Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT / RA |
Parkinson's disease and dementia have worsened; Parkinson's disease and dementia have worsened; Parkinson's disease and dementia have worsened; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 68-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown, 0.3 ml single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease and dementia" (ongoing); "Parkinson's disease and dementia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), PARKINSONISM (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 05Mar2021, outcome "not recovered" and all described as "Parkinson's disease and dementia have worsened". The events "parkinson's disease and dementia have worsened" required physician office visit. Clinical course: Patient caregiver states since receiving covid vaccination, patient's health conditions such as Parkinson's Disease and dementia have worsened and states these health conditions are ongoing at this time. For Result or outcome of adverse events the patient was doctor or other healthcare professional office/clinic visit The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The reported events Dementia, Parkinson's disease, condition aggravated are most likely related to intercurrent/progressive nature of the underlying condition but due to the limited information available the causal association with suspect BNT162b2 can not 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.
Dementia; Parkinson's disease