant). On an unknown date, the patient experienced DRUG INEFFECTIVE (Drug ineffective) and VOMITING (Can't keep fluids down) (seriousness criterion medically significant). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) on 07-Dec-2021 at an unspecified dose and frequency; BENZONATATE (TESSALON PERLE) from 06-Dec-2021 to 08-Dec-2021 at a dose of as necessary; AZITHROMYCIN (oral) from 28-Nov-2021 to 06-Dec-2021 at a dose of 250 milligram and MONOCLONAL ANTIBODY 17-1A (intravenous) 01-Dec-2021 at an unspecified dose and frequency. On 28-Nov-2021, ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) had resolved. On 14-Dec-2021, HEPATIC ENZYME ABNORMAL (hepatic enzymes abnormal) had resolved. At the time of the report, COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs/ Dehydration COVID Pneumonia), DEHYDRATION (Severe dehydration), ASTHENIA (very weak) and FEEDING DISORDER (Unable to eat / Drink) had resolved and DRUG INEFFECTIVE (Drug ineffective) and VOMITING (Can't keep fluids down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Chest X-ray: normal (normal) normal. On 21-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive. On 22-Nov-2021, Anion gap: 16 (normal) 16 Normal value low: 10 mmol/L Normal value high: 20 mmol/L. On 22-Nov-2021, Blood bicarbonate: 25 (normal) 25 Normal value low: 21 mmol/L Normal value high: 32 mmol/L. On 22-Nov-2021, Blood calcium: 8.40 (normal) 8.40 Normal value low: 8.6 mg/dL Normal value high: 10.3 mg/dL. On 22-Nov-2021, Blood chloride: 98 (normal) 98 Normal value low: 98 mmol/L Normal value high: 107 mmol/L. On 22-Nov-2021, Blood creatinine: 1.08 (normal) 1.08 Normal value low: 0.50 mg/dL Normal value high: 1.30 mg/dL. On 22-Nov-2021, Blood potassium: 3.60 (normal) 3.60 Normal value low: 3.5 mmol/L Normal value high: 5.3 mmol/L. On 22-Nov-2021, Blood sodium: 135 (Low) 135 Normal value low: 136 mmol/L Normal value high: 145 mmol/L. On 22-Nov-2021, Blood urea: 19 (normal) 19 Normal value low: 6 mg/dL Normal value high: 23 mg/dL. On 22-Nov-2021, Glomerular filtration rate: >60 (normal) >60 mL/min/1.73m^2 and >60 (normal) >60 mL/min/1.73m^2. On 22-Nov-2021, Haematocrit: 40.40 (Low) 40.40 Normal value low: 41.0 % Normal value high: 52.0 %. On 22-Nov-2021, Haemoglobin: 13.50 (normal) 13.50 Normal value low: 13.5 g/dL Normal value high: 17.5 g/dL. On 22-Nov-2021, Mean cell haemoglobin concentration: 33.40 (normal) 33.40 Normal value low: 32.0 g/dL Normal value high: 36.0 g/dL. On 22-Nov-2021, Mean cell volume: 88.00 (normal) 88.00 Normal value low: 80 ft Normal value high:100 ft. On 22-Nov-2021, Platelet count: 108 (Low) 108 Normal value low: 150*10E9/L Normal value high: 450*10E9/L. On 22-Nov-2021, Red blood cell count: 4.61 (normal) 4.61 Normal value low: 4.50*10E12/L Normal value high: 5.90*10E12/L. On 22-Nov-2021, Red cell distribution width: 13.70 (normal) 13.70 Normal value low: 11.5 % Normal value high: 14.5 %. On 22-Nov-2021, White blood cell count: 3.30 (Low) 3.30 Normal value low: 4.4*10E9/L Normal value high: 11.3*10E9/L. On 28-Nov-2021, Alanine aminotransferase: 60 (High) 60 Normal value low: 10 U/L Normal value high: 52 U/L. On 28-Nov-2021, Anion gap: 16 (normal) 16 Normal value low: 10 mmol/L Normal value high: 20 mmol/L. On 28-Nov-2021, Aspartate aminotransferase: 46 (High) 46 Normal value low: 9 U/L Normal value high: 39 U/L. On 28-Nov-2021, Basophil count: 0.30 (normal) 0.30 Normal value low: 0.0 % Normal value high: 2.0 % and 0.02 (normal) 0.02 Normal value low: 0.00*10E9/L Normal value high: 0.10*10E9/L. On 28-Nov-2021, Blood albumin: 3.50 (normal) 3.50 Normal value low: 3.4 g/dL Normal value high: 5.0 g/dL. On 28-Nov-2021, Blood alkaline phosphatase: 85 (normal) 85 Normal value low: 33 U/L Normal value high: 136 U/L. On 28-Nov-2021, Blood bicarbonate: 26 (normal) 26 Normal value low: 21 mmol/L Normal value high: 32 mmol/L. On 28-Nov-2021, Blood bilirubin: 1.30 (normal) 1.30 Normal value low: 0.0 mg/dL Normal value high: 1.2 g/dL. On 28-Nov-2021, Blood calcium: 8.60 (normal) 8.60 Normal value low: 8.6 mg/dL Normal value high: 10.3 mg/dL. On 28-Nov-2021, Blood chloride: 98 (normal) 98 Normal value low: 98 mmol/L Normal value high: 107 mmol/L. On 28-Nov-2021, Blood creatinine: 0.84 (normal) 0.84 Normal value low: 0.50 mg/dL Normal value high: 1.30 mg/dL. On 28-Nov-2021, Blood glucose: 192 (High) 192 Normal value low: 74 mg/dL Normal value high: 99 mg/dL. On 28-Nov-2021, Blood potassium: 4.00 (normal) 4.00 Normal value low: 3.5 mmol/L Normal value high: 5.3 mmol/L. On 28-Nov-2021, Blood sodium: 136 (normal) 136 Normal value low: 136 mmol/L Normal value high: 145 mmol/L. On 28-Nov-2021, Blood urea: 19 (normal) 19 Normal value low: 6 mg/dL Normal value high: 23 mg/dL. On 28-Nov-2021, Chest X-ray: abnormal (abnormal) Probable bilateral pneumonia, potentially COVID-19. On 28-Nov-2021, Electrocardiogram: abnormal (abnormal) Right bundle branch block. On 28-Nov-2021, Electrocardiogram PR prolongation: 164 (Inconclusive) 164 ms. On 28-Nov-2021, Electrocardiogram QRS complex: 154 (Inconclusive) 154 ms. On 28-Nov-2021, Electrocardiogram QT interval: 486 (Inconclusive) 486 ms. On 28-Nov-2021, Eosinophil count: 0.80 (normal) 0.80 Normal value low: 0.0 % Normal value high: 6.0 % and 0.06 (normal) 0.06 Normal value low: 0.00*10E9/L Normal value high: 0.40*10E9/L. On 28-Nov-2021, Glomerular filtration rate: >60 (normal) >60 mL/min/1.73m^2 and >60 (normal) >60 mL/min/1.73m^2. On 28-Nov-2021, Haematocrit: 39.90 (Low) 39.90 Normal value low: 41.0 % Normal value high: 52.0 %. On 28-Nov-2021, Haemoglobin: 13.10 (normal) 13.10 Normal value low: 13.5 g/dL Normal value high: 17.5 g/dL. On 28-Nov-2021, Immature granulocyte count: 2.40 (normal) 2.40 Normal value low: 0.0 % Normal value high: 0.9 %. On 28-Nov-2021, Lymphocyte count: 15.20 (normal) 15.20 Normal value low: 13 % Normal value high: 44 % and 1.10 (normal) 1.10 Normal value low: 0.80*10E9/L Normal value high: 3.00*10E9/L. On 28-Nov-2021, Mean cell haemoglobin concentration: 32.80 (normal) 32.80 Normal value low: 32.0 g/dL Normal value high: 36.0 g/dL. On 28-Nov-2021, Mean cell volume: 88.00 (normal) 88.00 Normal value low: 80 ft Normal value high:100 ft. On 28-Nov-2021, Monocyte count: 10.20 (normal) 10.20 Normal value low: 2 % Normal value high: 10 % and 0.74 (normal) 0.74 Normal value low: 0.05*10E9/L Normal value high: 0.80*10E9/L. On 28-Nov-2021, Neutrophil count: 71.10 (normal) 71.10 Normal value low: 40 % Normal value high: 80 % and 5.14 (normal) 5.14 Normal value low: 1.60*10E9/L Normal value high: 5.50*10E9/L. On 28-Nov-2021, Platelet count: 256 (normal) 256 Normal value low: 150*10E9/L Normal value high: 450*10E9/L. On 28-Nov-2021, Protein total: 6.30 (normal) 6.30 Normal value low: 6.4 g/dL Normal value high: 8.2 g/dL. On 28-Nov-2021, Red blood cell count: 4.52 (normal) 4.52 Normal value low: 4.50*10E12/L Normal value high: 5.90*10E12/L. On 28-Nov-2021, Red cell distribution width: 13.40 (normal) 13.40 Normal value low: 11.5 % Normal value high: 14.5 %. On 28-Nov-2021, White blood cell count: 7.20 (normal) 7.20 Normal value low: 4.4*10E9/L Normal value high: 11.3*10E9/L. On 01-Dec-2021, Alanine aminotransferase: 61 (High) 61 Normal value low: 10 U/L Normal value high: 52 U/L. On 01-Dec-2021, Angiogram: normal (normal) normal. On 01-Dec-2021, Anion gap: 16 (normal) 16 Normal value low: 10 mmol/L Normal value high: 20 mmol/L. On 01-Dec-2021, Aspartate aminotransferase: 41 (High) 41 Normal value low: 9 U/L Normal value high: 39 U/L. On 01-Dec-2021, Basophil count: 0.20 (normal) 0.20 Normal value low: 0.0 % Normal value high: 2.0 % and 0.02 (normal) 0.02 Normal value low: 0.00*10E9/L Normal value high: 0.10*10E9/L. On 01-Dec-2021, Blood albumin: 3.30 (normal) 3.30 Normal value low: 3.4 g/dL Normal value high: 5.0 g/dL. On 01-Dec-2021, Blood alkaline phosphatase: 96 (normal) 96 Normal value low: 33 U/L Normal value high: 136 U/L. On 01-Dec-2021, Blood bicarbonate: 26 (normal) 26 Normal value low: 21 mmol/L Normal value high: 32 mmol/L. On 01-Dec-2021, Blood bilirubin: 1.80 (normal) 1.80 Normal value low: 0.0 mg/dL Normal value high: 1.2 g/dL. On 01-Dec-2021, Blood calcium: 8.50 (normal) 8.50 Normal value low: 8.6 mg/dL Normal value high: 10.3 mg/dL. On 01-Dec-2021, Blood chloride: 98 (normal) 98 Normal value low: 98 mmol/L Normal value high: 107 mmol/L. On 01-Dec-2021, Blood creatinine: 0.75 (normal) 0.75 Normal value low: 0.50 mg/dL Normal value high: 1.30 mg/dL. On 01-Dec-2021, Blood glucose: 139 (High) 139 Normal value low: 74 mg/dL Normal value high: 99 mg/dL. On 01-Dec-2021, Blood magnesium: 1.80 (normal) 1.80 Normal value low: 1.60 mg/dL Normal value high: 2.40 mg/dL. On 01-Dec-2021, Blood potassium: 3.60 (normal) 3.60 Normal value low: 3.5 mmol/L Normal value high: 5.3 mmol/L. On 01-Dec-2021, Blood sodium: 136 (normal) 136 Normal value low: 136 mmol/L Normal value high: 145 mmol/L. On 01-Dec-2021, Blood urea: 23 (normal) 23 Normal value low: 6 mg/dL Normal value high: 23 mg/dL. On 01-Dec-2021, Computerised tomogram: abnormal (abnormal) abnormal. On 01-Dec-2021, Electrocardiogram: normal (normal) normal. On 01-Dec-2021, Electrocardiogram PR prolongation: 162 (Inconclusive) 162 ms. On 01-Dec-2021, Electrocardiogram QRS complex: 160 (Inconclusive) 160 ms. On 01-Dec-2021, Electrocardiogram QT interval: 482 (Inconclusive) 482 ms. On 01-Dec-2021, Eosinophil count: 1.80 (normal) 1.80 Normal value low: 0.0 % Normal value high: 6.0 % and 0.16 (normal) 0.16 Normal value low: 0.00*10E9/L Normal value high: 0.40*10E9/L. On 01-Dec-2021, Fibrin D dimer: 1705 (abnormal) 1705 ng/mL. On 01-Dec-2021, Glomerular filtration rate: >60 (normal) >60 mL/min/1.73m^2 and >60 (normal) >60 mL/min/1.73m^2. On 01-Dec-2021, Haematocrit: 37.40 (Low) 37.40 Normal value low: 41.0 % Normal value high: 52.0 %. On 01-Dec-2021, Haemoglobin: 12.80 (normal) 12.80 Normal value low: 13.5 g/dL Normal value high: 17.5 g/dL. On 01-Dec-2021, Immature granulocyte count: 2.10 (normal) 2.10 Normal value low: 0.0 % Normal value high: 0.9 %. On 01-Dec-2021, Lymphocyte count: 8.30 (Low) 8.30 Normal value low: 13 % Normal value high: 44 % and 0.72 (Low) 0.72 Normal value low: 0.80*10E9/L Normal value high: 3.00*10E9/L. On 01-Dec-2021, Mean cell haemoglobin concentration: 34 (normal) 34 Normal value low: 32.0 g/dL Normal value high: 36.0 g/dL. On 01-Dec-2021, Mean cell volume: 85 (normal) 85 Normal value low: 80 ft Normal value high:100 ft. On 01-Dec-2021, Monocyte count: 8.20 (normal) 8.20 Normal value low: 2 % Normal value high: 10 % and 0.71 (normal) 0.71 Normal value low: 0.05*10E9/L Normal value high: 0.80*10E9/L. On 01-Dec-2021, Neutrophil count: 79.40 (normal) 79.40 Normal value low: 40 % Normal value high: 80 % and 6.92 (normal) 6.92 Normal value low: 1.60*10E9/L Normal value high: 5.50*10E9/L. On 01-Dec-2021, Platelet count: 420 (normal) 420 Normal value low: 150*10E9/L Normal value high: 450*10E9/L. On 01-Dec-2021, Protein total: 6.20 (normal) 6.20 Normal value low: 6.4 g/dL Normal value high: 8.2 g/dL. On 01-Dec-2021, Red blood cell count: 4.42 (normal) 4.42 Normal value low: 4.50*10E12/L Normal value high: 5.90*10E12/L. On 01-Dec-2021, Red cell distribution width: 13.40 (normal) 13.40 Normal value low: 11.5 % Normal value high: 14.5 %. On 14-Dec-2021, Alanine aminotransferase: 37 (normal) 37 Normal value low: 10 U/L Normal value high: 52 U/L. On 14-Dec-2021, Anion gap: 14 (normal) 14 Normal value low: 10 mmol/L Normal value high: 20 mmol/L. On 14-Dec-2021, Aspartate aminotransferase: 20 (normal) 20 Normal value low: 9 U/L Normal value high: 39 U/L. On 14-Dec-2021, Blood albumin: 3.40 (normal) 3.40 Normal value low: 3.4 g/dL Normal value high: 5.0 g/dL. On 14-Dec-2021, Blood alkaline phosphatase: 87 (normal) 87 Normal value low: 33 U/L Normal value high: 136 U/L. On 14-Dec-2021, Blood bicarbonate: 28 (normal) 28 Normal value low: 21 mmol/L Normal value high: 32 mmol/L. On 14-Dec-2021, Blood bilirubin: 0.80 (normal) 0.80 Normal value low: 0.0 mg/dL Normal value high: 1.2 g/dL. On 14-Dec-2021, Blood calcium: 9.40 (normal) 9.40 Normal value low: 8.6 mg/dL Normal value high: 10.3 mg/dL. On 14-Dec-2021, Blood chloride: 100 (normal) 100 Normal value low: 98 mmol/L Normal value high: 107 mmol/L. On 14-Dec-2021, Blood creatinine: 0.74 (normal) 0.74 Normal value low: 0.50 mg/dL Normal value high: 1.30 mg/dL. On 14-Dec-2021, Blood potassium: 3.60 (normal) 3.60 Normal value low: 3.5 mmol/L Normal value high: 5.3 mmol/L. On 14-Dec-2021, Blood urea: 13 (normal) 13 Normal value low: 6 mg/dL Normal value high: 23 mg/dL. On 14-Dec-2021, Protein total: 7.40 (normal) 7.40 Normal value low: 6.4 g/dL Normal value high: 8.2 g/dL. On an unknown date, Body temperature: 101 (High) 101 degree Farenheit. On an unknown date, Hepatic enzyme abnormal: abnormal (abnormal) liver enzymes are up. On an unknown date, Oxygen saturation: 84-94 (abnormal) 84-94%.         Concomitant medications were not reported. Patient experienced fever for 2 days, chills, shortness of breath, muscle aches for 14 days, cough for 21 days, diarrhea for 10 days and fatigue was ongoing at the time of report. Patient went to ER for three times, on 21-Nov-2021, 28-Nov-2021 and 01-Dec-2021. On 21-Nov-2021 to 06-Dec2021, Oxygen saturation was performed and the result was 88-93%. On 28-Nov-2021 and 01-Dec-2021, Ventricular rate and Atrial rate was measured and reported as 70 and 63 respectively.  Company Comment: This spontaneous case concerns a 75 year old male with no medical history reported , who experienced , serious ( Medically Significant ) , unexpected AESI  events of Covid19 pneumonia  which occurred on an unknown date in Nov. 2021  after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid19 Vaccine ) . Also on an unknown date in Nov, 2021 , he experienced  Serious ( Medically Significant  ) , unexpected events of hepatic enzyme abnormality and vomiting after vaccination with the 3rd dose of mRNA-1273 vaccine . Additional event of Drug ineffective was also coded for this case . I it was noted that the patient made ER visit and it was suspected that he might already been infected upon receiving the 3rd dose of the vaccine.  The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The age of the patient can be considered as a confounder for this case ( elderly population are vulnerable to Covid19 infection and its complications due to their altered immune response) The benefit -risk relationship of mRNA -1273 ( Moderna Covid19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received - Reporter details added On 30-Nov-2021: Follow up received - No New information On 11-Dec-2021: Follow-up information included no new information. On 19-Jan-2022: Added medical history, lab data, treatment medications and updated events, events outcome and reporter causality.; Sender's Comments: This spontaneous case concerns a 75 year old male with relevant medical history of Diabetes  Mellitus type 2 and obesity who experienced , Serious ( Medically significant ) , unexpected , AESI event of Covid 19 Pneumonia  which occurred 13 days post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . Five days post vaccination with the 3rd dose , he experienced Serious , unexpected event  hepatic enzyme abnormal , six days post vaccination , he experienced  Serious , unexpected  altered state of consciousness,  non-serious , unexpected event of asthenia and feeding disorder .  Fifteen   days post vaccination with the 3rd dose , he experienced  Serious , unexpected eventof  dehydration while on an unknown date post vaccination with the 3rd dose , he experienced  Non-serious , unexpected event of Drug ineffective and  serious, unexpected event of  vomiting.   It was noted that the patient   made ER visits  ( 3x ) and it was suspected that he might already been infected upon receiving  the 3rd dose of the vaccine. On his last ER visit   he was given monoclonal antibodies and on Ct scan he was noted to have lung nodule mass vs hiatal hernia  in the esophagus .  He was also treated with Benzonatate , Salbutamol and Azithromycin  ( oral ).  The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The age of the patient can be considered as a confounder for this case ( elderly population are vulnerable to Covid 19 infection and its complications due to their altered immune response) The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.