Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood albumin decreased, Blood glucose
Clinical narrative: She has had some falls; covid; covid; Fatigue; A1C is 8.1, so it is high; Red blood count in hemoglobin hematocrit those are little on the low side; Red blood count in hemoglobin hematocrit those are little on the low side; Red blood count in hemoglobin hematocrit those are little on the low side; Platelets counts little on the low side; Glucose a little high; Albumin and her proteins are little low; Glucose a little high; Albumin and her proteins are little low; Glucose a little high; Albumin and her proteins are little low; Lactic Acid was 2.1 so it was a little high; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (ongoing); "TIA" (ongoing); "Atrial fibrillation" (ongoing); "Mild Cognitive Impairment" (ongoing); "CAD-LAD stent" (not ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for arterial stent insertion; EMPAGLIFLOZIN; IRON; PROZAC taken for depression; LIPITOR taken for atrial fibrillation, transient ischaemic attack; DONEPEZIL taken for cognitive disorder; METOPROLOL taken for atrial fibrillation. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "covid"; FATIGUE (hospitalization), outcome "unknown"; FALL (hospitalization), outcome "unknown", described as "She has had some falls"; GLYCOSYLATED HAEMOGLOBIN INCREASED (medically significant), outcome "unknown", described as "A1C is 8.1, so it is high"; RED BLOOD CELL COUNT DECREASED (non-serious), HAEMATOCRIT DECREASED (non-serious), HAEMOGLOBIN DECREASED (non-serious), outcome "unknown" and all described as "Red blood count in hemoglobin hematocrit those are little on the low side"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Platelets counts little on the low side"; BLOOD GLUCOSE INCREASED (non-serious), BLOOD ALBUMIN DECREASED (non-serious), HYPOPROTEINAEMIA (non-serious), outcome "unknown" and all described as "Glucose a little high; Albumin and her proteins are little low"; BLOOD LACTIC ACID INCREASED (non-serious), outcome "unknown", described as "Lactic Acid was 2.1 so it was a little high". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Unknown results; Aspartate aminotransferase: Unknown results; Blood albumin: little low; Blood glucose: little high; Blood lactic acid: 2.1, notes: little high; Full blood count: Unknown results; Glycosylated haemoglobin: 8.1, notes: high; Haematocrit: on the low side; Haemoglobin: on the low side; Platelet count: little on the low side; Protein total: little low; Red blood cell count: little on the low side, notes: Red blood count in hemoglobin haematocrit; Troponin: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19, fatigue. Clinical course: Reporter stated that had a patient, they came in to their hospital and the only real symptom that she had for COVID was fatigue and she had some falls.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association and/or known drug safety profile, a reasonable possibility that the events drug ineffective, Covid-19,  fatigue, fall, and glycosylated haemoglobin increased  are related to bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300360845 same reporter/ patient, different drug;