Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Immunodeficiency, Malaise
Clinical narrative: Death; imbruvica lowered immunity; COVID-19  infection; did not do well; This spontaneous case was reported by a physician and describes the occurrence of DEATH (Death) and IMMUNODEFICIENCY (imbruvica lowered immunity) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), IMMUNODEFICIENCY (imbruvica lowered immunity) (seriousness criterion medically significant), COVID-19 (COVID-19  infection) and MALAISE (did not do well). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, IMMUNODEFICIENCY (imbruvica lowered immunity), COVID-19 (COVID-19  infection) and MALAISE (did not do well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After the booster, the patient contracted Covid 19 infection. Physician felt like Imbruvica lowered the his immunity which made him not able to overcome Covid 19 infection despite being vaccinated and physician had stopped Imbruvica treatment during the time.  The reporter's causality for the event(s) of death, Imbruvica lowered immunity, covid 19 infection, did not do well with Imbruvica (Ibrutinib) was a reasonable possibility.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns 46-years-old, male patient with no reported medical history, who experienced the unexpected fatal event of Death (medically significant and death) and Unexpected serious (medically significant) event of Immunodeficiency and Unexpected non-serious event of COVID-19 which occurred in context to third dose of mRNA-1273 vaccine. It was noted that patient had received IBRUTINIB (IMBRUVICA) for an unknown indication. Patient died on unspecified day after vaccination. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The reported cause of death was unknown and whether autopsy performed was also unknown. Though, no relevant medical history was reported; concomitant administration of IBRUTINIB (IMBRUVICA) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 46-years-old, male patient with no reported medical history, who experienced the unexpected fatal event of Death (medically significant and death) and Unexpected serious (medically significant) event of Immunodeficiency and Unexpected non-serious event of COVID-19 which occurred in context to third dose of mRNA-1273 vaccine. It was noted that patient had received IBRUTINIB (IMBRUVICA) for an unknown indication. Patient died on unspecified day after vaccination. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The reported cause of death was unknown and whether autopsy performed was also unknown. Though, no relevant medical history was reported; concomitant administration of IBRUTINIB (IMBRUVICA) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: death.