Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Computerised tomogram head, Culture urine, Electroencephalogram, Encephalopathy
Clinical narrative: Breakthrough Seizures; EEG revealed infective encephalopathy; EEG revealed infective encephalopathy; hip fracture secondary to fall; hip fracture secondary to fall; This literature-non-study case was reported in a literature article and describes the occurrence of SEIZURE (Breakthrough Seizures), ENCEPHALOPATHY (EEG revealed infective encephalopathy), INFECTION (EEG revealed infective encephalopathy) and HIP FRACTURE (hip fracture secondary to fall) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.       The patient's past medical history included Seizures (controlled  for 20-year history).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Breakthrough Seizures) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced ENCEPHALOPATHY (EEG revealed infective encephalopathy) (seriousness criteria hospitalization and medically significant), INFECTION (EEG revealed infective encephalopathy) (seriousness criteria hospitalization and medically significant), HIP FRACTURE (hip fracture secondary to fall) (seriousness criteria hospitalization and medically significant) and FALL (hip fracture secondary to fall). The patient was treated with Rehabilitation therapy for Seizure. At the time of the report, SEIZURE (Breakthrough Seizures), ENCEPHALOPATHY (EEG revealed infective encephalopathy), INFECTION (EEG revealed infective encephalopathy), HIP FRACTURE (hip fracture secondary to fall) and FALL (hip fracture secondary to fall) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: unremarkable. On an unknown date, Computerised tomogram head: unremarkable. On an unknown date, Culture urine: (Positive) positive E. coli urine culture. On an unknown date, Electroencephalogram: unremarkable and no recurrent seizures revealed infective encephalopathy.. On an unknown date, Magnetic resonance imaging head: unremarkable. On an unknown date, Troponin: elevated.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered SEIZURE (Breakthrough Seizures), ENCEPHALOPATHY (EEG revealed infective encephalopathy) and INFECTION (EEG revealed infective encephalopathy) to be related. No further causality assessments were provided for HIP FRACTURE (hip fracture secondary to fall) and FALL (hip fracture secondary to fall).    Concomitant medication was not reported.  It was reported that the patient suffered chills and tremors 3 hours after first dose of the Moderna vaccine. After 2 hours, the patient was discharged after the tremors abated. 7 hours later, the patient was found altered, feverish, and tachycardic and was treated with antibiotics, but family reported that she still experienced 'atypical seizures' that subsided after phenobarbital administration. The patient baseline mental status returned 3 days after admission, but experienced altered mental status and seizures shortly after discharge, requiring readmission. Also, the patient was acutely encephalopathic with recurrent rigors, severe fevers, and seizures. Following stabilization and discharge to long term acute care, the patient suffered a hip fracture secondary to a fall with subsequent transfer to acute rehab. The patient was transferred to acute rehab and the assessment/results showed that the patient remained confused and agitated throughout her course. The pain was difficult to control, but mobility and self-care did improve. No further epileptic activity was witnessed during her inpatient stay. Unfortunately, the patient remained max assist with most tasks requiring substantial care upon discharge.  Company comment: This literature-non-study case report concerns a 71-year-old female patient with past medical history of Seizures that were controlled for 20 years, who experienced serious (due to medical significance and hospitalization) unexpected events of Seizure, Encephalopathy, Infection and Hip fracture, as well as non serious unexpected event of Fall. Reportedly, 3 hours after vaccination with the first dose of the mRNA-1273 vaccine, the patient presented to the emergency department with chills and tremors, however, after 2 hours, she was discharged after her tremors abated. Seven hours later, the patient was found altered, feverish, and tachycardic and workup revealed elevated troponin levels and positive E. coli urine culture. She was treated with antibiotics, but she still experienced atypical seizures' that subsided after phenobarbital administration. MRI brain, EEG, CT head, and cardiac workup were unremarkable. Reportedly, the patient's baseline mental status returned 3 days after admission, but as she again experienced altered mental status and seizures shortly after discharge, the patient was readmitted. She was acutely encephalopathic with recurrent rigors, severe fevers, and seizures. EEG showed no recurrent seizures, but revealed infective encephalopathy. Following stabilization and discharge to long-term acute-care, the patient suffered a hip fracture secondary to a fall with subsequent transfer to acute rehabilitation. During acute inpatient rehabilitation, she remained confused and agitated throughout her course. Her pain was difficult to control, but mobility and self-care did improve. No further epileptic activity was witnessed during her inpatient stay. Unfortunately, she remained max assist with most tasks requiring substantial care upon discharge. The patient's elderly age and fall remains a confounder for hip fracture. Having in mind nature of the reported event of Fall and subsequent hip fracture (as traumatic nature of the event), the company causality for these two events is assessed as not related to the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up received by safety on 08-Dec-2022 has Email with Agency and article propagated and contains non-significant information: Reporter information updated; Sender's Comments: This literature-non-study case report concerns a 71-year-old female patient with past medical history of Seizures that were controlled for 20 years, who experienced serious (due to medical significance and hospitalization) unexpected events of Seizure, Encephalopathy, Infection and Hip fracture, as well as non serious unexpected event of Fall. Reportedly, 3 hours after vaccination with the first dose of the mRNA-1273 vaccine, the patient presented to the emergency department with chills and tremors, however, after 2 hours, she was discharged after her tremors abated. Seven hours later, the patient was found altered, feverish, and tachycardic and workup revealed elevated troponin levels and positive E. coli urine culture. She was treated with antibiotics, but she still experienced atypical seizures' that subsided after phenobarbital administration. MRI brain, EEG, CT head, and cardiac workup were unremarkable. Reportedly, the patient's baseline mental status returned 3 days after admission, but as she again experienced altered mental status and seizures shortly after discharge, the patient was readmitted. She was acutely encephalopathic with recurrent rigors, severe fevers, and seizures. EEG showed no recurrent seizures, but revealed infective encephalopathy. Following stabilization and discharge to long-term acute-care, the patient suffered a hip fracture secondary to a fall with subsequent transfer to acute rehabilitation. During acute inpatient rehabilitation, she remained confused and agitated throughout her course. Her pain was difficult to control, but mobility and self-care did improve. No further epileptic activity was witnessed during her inpatient stay. Unfortunately, she remained max assist with most tasks requiring substantial care upon discharge. The patient's elderly age and fall remains a confounder for hip fracture. Having in mind nature of the reported event of Fall and subsequent hip fracture (as traumatic nature of the event), the company causality for these two events is assessed as not related to the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.