Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Listless, Magnetic resonance imaging, Parkinson's disease, Somnolence, Visual impairment
Clinical narrative: Autoimmune disorder; Parkinson's disease aggravated; He had been listless and tired, but it was also being more hot here; Low blood pressure; Fall/The patient collapsed; Fine motor skill dysfunction; Vision decreased; Sickness; Blood pressure high; Sleepiness; Tiredness; Listless; Device alarm issue; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4480033-00.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation; carbidopa, levodopa (DUOPA), since 08Feb2022 (ongoing) (Lot number: 1161423), cutaneous for parkinson's disease. The patient's relevant medical history included: "Sore arm", start date: 27Jan2021 (unspecified if ongoing); "Alcohol use/occasional beer" (unspecified if ongoing); "Beestings allergy" (unspecified if ongoing), notes: Beestings allergy; "No tobacco user" (unspecified if ongoing), notes: No tobacco user. Concomitant medication(s) included: CARBIDOPA LEVODOPA taken for product used for unknown indication; VITAMIN D NOS taken for product used for unknown indication; MYRBETRIQ taken for product used for unknown indication; ELIQUIS taken for product used for unknown indication; ARICEPT taken for product used for unknown indication; TIKOSYN taken for product used for unknown indication; RITALIN taken for product used for unknown indication; MIRTAZAPINE taken for product used for unknown indication; MELATONIN taken for product used for unknown indication; PROCAINAMIDE taken for product used for unknown indication. Past drug history included: Procainamide allergy, reaction(s): "Known allergies: Procainamide allergy". The following information was reported: SOMNOLENCE (hospitalization, medically significant) with onset Feb2022, outcome "not recovered", described as "Sleepiness"; FALL (hospitalization, medically significant) with onset 08Mar2022, outcome "recovered" (2022), described as "Fall/The patient collapsed"; HYPOTENSION (hospitalization, medically significant) with onset 08Mar2022, outcome "recovered" (2022), described as "Low blood pressure"; HYPERTENSION (hospitalization, medically significant) with onset Mar2022, outcome "recovered" (2022), described as "Blood pressure high"; FINE MOTOR SKILL DYSFUNCTION (hospitalization, medically significant) with onset Mar2022, outcome "recovered"; ILLNESS (hospitalization, medically significant) with onset Mar2022, outcome "recovered" (2022), described as "Sickness"; VISUAL IMPAIRMENT (hospitalization, medically significant) with onset Mar2022, outcome "not recovered", described as "Vision decreased"; DEVICE ALARM ISSUE (non-serious) with onset 2022, outcome "unknown"; LISTLESS (hospitalization, medically significant) with onset 2022, outcome "unknown"; FATIGUE (hospitalization, medically significant) with onset 2022, outcome "not recovered", described as "Tiredness"; AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "unknown"; PARKINSON'S DISEASE (hospitalization, medically significant), outcome "unknown", described as "Parkinson's disease aggravated"; FEELING HOT (non-serious), outcome "unknown", described as "He had been listless and tired, but it was also being more hot here". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; (unspecified date) Low, notes: 77/50; Magnetic resonance imaging: (Mar2022) Negative for stroke. The action taken for carbidopa, levodopa was dosage not changed.  The reporter's assessment of the causal relationship of "vision decreased", "sickness", "low blood pressure", "fall/the patient collapsed", "fine motor skill dysfunction", "listless", "autoimmune disorder", "tiredness", "blood pressure high", "sleepiness", "parkinson's disease aggravated", "device alarm issue" and "he had been listless and tired, but it was also being more hot here" with the suspect product(s) BNT162b2 provided as Not Related and for the event "autoimmune disorder" reported as Not Reported.  Clinical course: On unknown dates, the patient experienced possible autoimmune disease and progression of parkinson's disease. In 2022, the patient experienced listless, pump alarm/pump beeped and could not get it to stop/beeping had become daily/beeping occured more frequently than it had been/beeping occurs with patient movement/change of position and tired. In Feb2022, the patient experienced falls asleep constantly. In Mar2022, the patient experienced worsened vision, sick dur to due to medications, worsened motor skills due to hospitalization and high blood pressure. On 08Mar2022, the patient experienced low blood pressure and patient collapsed. In 2022, the sick dur to due to medications, low blood pressure, patient collapsed and high blood pressure resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had received this new pump approximately in May2022 and they had problems with the beeping since they received it. The beeping was occurring more frequently than it had been. He had changed the batteries, the tubing was not kinked and it had been flushing appropriately. The beeping occurred with patient's movement and change of position. He had been listless and tired, but it was also being more hot here. It not sure if he was getting the adequate dose or if it was the heat. It was going off this boxing class and he would have to tap it or move it around when the beeping started and it would stop for about five minutes. He hospitalized from 10Mar to 14Mar2022 due to the medications were not balanced. He had been given intravenous fluids in the hospital. He had received two rounds of physical therapy after his hospitalization from Apr to Jun2022. Nurse case manager offered to warm transfer the alternate contact to accredo specialty pharmacy nurse line and alternate contact asked if she could call them after their event later on 21Jul2022. The pump had been stopped because the sound was too annoying. Alternate Contact stated they have not sent the previous pump back to the Specialty Pharmacy and Alternate Contact was going to possibly try and use that if she could not get this pump to stop beeping. Standard lab test had been taken but result was unknown. One of the lab test had indicated towards a possible autoimmune disease. His physician was aware and showed no concern in regards to the result. He had seen the Ophthalmologist for his worsened vision and they did not know why his vision had worsened. The suspected it may be due to his parkinson's disease. Patient's relative alternative etiology for Worsened motor Skills was hospitalization and sick was due to his medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect  BT162B2 cannot be excluded for reported events. Case will be further reviewed on receipt of FU information.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