Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gingival bleeding, Haemoglobin, Haemoglobin decreased, Joint swelling, Oropharyngeal pain
Clinical narrative: WHITE BLOOD CELL COUNT FROM 123000 TO 13500; MORE BRUISING; HAEMOGLOBIN LOW; WHOOSHING IN EAR; FATIGUE; DIARRHEA; BRAIN FOG/NOT MYSELF; SWELLING IN BILATERAL FEET AND ANKLES; GUM BLEEDING; SORE THROAT; ANXIOUS; This solicited report received from a consumer via MC-2018-191: SUPPORT PROGRAM concerned a 58 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: lower leg calf cramp, and concurrent conditions included: b-cell chronic lymphocytic leukaemia, and other pre-existing medical conditions included: The patient had no known allergies. The patient was treated with ibrutinib (tablet, oral, batch number: 1146381 expiry: NOV-2023) 420 mg, 1 time every 1 day, from 09-SEP-2021 for b-cell chronic lymphocytic leukaemia. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total was administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced fatigue, sore throat, gum bleeding, anxiety which wakes her up, diarrhea, brain fog, she was not herself, swooshing in ear, and slight swelling in bilateral feet and ankles. On 24-SEP-2021, the patient had performed hemoglobin test which was low (below 6) and the patient was given blood transfusion. On an unspecified date, the patient had performed white blood count which was 123,000 (Unit Unspecified), and when she performed for the second time her white blood count was decreased to 13,500 (Unit Unspecified). The patient reported that she had noticed more bruising (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient recovered from diarrhea, was recovering from white blood cell count decreased, had not recovered from haemoglobin low, whooshing in ear, brain fog/not myself, swelling in bilateral feet and ankles, gum bleeding, fatigue, sore throat, and anxious, and the outcome of more bruising was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and haemoglobin low, and white blood cell count from 123000 to 13500 as possible; and between ibrutinib, and white blood cell count from 123000 to 13500 as possible. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and brain fog/not myself, swelling in bilateral feet and ankles, gum bleeding, sore throat, anxious, more bruising, whooshing in ear, fatigue, and diarrhea; and between ibrutinib, and haemoglobin low, brain fog/not myself, swelling in bilateral feet and ankles, gum bleeding, sore throat, anxious, more bruising, whooshing in ear, fatigue, and diarrhea. Company causality between covid-19 vaccine ad26.cov2.s, and haemoglobin low, white blood cell count from 123000 to 13500, gum bleeding, sore throat, anxious, and more bruising was not related, and between covid-19 vaccine ad26.cov2.s, and brain fog/not myself, swelling in bilateral feet and ankles, whooshing in ear, fatigue, and diarrhea was related; and between ibrutinib, and haemoglobin low, gum bleeding, sore throat, anxious, more bruising, fatigue, and diarrhea was related, and between ibrutinib, and white blood cell count from 123000 to 13500, brain fog/not myself, swelling in bilateral feet and ankles, and whooshing in ear was not related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210950557.; Sender's Comments: V0-20211143015- covid-19 vaccine ad26.cov2.s - haemoglobin low, white blood cell count from 123000 to 13500  . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY 20211143015- Imbruvica - haemoglobin low, white blood cell count from 123000 to 13500 -This event(s) is labeled per RSI and is therefore considered potentially related.