Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Body temperature, Body temperature increased, Breast mass, Dermatitis atopic
Clinical narrative: open biopsy surgery; open biopsy surgery,after the surgery; had a mammogram that have an area; horrible flare on skin (inaudible); increased temperature; diarrhea; Fatigue;    This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA474038 (Sanofi).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen from 12Dec2022 (Batch/Lot number: unknown) to 12Dec2022 at loading dose of 600 mg 1x followed by 300mg qow, second regimen from 28Oct2022 (Batch/Lot number: unknown) to 28Oct2022 at loading dose of 600 mg 1x followed by 300mg qow and third regimen from 03Sep2021 (Batch/Lot number: unknown) to 03Sep2021 at loading dose of 600 mg 1x followed by 300mg qow for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; BODY TEMPERATURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "increased temperature"; BIOPSY (medically significant), outcome "unknown", described as "open biopsy surgery"; SURGERY (medically significant), outcome "unknown", described as "open biopsy surgery,after the surgery "; BREAST MASS (non-serious), outcome "not recovered", described as "had a mammogram that have an area"; DERMATITIS ATOPIC (non-serious), outcome "not recovered", described as "horrible flare on skin (inaudible)". The patient underwent the following laboratory tests and procedures: Biopsy: (15Nov2022) Unknown results; Body temperature: (unspecified date) increased temperature; Mammogram: (unspecified date) Unknown results. The action taken for dupilumab was temporarily withdrawn on 03Sep2021. Therapeutic measures were taken as a result of breast mass.  The reporter's assessment of the causal relationship of "open biopsy surgery", "surgery","increased temperature", "diarrhea", "fatigue", "had a mammogram that have an area" and "horrible flare on skin (inaudible)" 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.  Clinical course: This case involves a 72 years old female patient who had increased temperature, diarrhea, fatigue, open biopsy surgery, had a mammogram that have an area and horrible flare on skin (inaudiable) while being treated with Dupilumab (Dupixent) delivered via Dupilumab prefilled pen and Tozinameran (Pfizer Biontech Covid-19 Vaccine). This patients past medical history, medical history, medical treatment (s), vaccination (s) and family history were not provided. In 2022, the patient started taking Pfizer Biontect Covid-19 vaccine (Tozinameran) (dose, form, frequency, strength, lot/batch and expiration date: not provided) for Prophylactic vaccination. On an unknown date patient started Dupilumab (Dupixent) solution for injection initial loading dose of 600 mg 1X followed by 300mg QOW since 03Sep2021, strength: 300mg (with an unknown batch number, route and expiration date) for Atopic dermatitis. On an unknown date in 2022 the patient developed a non-serious events "increased temperature" (body temperature) diarrhea (diarrhea), fatigue (unknown latency) following the first dose intake of Dupilumab and Tozinameran. On 15Nov2022 the patient developed a non-serious event open biopsy surgery (surgery) (unknown latency) following the first dose intake of Dupilumab AB and Tozinameran. Relevant laboratory test result included: Body temperature. On an unknown date [increased temperature]. It was reported patient stated that she had open biopsy surgery 15Nov but doctor did not want her to Dupixent before because it could have caused side effects. Patient will resume today as instructed. No further information was provided. Further reported she had an open breast biopsy on 15Nov202, as an outpatient that was because she had a mammogram that have an area that needed further investigation. When she was going for the prep visit, the nurse practitioner told her to stop taking the Dupixent, the last time she took the dose was yesterday. Prior that she took a dose on 28Oct2022, because the nurse practitioner told her stop taking it until after the breast biopsy. She had the result biopsy until 7 to 10 business days. Because they held the Dupixent, she is experiencing a horrible flare on her skin (inaudible). It is uncomfortable with her wearing the elastic and bra after the surgery and they put her back on Dupixent again yesterday. She is still having flare, she had it two days ago. Action taken: Drug withdrawn for surgery, breast mass: not applicable for dermatitis atopic and unknown for rest of the events . Action taken with Tozinameran (Pfizer Biontech Covid-19 Vaccine) was not applicable. It was not reported if the patient received corrective treatment for the events. At time of reporting, the outcome was unknown for the event increased temperature, was unknown for the event diarrhea, was unknown for the event fatigue, was recovering/resolving for the event open biopsy surgery, was not recovered/not resolved for all the event had a mammogram that have an area and was not recovered/not resolved for the event horrible flare on skin (inaudiable). Additional information was received on 16Nov2022 from patient: New event of surgery added. Text amended accordingly. Additional information was received on 17Nov2022 from patient. Event breast mass, dermatitis atopic were added. Clinical course updated and text amended accordingly.  The reporter's assessment of the causal relationship of "open biopsy surgery", "surgery", "increased temperature", "diarrhea", "fatigue", "had a mammogram that have an area" and "horrible flare on skin (inaudible)" 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.  Reported causality and Company causality: Not reported for all events.  Case serious: No Company Agent causal: No Case listedness: Unlisted Case outcome: Unknown  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 currently available,The casual association between the reported events and suspected drug cannot be completely 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.