Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid illness; covid illness; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HF9275) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol abnormal" (ongoing); "Blood pressure abnormal" (ongoing); "Gout" (ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Non-smoker" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL oral taken for gout (ongoing); AMLODIPINE/VALSARTAN oral taken for blood pressure abnormal (ongoing); ROSUVASTATIN oral taken for blood cholesterol abnormal (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Site and route of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EK5730), administration date: 27Dec2020, for COVID-19 Immunization; bnt162b2 (DOSE 2, SINGLE, Site and route of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3249), administration date: 19Jan2021, for COVID-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Site and route of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0191), administration date: 23Sep2021, for COVID-19 Immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE , Site and route of injection: LA, Route of administration: Intramuscular, Batch/Lot number: 3203080), administration date: 23Dec2021, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: 3203080), administration date: 27May2022, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Batch/Lot number: GJ5342), administration date: 14Sep2022, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE, Batch/Lot number: GH9703), administration date: 26Apr2023, for COVID-19 Immunization; influenza (Batch/Lot number: QUAD 371596, Route: Intramuscular, Anatomical Site of Injection: Right arm), administration date: 17Sep2023, for Influenza immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2023, outcome "recovered" (15Oct2023) and all described as "covid illness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Positive; (15Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 03Oct2023 to 08Oct2023. No Specific relevance for thromboembolic events with thrombocytopenia. Patient was not hospitalized. Not admitted to an Intensive Care Unit. Patient did not display clinical signs at rest indicative of severe systemic illness. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not have Multiorgan Failure, Respiratory issue, Dyspnea, Tachypnea, Hypoxemia, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome (ARDS), Heart failure, Cardiogenic shock, Acute myocardial infarction, Arrhythmia, Myocarditis. No Cardiovascular issue. Also patient had no Gastrointestinal/Hepatic problem, Vomiting, Diarrhea, Abdominal pain, Jaundice, Acute liver failure, Vascular problem, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Acute kidney injury, Renal failure, Altered consciousness, Convulsions/seizures, Encephalopathy, Meningitis, Cerebrovascular accident, Hematological issue, Thrombocytopenia, Disseminated intravascular coagulation, Dermatological issue, Chill blains, Erythema multiforme and multisystem inflammatory syndrome. Patient did not had any pre-existing diseases worsened during the SARS-CoV2 infection.Patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Developed Covid with symptoms sore throat, fever on 03Oct2023.  Causality assessment: Reporter/Patient did not considered the Pfizer product had a causal effect to the adverse event.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.