Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haptoglobin, Hepatic enzyme, Incontinence, International normalised ratio, Malaise
Clinical narrative: Extra dose administered; Confusional state; Coronary artery stenosis; Cough; Delusional perception; Diarrhoea; Dysarthria; Fatigue; Arteriosclerosis; Gait inability; Incontinence; Malaise; Memory impairment; Mental status changes; Speech disorder developmental; Pyrexia; This case was received via FDA VAERS (Reference number: 1685255) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered), CONFUSIONAL STATE (Confusional state), CORONARY ARTERY STENOSIS (Coronary artery stenosis), COUGH (Cough), DELUSIONAL PERCEPTION (Delusional perception), DIARRHOEA (Diarrhoea), DYSARTHRIA (Dysarthria), FATIGUE (Fatigue), ARTERIOSCLEROSIS (Arteriosclerosis), GAIT INABILITY (Gait inability), INCONTINENCE (Incontinence), MALAISE (Malaise), MEMORY IMPAIRMENT (Memory impairment), MENTAL STATUS CHANGES (Mental status changes), SPEECH DISORDER DEVELOPMENTAL (Speech disorder developmental) and PYREXIA (Pyrexia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     The patient's past medical history included Polyarthralgia and Depression. Concurrent medical conditions included Drug allergy (Lisinopril intolerance- dry cough), Multiple myeloma, Type 2 diabetes mellitus and Sleep apnea (obstructive sleep apnea on CPAP). Concomitant products included ACYCLOVIR [ACICLOVIR], AMLODIPINE, ATORVASTATIN, CYCLOPHOSPHAMIDE and CARFILZOMIB;DEXAMETHASONE for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Fatigue) (seriousness criterion hospitalization) and MALAISE (Malaise) (seriousness criterion hospitalization). 02-Sep-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), CORONARY ARTERY STENOSIS (Coronary artery stenosis) (seriousness criteria hospitalization and medically significant), DELUSIONAL PERCEPTION (Delusional perception) (seriousness criterion hospitalization), DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization), DYSARTHRIA (Dysarthria) (seriousness criterion hospitalization), ARTERIOSCLEROSIS (Arteriosclerosis) (seriousness criterion hospitalization), GAIT INABILITY (Gait inability) (seriousness criterion hospitalization), INCONTINENCE (Incontinence) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Memory impairment) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), SPEECH DISORDER DEVELOPMENTAL (Speech disorder developmental) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered), CONFUSIONAL STATE (Confusional state), CORONARY ARTERY STENOSIS (Coronary artery stenosis), COUGH (Cough), DELUSIONAL PERCEPTION (Delusional perception), DIARRHOEA (Diarrhoea), DYSARTHRIA (Dysarthria), FATIGUE (Fatigue), ARTERIOSCLEROSIS (Arteriosclerosis), GAIT INABILITY (Gait inability), INCONTINENCE (Incontinence), MALAISE (Malaise), MEMORY IMPAIRMENT (Memory impairment), MENTAL STATUS CHANGES (Mental status changes), SPEECH DISORDER DEVELOPMENTAL (Speech disorder developmental) and PYREXIA (Pyrexia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Angiogram cerebral: abnormal (abnormal) CTA head and neck shows no LVO but does show extensive luminal irregularities of 50 to 70% stenosis throughout the bilateral V4 segments right greater than left as well as basilar artery underlying atherosclerosis.. On 02-Sep-2021, Arteriogram carotid: abnormal (abnormal) Abnormal. On 02-Sep-2021, Blood bilirubin: high (High) Liver profile elevated with total bilirubin. On 02-Sep-2021, Blood creatinine: high (High) increased and high (High) SCr slightly elevated as well as UN. On 02-Sep-2021, Blood culture: negative (Negative) no growth to date. On 02-Sep-2021, Blood lactate dehydrogenase: high (High) LDH elevated to 286.. On 02-Sep-2021, Blood urea: high (High) increased. On 02-Sep-2021, Chest X-ray: normal (normal) Chest x-ray unremarkable.. On 02-Sep-2021, Computerised tomogram head: normal (normal) CT head shows no abnormalities.. On 02-Sep-2021, Culture urine: negative (Negative) urine cultures - no growth to date. On 02-Sep-2021, Haptoglobin: normal (normal) Haptoglobin within normal limits.. On 02-Sep-2021, Hepatic enzyme: high (High) increased No leukocytosis. On 02-Sep-2021, International normalised ratio: high (High) Liver profile elevated with INR elevated. On 02-Sep-2021, SARS-CoV-2 test: negative (Negative) COVID PCR negative; UA unremarkable. On 02-Sep-2021, Troponin: normal (normal) troponins negative. On 02-Sep-2021, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug information provided.  The patient left from work around 3 PM on 07-Sep-2021 and did not arrive home at a regular time. His son was called to find him. The patient was found resting in his car at the gas station right across his work. The patient was confused and took time to respond to questions. The family stated his speech was delayed, slightly slurred and had inability to walk. The patient received third covid shot on 01-Sep-2021 and had more side effects including cough, general malaise and fatigue. The patient stated that he was "delutionall" as he lays on the bed but no aware how he lays on the floor. The patient denied fall and passing out. Upon arrival, the patient was found to have his underwear wet, unclear it was from bowel or urinary. The patient had chronic diarrhea for the past month.  At the time of this visit, patient was alert and oriented, responded to questions appropriately. The patient said he said he did not remember what happened at all. From 3pm to 11pm, memory was blank."  The patient was close to his mental status baseline on 09-Sep-2021 and anticipated to be discharged on 10-Sep-2021.  Company Comment: This case of extradose administered concerns a 68-year-old, male subject with a history of Depression, Multiple myeloma, Type 2 diabetes mellitus and Sleep apnea, who experienced the unexpected events of CONFUSIONAL STATE, CORONARY ARTERY STENOSIS, COUGH, DELUSIONAL PERCEPTION, DIARRHOEA, DYSARTHRIA, FATIGUE, ARTERIOSCLEROSIS, GAIT INABILITY, INCONTINENCE, MALAISE, MEMORY IMPAIRMENT, MENTAL STATUS CHANGES, SPEECH DISORDER DEVELOPMENTAL and PYREXIA. The events occurred the following day after the third dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The medical history of Depression, Multiple myeloma, Type 2 diabetes mellitus and Sleep apnea remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case of extradose administered concerns a 68-year-old, male subject with a history of Depression, Multiple myeloma, Type 2 diabetes mellitus and Sleep apnea, who experienced the unexpected events of CONFUSIONAL STATE, CORONARY ARTERY STENOSIS, COUGH, DELUSIONAL PERCEPTION, DIARRHOEA, DYSARTHRIA, FATIGUE, ARTERIOSCLEROSIS, GAIT INABILITY, INCONTINENCE, MALAISE, MEMORY IMPAIRMENT, MENTAL STATUS CHANGES, SPEECH DISORDER DEVELOPMENTAL and PYREXIA. The events occurred the following day after the third dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The medical history of Depression, Multiple myeloma, Type 2 diabetes mellitus and Sleep apnea remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.