Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Hypertension, Malaise, Metabolic acidosis, Nasopharyngitis
Clinical narrative: ACUTE KIDNEY INJURY; ACUTE MYOCARDIAL INFARCTION; SYNCOPE; ANGIOGRAM PULMONARY NORMAL; ANION GAP; BLOOD BICARBONATE DECREASED; BLOOD CREATININE INCREASED; BLOOD ELECTROLYTES NORMAL; BLOOD GLUCOSE NORMAL; BLOOD TEST; BLOOD UREA NORMAL; COVID-19; CHEST X-RAY NORMAL; COMPUTERISED TOMOGRAM HEAD NORMAL; COMPUTERISED TOMOGRAM SPINE; DIZZINESS; ELECTROCARDIOGRAM; FALL; FEELING ABNORMAL; FIBRIN D DIMER INCREASED; HAEMOGLOBIN DECREASED; HYPERTENSION; METABOLIC ACIDOSIS; NASOPHARYNGITIS; PLATELET COUNT DECREASED; RESPIRATORY SYMPTOM; SARS-COV-2 TEST POSITIVE; SKIN ABRASION; TACHYCARDIA; TROPONIN NORMAL; VIRAL INFECTION; WHITE BLOOD CELL COUNT DECREASED; MALAISE; FATIGUE; VOMITING; NAUSEA; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System, VAERS ID 2596142) concerned a 54 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: partial colectomy (with a colostomy bag), and concurrent conditions included: tachycardia, hypertension, and right proximal humeral fracture and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 for an unspecified indication. Age at time of vaccination 54 years old. No concomitant medications were reported. The patient was presented to the emergency department via emergency medical services (EMS) for feeling dizzy and having a syncopal episode at home and the patient stated that, over the past approximately 1 week, on an unspecified date in MAR-2023, he did not felt well, he felt like he was fighting a cold and day before reporting he developed nausea and vomiting and stated he had multiple bouts of vomiting. He denied abdominal pain, diarrhea and he had normal bowel movements into his colostomy bag. When the patient was in the kitchen he felt dizzy and then had a syncopal episode causing an abrasion to the top of his head. He did not take blood thinners. He stated he felt he was out for maybe a minute or 2 and then he stood up and called for his friend. He denied any associated chest pain, shortness of breath, palpitations or headache prior to the episode, however he stated he felt dizzy. Upon arrival he denied a headache or neck pain or any other injuries aside from the abrasion. He was in a sling for a known right humeral fracture. Associated Symptoms: dizziness, fall, fatigue, nausea, URI symptoms and vomiting. Patient was seen upon arrival to the emergency department. Vitals were reviewed and noted for hypertension of 106/102 (blood pressure) as well as tachycardia of 106 (heart rate). Patient was 100 percent on room air. He had a known right humeral fracture. He was in a sling for this. Patient already had an IV (intravenous) established by emergency medical services (EMS), he would receive a 1 L normal saline bolus, blood work performed, chest x-ray, Electrocardiogram (EKG) and a computerized tomography (CT) head. A rapid COVID was also ordered also be updated on his tetanus. Differential diagnosis includes but was not limited to Non-ST-elevation myocardial infarction (NSTEMI), pulmonary embolism (PE), intracranial abnormality, electrolyte normality, viral syndrome etc. Review of medical record showed: patient was seen in facility on 21-FEB-2023 and was diagnosed with a right proximal humeral fracture. Patient labs were reviewed, glucose 132, blood urea nitrogen (BUN) 16 with a creatinine 1.7. Patient baseline creatinine was 1.0 from last month. Anion gap was 18 with a bicarb of 20. Troponin was negative. D-dimer was elevated at 722, a CTA chest was ordered, especially given patient tachycardia. Hemoglobin 13.7, WBC 3.4 and platelets were 119. Rapid COVID was positive. Chest x-ray negative. CT head and CT C-spine were negative for any bleed or fracture. He stated he overall does not felt well, he was fatigued. Given his elevated creatinine, and offered patient observation admission, and he was agreeable to this. The Computed Tomography Angiography (CTA) chest negative for pulmonary embolism (PE). Patient would be given a total of 2 L normal saline bolus followed by fluids at 130 cc/h. 1825. The onsite doctor accepted this patients admission. The diagnosis was acute kidney injury (AKI), anion gap metabolic acidosis and COVID infection was found.  The patient experienced acute kidney injury, acute myocardial infarction, angiogram pulmonary normal, anion gap, blood bicarbonate decreased, blood creatinine increased, blood electrolytes normal, blood glucose normal, blood test, blood urea normal, covid-19, chest x-ray normal, computerised tomogram head normal, computerised tomogram spine, electrocardiogram, experienced fall, feeling abnormal, fibrin d dimer increased, haemoglobin decreased, hypertension, metabolic acidosis, nasopharyngitis, platelet count decreased, respiratory symptom, sars-cov-2 test positive, tachycardia, troponin normal, viral infection, white blood cell count decreased, fatigue, malaise and was hospitalized (date unspecified). The number of days of hospitalization was 3 days. It was unknown whether the patient was discharged from the hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, acute myocardial infarction, angiogram pulmonary normal, anion gap, blood bicarbonate decreased, blood creatinine increased, blood electrolytes normal, blood glucose normal, blood test, blood urea normal, covid-19, chest x-ray normal, computerised tomogram head normal, computerised tomogram spine, dizziness, electrocardiogram, fall, fatigue, feeling abnormal, fibrin d dimer increased, haemoglobin decreased, hypertension, malaise, metabolic acidosis, nasopharyngitis, nausea, platelet count decreased, respiratory symptom, sars-cov-2 test positive, skin abrasion, syncope, tachycardia, troponin normal, viral infection, vomiting and white blood cell count decreased was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with a product quality complaint: 90000276706. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from department on 11-APR-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20230365916- Acute kidney injury, Acute myocardial infarction, Syncope, Angiogram pulmonary normal, Anion gap, Blood bicarbonate decreased, Blood creatinine increased, Blood electrolytes normal, Blood glucose normal, Blood test, Blood urea normal, Chest x-ray normal, Computerised tomogram head normal, Computerised tomogram spine, Dizziness, Electrocardiogram, Fall, Feeling abnormal, Fibrin d dimer increased, Haemoglobin decreased, Hypertension, Metabolic acidosis, Platelet count decreased, Skin abrasion, Tachycardia, Troponin normal, Viral infection, White blood cell count decreased, Malaise, Fatigue, Vomiting, Nausea. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  20230365916-Covid-19, Nasopharyngitis, Respiratory symptom, Sars-cov-2 test positive. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.