Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood culture, COVID-19, Computerised tomogram thorax, Diarrhoea
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     patient is on chemotherapy (taxol for chemo)for breast cancer  once a week.  Concurrent medical conditions included Breast cancer (on week 3 of a 3-month cycle of chemotherapy with taxol), Hypertension, Depression, GERD, Drug allergy (allergic to clindamycin) and Obesity. Concomitant products included TAXOL for Chemotherapy, BUPROPION and TRAZODONE for Depression, OMEPRAZOLE for GERD, AMLODIPINE BESILATE (NORVASC) and LISINOPRIL for Hypertension, SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced COVID-19 (COVID-19 pcr positive) (seriousness criterion hospitalization), PNEUMONIA (B/l pneumonia) (seriousness criterion hospitalization prolonged), HYPOXIA (Hypoxia) (seriousness criterion hospitalization), DIARRHOEA (Refractory diarrhea) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), VOMITING (Vomiting) (seriousness criterion hospitalization prolonged), HYPOPHAGIA (Poor po) (seriousness criterion hospitalization prolonged) and ANAEMIA (Anemia) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion hospitalization prolonged). The patient was hospitalized until 26-Apr-2021 due to COVID-19 and PNEUMONIA. At the time of the report, COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood culture: negative (Negative) Negative. In April 2021, Computerised tomogram thorax: b/l pneumonia (abnormal) b/l pneumonia and negative for pe (Negative) Negative for PE. In April 2021, Influenza virus test: negative (Negative) Negative. In April 2021, Legionella test: negative (Negative) Negative. In April 2021, Oxygen saturation: 79 % (Low) low requiring oxygen. In April 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient required oxygen during hospital course for hypoxia and was discharged home on it. Patient also needed two units of blood for anemia. Patient was not a candidate for regeneron or toci. Company comment :This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.