Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This is a solicited report from contactable consumer (Patient) via a Non-Interventional Study based on information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4117035-00. A 86 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 86 years as dose 3, single for Covid-19 immunisation; ibrutinib (IMBRUVICA), first regimen since Apr2018 (Lot number: 1152477) at 280 mg 1x/day and second regimen (ongoing) (Lot number: 1152477) at 420 mg 1x/day (420 mg (420 mg (420 mg,1 in 1 d)), all oral for chronic lymphocytic leukaemia, chronic lymphocytic leukaemia; iron (IRON), (Batch/Lot number: unknown), oral. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, single, Route of administration: Intramuscular), administration date: 29Jan2021, when the patient was 85-year-old, for COVID-19 Immunization, reaction(s): "three Covid vaccinations and none of them worked"; BNT162b2 (Dose: 2, single, Route of administration: Intramuscular), administration date: 19Feb2021, when the patient was 86-year-old, for COVID-19 Immunization, reaction(s): "three Covid vaccinations and none of them worked". On an unspecified date in 2021, the patient experienced tiredness, iron low, blood in urine and COVID-19 antibody test negative (outcome not recovered), VACCINATION FAILURE (medically significant) with onset 2021, outcome "not recovered"; suspected Covid-19 (medically significant) with onset 2021; PAIN (non-serious), outcome "unknown", IRON DEFICIENCY ANAEMIA (non-serious), outcome "unknown"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Red Blood Cell Count: Low. The patient stated that she received three COVID vaccinations and that none of them worked with Ibrutinib (IMBRUVICA). Action taken for the suspect Ibrutinib (IMBRUVICA) was does not changed. The patient underwent lab test and procedures which included SARS-CoV-2 test: Negative (COVID-19 antibody test negative), iron: low, and blood in urine, all tests on an unspecified date in 2021. The clinical outcome of COVID-19 antibody test negative was not recovered, while outcome for other events was unknown. COVID-19 antibody test negative (SARS-CoV-2 antibody test negative): Not recovered/not resolved. Solicited report by a consumer of an 86 year old female with events of non-serious tired, low iron, blood in urine, patient received three Covid vaccinations and that none of them worked, sore from taking iron pills and anemia with Imbruvica (ibrutinib). There was no reported medical history. On unknown dates, the patient experienced tired, low iron, blood in urine, sore from taking iron pills and anemia. In 2021, the patient experienced patient received three Covid vaccinations and that none of them worked. Pfizer BioNTech COVID-19 VACCINE (TOZINAMERAN) and IRON were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Relevant Laboratory & Other Diagnostic Tests, Unknown date LAB TEST: low iron, Unknown date RED BLOOD CELL COUNT: Low, Change History On 22Dec2021, received updates to suspect drug information and narrative description. On 30Mar2022, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures, narrative description and medical history. The events of 'sore from taking iron pills'' and 'anemia' were added IMBRUVICA (Tablet) (IBRUTINIB), 1152477-, 1152477, Daily dose: 280 mg (280 mg, -2), Route of Admin: Oral, Indication for use: CHRONIC LYMPHOCYTIC LEUKAEMIA, Therapy dates: Apr2018. drug: IMBRUVICA (Tablet) (IBRUTINIB), 1152477-, 1152477 ,Daily dose: 1) 280 mg (280 mg, 1 in 1 D) 2) 420 mg (420 mg, 1 in1 D) Route of Admin: 1) Oral 2) Oral, Therapy dates: 1) Apr2018- Discontinued, 2) Unknown-Ongoing Concomitant drugs and dates of administration (exclude those used to treat event), Concomitant Drugs Not Reported, Other relevant history, No Known allergies, No relevant medical history. The action taken for ibrutinib was dosage increased; for iron was unknown. The reporter causality for suspects BNT162B2 and Imbruvica with events vaccination failure, tiredness, iron low, blood in urine and COVID-19 antibody test negative was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for IMBRUVICA (IBRUTINIB) The reporter's causality for the event(s) of tired, low iron, blood in urine, patient received three Covid vaccinations and that none of them worked, sore from taking iron pills and anemia was not provided. The reporter's causality for the event(s) of FALLING ASLEEP, SLUGGISH, NUMBNESS IN TOES AND FEET and TINGLING IN TOES AND FEET was not provided. The reporter's assessment of the causal relationship of the event with the suspect product 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. Follow-up (04Apr2022): This is a solicited follow-up report based on information received by Pfizer from Regulatory Authority (mfr. Control no.: 21K-163-4117035-00). A contactable consumer reported that: Updated information included: Reporter contact ability, yes, Lab data (Red blood cell count), IMBRUVICA (Start date for dose slider #01, New Dosage regimens, action taken), New events. New co-suspect (Iron). Follow-up (28Apr2022): This is a solicited follow-up report based on the information received by Pfizer from Regulatory Authority (Mfg. Control No.: 21K-163- 4117035-00). A contactable consumer (patient) reported that: Updated information included: New event added. Lot Number added in dosage regimen for Imbruvica. Email address added in slider #2. Relevant Med History added. 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 in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.