Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Lymphadenopathy, Pain in jaw
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died in sleep) in a 60-year-old male patient 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) tablet for Chronic lymphocytic leukemia. The patient's past medical history included COVID-19 in November 2020 and Pneumonia. Concurrent medical conditions included Chronic lymphocytic leukemia. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In 2021, the patient experienced PAIN IN JAW (Jaw pain) and LYMPHADENOPATHY (Swollen lymph nodes). The patient died on 01-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN JAW (Jaw pain) had not resolved and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. No concomitant medication was reported. The patient died in his sleep on 01 Oct 2021 passed away after 60 pill and his physician said it was related to Imbruvica. The patient had pain in his jaw prior to his passing. Also, the after patient received the Moderna COVID19 vaccine that he had swollen lymph nodes. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided. 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 a 60-year-old male patient with relevant medical history of COVID-19 and Chronic lymphocytic leukemia treated with Ibrutinib, who experienced the unexpected, serious  (fatal and medically significant) event of Death (reported as Died in sleep) 6 months and 14 days after receiving the first dose of mRNA-1273 vaccine. Patient experienced jaw pain prior to his demise. Cause of death was reported as unknown. No autopsy report was provided. The relevant medical history of COVID-19 and Chronic lymphocytic leukemia could be considered as contributory factors while Ibrutinib may cause Sudden cardiac death as a serious adverse effect. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received contains non-significant information. Sender's Comments: This spontaneous case concerns a 60-year-old male patient with relevant medical history of COVID-19 and Chronic lymphocytic leukemia treated with Ibrutinib, who experienced the unexpected, serious  (fatal and medically significant) event of Death (reported as Died in sleep) 6 months and 14 days after receiving the first dose of mRNA-1273 vaccine. Patient experienced jaw pain prior to his demise. Cause of death was reported as unknown. No autopsy report was provided. The relevant medical history of COVID-19 and Chronic lymphocytic leukemia could be considered as contributory factors while Ibrutinib may cause Sudden cardiac death as a serious adverse effect. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Died in sleep.