Reporte zur Charge FN0196

Symptomtext

involuntary vocal and motor tics; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 2, single (Lot number: FW0196) at the age of 35 years, in left arm for covid-19 immunisation. The patient's family history included: "family history of cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer , Prev dose brand unknown=False , Prev dose lot number=FF2587 , Prev dose lot unknown=False , Prev dose administration date= 30Aug2021, Prev dose administration time=01:00 PM, Prev dose dose number=1 , Prev dose vaccine location=Left arm), administration date: 30Aug2021, when the patient was 34-year-old, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: TIC (hospitalization) with onset 30Sep2021, outcome "not recovered", described as "involuntary vocal and motor tics". The patient was hospitalized for tic (hospitalization duration: 1 day(s)). The events "involuntary vocal and motor tics" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tic. Clinical course: Almost immediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light. Adverse event start date: 30Sep2021. AE resulted in hospitalization: 1. treatment ae was Yes. Ae treatment was resperidone, guanfacine. Adverse event stop date: 09Sep2022. covid was tested post vaccination.