Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatine phosphokinase
Clinical narrative: Legionnaire's disease; MRSA pneumonia; COVID-19; kidney injury; rhabdomyolysis; This literature-non-study case was reported in a literature article and describes the occurrence of PNEUMONIA LEGIONELLA (Legionnaire's disease), PNEUMONIA STAPHYLOCOCCAL (MRSA pneumonia), COVID-19 (COVID-19), ACUTE KIDNEY INJURY (kidney injury) and RHABDOMYOLYSIS (rhabdomyolysis) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Concurrent medical conditions included Smoker (Clinical history was significant only for a 35-pack-year smoking history), Obesity and Hyperglycaemia.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA LEGIONELLA (Legionnaire's disease) (seriousness criteria hospitalization and medically significant), PNEUMONIA STAPHYLOCOCCAL (MRSA pneumonia) (seriousness criteria hospitalization and medically significant), COVID-19 (COVID-19) (seriousness criterion hospitalization), ACUTE KIDNEY INJURY (kidney injury) (seriousness criterion hospitalization) and RHABDOMYOLYSIS (rhabdomyolysis) (seriousness criterion hospitalization). The patient was hospitalized for 12 days due to ACUTE KIDNEY INJURY, COVID-19, PNEUMONIA LEGIONELLA, PNEUMONIA STAPHYLOCOCCAL and RHABDOMYOLYSIS. The patient was treated with CEFTRIAXONE for Community acquired pneumonia, at a dose of 1 dosage form; DOXYCYCLINE for Community acquired pneumonia, at a dose of 1 dosage form; MOXIFLOXACIN for Legionnaire's disease and Pneumonia MRSA, at an unspecified dose and frequency; REMDESIVIR for COVID-19, at an unspecified dose and frequency; REMDESIVIR for COVID-19, at an unspecified dose and frequency; DEXAMETHASONE for COVID-19, at an unspecified dose and frequency; BARICITINIB for COVID-19, at an unspecified dose and frequency; CEFAZOLIN for Pneumonia MRSA, at an unspecified dose and frequency; SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE+TRIMETHOPRIM) for Pneumonia MRSA, at an unspecified dose and frequency; NORMAL SALINE (intravenous) for Acute kidney injury and Rhabdomyolysis, at an unspecified dose and frequency; ENOXAPARIN for Prophylactic, at an unspecified dose and frequency and OXYGEN for Adverse event, at a dose of requirement between 3 and 6 L/min. At the time of the report, PNEUMONIA LEGIONELLA (Legionnaire's disease), PNEUMONIA STAPHYLOCOCCAL (MRSA pneumonia), COVID-19 (COVID-19), ACUTE KIDNEY INJURY (kidney injury) and RHABDOMYOLYSIS (rhabdomyolysis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (9-59): 140 (High) 140 U/L. On an unknown date, Aspartate aminotransferase (10-35): 354 (High) 354 U/L. On an unknown date, Blood alkaline phosphatase (9-122): 60 (normal) 60 U/L. On an unknown date, Blood creatine phosphokinase (11-204): 6343 (High) 6343 U/L and normal (normal) normal. On an unknown date, Blood creatinine: acute kidney injury with a creatinine of 1.47 acute kidney injury with a creatinine of 1.47mg/dL  (baseline 0.7mg/dL) and normal (normal) normal. On an unknown date, Blood glucose (70-100): 110 (High) 110 mg/dL. On an unknown date, Blood pressure measurement: 152/84 152/84 mmHg. On an unknown date, Blood sodium (136-144): 123, hyponatraemia (Low) notable for hyponatraemia with a sodium of 123 mEq/L. On an unknown date, Blood urea (6-20): 35 (High) 35 mg/dL. On an unknown date, C-reactive protein: greater than 300.0 (High) greater than 300.0 mg/L. On an unknown date, Chest X-ray: abnormal (abnormal) A chest X-ray demonstrated near complete opacification of the left hemithorax with air bronchograms. On an unknown date, Fibrin D dimer: 4.92 (High) 4.92 mg/L Normal value less than or equal to 0.56 mg/L. On an unknown date, Glycosylated haemoglobin: 7.1 7.1 %. On an unknown date, Haemoglobin (120-180): 148 (normal) 148 g/L. On an unknown date, Heart rate: 122 patient was afebrile with a heart rate of 122 beats/min and normal (normal) heart rate improved to normal after 24 hours of the initial therapies.. On an unknown date, Legionella test: positive (Positive) Positive. On an unknown date, Lymphocyte count (1000-4000): 300 (Low) 300 cells/µL. On an unknown date, Neurological examination: normal (normal) normal. On an unknown date, Neutrophil count (37-84): 96 (High) 96%. On an unknown date, Oxygen saturation: 89 89 % on room air. On an unknown date, Platelet count (140-440): 354 (normal) 354 10^9/L. On an unknown date, Procalcitonin: 34.00 (High) 34.00ng/mL normal greater than or equal to 0.25ng/mL. On an unknown date, Respiratory rate: 24 24 breaths/min and normal (normal) heart rate improved to normal after 24 hours of the initial therapies.. On an unknown date, SARS-CoV-2 test: negative (Negative) initially negative, positive (Positive) Positive with a high cycle threshold of 41.6. and negative (Negative) Repeat SARS-CoV-2 PCR testing performed in the hospital 1week after the patient's admission test was negative. On an unknown date, Staphylococcus test: positive (Positive) Positive and negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative. On an unknown date, Urine analysis: abnormal A urinalysis demonstrated 3+ blood with microscopy showing only 610 red blood cells per high-powered field concerning for rhabdomyolysis due to bacterial myositis or COVID-19-associated  myositis. On an unknown date, White blood cell count (4000-10000): 17300 (High) 17300 white cells/µL.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered PNEUMONIA LEGIONELLA (Legionnaire's disease), PNEUMONIA STAPHYLOCOCCAL (MRSA pneumonia), COVID-19 (COVID-19), ACUTE KIDNEY INJURY (kidney injury) and RHABDOMYOLYSIS (rhabdomyolysis) to be related.    Patient presented to emergency department after one day history of dyspnea at rest and pleuritic left sided chest pain. One week prior to admission, patient had abrupt onset fever, drenching night sweats, headache, productive cough, nasal congestion, sore throat and myalgia. On review of systems, it was noted watery diarrhoea occurring four times per day over the past week and disorientation starting the day prior to presentation.  Patient requiring 4 L/min of supplemental oxygen to maintain saturation above 96%. Body mass index was noted to be 33.05 kg/m2. Patient was profusely diaphoretic and speaking slowly due to shortness of breath and fatigue. Rhonchi were auscultated in the left posterior lung fields with egophony in the left lower lung field. Patient exhibited diffuse muscle tenderness in the lower extremities but without discrete lesions, oedema or erythema.  Patient continued to require 2 L/min of supplemental oxygen to maintain a normal oxygen saturation, so the patient was discharged on 2 L/min of supplemental oxygen.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up received by safety on 11-Mar-2022 has Email with Agency received from team and contains significant information. Reporter information, Literature information, Patient demography, Relevant history, Lab data, Product tab, Event data and I narrative were updated. On 11-Mar-2022: Follow up received by safety on 11-Mar-2022 included an Email from author with attached supplemental report containing no significant information.  Company comment: This is a literature non-study case. Concerning  a 50-year-old, male patient with Concurrent medical conditions of Smoker, Obesity and Hyperglycaemia, who experienced the unexpected serious events of Pneumonia legionella, Pneumonia staphylococcal, Covid-19, Acute Kidney Injury, Rhabdomyolysis. The events occurred on an unknown date after the first dose of mRNA-1273 COVID 19 Vaccine. Patients showed elevated results of Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood glucose, Blood pressure, Blood urea, C-reactive protein, Fibrin D dimer, Glycosylated haemoglobin, Heart rate, Neutrophil count, Procalcitonin, White blood cell count and Positive for Staphylococcus test, Legionella test and Abnormal results of Chest X-ray, Urine analysis.  Noted low results of Blood sodium, Lymphocyte count, Oxygen saturation.  Patient was treated with Doxycycline (1 dosage form), Ceftriaxone  (1 dosage form), Mofloxacin unspecified dose,  Sulfamethoxazole-Trimethoprim unspecified dose, Normal saline unspecified dose, enoxaparin unspecified dose. The reporter assessed the events as related to the product. The concurrent medical conditions of Smoker, Obesity and Hyperglycaemia remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a literature non-study case. Concerning  a 50-year-old, male patient with Concurrent medical conditions of Smoker, Obesity and Hyperglycaemia, who experienced the unexpected serious events of Pneumonia legionella, Pneumonia staphylococcal, Covid-19, Acute Kidney Injury, Rhabdomyolysis. The events occurred on an unknown date after the first dose of mRNA-1273 COVID 19 Vaccine. Patients showed elevated results of Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood glucose, Blood pressure, Blood urea, C-reactive protein, Fibrin D dimer, Glycosylated haemoglobin, Heart rate, Neutrophil count, Procalcitonin, White blood cell count and Positive for Staphylococcus test, Legionella test and Abnormal results of Chest X-ray, Urine analysis.  Noted low results of Blood sodium, Lymphocyte count, Oxygen saturation.  Patient was treated with Doxycycline (1 dosage form), Ceftriaxone  (1 dosage form), Mofloxacin unspecified dose,  Sulfamethoxazole-Trimethoprim unspecified dose, Normal saline unspecified dose, enoxaparin unspecified dose. The reporter assessed the events as related to the product. The concurrent medical conditions of Smoker, Obesity and Hyperglycaemia remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.