Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Head injury, Pallor, Physical assault, Psychotic disorder
Clinical narrative: picking up a piece of glass and cutting his face with it.; hit her head on the garage door; had a very blank look on her face; hallucination/ heard someone talking/ heard dogs barking/growling; psychotic episodes/physical attack/ not making sense and not staying on topic; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination/ heard someone talking/ heard dogs barking/growling) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002f21a, 008b21a and 047b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Yeast infection on 20-Oct-2021 and Vaginosis bacterial on 20-Oct-2021. Concomitant products included DROSPIRENONE from 20-Oct-2021 to an unknown date for Birth control.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced HALLUCINATION (hallucination/ heard someone talking/ heard dogs barking/growling) (seriousness criterion medically significant) and PSYCHOTIC DISORDER (psychotic episodes/physical attack/ not making sense and not staying on topic). On 12-Nov-2021, the patient experienced PALLOR (had a very blank look on her face). On 13-Nov-2021, the patient experienced HEAD INJURY (hit her head on the garage door). On 15-Nov-2021, the patient experienced PHYSICAL ASSAULT (picking up a piece of glass and cutting his face with it.). On 13-Nov-2021, HEAD INJURY (hit her head on the garage door) had resolved. At the time of the report, HALLUCINATION (hallucination/ heard someone talking/ heard dogs barking/growling) had not resolved and PSYCHOTIC DISORDER (psychotic episodes/physical attack/ not making sense and not staying on topic), PHYSICAL ASSAULT (picking up a piece of glass and cutting his face with it.) and PALLOR (had a very blank look on her face) outcome was unknown.            Treatment Birth control pill was reported. It was reported that patient started having psychotic episodes, she was incarcerated for breaking into another house and almost killing someone. Patient was in jail. Tried to kill reporter and tried to kill somebody else. Consent to follow up by safety was provided. On 11-Nov-2021 Patient accused reporter of having a man in the car listening to what she was telling me.  There was no man in the car but she was convinced she heard someone talking. On the same day she said she heard dogs barking/growling. On 13-Nov-2021 patient left the house, hit her head on the garage door as it was going up and it did not even phase her. She grabbed her head and kept walking. On 14-Nov-2021 Patient said she had a CBD pen. Jas got her laptop (I never saw the pen) and went in the house.  She went to bed. On 15-Nov-2021 patient took truck, which she never drives, and ran it into a random house's privacy gate, got out, walked in the house and started telling the owners that she loved their house and then assaulted the owner with a coffee cup. Hitting him on the head with it then picking up a piece of glass and cutting his face with it.  Company Comment: This case concerns a 20-year-old female patient, with no relevant medical history reported, who experienced serious unexpected event of hallucination after third dose of mRNA-1273. The event occurred the same day after the third dose. The re-challenge is not applicable since further dose is not expected and event outcome was unknown. Patient´s substance use (CBD pen) remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow-up information included patient height and weight updated, dosage detail, vaccine facility information, medical history, concomitant medications and event added. Case upgraded to serious.; Sender's Comments: This case concerns a 20-year-old female patient, with no relevant medical history reported, who experienced serious unexpected event of hallucination after third dose of mRNA-1273. The event occurred the same day after the third dose. The re-challenge is not applicable since further dose is not expected and event outcome was unknown. Patient´s substance use (CBD pen) remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.