Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer recurrent, Computerised tomogram, Positron emission tomogram, Pulmonary mass
Clinical narrative: Ductal carcinoma/ Booster shot may have jump started cancer; Three little specks and one nodule in the lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 breast cancer" (unspecified if ongoing); "Bilateral mastectomy" (not ongoing), notes: 25 years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Ductal carcinoma/ Booster shot may have jump started cancer", "Three little specks and one nodule in the lung". The following information was reported: BREAST CANCER RECURRENT (medically significant), outcome "unknown", described as "Ductal carcinoma/ Booster shot may have jump started cancer"; PULMONARY MASS (non-serious), outcome "unknown", described as "Three little specks and one nodule in the lung". The events "ductal carcinoma/ booster shot may have jump started cancer" and "three little specks and one nodule in the lung" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) ductal carcinoma; Computerised tomogram: (unspecified date) did not show anything, notes: did not show anything; Positron emission tomogram: (unspecified date) showed up as cancer, notes: showed up as cancer; (02Nov2022) three little specks and one nodule in the lung; Ultrasound scan: (unspecified date) soft tissue swelling. Therapeutic measures were taken as a result of breast cancer recurrent. Clinical Course: The Patient called in and stated that she has stage 4 breast cancer and received the Covid booster shots before and wanted to know if it interfered with her taking Ibrance, patient stated she asked her provider but no one knows. The patient had her third booster today. Patient talked to her oncologist that told her to get the 3rd booster as she already had 2 boosters. Patient has not noticed any difference at all after getting it. Patient was approved to get an extra month since she was going on vacation. Patient was wondering if the booster jumpstarted this cancer but nobody could say for sure. After the 2nd booster shot patient had swelling under her arm, it was not on the lymph node as it was on the front part of arm, that was soft tissue. Patient did an ultrasound at her local hospital and they said it was just soft tissue swelling. Patient did not go away so a couple of months later she did another ultrasound with the same thing and then did a CAT Scan that did not show anything. Patient stated this was all over a 9 month period. Her doctor sent her to the main hospital 100 miles away where the radiologist said there was definitely something there. Patient stated that then they did a biopsy that came back as ductal carcinoma. She had her do a PET Scan and it showed up as cancer. Patient had 3 little hard bumps in her armpit which was cancer. Patient she also had 3 little specks and 1 nodule in the lungs. After the second booster shot patient had swelling on front part of her arm that was soft tissue which was diagnosed as cancer. Believed that the booster shot may have jump started cancer. After the swelling, they did an ultrasound, CAT scan and biopsy. Patient stated that they showed that she had three little hard bumps in her armpit that was cancer, had three little specks and one nodule in the lung. Clarified that the bumps in her armpit was still there like marbles before and are now like little nubbies not like they were before. Later clarified that this happened after the first booster shot. Mentioned that her doctor stated that the booster shot had nothing to do with the cancer and that the doctor that did the biopsy seemed to think that it could have. Guessed that nobody seemed to know. Had a PET scan on 02Nov2022 and the three little specks and one nodule in the lung showed up on it. Started taking Ibrance 100mg tablet on 01Dec2022. Had no side effects from Ibrance and it was working. Patient got first two boosters at a Pharmacy.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107377 same patient, different product;US-PFIZER INC-202300108891 Same patient and product, different dose and event;