Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Delusion of parasitosis, Hallucination, auditory, Hallucination, visual, Hypersensitivity, Mania
Clinical narrative: Auditory hallucinations; visual hallucinations; suicidal ideations; Thought he had a parasite on his brain; Episode of mania/ "A full-blown manic episode"; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, AUDITORY (Auditory hallucinations), HALLUCINATION, VISUAL (visual hallucinations), SUICIDAL IDEATION (suicidal ideations), DELUSION OF PARASITOSIS (Thought he had a parasite on his brain) and MANIA (Episode of mania/ "A full-blown manic episode") in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Stress, Manic episode (Severely depressed - Manic episodes (Bipolar 2)) since 05-Apr-2003, Depression (Severely depressed) and Bipolar disorder since 04-May-2003.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced HALLUCINATION, AUDITORY (Auditory hallucinations) (seriousness criteria hospitalization and medically significant), HALLUCINATION, VISUAL (visual hallucinations) (seriousness criteria hospitalization and medically significant), SUICIDAL IDEATION (suicidal ideations) (seriousness criteria hospitalization and medically significant), DELUSION OF PARASITOSIS (Thought he had a parasite on his brain) (seriousness criteria hospitalization and medically significant), MANIA (Episode of mania/ "A full-blown manic episode") (seriousness criterion hospitalization) and HYPERSENSITIVITY (allergic reaction). The patient was treated with MELATONIN for Sleeplessness, at a dose of 1 dosage form. At the time of the report, HALLUCINATION, AUDITORY (Auditory hallucinations), HALLUCINATION, VISUAL (visual hallucinations), SUICIDAL IDEATION (suicidal ideations), DELUSION OF PARASITOSIS (Thought he had a parasite on his brain), MANIA (Episode of mania/ "A full-blown manic episode") and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            Two weeks after the second vaccine, the patient experienced an episode of mania, which had not happened for a long time. The patient did not know if it was the vaccine or the heat, the lack of sleep and the coffee and stated that  he had been working a lot, doing exercise regularly and was under a lot of stress.  The patient thought he had a parasite on his  brain and had auditory and visual hallucinations, a full-blown manic episode and also reported suicidal ideations. The patient went to three hospitals and ended up hospitalized. First hospital took a urine sample and recommended melatonin to sleep.  The patient reportedly was also going to started treatment with a psychiatrist.   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.  However patient´s medical history of bipolar disease with out medication treatment could be a confounder. Further information has been requested.; 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.  However patient´s medical history of bipolar disease with out medication treatment could be a confounder. Further information has been requested.