Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Breast operation, Cystitis, Illness, Immunodeficiency, Mastitis
Clinical narrative: Breast infection; a partial areola removal; bladder infection; sick; immune system was down; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4517074-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, Route of Admin: Intramuscular), administration date: 22Feb2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1, Route of Admin: Intramuscular), administration date: 02Feb2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: MASTITIS (hospitalization), outcome "unknown", described as "Breast infection"; BREAST OPERATION (hospitalization), outcome "unknown", described as "a partial areola removal"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immune system was down"; CYSTITIS (hospitalization), outcome "unknown", described as "bladder infection"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient was hospitalized for mastitis, cystitis (start date: Aug2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of an adult female with events of breast infection and bladder infection and non-serious sick and immune system was down hence caught COVID with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced breast infection, bladder infection, sick and immune system was down hence caught COVID. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient had been on HUMIRA for about a year and was sick off on the entire time. In Aug2022, she had to be hospitalized for bladder infection and breast infection. She had a partial areola removal. She tested positive for COVID, five days after her last dosage. Due to her immune system was down, she caught COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of breast infection, bladder infection, sick, immune system was down hence caught COVID unknown onset and immune system was down hence caught COVID unknown onset was not provided. Agency's opinion is that the events of breast infection, bladder infection, sick and immune system was down hence caught COVID. unknown onset are not assessable. Agency's opinion is that there is no reasonable possibility that the event of immune system was down hence caught COVID unknown onset is related to Humira (Adalimumab). Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) of breast infection, bladder infection, sick, immune system was down hence caught COVID, COVID-19 was reasonable possibility (Probable). Relevant Laboratory & Other Diagnostic Tests: Unknown date COVID-19 test: Positive  The reporter considered "breast infection", "immune system was down", "bladder infection" and "sick" related to BNT162b2. The reporter's assessment of the causal relationship of "a partial areola removal" 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.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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.