Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody positive, Epstein-Barr virus test, Hepatic enzyme, Hepatitis A antibody positive, Hepatitis A virus test
Clinical narrative: watery diarrhea; general malaise; non-quantified fever; vomiting; scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen; Hepatitis A virus; Epstein Barr virus; acute kidney injury; Cytomegalovirus; varicella-zoster virus; elevated hypertriglyceridemia; This literature-non-study case was reported in a literature article and describes the occurrence of DIARRHOEA (watery diarrhea), MALAISE (general malaise), PYREXIA (non-quantified fever), VOMITING (vomiting), RASH (scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen), HEPATITIS A ANTIBODY POSITIVE (Hepatitis A virus), EPSTEIN-BARR VIRUS ANTIBODY POSITIVE (Epstein Barr virus), ACUTE KIDNEY INJURY (acute kidney injury), CYTOMEGALOVIRUS TEST POSITIVE (Cytomegalovirus) and VARICELLA VIRUS TEST POSITIVE (varicella-zoster virus) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Obesity, Hyponatremia, Hypochloremia and High anion gap metabolic acidosis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced DIARRHOEA (watery diarrhea) (seriousness criterion hospitalization), MALAISE (general malaise) (seriousness criterion hospitalization), PYREXIA (non-quantified fever) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), RASH (scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen) (seriousness criterion hospitalization), HEPATITIS A ANTIBODY POSITIVE (Hepatitis A virus) (seriousness criterion medically significant), EPSTEIN-BARR VIRUS ANTIBODY POSITIVE (Epstein Barr virus) (seriousness criterion medically significant), ACUTE KIDNEY INJURY (acute kidney injury) (seriousness criterion medically significant), CYTOMEGALOVIRUS TEST POSITIVE (Cytomegalovirus) (seriousness criterion medically significant), VARICELLA VIRUS TEST POSITIVE (varicella-zoster virus) (seriousness criterion medically significant) and HYPERTRIGLYCERIDAEMIA (elevated hypertriglyceridemia). At the time of the report, DIARRHOEA (watery diarrhea), MALAISE (general malaise), PYREXIA (non-quantified fever), VOMITING (vomiting), HEPATITIS A ANTIBODY POSITIVE (Hepatitis A virus), EPSTEIN-BARR VIRUS ANTIBODY POSITIVE (Epstein Barr virus), CYTOMEGALOVIRUS TEST POSITIVE (Cytomegalovirus), VARICELLA VIRUS TEST POSITIVE (varicella-zoster virus) and HYPERTRIGLYCERIDAEMIA (elevated hypertriglyceridemia) outcome was unknown and RASH (scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen) and ACUTE KIDNEY INJURY (acute kidney injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood bilirubin: total bilirubin was elevated as well. (High) total bilirubin was elevated as well.. On an unknown date, Blood creatine phosphokinase: elevated (High) Further laboratory bloodwork reported elevated LDH, creatinine kinase. On an unknown date, Blood lactate dehydrogenase: elevated (High) elevated LDH. On an unknown date, Blood triglycerides: high (High) High. On an unknown date, Creatinine renal clearance: 18 creatinine clearance of 18ml/min. On an unknown date, Crystal urine present: few calcium oxalate crystals few calcium oxalate crystals. On an unknown date, Cytomegalovirus test: positive (Positive) In addition, infectious disease workup was performed, in which HAV, VZV, EBV, CMV IgM were positive. On an unknown date, Epstein-Barr virus test: positive (Positive) In addition, infectious disease workup was performed, in which HAV, VZV, EBV, CMV IgM were positive. On an unknown date, Hepatic enzyme: hepatic enzymes were more than five times elevated Hepatic enzymes were more than five times elevated. On an unknown date, Hepatitis A virus test: positive (Positive) Positive. On an unknown date, Urine analysis: urinalysis reported proteinuria Urinalysis reported proteinuria. On an unknown date, Urine leukocyte esterase: positive (Positive) positive leukocytes esterase. On an unknown date, Varicella virus test: positive (Positive) In addition, infectious disease workup was performed, in which HAV, VZV, EBV, CMV IgM were positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIARRHOEA (watery diarrhea), MALAISE (general malaise), PYREXIA (non-quantified fever), VOMITING (vomiting), RASH (scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen), HEPATITIS A ANTIBODY POSITIVE (Hepatitis A virus), EPSTEIN-BARR VIRUS ANTIBODY POSITIVE (Epstein Barr virus), ACUTE KIDNEY INJURY (acute kidney injury), CYTOMEGALOVIRUS TEST POSITIVE (Cytomegalovirus), VARICELLA VIRUS TEST POSITIVE (varicella-zoster virus) and HYPERTRIGLYCERIDAEMIA (elevated hypertriglyceridemia) to be possibly related.    No relevant concomitant medications were reported.   No treatment information was provided.  Associated symptoms were scattered non-blanching maculopapular rash from head to shoulders to mid back and abdomen, pustules inside ear and decrease urine output. Patient was unable to urinate for at least 48hrs.  Laboratory bloodwork was remarkable for hyponatremia, hypochloremia, high anion gap metabolic acidosis.  Patient was convinced that symptoms were related to COVID-19 vaccination. Etiology of symptoms remained unclear at admission, for that reason she was admitted and received isotonic IV fluids.  Patient received inpatient supportive care for five days.  Company comment: This case concerns a 36-year-old female patient with a relevant medical history of Type 2 diabetes mellitus and Hypertension, who experienced the unexpected serious (hospitalization) events of Diarrhoea, Pyrexia, Malaise, Vomiting, Rash, Acute kidney injury and Hepatitis A virus IgM antibody positive, Epstein-Barr virus IgM antibody positive, CMV IgM antibody positive and Varicella virus test positive mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 2 days after the second dose of mRNA- 1273 vaccine. Laboratory showed elevated hepatic enzymes and bilirubin, creatinine renal clearance of 18 ml/min, hyponatremia, hypochloraemia, high anion gap metabolic acidosis and proteinuria.  Diabetes mellitus and Hypertension remains a confounder. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received by safety 11-Nov-2021 included an Email with information received from research team with full text article with abstract and contains No new information.; Sender's Comments: This case concerns a 36-year-old female patient with a relevant medical history of Type 2 diabetes mellitus and Hypertension, who experienced the unexpected serious (hospitalization) events of Diarrhoea, Pyrexia, Malaise, Vomiting, Rash, Acute kidney injury and Hepatitis A virus IgM antibody positive, Epstein-Barr virus IgM antibody positive, CMV IgM antibody positive and Varicella virus test positive mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 2 days after the second dose of mRNA- 1273 vaccine. Laboratory showed elevated hepatic enzymes and bilirubin, creatinine renal clearance of 18 ml/min, hyponatremia, hypochloraemia, high anion gap metabolic acidosis and proteinuria.  Diabetes mellitus and Hypertension remains a confounder. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.