Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Prostate cancer
Clinical narrative: Prostastic cancer; This is a spontaneous report received from a contactable Other Health Professional (patient's wife). This other Health Professional reported for 80-year-old patient (Reporter's Husband) that: An 80-yeas-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Dec2020 (Batch/Lot Number: EH9899) as single dose (at the age of 80 year) for covid-19 immunisation. Medical history included ongoing diabetes mellitus has had for about 20 years, blood cholesterol from an unknown date and unknown if ongoing, Patient has a problem hearing from an unknown date and unknown if ongoing. Patient's family history reported as none. Concomitant medication(s) included dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes mellitus, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. Patient received second dose of bnt162b2 (Batch/Lot Number: EL3248) via an unspecified route of administration, administered in Deltoid Left on 17Jan2021 as single dose for covid-19 immunization. Patient was not received any other vaccine four weeks prior vaccination. Patient's wife called on behalf of husband who had the first dose of covid vaccine on 27Dec2020 and the second dose on 17Jan2021. Her husband had an IGG test in 06Jun2021 and was negative. Asked for information and recommendations on what to do she was not sure if he will need another shot. She Added that her husband has hx of prostatic cancer and received radiation for 8 weeks and is currently on anticancer medication. States they go out; concerned that her husband will catch covid. She stated the question she has is not for her, it's for her husband. Her husband has a problem hearing, that's why she is called. Her husband is there by her side, but she wants to ask questions, and asks agent if she is a nurse. She states after her husband had the vaccines; he was discovered to have prostatic cancer. She stated their children wanted to be sure she and her husband had some kind of Defensor antibodies, so they had the IgG antibody test. Her husband has zero, he has nothing. She had twenty, but her husband has nothing, and that is her question. She clarified the only reason she mentioned the prostate cancer is because he has radiation and is taking Xtandi. She confirmed this diagnosis occurred after the shot, and she thinks this is why he doesn't have any defence against the covid. She clarified her children said to ask for an antibody test because they were very concerned because of the cancer. The caller and her husband book took the IgG test., She has twenty and he has none. She clarifies she has antibodies, and her husband has none, and that is why they are so concerned. She stated she is a nurse; her husband is a physician. She clarified she was an LVN, but she and her husband are retired, they are almost eighty years old. Caller states he was diagnosed with prostate cancer in middle of Jan2021, after the first vaccine. The after that he had radiation and now is taking Farmigon, an antihormone. Caller states since he is receiving all of this cancer treatment, that is probably why he is not having any kind of defence, and that is her concern. When agent probes for seriousness criteria, caller states what she thinks is because he has all those kinds of treatment regarding the cancer, those kill whatever defence he has. She feels that because she has twenty and he has none. When probed for the seriousness criteria of having no antibodies, caller states that life threatening because they are afraid to go out, she doesn't want someone giving him what they have. Causality for him having no antibodies: No, Caller states to her it's because he received all of the cancer treatment. Caller stated the thing that changed right now is the cancer, and her husband is diabetic too for about twenty years. Caller states he is very hard to hear, but she is going to pass the phone to him so he can tell agent what kind of meds he has right now. The patient underwent lab tests and procedures which included blood immunoglobulin g: zero on 06Jun2021 He has zero, nothing. Patient visited to physician's office for the event prostatic cancer. Therapeutic measures were taken as a result of the events with Xtandi 80 mg daily is a new medication since Feb2021. radiation and a Farmigon shot, once every month, starting 27Jan2021.The first dose of the Farmigon was 240 mg, but now his current dose is 80 mg, once every month. And antihormone. The outcome of the event was reported as unknown. Pfizer covid vaccine: Was discovered to have prostatic cancer - Unrelated  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Prostate cancer) 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