Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA levels have gone up and gotten high enough for need to biopsy his prostate for cancer/PSA level rose to 9.24; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), 0.3 ml single (Lot number: GJ6739) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 01, Anatomical Site of injection: Left deltoid , Route of Administration: intramuscular. , Batch/Lot number: EL8982), administration date: 03Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (dose 02, Anatomical Site of injection: Left deltoid , Route of Administration: intramuscular , Batch/Lot number: EN6201), administration date: 24Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 03, Batch number: EWW015, Dosage text: .3ml intramuscular once left deltoid, Indication as Reported by the Primary Source: media recommending that a booster was available and it made sense if had initial two to get it), administration date: 27Sep2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Mentioned that his levels increased to 6.16 after the first booster that was administered on 27Sep2021"; BNT162b2 (Dose: 04, Batch/lot number : FK9893, Dosage text: .3ml intramuscular once left deltoid, Indication as Reported by the Primary Source: indicated that the booster was available everybody encouraging get the booster when it came out), administration date: 18Apr2022, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset 11Nov2022, outcome "unknown", described as "PSA levels have gone up and gotten high enough for need to biopsy his prostate for cancer/PSA level rose to 9.24". The events "psa levels have gone up and gotten high enough for need to biopsy his prostate for cancer/psa level rose to 9.24" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reported that he had received five Pfizer COVID-19 vaccines. Two of them were the two initial ones and three COVID-19 boosters and the last one was on 20Oct2022. Seemed the last booster was the Bivalent and was going to get a biopsy done at a hospital because his PSA levels have gone up. Past three times it was at least 4 and the second to last time it increased to 6 something and on 11Nov2022 it got up to 9.24. Because it was trending up, they want to do a biopsy to see if it was prostate cancer. Caller stated that his PSA levels had gradually gone up before he got the fourth vaccine. Had his first COVID vaccine in Feb2021 and the levels had gone up prior to that but not above the acceptable level. Acceptable level was 4.0. Later clarified that the levels had exceeded acceptable level in Aug2019 before he had the vaccines. Wanted to mention the two PSA levels prior to his first Pfizer COVID 19 vaccine that they were done in 2019 and one was 3.86 and 4.39 there was a trending increase that started before the first COVID booster. Later clarified that he has only had two PSA levels since he started the COVID 19 vaccinations. Provided that the PSA acronym was for the prostate specific antigen. There was no doctor that prescribed these. Got them on his own. PSA levels have gone up to 6.16. Mentioned that his levels increased to 6.16 after the first booster that was administered on 27Sep2021. Had the first PSA level done on 27Dec2021 and that level 6.16. Mentioned that there was a PSA done since then on 11Nov2022 and it rose to 9.24. Stated that he did not recover from it because it went up to 9.24. Just monitored it no treatment. PSA level rose to 9.24: Does not know whether it has gone up, stayed the same or gone down. Clarified later in the report that the outcome as unknown. Treatment: Urologist wanted to do prostate biopsy to see if prostate cancer was present. The prior vaccinations within 4 weeks were reported as none. Caller was going to the hospital next month to have a biopsy done and he was asking if the last booster shot which was the bivalent will give him adequate protection.  No follow-up attempts are possible. No further information is expected.