Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Insomnia, Logorrhoea, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: Sleeping maybe for 30 minutes; Incomplete course of vaccination; He was very quiet and he just sat there and stared and he was that way the whole day; Talking to and seeing people who were not there, talking to dead people; Chemical imbalance of the brain; Talked all day and all night; Son was getting violent; He dropped the spoon as if he did not know what to do with it, he did not know what to do in the shower either; Illusions; Delusions; Patient couldn't bath and feed himself; Headache; Stomach was hurting; Nightmares; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HALLUCINATION (Talking to and seeing people who were not there, talking to dead people) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fragile X syndrome (was diagnosed with Fragile X when he was a child). Concomitant products included BUSPIRONE, AMLODIPINE and BENAZEPRIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was hurting), NIGHTMARE (Nightmares) and HEADACHE (Headache). On 21-Mar-2021, the patient experienced MEMORY IMPAIRMENT (He dropped the spoon as if he did not know what to do with it, he did not know what to do in the shower either), ILLUSION (Illusions), DELUSION (Delusions) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient couldn't bath and feed himself). On an unknown date, the patient experienced HALLUCINATION (Talking to and seeing people who were not there, talking to dead people) (seriousness criterion medically significant), CEREBRAL DISORDER (Chemical imbalance of the brain), LOGORRHOEA (Talked all day and all night), AGGRESSION (Son was getting violent), APATHY (He was very quiet and he just sat there and stared and he was that way the whole day), INSOMNIA (Sleeping maybe for 30 minutes) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination). The patient was treated with LORAZEPAM ongoing since an unknown date at a dose of 0.5 mg; OLANZAPINE (ZYPREXA) ongoing since an unknown date at a dose of 5 mg and QUETIAPINE FUMARATE ongoing since an unknown date at a dose of 50 mg. At the time of the report, HALLUCINATION (Talking to and seeing people who were not there, talking to dead people), CEREBRAL DISORDER (Chemical imbalance of the brain), LOGORRHOEA (Talked all day and all night), ABDOMINAL PAIN UPPER (Stomach was hurting), NIGHTMARE (Nightmares), AGGRESSION (Son was getting violent), MEMORY IMPAIRMENT (He dropped the spoon as if he did not know what to do with it, he did not know what to do in the shower either), ILLUSION (Illusions), DELUSION (Delusions), APATHY (He was very quiet and he just sat there and stared and he was that way the whole day), INSOMNIA (Sleeping maybe for 30 minutes), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient couldn't bath and feed himself) and HEADACHE (Headache) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood count: low (Low) Low. In March 2021, Computerised tomogram: abnormal (abnormal) a chemical imbalance of the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that  the patient talked day and night (sleeping maybe for 30 minutes)  for 3 weeks, symptoms are not as bad as they were in the beginning and they come and to a Psychiatrist and his blood work showed low blood count. Patient is under Psych care now, and was prescribed Quetiapine Fumarate, Zyprexa, and Lorazepam. Patient was diagnosed with Fragile X when he was a child, but he is high function individual. Psychiatrist advised patient not to get the second vaccine dose.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: New events and medical history added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.