Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
left sided neurological issues, including tremors & tingling, weakness; intermittent heart palpitations; left sided neurological issues, including tremors & tingling, weakness; left sided neurological issues, including tremors & tingling, weakness; This is a spontaneous report received from a Physician from a sales representative. A 74-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dsoe 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Nov2024, outcome "not recovered", described as "intermittent heart palpitations"; HEMIPARESIS (medically significant), TREMOR (non-serious), PARAESTHESIA (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "left sided neurological issues, including tremors & tingling, weakness". Therapeutic measures were taken as a result of hemiparesis, palpitations, tremor, paraesthesia. Clinical course: Experiencing intermittent heart palpitations, left sided neurological issues, including tremors & tingling, weakness. Periodic flare-ups of these symptoms. Patient was received Physical therapy as treatment received for the adverse event. Patient was not received any other vaccines on the same date as the vaccine(s) and other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Hemiparesis and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.