Sex: M
Vaccine: COVID19
Symptoms: Paranoia, Psychotic disorder
Clinical narrative: Agitation; Aggression; Delusion; Paranoia; An autoimmune induced condition; Psychosis; Mania; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as an unknown dose, single for COVID-19 immunization. The patient's medical history included bipolar disorder from 2017 and ongoing. The reporter stated that certainly remote family history of bipolar disorder. The patient's concomitant medications included quetiapine fumarate (SEROQUEL) 400mg tablet once at night taken for bipolar disorder from 2019 to May2021. Vaccination facility type was reported as large clinic not military facility. No additional vaccines administered on same date of the Covid-19 vaccine. The physician was not aware if the patient was on any other medications 4 weeks prior to vaccination. The reporter was not aware if the patient had any other adverse events prior vaccination. On an unknown date in Feb2021, the reported stated that, he had a patient of his that had been having varying psychosis. Psychosis was ongoing and persisting. On 01Feb2021, the patient had mania. It was ongoing. He was admitted to the psychiatric hospital for the last 5 or 6 months. We are beginning to suspect it as autoimmune induced condition. There have been other reports of mania, agitation, aggression, delusion and paranoia. He was trying to figure out what to do. He doesn't want to assume it's the vaccine, he knew some autoimmune causes psychotic episodes. The physician stated that he had no idea who that was. He was a college student and he's seeing him. The reporter clarified that patient had only experienced psychosis and mania as the adverse events. Pfizer had reports of people what have gotten covid and had mania. The events psychosis and mania resulted patient to visit emergency room/physician office. He's been in and out of the hospital since roughly February. Hospitalized immediately from emergency room to the psychiatric unit. He saw him in his office. Most recent hospitalization was 35 days. No Relevant test and investigation assessment were reported. The outcome of the events mania, psychosis was not recovered, and the outcome of other events was unknown.  No further details were provided. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events autoimmune disorder, psychosis, mania, paranoia, delusion, agitation, and aggression and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.