Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
was not able to walk; losing 20 lbs afterwards as well.; LIVE TELEPHONIC VACCINE GAP ASSESSMENT PROGRAM (LTVGA) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID: . An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (medically significant) with onset 01Oct2023 at 12:00, outcome "not recovered", described as "was not able to walk"; WEIGHT DECREASED (non-serious) with onset Oct2023, outcome "unknown", described as "losing 20 lbs afterwards as well.". The event "was not able to walk" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight: (Oct2023) losing 20 lbs. Therapeutic measures were taken as a result of gait inability. Clinical course: The patient mentioned 3 days after receiving the vaccine he could not walk. It became so severe that he had to go to the doctor where he was given a cortisone shot that did not help. Also stated he had issues with his legs ever since. Mentioned losing 20 lbs afterwards as well. The reporter's assessment of the causal relationship of "was not able to walk" and "losing 20 lbs afterwards as well." with the suspect product(s) BNT162b2 omi xbb.1.5 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. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Considering a implied drug-event temporal relationships, a reasonable possibility that the events gait inability, weight decreased are related to the suspect drug BNT162b2 omi xbb.1.5 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.
Test Date: 202310; Test Name: Weight; Result Unstructured Data: Test Result:losing 20 lbs lbs