Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Capsular contracture associated with breast implant, Device breakage, Investigation
Clinical narrative: breast implant on right side was ruptured; swelling in axillary and breast; capsular contracture; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2022 as dose 3 (booster), single (Lot number: FN2908) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: T3/T4 SUPPORT; ASPIRIN (E.C.); VITAMIN C [ASCORBIC ACID]. Past drug history included: Demerol, reaction(s): "Known allergies: demerol", notes: Known allergies: demerol. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FA7484, Location of injection: Arm Right), administration date: 29Jul2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FC3181, Location of injection: Arm Right), administration date: 21Aug2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "swelling in axillary and breast"; Sudafed (Known allergies: sudafed), reaction(s): "Known allergies: sudafed"; Augmenting (Known allergies: augmenting), reaction(s): "Known allergies: augmenting". The following information was reported: DEVICE BREAKAGE (medically significant) with onset 14Aug2022, outcome "not recovered", described as "breast implant on right side was ruptured"; CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (medically significant) with onset 14Aug2022, outcome "not recovered", described as "capsular contracture"; BREAST SWELLING (medically significant) with onset 14Aug2022, outcome "not recovered", described as "swelling in axillary and breast". The events "breast implant on right side was ruptured", "swelling in axillary and breast" and "capsular contracture" required physician office visit. The patient underwent the following laboratory tests and procedures: testing: Unknown results. Therapeutic measures were not taken as a result of device breakage, breast swelling, capsular contracture associated with breast implant.  Clinical course: Reported as, Had significant swelling in axillary and breast. After booster, swelling in breast did not subside. Went to physician, sent for testing - breast implant on right side ( all 3 shots on right arm) was ruptured with capsular contracture. Other medical history - factor 5 (as reported). Unknown if patient experienced COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient did not received other vaccine within four weeks of COVID vaccine.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Device breakage, Breast swelling and Capsular contracture due to temporal relationship.   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.