Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, Inappropriate schedule of product administration, Seizure, Unresponsive to stimuli
Clinical narrative: Not responsive; Brain seizure; Encephalopathy; Received second dose more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of UNRESPONSIVE TO STIMULI (Not responsive), SEIZURE (Brain seizure) and ENCEPHALOPATHY (Encephalopathy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first dose). On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (Not responsive) (seriousness criteria hospitalization prolonged and medically significant), SEIZURE (Brain seizure) (seriousness criteria hospitalization prolonged and medically significant) and ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized on 01-Oct-2021 due to ENCEPHALOPATHY, SEIZURE and UNRESPONSIVE TO STIMULI. On 26-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first dose) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Not responsive), SEIZURE (Brain seizure) and ENCEPHALOPATHY (Encephalopathy) outcome was unknown.            Patient was taken by ambulance to ER of hospital, he was admitted that night and has been there ever since, discussing to move him into palliative care.  No concomitant medication were provided. No treatment information were provided.  Company comment: This case of inappropriate schedule of vaccine administered concerning a 75-year-old male patient with no reported medical history, who experienced the unexpected events of encephalopathy, unresponsive to stimuli and seizure. The events occurred following an unspecified date after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Events assessed as serious as the events resulted in hospitalization and considered as important medical event.  Encephalopathy is an adverse event of special interest.; Sender's Comments: This case of inappropriate schedule of vaccine administered concerning a 75-year-old male patient with no reported medical history, who experienced the unexpected events of encephalopathy, unresponsive to stimuli and seizure. The events occurred following an unspecified date after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Events assessed as serious as the events resulted in hospitalization and considered as important medical event.  Encephalopathy is an adverse event of special interest.