Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales representative. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metastatic Prostate Cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; manufacturer unknown), for Covid-19 immunisation. The following information was reported: METASTASIS (life threatening, medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "metastasis of prostate cancer.". Therapeutic measures were taken as a result of metastasis. Clinical course: Dr. reported about a month after he received his 3rd Pfizer Covid vaccine, he had metastasis of prostate cancer. Dr. considered the event resulted in life threatening illness (immediate risk of death from the event). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event metastasis and the suspect drug BNT162B2 OMICRON (KP.2) 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.
Prostate cancer metastatic