Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Gastrointestinal disorder, Malnutrition, Swelling
Clinical narrative: Bilateral upper and lower involuntary movements with audible grunt; 25 lb. weight loss in 2 months; Malnutrition; Dehydration; 20+ falls; Bilateral swollen hands/feet and crooked/contracted fingers/toes; Some cognitive deficits; Intermittent locked jaw; Severe fatigue; Tonic seizures; Gastrointestinal issue; Constipation; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of TONIC CONVULSION (Tonic seizures), GASTROINTESTINAL DISORDER (Gastrointestinal issue), CONSTIPATION (Constipation), DYSARTHRIA (Slurred speech), DYSKINESIA (Bilateral upper and lower involuntary movements with audible grunt), WEIGHT DECREASED (25 lb. weight loss in 2 months), MALNUTRITION (Malnutrition), DEHYDRATION (Dehydration), FALL (20+ falls), SWELLING (Bilateral swollen hands/feet and crooked/contracted fingers/toes), COGNITIVE DISORDER (Some cognitive deficits), TRISMUS (Intermittent locked jaw) and FATIGUE (Severe fatigue) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate cancer.    On 29-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In December 2023, the patient experienced GASTROINTESTINAL DISORDER (Gastrointestinal issue) (seriousness criteria disability and medically significant), CONSTIPATION (Constipation) (seriousness criteria disability and medically significant) and DYSARTHRIA (Slurred speech) (seriousness criteria disability and medically significant). In January 2024, the patient experienced TONIC CONVULSION (Tonic seizures) (seriousness criteria disability and medically significant), DYSKINESIA (Bilateral upper and lower involuntary movements with audible grunt) (seriousness criteria disability and medically significant), WEIGHT DECREASED (25 lb. weight loss in 2 months) (seriousness criteria disability and medically significant), MALNUTRITION (Malnutrition) (seriousness criteria disability and medically significant), DEHYDRATION (Dehydration) (seriousness criteria disability and medically significant), FALL (20+ falls) (seriousness criteria disability and medically significant), SWELLING (Bilateral swollen hands/feet and crooked/contracted fingers/toes) (seriousness criteria disability and medically significant), COGNITIVE DISORDER (Some cognitive deficits) (seriousness criteria disability and medically significant), TRISMUS (Intermittent locked jaw) (seriousness criteria disability and medically significant) and FATIGUE (Severe fatigue) (seriousness criteria disability and medically significant). At the time of the report, TONIC CONVULSION (Tonic seizures), GASTROINTESTINAL DISORDER (Gastrointestinal issue), CONSTIPATION (Constipation), DYSARTHRIA (Slurred speech), DYSKINESIA (Bilateral upper and lower involuntary movements with audible grunt), WEIGHT DECREASED (25 lb. weight loss in 2 months), MALNUTRITION (Malnutrition), DEHYDRATION (Dehydration), FALL (20+ falls), SWELLING (Bilateral swollen hands/feet and crooked/contracted fingers/toes), COGNITIVE DISORDER (Some cognitive deficits), TRISMUS (Intermittent locked jaw) and FATIGUE (Severe fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Reported rapid decline in ADLs. Lab investigations include CT scan, further neurological testing in process including lumbar puncture and MRI with contrast, EEG with no results being reported. Treatment information was not reported.  Company Comment This is an spontaneous case concerning in a patient of a 79-year-old male patient with medical history of Prostate cancer. who experienced the unexpected seriousness criteria medically significant and disability events of tonic convulsion (AESI), gastrointestinal disorder, constipation, dysarthria, dyskinesia, weight decreased, malnutrition, dehydration, fall, swelling, cognitive disorder, trismus, fatigue beginning the following month after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. Lab investigations include CT scan, further neurological testing in process including lumbar puncture and MRI with contrast, EEG with no results being reported. At the time of the report, the event´s had not resolved. The medical history is a contributor for the events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.