Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Glycosylated haemoglobin, Immune system disorder, Off label use, Pancreatic carcinoma
Clinical narrative: adenocarcinoma of the pancreas; some immune system challenges; a participant in the 3rd booster Pfizer-BioNTech COVID-19 Vaccine study; a participant in the 3rd booster Pfizer-BioNTech COVID-19 Vaccine study; This is a spontaneous report from a contactable other HCP. A 79-year-old male patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiry date was unknown), via an unspecified route of administration on shoulder (arm) left on an unspecified date as dose 3, single for COVID-19 immunization. The patient medical history included Hypertension and diabetes (but his A1C test is normal). He has a bad family history of cardiovascular disease. The patient Concomitant medications included fish oil (O3 OMEGA 3) taken for unspecified indication, start and stop date was not reported, fish oil taken for unspecified indication, start and stop date was not reported. He takes a statin, Omega 3 Fish Oil as preventatives. The historical vaccines included patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: P220395-0021L), via an unspecified route of administration on shoulder right on 21Sep2020 (at the age of 78 years) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: P220395-0047L), via an unspecified route of administration on shoulder right on 30Aug2020(at the age of 78 years) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced adenocarcinoma of the pancreas and some immune system challenges. It was reported that Caller was recently diagnosed with "adenocarcinoma of the pancreas", and it can be "removed without any metastases". Caller mentioned that he was terminated on 2nd study (for the 3rd immunization) and switched to a different study: still for the Pfizer-BioNTech COVID-19 Vaccine. Prior to the switch, Caller had his antibody titers measured. Caller wanted to know if he has enough COVID-19 antibodies without un-blinding the study. He reports he was a participant in the Covid 19 vaccine study and he is now in the new study regarding the third booster Covid 19 vaccine. He was recently diagnosed with a mass in his pancreas, an adenocarcinoma in his pancreas. The adenocarcinoma is highly isolated and can be removed without any metastasis. He is calling because he wants the results for the Covid 19 antibody titer that he recently had drawn 6-8 weeks ago. He has had Covid 19 antibody testing since being a part of the original study. He has received a third injection in the new study but he does not know if he received a placebo or if he received a third Covid 19 vaccine. He sees no reason why the Covid 19 antibody titer can't be unblinded, meaning, making the results known to him despite the fact that he is part of the third Covid 19 booster study.He would like the results of the Covid 19 antibody test. He's wondering if he has enough Covid 19 antibodies prior to treatment of his adenocarcinoma. This part of the study was unblinded and he knows that he did receive both doses of the Covid 19 vaccine. He was given a third injection but he can't recall the exact date. He either received a placebo or the Covid 19 vaccine booster. He had to turn his head when getting the injection because the consistencies of the placebo and the Covid 19 vaccine are different. He received the third injection in his left shoulder. He has no NDC/Lot/Expiry for this dose. When probing if caller was a healthcare professional he states he worked as a physician's assistant and later he got his MD. But he worked only as a physician's assistant. Caller is a Dr. but is also a participant in the Clinical vaccine study and he just recently got a 3rd injection. He's needing to know what the value of that report shows because they found a mass in his pancreas and he needs to know if he has any antibody's. It was reported that Phase 3 Covid trial participant is about to have a surgery and stated he is worried he may have some immune system challenges. The lab tests included test: Glycosylated haemoglobin, result: Normal on an unknown date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the available information reported event pancreatic carcinoma cannot be totally assessed. This case will be reassessed when additional information particularly the clinical course of pancreatic carcinoma becomes 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.