Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mastication disorder, Medical device site erosion, On and off phenomenon, Seizure, Stoma site discharge
Clinical narrative: Stoma site discharge; Bradykinesia; Disease progression; Unpredictable off motor fluctuations; Medical device site erosion; Wound discharge increased; Fall; Chewing difficulty; Tooth resorption; seizes; Brain freeze; Drooling; This is a solicited report from a marketing program (FACILITATED COLLECT) based on information received by Pfizer from regulatory authority (manufacturer control number: 20K-163-3623629-00).   A contactable consumer (patient) and a nurse reported that an 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular at age of 82 years on Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; carbidopa, levodopa (DUOPA), via Percutaneous J-tube, from 20Aug2020 (Batch/Lot number was not reported) to an unspecified date, at 100 mg then from an unspecified date (Batch/Lot number was not reported) and ongoing, at 100 mg for an unspecified indication. The patient medical history included started having the stent placements in 2018, issue was the same and had not worsened; decreased output and kidney function, kidney structure and inflammation, non-smoker, abstains from alcohol, no known drug allergies. Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication from an unspecified start date and ongoing; escitalopram (ESCITALOPRAM) taken for an unspecified indication from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; carbidopa monohydrate, levodopa (SINEMET) taken for an unspecified indication from an unspecified start date and ongoing; donepezil (DONEPEZIL) taken for an unspecified indication from an unspecified start date and ongoing; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION AREDS) taken for an unspecified indication from an unspecified start date and ongoing; ubidecarenone (CO-ENZYME Q10) taken for an unspecified indication from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication from an unspecified start date and ongoing; calcium phosphate dibasic, phytomenadione (VITAMIN K [CALCIUM PHOSPHATE DIBASIC;PHYTOMENADIONE]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d2 (VITAMIN D2) taken for an unspecified indication from an unspecified start date and ongoing; acetyl-l-carnitine arginate dihydrochloride, acetylcarnitine hydrochloride (ACETYL L CARNITINE ARGINATE) taken for an unspecified indication from an unspecified start date and ongoing; pimavanserin tartrate (NUPLAZID) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at age of 82 years on May2021 for covid-19 immunisation. The patient experienced seizes on Jun2021, tooth resorption on 28Oct2021, stoma site discharge, brain freeze on Jun2021, fall, chewing difficulty, drooling on 2021, bradykinesia, disease progression, unpredictable off motor fluctuations, medical device site erosion, wound discharge increased. Clinical course: Solicited report from the USA by a consumer with events of stent placement between  kidney and bladder, stent placed, stent replacement on right kidney, stent replacement on kidney, internal  reabsorption surgery, seizes and root canal and non-serious oozing stoma/little raw around the tube, brain  freeze, fall from walking, stop from chewing food, drooling, response time slower, there was progression of  illness, off sometimes and new tube and little raw around the area where tube was in/kept on eye it because it  was oozes with duopa (levodopa/carbidopa). Information was also received from a healthcare professional. The patient had a relevant medical history of decreased output and kidney function and kidney structure and inflammation. On unknown dates, the patient experienced stent replacement on kidney, oozing stoma/little raw around the tube, fall from walking, stop from chewing food, drooling, response time slower, there was progression of illness, off sometimes and new tube and little raw around the area where tube was in/kept on eye it because it was oozes. on 30Sep2020, the patient experienced stent placement between kidney and bladder. In Jun2021, the patient experienced seizes and brain freeze. on 30Jun2021, the patient experienced stent replacement on right kidney. On 01Jul2021, the patient experienced stent placed. On 18Oct2021, the patient experienced root canal. On 28Oct2021, the patient experienced internal reabsorption surgery. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 30Jun2021, she had a stent replacement on her Right kidney as an outpatient procedure. She needed replacement stent of her kidney in every six to eight months. In about 2019 or 2020 she started the DUOPA medication. Her Morning Dose was decreased from 10ml to 7ml. She had outpatient but no overnight admission to hospital. New tube was placed and was a little raw around the area where the tube was in. RN was keeping an eye on it because it was oozing. A Stent was put in by her kidney recently in 2021 (replaced ever five to six months). Her response time was slower and she understood there was progression of illness, but this seemed different to her since she got the Covid vaccine. She was concerned about the effect it might have had on her (states off sometimes). Her PEG-J tube was replaced in Jul2021, physician wanted to replace because it was in a year. She had brain freeze where she could be walking and just fall or chewing food and just stop. She could  not be left alone. She started drooling (2021) when brain freeze. No additional details provided. Registered nurse reported patient with root canal on 18Oct2021, internal reabsorption surgery on 28Oct2021, brain freezes and seizes after covid-19 vaccination in Jun2021. Patient was not enrolled in a COVID-19 Vaccine Trial.  Information received on 20Oct2021. It was determined that this case was considered a duplicate of AER 21K-#. AER 21K-# would be logically invalidated. Causality for Duopa(Levodopa/Carbidopa): The reporters causality for the event(s) of stent placement between kidney and bladder, stent placed, stent  replacement on right kidney, stent replacement on kidney, internal reabsorption surgery, seizes, oozing  stoma/little raw around the tube, brain freeze, fall from walking, stop from chewing food, drooling, response  time slower, there was progression of illness, off sometimes, new tube and little raw around the area where  tube was in/kept on eye it because it was oozes unknown onset, new tube and little raw around the area where  tube was in/kept on eye it because it was oozes unknown onset and root canal was not provided. AbbVies opinion is that there is no reasonable possibility that the events of stent placement between kidney  and bladder, stent placed, stent replacement on right kidney, stent replacement on kidney, internal reabsorption surgery, seizes, oozing stoma/little raw around the tube, brain freeze, fall from walking, stop  from chewing food, drooling, response time slower, there was progression of illness, off sometimes, new tube and little raw around the area where tube was in/kept on eye it because it was oozes unknown onset, new tube  and little raw around the area where tube was in/kept on eye it because it was oozes unknown onset and root canal are related to Duopa(Levodopa/Carbidopa). The action taken in response to the events for carbidopa, levodopa was unknown. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based 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 the information in the case report and a plausible temporal relationship,  a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.   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.