Age: 78.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Biopsy, Blood creatinine, Blood creatinine abnormal, COVID-19, Computerised tomogram
Clinical narrative: feeling bad; Hemoglobin was 12; he has been through a biopsy of a mass that they found; abnormal creatinine; tested 3 times positive; tested 3 times positive; having frequent urination; fatigue; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 07Oct2024 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Atrial fib" (ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation (ongoing); LOSARTAN taken for hypertension; CHLORTHALIDONE taken for hypertension; LIPITOR. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2020, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Comirnaty (2023-2024 formula) (DOSE 5 (BOOSTER), SINGLE), administration date: Apr2024, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2024, outcome "not recovered"; POLLAKIURIA (non-serious) with onset 07Nov2024, outcome "not recovered", described as "having frequent urination"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2024, outcome "unknown" and all described as "tested 3 times positive"; BLOOD CREATININE ABNORMAL (non-serious) with onset 26Dec2024, outcome "unknown", described as "abnormal creatinine"; MASS (medically significant) with onset 27Dec2024, outcome "unknown", described as "he has been through a biopsy of a mass that they found"; HAEMOGLOBIN DECREASED (non-serious) with onset Jan2025, outcome "unknown", described as "Hemoglobin was 12"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad". The event "he has been through a biopsy of a mass that they found" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Unknown result; Blood creatinine: (26Dec2024) abnormal; Computerised tomogram: (2024) Unknown results; (unspecified date) Unknown results; Haemoglobin: (Mar2024) down three points; (Jan2025) 12, notes: it is low; test: (27Dec2024) mass; labs: (unspecified date) minimally changed; Pathology test: (unspecified date) Unknown results; Positron emission tomogram: (unspecified date) normal; SARS-CoV-2 test: (Dec2024) Positive; Ultrasound scan: (unspecified date) Unknown results; (2024) Unknown results; Weight: (unspecified date) about 207. Therapeutic measures were not taken as a result of drug ineffective, covid-19, mass, pollakiuria, fatigue, blood creatinine abnormal, haemoglobin decreased.  Clinical course: The Pfizer Covid-19 vaccine was given along with a flu vaccine on the same day as her husband started experiencing fatigue more than usual, he's a retired physician. He had shots on 07Oct and a month later began having frequent urination. A week before Christmas (Dec2024), he started having cold symptoms and got tested 3 times for Covid. She's asking if there could have been some assault on his immune system as it's his first time having 2 shots together. Fatigued continued and patient got some lab work done on the 26Dec after this had gone on for a little while and the lab work came back with an abnormal creatinine, hemoglobin was down three points from Mar (2024) of the same year and that began their journey of ultrasound, CAT scan. Trying to investigate what the fatigue and these blood counts were all about. His labs have minimally changed he has been through a biopsy of a mass that they found on the 27Dec following an ultrasound and the CT scan of his abdomen and then but his lab work is what just spoke. It is so crazy and they have done with the biopsy. They have done all the testing, laboratory testing, pathology and they cannot come up with a solid answer with what and they have not seen anything like this. Also, the reporter read some things that it is possible that an individual could have an abnormal PET scan. Her husband's PET scan was normal and the reason she has concern about this is the proximity in time. From the time of these vaccinations to when the patient became feeling bad. Patient was great right until up that time and no issues of any kind. Patient hadn't been sick and then so unusual that these symptoms started a couple of weeks after these vaccines. Reporter further stated, "we are not saying it is from the vaccine. I am just trying to gather information if it could be something that has happened with his immune system response with getting both the Flu vaccine and COVID vaccine together or one or the other or do we have another process going on here and so, he is being seen by doctors, many doctors, he had a biopsy and they cannot get completely to the bottom of this. They said this is the one of the most difficult cases they have ever had to look at and it is been, it will be six weeks on Friday and so, I just decided I told him I am going to call Pfizer and see if there is been other reported incidence of anything like this plus an abnormal PET Scan with sides that light up in both bone."; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded. As there is limited information in the case provided, the causal association between the event mass and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  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.