Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic dilatation, Arteriosclerosis coronary artery, Atrial fibrillation, Large intestine polyp
Clinical narrative: Arteriosclerosis of coronary artery bypass graf; Paroxysmal atrial fibrillation; Aortic root dilatation; History of polyp of colon; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Onychomycosis of toenails", start date: 12Nov2020 (unspecified if ongoing); "Hyperlipidemia", start date: 30Jan2014 (unspecified if ongoing); "Tinnitus", start date: 30Jan2014 (unspecified if ongoing); "Hearing loss", start date: 30Jan2014 (unspecified if ongoing); "Essential hypertension", start date: 30Jan2014 (unspecified if ongoing); "Coronary atherosclerosis", start date: 11Nov2020 (unspecified if ongoing); "Systolic dysfunction", start date: 27May2020 (unspecified if ongoing); "Dyssomnia", start date: 30Jan2014 (unspecified if ongoing); "Prediabetes", start date: 28Nov2018 (unspecified if ongoing); "Ex-smoker", start date: 16Mar2018 (unspecified if ongoing); "Blood unit collection for directed donation, donor", start date: 12Dec2020 (unspecified if ongoing); "Coronary artery bypass graft" (unspecified if ongoing); "Repair bowel opening - colostomy reversal" (unspecified if ongoing); "Tonsillectomy" (unspecified if ongoing); "Colonoscopy" (unspecified if ongoing), notes: Colonoscopy - 04Mar2022 - f/u 7 years; "Coronary Artery Bypass", start date: 15May2020 (unspecified if ongoing); "Aortocoronary artery bypass of four or more coronary arteries with saphenous vein graft", start date: 15May2020 (unspecified if ongoing), notes: Aortocoronary artery bypass of four or more coronary arteries with saphenous vein graft -15May2020 - PLA&RPDA as a, sequential graft & left radial artery to obtuse marginal #1; "Cabg vein four", start date: 15May2020 (unspecified if ongoing); "Endoscopic harvesting of radial artery", start date: 15May2020 (unspecified if ongoing), notes: Endoscopic harvesting of radial artery - 15May2020 - LEFT radial artery; "Endoscopic harvesting of saphenous vein", start date: 15May2020 (unspecified if ongoing); "Insertion of catheter into artery", start date: 15May2020 (unspecified if ongoing), notes: Insertion of catheter into artery - 15May2020 - LEFT common femoral arterial line insertion; "Us guide intraop - 15May2020 - ascending aorta & aortic arch", start date: 15May2020 (unspecified if ongoing); "Left atrial appendage closure", start date: 15May2020 (unspecified if ongoing); "Angiography of coronary artery", start date: 15May2020 (unspecified if ongoing); "Colonoscopy", start date: 24Apr2021 (unspecified if ongoing); "Appendectomy", start date: 19Oct2011 (unspecified if ongoing); "Laparo partial colectomy", start date: 10Jan2010 (unspecified if ongoing); "Gastrointestinal Surgery", start date: 09Jan2010 (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "Heart Problems" (unspecified if ongoing); "Pulmonary Embolism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cartia xt, reaction(s): "premature atrial contraction"; Digoxin, reaction(s): "loss of appetite"; Cartia xt, reaction(s): "drug allergy"; Digoxin, reaction(s): "drug allergy"; Diltiazem, reaction(s): "drug allergy"; Metoprolol, reaction(s): "anxiety attacks"; Metoprolol, reaction(s): "drug allergy"; Promethazine, reaction(s): "hallucinations"; Promethazine, reaction(s): "drug allergy". Vaccination history included: td (adult), adsorbed (Amt.: 0.5 ML, Route: Intramuscular, Lot: A12381, Mfr.: Biologic Laboratories , Exp. Date: 16Jan2022), administration date: 11Nov2020, when the patient was 66-year-old, for Immunization; tdap (Vaccine Type: Tdap, Date: 12Nov2010, Lot: C3539AA), administration date: 12Nov2010, when the patient was 56-year-old, for Immunization; influenza, high-dose, quadrivalent (Vaccine Type: influenza, high-dose, quadrivalent, Date: 06Oct2020, Amt.: 0.7 ML, Route: Intramuscular, Lot#: UJ462AA, Mfr.: Sanofi Pasteur, Exp. Date: 30Jun2021), administration date: 06Oct2020, when the patient was 66-year-old, for Immunization; influenza, high-dose seasonal (Vaccine Type: influenza, high-dose seasonal, Date: 27Sep2019, Lot#: UJ253AA, Mfr.: Sanofi Pasteur), administration date: 27Sep2019, when the patient was 65-year-old, for Immunization; influenza, injectable, quadrivalent, preservative free (Vaccine Type: influenza, injectable, quadrivalent, preservative free, Date: 28Sep2018, Amt.: 0.5 ML, Route: Intramuscular, Lot#: UJ034AD, Mfr.: Sanofi Pasteur, Exp. Date: 30Jun2021), administration date: 28Sep2018, when the patient was 64-year-old, for Immunization; influenza, injectable, quadrivalent, preservative free (Vaccine Type: influenza, injectable, quadrivalent, preservative free, Date: 30Sep2017, Lot#: XT32308, Mfr.: Seqirus), administration date: 30Sep2017, when the patient was 61-year-old, for Immunization; influenza, injectable, quadrivalent, preservative free (Vaccine Type: influenza, injectable, quadrivalent, preservative free, Date: 27Aug2016, Lot#: L2DR5, Mfr.: Glaxo smith kline), administration date: 27Aug2016, when the patient was 59-year-old, for Immunization; influenza, injectable, quadrivalent, preservative free (Vaccine Type: influenza, injectable, quadrivalent, preservative free, Date: 30Aug2015, Lot#: SS25T, Mfr.: Glaxo smith Kline), administration date: 30Aug2015, when the patient was 60-year-old, for Immunization; influenza, seasonal, injectable (Vaccine Type: influenza, seasonal, injectable, Date: 19Sep2013), administration date: 19Sep2013, when the patient was 58-year-old, for Immunization; influenza, seasonal, injectable (Vaccine Type: influenza, seasonal, injectable, Date: 16Sep2012), administration date: 16Sep2012, when the patient was 57-year-old, for Immunization; influenza, seasonal, injectable (Vaccine Type: influenza, seasonal, injectable, Date: 12Sep2011), administration date: 12Sep2011, when the patient was 56-year-old, for Immunization; influenza, seasonal, injectable (Vaccine Type: influenza, seasonal, injectable, Date: 21Sep2010), administration date: 21Sep2010, when the patient was 55-year-old, for Immunization; influenza, seasonal, injectable (Vaccine Type: influenza, seasonal, injectable, Date: 17Sep2010), administration date: 17Sep2010, when the patient was 55-year-old, for Immunization; pneumococcal polysaccharide ppv23 (Vaccine Type: pneumococcal polysaccharide PPV23, Date: 24Sep2020, Dose: 0.5 ML, Route: Intramuscular, Lot: T020638, Mfr.: Menok and Co., Exp. date: 26Feb2022), administration date: 24Sep2020, when the patient was 66-year-old, for Immunization; pneumococcal conjugate pcv 13 (Vaccine Type: pneumococcal conjugate PCV 13, Date: 25Oct2019, Dose: 0.5 ML, Route: Intramuscular, Lot: AG8347, Mfr.: Pfizer. Inc, Exp. date: 31May2021), administration date: 25Oct2019, when the patient was 65-year-old, for Immunization; pneumococcal polysaccharide ppv23 (Vaccine Type: pneumococcal polysaccharide PPV23, Date: 01Jan2006), administration date: 01Jan2006, when the patient was 51-year-old, for Immunization; zoster recombinant (Vaccine Type: Zoster recombinant, Date: 16Mar2019, Lot: HM3NC, Mfr.: GlaxoSmithKline), administration date: 16Mar2019, when the patient was 64-year-old, for Immunization; zoster live (Vaccine Type: Zoster recombinant, Date: 16Mar2019, Lot: HM3NC, Mfr.: GlaxoSmithKline), administration date: 16Mar2019, when the patient was 64-year-old, for Immunization; zoster recombinant (Vaccine Type: Zoster recombinant, Date: 16Jan2019, Lot: SHINGRIX), administration date: 16Jan2019, when the patient was 64-year-old, for Immunization; zoster live (Vaccine Type: Zoster Live, Date: 14Feb2015), administration date: 14Feb2015, when the patient was 60-year-old, for Immunization; BNT162b2 (DOSE 1, SINGLE, Covid-19, mRNA, LNP-S, PF, 30mcg/0.3mL dose (Pfizer-BioNTech), Date: 16Jan2021, Lot #: EL9261, Mfr. (manufacturer): Pfizer, Inc.), administration date: 16Jan2021, when the patient was 66-year-old, for Covid-19 immunization; moderna coviD-19 (DOSE 2, SINGLE, Covid-19, mRNA, LNP-S, PF, 100mcg/0.5mL dose , Date: 06Feb2021, AmL: 0.5 mL, Route: Intramuscular, Lot #: 028L20A, Mfr. (manufacturer): Moderna, Inc., Expiration date: 09Jul2021), administration date: 06Feb2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: LARGE INTESTINE POLYP (non-serious) with onset 18Nov2021, outcome "unknown", described as "History of polyp of colon"; AORTIC DILATATION (non-serious) with onset 11Jan2022, outcome "unknown", described as "Aortic root dilatation"; ARTERIOSCLEROSIS CORONARY ARTERY (medically significant) with onset 11Jan2022, outcome "unknown", described as "Arteriosclerosis of coronary artery bypass graf"; ATRIAL FIBRILLATION (medically significant) with onset 11Jan2022, outcome "unknown", described as "Paroxysmal atrial fibrillation". Therapeutic measures were taken as a result of arteriosclerosis coronary artery.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events  arteriosclerosis coronary artery , atrial fibrillation and suspect BNT162B2 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202300190303 same patient/reporter/drug, different dose number/event;