Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac dysfunction, Death, Decubitus ulcer, Fatigue, Haemorrhagic stroke
Clinical narrative: infections & fever from a bed sore; Hemorrhage stroke; Heart attack; only 25% of his heart is working; bed sore/pressure sore injury/Infection/Infected/pressure ulcer infected; Death; Sore at the injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), HAEMORRHAGIC STROKE (Hemorrhage stroke), MYOCARDIAL INFARCTION (Heart attack), CARDIAC DYSFUNCTION (only 25% of his heart is working) and INFECTION (infections & fever from a bed sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN, ATORVASTATIN CALCIUM, DILTIAZEM, LOSARTAN and TAMSULOSIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site) and FATIGUE (Tired). On 13-May-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhage stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant), CARDIAC DYSFUNCTION (only 25% of his heart is working) (seriousness criterion medically significant), INFECTION (infections & fever from a bed sore) (seriousness criterion hospitalization) and DECUBITUS ULCER (bed sore/pressure sore injury/Infection/Infected/pressure ulcer infected). The patient died on 30-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGIC STROKE (Hemorrhage stroke), MYOCARDIAL INFARCTION (Heart attack), CARDIAC DYSFUNCTION (only 25% of his heart is working), INFECTION (infections & fever from a bed sore), DECUBITUS ULCER (bed sore/pressure sore injury/Infection/Infected/pressure ulcer infected), VACCINATION SITE PAIN (Sore at the injection site) and FATIGUE (Tired) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFECTION (infections & fever from a bed sore) and DECUBITUS ULCER (bed sore/pressure sore injury/Infection/Infected/pressure ulcer infected) to be related. No further causality assessments were provided for DEATH (Death), HAEMORRHAGIC STROKE (Hemorrhage stroke), MYOCARDIAL INFARCTION (Heart attack), CARDIAC DYSFUNCTION (only 25% of his heart is working), VACCINATION SITE PAIN (Sore at the injection site) and FATIGUE (Tired).    Company comment: This is a fatal spontaneous case concerning a 79 year-old, male patient with no reported medical history and concomitant use of warfarin and atorvastatin, who experienced the serious unexpected, events of Haemorrhagic stroke (AESI), Myocardial infarction (AESI), Cardiac dysfunction, after the second dose of mRNA-1273 vaccine. One day after vaccination, the patient experienced headache, weakness in legs and profuse vomiting. The patient was transferred to a hospital with diagnosis of haemorrhagic stroke and subsequent left side hemiplegia. The patient developed infected decubital ulcer, myocardial infarction that was not initially noted, as well as cardiac dysfunction with just 25% of his heart working during hospitalization. The patient died approximately 4 months after the events onset and vaccine administration. Cause of death was not reported and it was not reported whether an autopsy was performed. The mentioned concomitant medication remains a confounder for the event Haemorrhagic stroke. No further information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Patient reported that on 12-May-2021, he experienced headache, was sore at the injection site, & was tired. On 13-May-2021 he had headache, weakness in his legs & almost fell, profuse vomiting, & throwing up in his mouth because he was sitting up and could not move. The ER Dr said he had a hemorrhage stroke. He was paralyzed on his left side. He was at that hospital for only a few hrs.On 13-May-2021 - 04-Jun-2021, he was transferred to another hospital, because the Neurologist he needed was not available at that hospital.  Patient reported that on 04-Jun-2021 - 24-Jun-2021, he was transferred to a rehab facility. They didn't take good care of him. while he was there, he developed a bad bed sore. He also had a heart attack while there but nobody knew. Only 25% of his heart was working. 04-Jun-2021 - 24-Jun-2021, admitted to a rehab facility. 21-Jun-2021 - 26-Jun-2021, he was admitted to the hospital. 26-Jun-2011, he was discharged back to the rehab facility. 06-Jul-2021 - 20-Jul-2021, he was admitted to the hospital.  20-Jul-2021, he was discharged to a different rehab facility. He was also on a feeding tube. Treatment information was not provided.  Prior to passing patient was in the ICU again and returned to the nursing home and died 3 days later.  Upon on internal review on 28-SEP-2022, it was identified that, for the case MOD-2021-301245, one of the report (FDA) was erroneously nullified instead of submitting a follow up report. Since only one report cannot be nullified, the entire case has to be nullified and a new case MOD-2021-653702 has been created. All the information from the case MOD-2021-301245 has been incorporated into the case MOD-2021-653702 which will be retained. The newly created case MOD-2021-653702 should be added as a part of open QI as it was identified in the reconciliation. Hence, the case MOD-2021-301245 will be nullified and deleted from safety database.   This case was linked to MOD-2021-302089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated patient initial On 30-Aug-2021: Follow Up received on 30 Aug 2021 contains added Events On 18-Oct-2021: Follow-up document contains significant information (Patient death). On 28-Sep-2022: Upon on internal review on 28-SEP-2022, it was identified that, for the case MOD-2021-301245, one of the report (FDA) was erroneously nullified instead of submitting a follow up report. Since only one report cannot be nullified, the entire case has to be nullified and a new case MOD-2021-653702 has been created. All the information from the case MOD-2021-301245 has been incorporated into the case MOD-2021-653702 which will be retained. The newly created case MOD-2021-653702 should be added as a part of open QI as it was identified in the reconciliation. Hence, the case MOD-2021-301245 will be nullified and deleted from safety database. Events hemiplegia, muscular weakness, vomiting, headache, Dysgraphia and Mobility decreased were deleted as these are symptoms of the event Haemorrhagic stroke; Sender's Comments: This is a fatal spontaneous case concerning a 79 year-old, male patient with no reported medical history and concomitant use of warfarin and atorvastatin, who experienced the serious unexpected, events of Haemorrhagic stroke (AESI), Myocardial infarction (AESI), Cardiac dysfunction, after the second dose of mRNA-1273 vaccine. One day after vaccination, the patient experienced headache, weakness in legs and profuse vomiting. The patient was transferred to a hospital with diagnosis of haemorrhagic stroke and subsequent left side hemiplegia. The patient developed infected decubital ulcer, myocardial infarction that was not initially noted, as well as cardiac dysfunction with just 25% of his heart working during hospitalization. The patient died approximately 4 months after the events onset and vaccine administration. Cause of death was not reported and it was not reported whether an autopsy was performed. The mentioned concomitant medication remains a confounder for the event Haemorrhagic stroke. No further information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death