Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT / LA |
kidney failure; worsening COPD; worsening COPD; consistently runny nose; high blood sugar; This is a spontaneous report received from an Other HCP, Program ID. A 78-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2020 as dose number unknown, single intramuscular, in left arm for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RENAL FAILURE (medically significant), outcome "not recovered", described as "kidney failure"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "worsening COPD"; RHINORRHOEA (non-serious), outcome "not recovered", described as "consistently runny nose"; BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "high blood sugar". The events "kidney failure", "worsening copd", "consistently runny nose" and "high blood sugar" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose: high. Clinical Course: Patient states he has had worsening health conditions since first covid vaccination in 2020 (this particular date unavailable) such as consistently runny nose, worsening COPD and kidney failure, and high blood sugar. He state these issues are ongoing. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the limited information and lack of an alternative etiology, the association between the event "kidney failure" with BNT162b2 can not be fully 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.
Medical History/Concurrent Conditions: COPD
Test Name: blood sugar; Result Unstructured Data: Test Result:high