Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT / LA |
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | UNK | — | OT / LA |
Kidney failure; Worsening COPD; High blood sugar; Runny nose; This is a spontaneous report received from an Other HCP from License Party. Other Case identifier(s): 2025SA375866 (SANOFI Patient Safety & Pharmacovigilance), AE-022201 (BIONTECH). A 70-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 28Sep2021 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), outcome "not recovered", described as "Worsening COPD"; BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "High blood sugar"; RHINORRHOEA (non-serious), outcome "not recovered", described as "Runny nose". The patient underwent the following laboratory tests and procedures: Blood glucose: High. Clinical information: Information regarding batch number corresponding to the one at time of event occurrence is requested. The event renal failure was considered as medically significant. It was not reported if the patient received a corrective treatment for all the events. Sanofi comment: Sanofi company comment dated 18Dec2025: This case involves a 70-year-old male patient who experienced kidney failure, worsening copd, high blood sugar and consistently runny nose after receiving COVID-19 vaccine and influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. Case was assessed as serious. Company agent causality reported as yes. Batch/lot number is not provided, and it cannot be obtained. BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: As there is limited information in the case provided, the causal association between the event renal failure and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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