Received Jan 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Had breast cancer; she got COVID 3 times; it did not work because she got COVID 3 times; bruising on her legs; This is a spontaneous report received from a Nurse. A 66-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 immunization, reaction(s): "Covid-19", "Drug ineffective"; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DODOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization, reaction(s): "Drug ineffective". The following information was reported: BREAST CANCER (medically significant), outcome "not recovered", described as "Had breast cancer"; COVID-19 (medically significant), outcome "unknown", described as "she got COVID 3 times"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "it did not work because she got COVID 3 times"; CONTUSION (non-serious), outcome "not recovered", described as "bruising on her legs". It was unknown if therapeutic measures were taken as a result of breast cancer, covid-19, drug ineffective, contusion. Additional information: Nurse reported that, patient described receiving COVID Vaccine 3 times and will never again do it as she was healthy before receiving vaccines and it did not work because she got COVID 3 times, had breast cancer and also bruising on her legs (that has not recovered) and she can never even wear skirts again due to this bruising. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the available information, the event breast cancer is most likely related to an intercurrent or underlying condition and is not related to the suspect drug BNT162b2 omicron (lp.8.1), there is no compelling evidence to implicate suspect drug with the event. The effect of a vaccine varies from person to person and is influenced by several factors, however, causal association cannot be excluded between the reported events of drug ineffective, COVID-19 and suspect BNT162b2 omicron (lp.8.1) use. 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.