Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Contusion, Haemoglobin, Interchange of vaccine products, White blood cell count
Clinical narrative: Dose 1 and 2 of Janssen COVID-19 Vaccine and Pfizer Biontech booster; Chronic anemia; white blood cell count from 123000 to 13500; more bruising; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 20211143015(1) (Janssen Research & Development).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for immunisation; ibrutinib (IMBRUVICA), first regimen oral from 09Sep2021 (Lot number: 1146381, Expiration Date: Nov2023) to 2021 at 280 mg 1x/day and second regimen oral since Dec2021 (Batch/Lot number: unknown) at 140 mg (140 mg, 1 in 2 days) for chronic lymphocytic leukaemia. Relevant medical history included: "Lower leg calf cramp" (not ongoing); "B-cell chronic lymphocytic leukaemia" (ongoing); "Whooshing in Ear", start date: Sep2021 (ongoing); "Brain for/ not myself", start date: Sep2021 (ongoing); "Swelling in Bilateral feet and ankles", start date: Sep2021 (ongoing); "Gum bleeding", start date: Sep2021 (ongoing); "Sore throat", start date: Sep2021 (ongoing); "Anxious", start date: Sep2021 (ongoing); "Fatigue", start date: Sep2021 (ongoing); "Diarrhoea", start date: Sep2021 (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAEMIA (medically significant), outcome "unknown", described as "Chronic anemia"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose 1 and 2 of Janssen COVID-19 Vaccine and Pfizer Biontech booster"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "recovering", described as "white blood cell count from 123000 to 13500"; CONTUSION (non-serious), outcome "unknown", described as "more bruising". The patient underwent the following laboratory tests and procedures: haemoglobin: 5.5; white blood cell count: 123000; 13500. The action taken for ibrutinib was unknown.  The reporter considered "chronic anemia", "dose 1 and 2 of janssen covid-19 vaccine and pfizer biontech booster", "white blood cell count from 123000 to 13500" and "more bruising" not related to bnt162b2 and not reported for janssen covid-19 vaccine and ibrutinib.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Interchange of vaccine products, Anaemia, White blood cell count decreased and contusion  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.