Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Heavy menstrual bleeding, Inflammation, Weight, Weight increased
Clinical narrative: Gained little weight; Heavy menstrual bleeding; Inflammation; Breast cancer; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486788-00.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years and on 12Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160839) at unk, citrate free, subcutaneous for rheumatoid arthritis, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant) with onset Oct2021, outcome "unknown"; WEIGHT INCREASED (non-serious), outcome "recovering", described as "Gained little weight"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown"; INFLAMMATION (non-serious), outcome "recovering". The patient underwent the following laboratory tests and procedures: Weight: went from 215 to 170. The action taken for adalimumab was unknown.  The reporter considered "breast cancer" related to BNT162b2. The reporter's assessment of the causal relationship of "gained little weight", "heavy menstrual bleeding" and "inflammation" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of BREAST CANCER was not provided. The reporter's causality for the event(s) of gained little weight, heavy menstrual bleeding and inflammation with HUMIRA(ADALIMUMAB) was no reasonable possibility. (withheld) opinion is that the events of breast cancer and heavy menstrual bleeding are not assessable. (withheld) opinion is that there is no reasonable possibility that the events of gained little weight and inflammation are related to HUMIRA(ADALIMUMAB). Causality as per reporter and Causality as per Mfr for events with Humaira was not reported. Causality for breast cancer as per reporter was possible, for weight gain, Bleeding menstrual heavy, Inflammation as not reported.  Clinical information: It was reported that events with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced gained little weight, heavy menstrual bleeding and inflammation. In Oct2021, the patient experienced breast cancer. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. There was no reported medical history. The patient was gaining a little weight and went from 215 to 170. She had a breast cancer scare in Oct2021, it was benign and runs in the family and she thought it might had come from the COVID shot. She had some inflammation which under control. The Humira worked well with the right diet, and she was having heavy menstrual bleeding. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of breast cancer, weight increased, heavy menstrual bleeding and inflammation and the suspect product 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.