Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Mobility decreased, Presyncope, Tremor
Clinical narrative: Hallucinated; Kind of blacked out; She had a really bad feeling/Thought she was going die/All of a sudden it hit her; Lots of weakness; Could not move her legs//Could not move from the waist down/Worse part was that she could not move her legs/ It was like she was paralyzed/Didn't get out of bed until noon the next day; Shaking with the chills; Confused; Terrible dream/Woke up with a terrible dream; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced HALLUCINATION (Hallucinated) (seriousness criterion medically significant), PRESYNCOPE (Kind of blacked out), FEELING ABNORMAL (She had a really bad feeling/Thought she was going die/All of a sudden it hit her), ASTHENIA (Lots of weakness), MOBILITY DECREASED (Could not move her legs//Could not move from the waist down/Worse part was that she could not move her legs/ It was like she was paralyzed/Didn't get out of bed until noon the next day), TREMOR (Shaking with the chills), CONFUSIONAL STATE (Confused), ABNORMAL DREAMS (Terrible dream/Woke up with a terrible dream) and CHILLS (Chills). At the time of the report, HALLUCINATION (Hallucinated), PRESYNCOPE (Kind of blacked out), FEELING ABNORMAL (She had a really bad feeling/Thought she was going die/All of a sudden it hit her), ASTHENIA (Lots of weakness), MOBILITY DECREASED (Could not move her legs//Could not move from the waist down/Worse part was that she could not move her legs/ It was like she was paralyzed/Didn't get out of bed until noon the next day), TREMOR (Shaking with the chills), CONFUSIONAL STATE (Confused), ABNORMAL DREAMS (Terrible dream/Woke up with a terrible dream) and CHILLS (Chills) outcome was unknown.            Company Comment - This case concerns a  70-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of hallucination (criteria - medically significant). The event occurred on the evening of the same day she received the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.  Concomitant product information was not provided. Treatment information was not provided. Patient stated that she and her husband did not have any side effect after the 1st dose of the Moderna COVID 19 vaccine. After the 2nd dose, she was fine all day, she went to bed 9:30 pm and woke up at 11 pm.  Patient had events like scared to take the booster dose and she does not know if she passed out. . She received the vaccine on Monday, she was not back to normal until Wednesday. Her doctor has retired but she spoke to her nurse practitioner; the nurse practitioner told her to be very careful and recommended that she should not take the booster.She did not take any medication to alleviate any of her symptoms.; Sender's Comments: This case concerns a  70-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of hallucination (criteria - medically significant). The event occurred on the evening of the same day she received the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.