Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pneumonia; Stroke/couldn't talk and was blind; Couldn't talk and was blind; Couldn't talk; Nausea; Arm was sore at the injection site; He was sweating a lot; Body aches; Temperature was 99.4°F; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), CEREBROVASCULAR ACCIDENT (Stroke/couldn't talk and was blind) and BLINDNESS (Couldn't talk and was blind) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (He has cancer, & got an infusion of Keytruda that day( date not specified)).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (He was sweating a lot), MYALGIA (Body aches), PYREXIA (Temperature was 99.4°F), CHILLS (Had chills) and VACCINATION SITE PAIN (Arm was sore at the injection site). On 15-Mar-2021, the patient experienced NAUSEA (Nausea). In April 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria death, hospitalization, medically significant and life threatening), CEREBROVASCULAR ACCIDENT (Stroke/couldn't talk and was blind) (seriousness criteria death, hospitalization prolonged, medically significant and life threatening), BLINDNESS (Couldn't talk and was blind) (seriousness criteria disability and medically significant) and APHASIA (Couldn't talk). The patient was treated with Surgery for Cerebrovascular accident. The patient died on 17-Apr-2021. The reported cause of death was Pneumonia and stroke/couldn't talk and was blind. It is unknown if an autopsy was performed. At the time of death, BLINDNESS (Couldn't talk and was blind), APHASIA (Couldn't talk), HYPERHIDROSIS (He was sweating a lot), MYALGIA (Body aches), PYREXIA (Temperature was 99.4°F), CHILLS (Had chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.4 f (High) High.         No Concomitant product use was reported. No treatment information was provided.  The reporter was calling on behalf of their husband who received their 2nd dose of Moderna vaccine and on that night, their arm was sore at the injection site. The patient's body temperature was 99.4°F and had chills and developed body aches. Reportedly, the patient was sweating a lot and on 15-Mar-2021 morning, the patient experienced nausea.  It was also reported that the patient had cancer and got an infusion of Keytruda that day (Date unspecified).  On 05-Aug-2021, the reporter informed that the patient contracted pneumonia in the beginning of Apr-2021 after the patient's second vaccine. The patient had a stroke on the 5th evening of hospitalization and was transferred to a second hospital where they did surgery.   Reportedly, the patient was not able to talk and was blind post-surgery. The reporter also informed that the patient died from getting the COVID vaccine and died on 17-Apr-2021.  Company Comment: Very limited information regarding these events has been provided at this time. Patient's advanced age along with the history of cancer may have been contributory for the occurrence of the events..   This case was linked to MOD-2021-046338 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up was received. The case has been upgraded to serious from non-serious. Added the first dose details including the dose start date and batch number. Added new events including Death, pneumonia, stroke, blindness and speech loss and the event outcomes. Added the date of death and the cause of death. Updated the description of event.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with the history of cancer may have been contributory for the occurrence of the events..; Reported Cause(s) of Death: Pneumonia; Stroke/couldn't talk and was blind