Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: falling face first on the floor/collapsed; This spontaneous case was reported by an other health care professional and describes the occurrence of FALL (falling face first on the floor/collapsed) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma (IgG multiple myeloma) on 01-Mar-2008, Hypertension (HTN) on 09-Aug-2015, Gait abnormal (Impaired Gait) on 11-Jul-2010, Cardiac arrhythmia (Cardiac arrhythmia- Pacemaker dependent) on 09-Aug-2015, DVT on 09-Aug-2015 and Pacemaker insertion (cardiac) (Cardiac arrhythmia- Pacemaker dependent). Concomitant products included POMALIDOMIDE from 21-May-2021 to an unknown date, DEXAMETHASONE from 21-May-2021 to an unknown date, GABAPENTIN (NEURONTIN) from 21-May-2021 to an unknown date and LACTULOSE for an unknown indication.    On 25-Oct-2021 at 8:49 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced FALL (falling face first on the floor/collapsed) (seriousness criterion death). The patient died on 30-Apr-2022. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FALL (falling face first on the floor/collapsed) to be not related.    No treatment medication was reported by reporter. It was reported that patient was involved in a study. Patient took third dose of Moderna vaccine on 25-Oct-2021. It was reported that study staff contacted patient on 3-May-2022 for month 6 blood withdraw per protocol and came to know that patient passed away on 30-Apr-2022. Patient wife already informed clinical team of her husband at medical center. patients wife reported that she left the patient home alone for few hours, when she retuned she found that patient had fallen face first in the bathroom. she called EMT for assistance but first responder did not proceed with any intervention. she stated that the cause of death had not yet been released. she reported that the death certificate was pending.  Company comment: This spontaneous case concerns a 77 year old male patient with relevant medical history of Multiple myeloma, Hypertension, Cardiac arrhythmia, Cardiac pacemaker insertion and Deep vein thrombosis who met with the unexpected fatal (seriousness criteria-death) event of Fall, about 6 months, 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was at home and collapsed falling face first on the floor; could not be revived by the rescue team. The cause of death was not known. No further information on autopsy details and details pertaining to the previous doses was available in the report. Elderly age of the patient and multiple co morbidities could be risk factors for the fatal outcome. The causality for the fatal event was 'not related' as per the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77 year old male patient with relevant medical history of Multiple myeloma, Hypertension, Cardiac arrhythmia, Cardiac pacemaker insertion and Deep vein thrombosis who met with the unexpected fatal (seriousness criteria-death) event of Fall, about 6 months, 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was at home and collapsed falling face first on the floor; could not be revived by the rescue team. The cause of death was not known. No further information on autopsy details and details pertaining to the previous doses was available in the report. Elderly age of the patient and multiple co morbidities could be risk factors for the fatal outcome. The causality for the fatal event was 'not related' as per the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death