Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (seizure) in a 68-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Falling (history of falling), Major depressive disorder, Metabolic encephalopathy and Unspecified protein-calorie malnutrition. Concurrent medical conditions included Dementia (unspecified dementia), Adult failure to thrive, Bradycardia, Schizophrenia, Epilepsy, Anemia, Hyperlipidemia, Essential hypertension and Generalized osteoarthritis. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In December 2024, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered SEIZURE (seizure) to be related. Patient had no known allergies. All the historical condition was as of 16-May-2024 according to the resident's face sheet. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Concomitant product use was not provided by the reporter. It was reported that patient was in a skilled nursing facility at the time of vaccination. There were no lab data or results were available. Treatment information was not provided. It was reported that seizure was risk from COVID vaccines.; Reporter's Comments: The medical history of Metabolic encephalopathy, concurrent medical conditions dementia, Schizophrenia and Epilepsy are confounders for the event. In view of the long non-suggestive onset latency the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Adult failure to thrive; Anemia; Bradycardia; Dementia (unspecified dementia); Epilepsy; Essential hypertension; Generalized osteoarthritis; Hyperlipidemia; Schizophrenia
Medical History/Concurrent Conditions: Falling (history of falling); Major depressive disorder; Metabolic encephalopathy; Unspecified protein-calorie malnutrition