Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Immunodeficiency; Respiratory tract congestion; Vaccination adverse reaction; Pelvic pain; Rib pain; Diarrhea; Anemia; Generalised muscle aches; General body pain; Back pain; MC-2018-191  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-4113219-00.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single and intramuscular, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, 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. The following information was reported: IMMUNODEFICIENCY (medically significant) with onset 2021, outcome "unknown", described as "Immunodeficiency"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "Respiratory tract congestion"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Vaccination adverse reaction"; PELVIC PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pelvic pain"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Rib pain"; DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Diarrhea"; ANAEMIA (non-serious) with onset 2021, outcome "unknown", described as "Anemia"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Generalised muscle aches"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "General body pain"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "Back pain". The patient underwent the following laboratory tests and procedures: blood test: anemia. The action taken for ibrutinib was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021 patient received booster dose manufactured by PFIZER BIONTECH. In 2021, the patient experienced Chest block, reaction to booster shot because of low immunity, pain during sex in pelvis, rib pain, diarrhea, anemia, all over body pain in bones and muscles and back pain. pfizer biontech covid-19 vaccine(TOZINAMERAN) was also considered suspect. Causality for IMBRUVICA (IBRUTINIB): The reporter's causality for the event(s) of 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 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. Causality for Respiratory tract congestion, Immunodeficiency, Vaccination adverse reaction, Pelvic pain, Rib pain, Diarrhea, Anemia, Generalised muscle aches, General body pain and Back pain as per reporter (Drug/Vaccine): Not Reported. The reporter's assessment of the causal relationship of the Respiratory tract congestion, Immunodeficiency, Vaccination adverse reaction, Pelvic pain, Rib pain, Diarrhea, Anemia, Generalised muscle aches, General body pain and Back pain with the suspect product bnt162b2 (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. Change History: On 24Nov2021, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "REACTION TO BOOSTER SHOT BECAUSE OF LOW IMMUNITY", "KNOT ON LEG", "STOMACH PAIN" and "ANEMIA" were added. On 09Dec2021, received updates to study information, event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures, narrative description and medical history. The events of "CHEST BLOCK", "pain during sex in pelvis" and "HEADACHE" were added. The events of "KNOT ON LEG", "STOMACH PAIN" and "PAINFUL INTERCOURSE" were removed. On 16Dec2021, received updates to study information, patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The events of "ALL OVER BODY PAIN IN BONES AND MUSCLES" and "BACK PAIN" were added. The events of "HEADACHE" and "CHEST PAIN" were removed. Other Relevant History: No known allergies.  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 available information in the case, the causal association between the events immunodeficiency, respiratory tract congestion, vaccine complication, pelvic pain, musculoskeletal chest pain, diarrhoea, anemia, myalgia, pain, back pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.