Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Infected bite, Laboratory test, Lyme disease, Lymphocyte count
Clinical narrative: COVID-19; COVID-19; Lyme disease; Loss of teeth; Sickness; Unable to walk; Sinus disorder; Blood pressure abnormal; Infected bite; Lymphocytes raised; This is a solicited report based on the information received by Pfizer from company (Mfr. Control No.#: 21K-163-4021754-00).   A non-contactable consumer (patient) reported that a 74-year-old male patient received bnt162b2 (BNT162B2), dose 1 and dose 2; both intramuscular on unspecified dates (Batch/Lot number was not reported) as single doses for COVID-19 immunisation; ibrutinib (IMBRUVICA), oral from 30Nov2018 (Batch/Lot number was not reported) and ongoing, at 280 mg, daily for chronic lymphocytic leukemia of b-cell type not achieve remission. Medical history included chronic lymphocytic leukemia of b-cell type not achieve remission from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID-19 (drug ineffective), Lyme disease, loss of teeth, sickness, unable to walk, sinus disorder, blood pressure abnormal, infected bite and lymphocytes raised on an unspecified date with outcome of not recovered. Events were described as follows: Solicited report from the country by a consumer of an elderly male with events of LOSING TEETH and SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE with IMBRUVICA (IBRUTINIB). On unknown dates, the patient experienced LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that his pressure was kind of borderline. He had a tick bite, that looked infected, and they wanted to treat as though Lyme disease. The patient also reported that recent labs were pretty good, but there was a little rise in his lymphocytes. His oncologist thought this may be lingering effects from COVID, which he had over the winter. The patient got sick as well when he got both of his shots. He lost his ability to walk for 7-8 hours after the first dose of Pfizer vaccine, terrible headache, fever, and chills. It was just bad. The patient also experienced lot of sinus problems. He had to have his teeth extracted. The patient thought the chemotherapy had affected his teeth. The patient started losing them like a kid. He had some surgery to get all those out, and now using dentures and a partial. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures on an unspecified date which included, recent labs were pretty good,  blood pressure measurement: abnormal, lymphocyte count: increased (little rise), and COVID test: positive. The action taken in response to the events for ibrutinib was dose not changed. Events reported as other medically important condition.  The reporter's assessment of the causal relationship of the events 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.  The reporter's causality for the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS,PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE was not provided. Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to IMBRUVICA(IBRUTINIB). Company's opinion is that the events of LOT OF SINUS PROBLEMS and PRESSURE WAS KIND OF BORDERLINE are not assessable.  Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN). Company's opinion is that the event SICK was not assessable.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported event of losing teeth, lot of sinus problems, pressure was kind of borderline, lost ability to walk, infected tick bite, little rise in lymphocytes, COVID-19, Drug ineffective, sickness and lyme disease.  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.