Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Gastrointestinal disorder, Incontinence
Clinical narrative: Altered consciousness; Incontinence; Gastrointestinal (Other: Yes); This is a spontaneous report received from a contactable reporter(s) (Physician).  An 82-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: EN6198) at the age of 81 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing); "M. I.", start date: 2005 (unspecified if ongoing), notes: Heart disease (M.I. 2005, Stent, A-Fib); "Stent" (unspecified if ongoing), notes: Heart disease (M.I. 2005, Stent, A-Fib); "A-Fib" (unspecified if ongoing), notes: Heart disease (M.I. 2005, Stent, A-Fib); "Dementia" (unspecified if ongoing); "Former smoker, quit smoking 1999." (unspecified if ongoing), notes: Former smoker, quit smoking 1999. Concomitant medication(s) included: MEMANTINE; QUETIAPINE; BUSPIRONE; METFORMIN; METOPROLOL SUCCINATE; OLMESARTAN MEDOXOMIL; ROSUVASTATIN; OXYCODONE; WARFARIN. Vaccination history included: BNT162b2 (Dose number: First dose, Site of injection: Unknown, Route: IM injection, Batch/lot number: EN6198), administration date: 25Feb2021, when the patient was 80-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: Second dose, Site of injection: Unknown, Route: IM injection, Batch/lot number: EP7534), administration date: 18Mar2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: ALTERED STATE OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Altered consciousness"; INCONTINENCE (non-serious), outcome "unknown"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Gastrointestinal (Other: Yes)".  Clinical course: Pfizer product had a causal effect to the adverse event was reported as yes. The patient was not hospitalized and was not admitted to an intensive care unit. The patient did not display any clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not had Respiratory, Multi organ failure, Dyspnea, Tachypnea, Hypoxemia, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome (ARDS), Other, Cardiovascular, Heart failure, Cardiogenic shock, Acute myocardial infarction, Arrhythmia, Myocarditis, Gastrointestinal/Hepatic, Vomiting, Diarrhea, Abdominal pain, Jaundice, Acute liver failure, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Convulsions/seizures, Encephalopathy, Meningitis, Cerebrovascular accident, Hematological, Thrombocytopenia, Disseminated intravascular coagulation, Dermatological, Chilblains, Erythema multiforme symptoms or signs. It was unknown if patient had Renal, Acute kidney injury, Renal failure, Other (e.g: multisystem inflammatory syndrome (MIS). The events did not require the initiation of new medication or other treatment or procedure. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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