Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgraphia, Dyskinesia, Dysphemia, Head titubation, Headache
Clinical narrative: Type 2 diabetes; stuttering when he speaks; tremors head/ head bobbing; tremors hand; Worsening dyskinesia; Can't write very well; Twinge in his pinky finger; Bad headache, worsened; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer (manufacturer control number: 2021ADA01324).   A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at age of 68 years old; amantadine hydrochloride (GOCOVRI), from 10Apr20219 to 2021, at 137 mg, 1x/day, then from 2021 to 2021, at 137 mg, 1x/day, then from May2021 to 2021, at 68.5 mg, 1x/day, then from 2021 to Oct2021, at 68.5 mg, 1x/day, then from Oct2021 and ongoing, at 137 mg, 1x/day; all orally for dyskinesia; metformin (manufacturer unknown), via an unspecified route of administration from Sep2021 to Sep2021, at unspecified dose for type 2 diabetes mellitus. Medical history included stent placement from 2005, dyskinesia, parkinson's disease (started around 2007 or 2008, in 2010 diagnosed with parkinson's), dystonia, essential hypertension, hyperlipidaemia, myocardial ischaemia, tremor, nephrolithiasis, lithotripsy, chronic kidney disease, arterial occlusive disease, osteoarthritis, type 2 diabetes mellitus, headache almost every day, drug dependence. Concomitant medications included rasagiline mesylate (AZILECT); botulinum toxin type a (BOTOX); carvedilol (COREG); fenofibrate (FENOFIBRATE); macrogol 3350 (MIRALAX); oxycodone hydrochloride, paracetamol (PERCOCET); clopidogrel bisulfate (PLAVIX); ciclosporin (RESTASIS); quetiapine fumarate (SEROQUEL); carbidopa monohydrate, entacapone, levodopa (STALEVO); testosterone cipionate (TESTOSTERONE CYPIONATE); alprazolam (XANAX SR); zolpidem (ZOLPIDEM); alirocumab (PRALUENT). The patient experienced type 2 diabetes, stuttering when he speaks, tremors head/ head bobbing, tremors hand, worsening dyskinesia, can't write very well, twinge in his pinky finger, bad headache, worsened in 2021. The action taken in response to the events for amantadine hydrochloride was unknown, for metformin was unknown. The outcome was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events T2DM, Dysphemia, Head titubation, Tremor, Dyskinesia, Dysgraphia, Muscle twitching and Headache and BNT162B2.  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.