Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: the caller's PSA had gone from 5.77 to 17 which is almost a three fold increase which means he should be dead because its so large; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 80-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single and via an  unspecified route of administration, administered in arm left, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "clogged heart artery with stents" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; METOPROLOL; CRESTOR. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (medically significant) with onset 2021, outcome "recovering", described as "the caller's PSA had gone from 5.77 to 17 which is almost a three fold increase which means he should be dead because its so large". The event "the caller's psa had gone from 5.77 to 17 which is almost a three fold increase which means he should be dead because its so large" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: prostatic specific antigen (PSA test): (2001) 1-2, notes: when the patient was 60 years old; (2011) between 0 and 1, notes: 10 years ago; (2020) 5.77; (2021) 17, notes: three fold increase; (2021) 15; (2021) 14.9. Additional information: It was reported that in the past, the patient had his prostate specific agent tested and shows a very small progression (10 years ago, the patient's PSA was between 0 and 1). The patient read in the literature that the PSA goes up as the person gets older. When the patient was 60 years old in 2001, PSA was 1-2. Last year, on 2020, PSA was 5.77. The patient thought that it was because of his age and his doctor didn't see anything wrong about it. A month after the vaccination, the patient underwent PSA test. The patient's PSA had gone from 5.11 to 17, which was almost a three-fold increase which means that the patient should be dead because it was so high. The patient went to his MD (medical doctor). The patient's doctors are a bunch of union workers that agree on everything about the vaccine, so he wasn't skeptical and didn't pull his blood before he got the vaccine. The caller won't know what his PSA was before the vaccine. Pfizer didn't warn people that this could happen, but the patient thinks that this does have something to do with it because the vaccine puts out proteins. The surface protein well that's what the vaccine does. The patient thought his MD would know and he isn't even thinking. The patient's doctors are not seeing if there are any effects of the vaccine on tests like the PSA. Now, the patient has to go back to this doctor and has to do something with this large number. The patient had his PSA re-tested on 2021 and it was 15. The patient doesn't think anyone was researching about this. The FDA didn't say anything about the PSA and the CDC didn't even comment about this critical vaccine. The patient afraid that he has cancer because it was so high. The caller was at the mercy of urologists and will take a biopsy and this created an ambivalence of the sick or not sick. The patient had a PSA test on 2021, 4 months after the vaccine, and the result was 14.9. The patient does not remember the exact dates his PSA was checked.   The lot numbers for bnt162b2 were not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Prostatic specific antigen increased. 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.