Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Headache, Menstruation irregular, Pain in extremity, Psychotic disorder
Clinical narrative: Psychosis; Mucous spitting; Cannabas induced psychosis; headache; entire body swollen; entire face swollen; menstrual stopped for 2 months/irregular menstration for 2 months; Pain in arm; rashes on the body; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (Psychosis), SECRETION DISCHARGE (Mucous spitting) and SUBSTANCE-INDUCED PSYCHOTIC DISORDER (Cannabas induced psychosis) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   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 10-May-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual stopped for 2 months/irregular menstration for 2 months), PAIN IN EXTREMITY (Pain in arm) and RASH (rashes on the body). On 04-Jul-2021, the patient experienced PSYCHOTIC DISORDER (Psychosis) (seriousness criterion hospitalization), GENERALISED OEDEMA (entire body swollen) and SWELLING FACE (entire face swollen). In July 2021, the patient experienced SECRETION DISCHARGE (Mucous spitting) (seriousness criterion hospitalization). In August 2021, the patient experienced SUBSTANCE-INDUCED PSYCHOTIC DISORDER (Cannabas induced psychosis) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEADACHE (headache). The patient was hospitalized from 08-Jul-2021 to 16-Jul-2021 due to PSYCHOTIC DISORDER and SECRETION DISCHARGE, and then from 27-Aug-2021 to 03-Sep-2021 due to SUBSTANCE-INDUCED PSYCHOTIC DISORDER. The patient was treated with OLANZAPINE on 16-Jul-2021 for Psychosis, at a dose of 10 milligram once a day and METHYLPHENIDATE HYDROCHLORIDE (RITALIN) on 24-Sep-2021 for Drug-induced psychosis, at an unspecified dose and frequency. At the time of the report, PSYCHOTIC DISORDER (Psychosis) had not resolved, SECRETION DISCHARGE (Mucous spitting), SUBSTANCE-INDUCED PSYCHOTIC DISORDER (Cannabas induced psychosis), GENERALISED OEDEMA (entire body swollen), SWELLING FACE (entire face swollen) and HEADACHE (headache) outcome was unknown and MENSTRUATION IRREGULAR (menstrual stopped for 2 months/irregular menstration for 2 months), PAIN IN EXTREMITY (Pain in arm) and RASH (rashes on the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were given. The patient went outside walking around the neighborhood at 4am thinking someone was visiting her. She took cold shower numerous times thinking she needed to bring the bad things out of her body. She changed characters from one to another all day and nights. any times, she made weird groan sound and spitted out mucus. She was taken to ER and later transferred to hospital psychiatry facility on July 8th where she stayed until July 16th. She was discharged with Olanzapine 10mg / day and her diagnosis was unknown psychosis. The medication ran out before she was scheduled to see an outpatient doctor. Afterwards, she started to hear some voices and was not able to sleep around August 25th. She admitted that she had 2 puffs of weeds with a few friends on Aug 21st. She asked to be taken to the same psychiatry facility on Aug 27th for treatment and medication. She was admitted and stayed there until Sept 3rd. She was discharged with Olanzapine 10gm / day and her diagnosis was Cannabis induced psychosis. This case concerns a 33-year-old female patient with no relevant medical history who experienced serious unexpected events of psychotic disorder and substance-induced psychotic disorder. The events occurred after the first dose of the mRNA-1273 with unknown psychosis occurring 25 days whereas substance induced psychotic disorder occurred approximately 3 months after the first dose. The patient was hospitalized due to the events. Initially, as reported, the patient had strange behaviour, changed personalities, moan sounds and spitted mucus. She was taken to ER then transferred to psychiatric facility. The second time, couple of months later, the patient consumed cannabis with friends and started having auditory hallucinations and asked to be admitted again. The rechallenge was positive since the events reoccurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received included events, batch number updated.; Sender's Comments: This case concerns a 33-year-old female patient with no relevant medical history who experienced serious unexpected events of psychotic disorder and substance-induced psychotic disorder. The events occurred after the first dose of the mRNA-1273 with unknown psychosis occurring 25 days whereas substance induced psychotic disorder occurred approximately 3 months after the first dose. The patient was hospitalized due to the events. Initially, as reported, the patient had strange behaviour, changed personalities, moan sounds and spitted mucus. She was taken to ER then transferred to psychiatric facility. The second time, couple of months later, the patient consumed cannabis with friends and started having auditory hallucinations and asked to be admitted again. The rechallenge was positive since the events reoccurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.