Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, SARS-CoV-2 test, SARS-CoV-2 test positive, White blood cell count, White blood cell count increased
Clinical narrative: White blood cell count high; COVID-19 virus test positive, Pyrexia, Hypersomnia and Asthenia; This spontaneous case was reported by a patient and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive, Pyrexia, Hypersomnia and Asthenia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In 2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive, Pyrexia, Hypersomnia and Asthenia). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White blood cell count high). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) was resolving and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive, Pyrexia, Hypersomnia and Asthenia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: High. In 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, White blood cell count: High.         The information was unknown whether patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of WBC count high, positive for COVID, no energy, sleep all day and  high temperature with IMBRUVICA (ibrutinib) was a reasonable possibility.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 67-years-old male patient with Concurrent medical conditions of Chronic lymphoid leukemia who experienced the unexpected non- serious AESI events of COVID-19 and that occurred in the context of second dose of mRNA-1273 vaccination with SARS-CoV-2 test Positive on unspecified date. The Clinical course, and treatment details were not provided, and the event outcome was resolved. It was noted that patient received dose with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) prior to current vaccination(interchange of vaccine products). Ongoing COVID-19 Pandemic and Concurrent medical conditions of Chronic lymphoid leukemia (suggestive of immunosuppression) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 67-years-old male patient with Concurrent medical conditions of Chronic lymphoid leukemia who experienced the unexpected non- serious AESI events of COVID-19 and that occurred in the context of second dose of mRNA-1273 vaccination with SARS-CoV-2 test Positive on unspecified date. The Clinical course, and treatment details were not provided, and the event outcome was resolved. It was noted that patient received dose with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) prior to current vaccination(interchange of vaccine products). Ongoing COVID-19 Pandemic and Concurrent medical conditions of Chronic lymphoid leukemia (suggestive of immunosuppression) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.