Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Insomnia, Nausea, Pallor, Paradoxical drug reaction
Clinical narrative: Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be.         No concomitant product information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.   This case was linked to MOD-2021-248336 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death