Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Drooling, Dyskinesia, Gait inability, Hypoaesthesia
Clinical narrative: right side of face numb and droop while having the event; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour/right side of face numb and droop while having the event; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.; Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.; changes in body temperature; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), GAIT INABILITY (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), NASOPHARYNGITIS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), TREMOR (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.) and DYSKINESIA (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.) in a 17-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030498) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BODY TEMPERATURE ABNORMAL (changes in body temperature). On 14-Dec-2023, the patient experienced MUSCULAR WEAKNESS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), GAIT INABILITY (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), NASOPHARYNGITIS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), TREMOR (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), DYSKINESIA (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.) and HYPOAESTHESIA (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour/right side of face numb and droop while having the event). On an unknown date, the patient experienced DROOLING (right side of face numb and droop while having the event). At the time of the report, MUSCULAR WEAKNESS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), GAIT INABILITY (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), NASOPHARYNGITIS (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), TREMOR (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), DYSKINESIA (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour.), BODY TEMPERATURE ABNORMAL (changes in body temperature), DROOLING (right side of face numb and droop while having the event) and HYPOAESTHESIA (Leg numbness, weakness unable to walk while having the event, cold chilled, changes in body temperature, tremors abnormal movements and shaking, last about 30-1 hour/right side of face numb and droop while having the event) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient did not lose consciousness but could not control the body movement. Since the reporting date, she has had 8 episodes with the last one on 14-Jan-2024 making her right side of face numb and droop while having the event. Her gait walk after episodes is abnormal and it takes several hours to walk normal. After each event she recovers to her normal self but then a couple days pass and she gets another, it is becoming frequent, and doctors had performed test all are normal. Treatment information was not reported.