Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a Spontaneous report from a contactable other healthcare professional (HCP). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunisation. Medical history included Bipolar disorder, Depression, Attention deficit hyperactivity disorder (ADHD) and sleep (disorder). Concomitant medication included cariprazine hydrochloride (VRAYLAR) orally from 18Mar2021 to 02Apr2021 at 1.5 mg, daily for Bipolar disorder; escitalopram oxalate (LEXAPRO) at 10 mg for Depression; amfetamine sulfate (EVEKEO) 2 times a day for ADHD; bupropion hydrochloride (WELLBUTRIN) and mirtazapine (REMERON) for sleep (disorder). It was reported patient experienced seizure on 02Apr2021 after using concomitantly Vraylar, Lexapro, Evekeo, Wellbutrin and Remeron, experienced seizure after using concomitantly Lexapro and Wellbutrin. The initial report from the United States was received via Company representative originating from a nurse on 15Apr2021, regarding an 18-year-old female patient who experienced seizure, drug interaction, and labelled drug-drug interacton medication error following the administration of cariprazine hydrochloride, amfetamine sulfate, escitalopram oxalate, mirtazapine, Pfizer Covid-19 and bupropion hydrochloride. Company received the report on 16Apr2021. Reportedly, the patient began cariprazine hydrochloride 1.5mg daily orally for Bipolar disorder on 18Mar2021, had the Covid-19 vaccine on 01Apr2021, and had a seizure on 02Apr2021. The patient had no history of seizures. The reporter did not believe the seizure was caused by the cariprazine hydrochloride (causality for seizure was also reported as unlikely). The patient was taken to the emergency room but not admitted, treatment and outcome unknown other than the emergency room staff advised the patient to "discontinue everything". The reporter assessed the relationship between cariprazine hydrochloride and the event of seizure as unlikely. Laboratory tests were not reported. The patient experienced the seizure one day after Covid 19 vaccine. Considering the short onset  latency, the vaccine was also considered co-suspect. The case in confounded by patient's use of co-suspect medications that could have lowered the seizure threshold. The following important missing medical information will be helpful for further case evaluation: medical history, indications and therapy dates for all suspects, action taken, lab results (drug blood levels), investigations, treatment, outcome. Treatment information was not provided. At the time of the report, the outcome of seizure was reported as unknown. This case was considered serious due to the following seriousness criterion: medically significant.  Information on batch number has been request.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Contributory role of concomitant medications should also be considered. 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 RAs, Ethics Committees, and Investigators, as appropriate.