Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Immunisation, Immunodeficiency, Limb discomfort, Musculoskeletal chest pain
Clinical narrative: Low immunity; booster; chest block; pain during sex in pelvis; Rib pain; Diarrhea; Anemia; Generalised muscle aches; General body pain; Back pain; stomach pain; knot on leg; MC-2018-191  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): 21K-163-4113219-00 (Agency).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral since 02Jul2021 (ongoing) (Batch/Lot number: unknown) at 420 mg 1x/day for chronic lymphocytic leukaemia. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 01Feb2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNODEFICIENCY (medically significant) with onset 2021, outcome "unknown", described as "Low immunity"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "chest block"; PELVIC PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain during sex in pelvis"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Rib pain"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea"; ANAEMIA (non-serious) with onset 2021, outcome "unknown", described as "Anemia"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Generalised muscle aches"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "General body pain"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "Back pain"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "knot on leg". The patient underwent the following laboratory tests and procedures: blood test: anemia. The action taken for ibrutinib was dosage not changed.  Clinical course: The reporter's causality for the event(s) CHEST BLOCK, REACTION TO BOOSTER SHOT BECAUSE OF LOW IMMUNITY onset in 2021, REACTION TO BOOSTER SHOT BECAUSE OF LOW IMMUNITY onset in 2021, PAIN DURING SEX IN PELVIS, RIB PAIN, ANEMIA and BACK PAIN with IMBRUVICA(IBRUTINIB) was not provided. The reporter's causality for the event(s) of DIARRHEA, ALL OVER BODY PAIN IN BONES AND MUSCLES onset in 2021 and ALL OVER BODY PAIN IN BONES AND MUSCLES onset in 2021 with IMBRUVICA(IBRUTINIB) was a reasonable possibility. NO KNOWN ALLERGIES. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's assessment of the causal relationship of the events with the suspect product 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 available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Immunodeficiency, Immunisation, Chest discomfort, Pelvic pain, Musculoskeletal pain, Diarrhoea, Anaemia, Myalgia, Pain, Back pain, Abdominal pain, Limb discomfort. 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.