Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
acute pancreatitis; kidney issues; weight loss of approximately 15 pounds; TARGETED IMMUNIZATION ENGAGEMENT This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2024 at 14:25 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious) with onset Sep2024, outcome "not recovered", described as "weight loss of approximately 15 pounds"; PANCREATITIS ACUTE (medically significant) with onset 23Sep2024, outcome "not recovered", described as "acute pancreatitis"; RENAL DISORDER (medically significant) with onset 23Sep2024, outcome "not recovered", described as "kidney issues". The events "acute pancreatitis", "kidney issues" and "weight loss of approximately 15 pounds" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight: (Sep2024) Decreased, notes: weight loss of approximately 15 pounds. Clinical course: Patient reported acute pancreatitis as well as kidney issues along with weight loss of approximately 15 pounds following vaccination on 23Sep2024. Stated she had not fully recovered and is still dealing with repurcussions at this time. Doctor or other healthcare professional office/clinic visit: Checked. The reporter's assessment of the causal relationship of "acute pancreatitis", "kidney issues" and "weight loss of approximately 15 pounds" 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: The events WEIGHT DECREASED, PANCREATITIS ACUTE, RENAL DISORDER are assessed as related to the suspect drug based temporal association. 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: 202409; Test Name: Weight; Result Unstructured Data: Test Result:Decreased; Comments: weight loss of approximately 15 pounds