Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; Recurrent pulmonary embolism; Skin lesion; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), 0.3 ml single (Batch/Lot number: unknown, Expiration Date: 17Sep2023) at the age of 67 years intramuscular 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: 30Jan2014 (unspecified if ongoing); "Heart failure with reduced ejection fraction", start date: 12Dec2020 (unspecified if ongoing); "Coronary artery bypass graft" (unspecified if ongoing); "Former smoker", stop date: 1975; "Tobacco user", start date: 1969, stop date: 1974, notes: started smoking tobacco at the age of 16 and quitted at the age of 21.; "Occasional alcohol consumption" (unspecified if ongoing); "Occasional caffeine consumption" (unspecified if ongoing); "Repair bowel opening - colostomy reversal" (not ongoing); "Tonsillectomy" (not ongoing); "Colonoscopy", start date: 04Mar2022 (not ongoing); "Aortocoronary artery bypass/ coronary artery bypass", start date: 15May2020 (not ongoing), notes: PLA&RPDA as a sequential graft and left radial artery to obtuse marginal.; "Endoscopic harvesting of saphenous vein", start date: 15May2020 (not ongoing); "Insertion of catheter into artery/ LEFT common femoral arterial line insertion", start date: 15May2020 (not ongoing); "Left atrial appendage closure", start date: 15May2020 (not ongoing), notes: w/25 mm AtriClip; "NSTEMI", start date: 12May2020 (unspecified if ongoing); "Appendectomy", start date: 19Oct2011 (not ongoing); "Laparo partial colectomy sigmoid resection", start date: 10Jan2010 (not ongoing); "Gastrointestinal Surgery", start date: 09Jan2010 (not ongoing); "Allergies" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "Ear or Hearing problem" (unspecified if ongoing); "Heart problem" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing); "Endoscopic harvesting of left radial artery", start date: 15May2020 (not ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE intramuscular taken for immunisation, on 12Oct2022 as dose number unknown, 0.7 ml single. Past drug history included: Cartia xt, reaction(s): "Premature atrial contraction"; Digoxin, reaction(s): "loss of apetite"; Diltiazem; Metoprolol, reaction(s): "anxiety attack"; Promethazine, reaction(s): "hallucinations". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot Number : EL9261, Strength 0.3 ml), administration date: 16Jan2021, for COVID-19 Immunization; coviD-19 vaccine moderna (DOSE 2, SINGLE, Strength : 0.5 ML,, Route of administration : Intramuscular, Batch/Lot Number : 028L20A, Expiration date : 09Jul2021), administration date: 06Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Strength : 0.3 ml), administration date: 25Sep2021, for COVID-19 Immunization, reaction(s): "Interchange of vaccine products", "Arteriosclerosis of coronary artery bypass graf", "Paroxysmal atrial fibrillation", "History of polyp of colon", "Aortic root dilatation"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Strength : 0.3 ml, Batch/Lot Number : FJ4991), administration date: 02Apr2022, for COVID-19 Immunization; td (Strength : 0.5 ML, Route of administration : Intramuscular, Batch/Lot Number : A123B1, Expiration date: 16Jan2022), administration date: 11Nov2020, for Immunization; tdap (Batch/Lot Number : C3539AA), administration date: 12Nov2010, for Immunization; influenza, high-dose, quadrivalent (Strength : 0.7 ML, Route of administration : Intramuscular, Batch/Lot Number : UJ741AC, Expiration date : 30Jun2022), administration date: 11Oct2021, for Immunization; influenza, high-dose, quadrivalent (Strength : 0.7 ML, Route of administration : Intramuscular, Batch/Lot Number : UJ462AA, Expiration date: 30Jun2021), administration date: 06Oct2020, for Immunization; influenza high dose seasonal (Batch/Lot Number : UJ253AA), administration date: 27Sep2019, for Immunization; influenza, injectable quadrivalent, preservative free (Strength : 0.7 ML, Route of administration : Intramuscular, Batch/Lot Number : UJ034AD, Expiration date : 30Jun2019), administration date: 28Sep2018, for Immunization; influenza, seasonal, injectable, preservative free (Batch/Lot Number : XT32308), administration date: 30Sep2017, for Immunization; influenza, seasonal, injectable, preservative free (Batch/Lot Number: L2DR5), administration date: 27Aug2016, for Immunization; influenza, seasonal, injectable, preservative free (Batch/Lot Number : 9525T), administration date: 30Aug2015, for Immunization; influenza, seasonal, injectable, administration date: 19Sep2013, for Immunization; influenza, seasonal, injectable, administration date: 16Sep2012, for Immunization; influenza, seasonal, injectable, administration date: 12Sep2011, for Immunization; influenza, seasonal, injectable, administration date: 21Sep2010, for Immunization; influenza, seasonal, injectable, administration date: 17Sep2009, for Immunization; pneumococcal polysacharide ppv23 (Pneumococcal polysacharide PPV23, Batch/Lot Number : T020638, Strength : 0.5 ML, Route of administration : Intramuscular, Expiration date : 26Feb2022), administration date: 24Sep2020, for Immunization; pneumococcal conjugate pcv13 (Batch/Lot Number : AG8347, Expiration date : 31May2021), administration date: 25Oct2019, for Immunization; pneumococcal polysacharide ppv23, administration date: 01Jan2006, for Immunization; zoster recombinant (Batch/Lot Number : HM3NC), administration date: 16Mar2019, for Immunization; zoster live, administration date: 16Mar2019, for Immunization; zoster recombinant (Batch/Lot Number : MG42F, Strength : 1 ML, Route of administration : Intramuscular, Expiration date : 25Sep2021), administration date: 16Jan2019, for Immunization; zoster live, administration date: 14Feb2015, for Immunization. Patients father had malignant tumor of lung, mother died at the age of 85 due to congestive heart failure, brother died at the age of 65 due to malignant tumor of lung, sister had congestive heart failure with onset at the age of 70. The following information was reported: SKIN LESION (non-serious) with onset 01Dec2022, outcome "unknown"; PULMONARY EMBOLISM (medically significant) with onset 03Mar2023, outcome "unknown", described as "Recurrent pulmonary embolism"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The events "recurrent pulmonary embolism" and "skin lesion" required physician office visit. The patient underwent the following laboratory tests and procedures: Angiocardiogram: (12May2020) NSTEMI; Colonoscopy: (24Apr2017) Unknown result, notes: Repeat in five years; Tobacco screening: (01Dec2022) Unknown result.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Interchange of vaccine products, Pulmonary embolism and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202300187551 same patient, different drug and different event;