Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Immunisation, Investigation, SARS-CoV-2 test, Smear cervix
Clinical narrative: Diagnosis of Inflammatory, triple postive breast on 30Nov2021 precluded by abrupt appearance of large mass and swelling of right breast in Jul2021; Diagnosis of Inflammatory, triple postive breast on 30Nov2021 precluded by abrupt appearance of large mass and swelling of right breast in Jul2021; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel", notes: Known allergies: Nickel. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EL1283, Vaccine location: Left arm, Dose number: 2), administration date: 03Feb2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "appearance of large mass", "Swelling of right breast"; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EL1283, Vaccine location: Left arm, Dose number: 1), administration date: 13Jan2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (disability, medically significant, life threatening) with onset 12Oct2021, outcome "unknown", described as "Dose received 3"; TRIPLE POSITIVE BREAST CANCER (disability, medically significant, life threatening), BREAST INFLAMMATION (disability, life threatening) all with onset 30Nov2021, outcome "not recovered" and all described as "Diagnosis of Inflammatory, triple postive breast on 30Nov2021 precluded by abrupt appearance of large mass and swelling of right breast in Jul2021". The event "diagnosis of inflammatory, triple postive breast on 30nov2021 precluded by abrupt appearance of large mass and swelling of right breast in jul2021" and "diagnosis of inflammatory, triple postive breast on 30nov2021 precluded by abrupt appearance of large mass and swelling of right breast in jul2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (2021) unknown results; sars-cov-2 test: (2021) unknown results; smear cervix: (08Jun2021) positive for hpv, notes: Positive; (20Sep2021) positive for hpv, notes: Positive. Therapeutic measures were taken as a result of triple positive breast cancer, breast inflammation.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relation, the association between the events of Immunisation, Triple positive breast cancer and breast inflammation and the suspect product of BNT162B2 cannot be completely ruled out. 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.