Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Dysstasia, Hallucination, Inappropriate schedule of product administration
Clinical narrative: psychosis episode; tested COVID-19 positive; anxiety; extended dosing interval between 1st and 2nd dose; hallucination; not able to get up; constantly in sleep; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychosis episode)  HALLUCINATION (hallucination), DYSSTASIA (not able to get up) and SOMNOLENCE (constantly in sleep) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 098C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PSYCHOTIC DISORDER (psychosis episode) (seriousness criterion hospitalization). On 15-Nov-2021, the patient experienced HALLUCINATION (hallucination) (seriousness criterion medically significant and hospitalization), DYSSTASIA (not able to get up) (seriousness criterion hospitalization) and SOMNOLENCE (constantly in sleep) (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 (tested COVID-19 positive), ANXIETY (anxiety) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended dosing interval between 1st and 2nd dose). The patient was treated with OLANZAPINE (ZYPREXA) for Psychosis, at an unspecified dose and frequency. At the time of the report, PSYCHOTIC DISORDER (psychosis episode), HALLUCINATION (hallucination), DYSSTASIA (not able to get up), SOMNOLENCE (constantly in sleep), COVID-19 (tested COVID-19 positive), ANXIETY (anxiety) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended dosing interval between 1st and 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that after 2nd dose, the patient  had a psychosis episode after 1 week, on 8-Nov-2021. On 15-Nov-2021, she was not getting up, constantly in sleep and had hallucination, they called 9-1-1 and sent her to ER and was admitted, not able to get up for 5 days and took her total 10 days to stay in the medical facility. She was then tested COVID-19 positive .She was cared in mental hospital section and given some psychosis medication, Olanzapine (Zyprex). She was on psychosis medication now. She had anxiety but no treatment was given. Consent provided for safety team to follow up with herself and HCP.  Company Comment - This case concerns a 33 year old female patient with no relevant medical history, who experienced the serious unexpected events of psychotic disorder, hallucination, not able to get up and constantly in sleep.  The event psychotic disorder occurred 9 days after the second dose of mRNA-1273 vaccine, the events hallucinations, not able to get up and constantly in sleep occurred 16 days after second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416302, MOD-2021-416537 (Patient Link).; Sender's Comments: This case concerns a 33 year old female patient with no relevant medical history, who experienced the serious unexpected events of psychotic disorder, hallucination ,not able to get up and constantly in sleep. The event psychotic disorder occurred 9 days after the second dose of mRNA-1273 vaccine, the events hallucinations, not able to get up and constantly in sleep occurred 16 days after second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.