Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: delirious; I lost the use of my legs. My legs were not, they just could not hold me up I could not get up; I'm a little unsteady; fell; disoriented; high fever; fainted; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (disoriented), PYREXIA (high fever), SYNCOPE (fainted), DELIRIUM (delirious), LIMB DISCOMFORT (I lost the use of my legs. My legs were not, they just could not hold me up I could not get up), FALL (fell) and GAIT DISTURBANCE (I'm a little unsteady) in a 92-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid disorder (Take medication, but nothing, no).    In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced DISORIENTATION (disoriented) (seriousness criterion hospitalization), PYREXIA (high fever) (seriousness criterion hospitalization), SYNCOPE (fainted) (seriousness criteria hospitalization and medically significant) and FALL (fell) (seriousness criterion hospitalization). On an unknown date, the patient experienced DELIRIUM (delirious) (seriousness criteria hospitalization and medically significant), LIMB DISCOMFORT (I lost the use of my legs. My legs were not, they just could not hold me up I could not get up) (seriousness criterion hospitalization) and GAIT DISTURBANCE (I'm a little unsteady) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to DELIRIUM, DISORIENTATION, FALL, GAIT DISTURBANCE, LIMB DISCOMFORT, PYREXIA and SYNCOPE. At the time of the report, DISORIENTATION (disoriented), PYREXIA (high fever), SYNCOPE (fainted), DELIRIUM (delirious), LIMB DISCOMFORT (I lost the use of my legs. My legs were not, they just could not hold me up I could not get up) and GAIT DISTURBANCE (I'm a little unsteady) outcome was unknown and FALL (fell) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use included unspecified thyroid medication.  Patient had no previous vaccine in past 4 weeks.  Patient reported that COVID vaccine has a bad effect on elderly. Patient was disoriented, and this was after a while, patient had taken it and a few hours later, high fever, disoriented, went to the bathroom, fell and just fainted. And patient lost the use of legs. Patient's legs were not, they just could not hold her up. She was on the floor in the bathroom for 5 hours, could not get up. Because she was delirious and did not put her watch on. She was there after 5 hours. She just put a towel down on the floor and put her head down. And then patient had the walker in the bathroom. So, she put the towel around her bottom and pushed the walker forward and dragged herself. And kept this process now for quite a while until she got out of the bathroom, down the hall, into the bedroom. And then when she tried to stand to get onto the bed, patient had reached for her watch that was charging on the night table, put it on. And as she tried to get into bed, fell hard, and watch called 9-1-1. She told HCP, but they did not do anything about it. Patient reported she was fine and was not experiencing any symptoms at the time of reporting. She went to the hospital, underwent million tests. Patient had to go to the hospital because if she cannot stand, she could not feed herself. Could not get to the kitchen, could not function. So, went to the hospital. Reported she seemed to be fine now at the time of reporting. She was old. She was little unsteady, but she was OK. Patient had to lose legs. Reported she feel just fine. Reported once it was passed, it passed. She was OK and was worried.  Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.