Sex: F
Vaccine: UNK
Symptoms: Confusional state, Dehydration, Diuretic therapy, Drug interaction, Electrocardiogram PR prolongation
Clinical narrative: PRE-RENAL ACUTE KIDNEY INJURY (AKI); HYPERKALEMIA; BRADYCARDIC; DIGOXIN TOXICITY; EKG SHOWED A PROLONGED PR INTERVAL AND SCOOPED ST SEGMENTS; DEHYDRATION; DRUG INTERACTIONS; ABDOMINAL PAIN; EKG SHOWED A PROLONGED PR INTERVAL AND SCOOPED ST SEGMENTS; ACUTE ONSET OF CONFUSION; VIRAL-LIKE SYNDROME; VOMITING; This spontaneous report received from a physician by a Regulatory Authority (US-MLMSERVICE-20220824-3753910-1) was received on 30-AUG-2022 and concerned an 84 year old female. This patient was also referenced in literature:  The patient's height, and weight were not reported. The patient's past medical history included: covid-19 immunization, and concurrent condition included: atrial fibrillation. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 immunization.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 immunization. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drugs included: amiodarone (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; furosemide ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for diuretic; and digoxin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced serious adverse reactions of viral-like syndrome associated with covid-19 vaccine; dehydration associated with covid-19 vaccine and furosemide; pre-renal acute kidney injury associated with covid-19 vaccine, amiodarone and furosemide; the patient experienced drug interactions; All of which precipitated Digoxin toxicity (confusion, abdominal pain, vomiting, hyperkalemia, bradycardia, prolonged PR interval and scooped ST segments). The patient with atrial fibrillation on digoxin presented with acute onset of confusion associated with a week history of abdominal pain, vomiting, and poor fluid intake. It was reported that a few days prior, Amiodarone was added to her drug regimen which included Lasix. Additionally, patient received the covid-19 booster vaccine which led to a viral-like syndrome resulting in dehydration. The patient was afebrile, normotensive, but bradycardic. EKG showed a prolonged PR interval and scooped ST segments. Labs showed hyperkalemia, pre-renal acute kidney injury (AKI), and a Digoxin level of 4.3 ng/mL (therapeutic range: 0.8-2.0 ng/mL). Digoxin and Lasix were held and Digoxin antidote, Digibind (treatment medication) was administered with normalizing heart rate, potassium, and clinical improvement (dose number in series 2). It was reported that the viral-like-syndrome after the booster vaccine with subsequent AKI secondary to dehydration likely precipitated Digoxin toxicity. Accompanying drug interactions of diuretics causing dehydration and hypokalemia, P-glycoprotein inhibitors (Amiodarone, Verapamil, Diltiazem, Quinidine), and ACE inhibitors can further worsen renal clearance and culminate in Digoxin toxicity. Laboratory data (dates unspecified) included: Blood pressure normotensive, Body temperature afebrile, EKG showed a prolonged PR interval and scooped ST segments, Heart rate normalizing, bradycardic, Lab test showed hyperkalemia, pre-renal acute kidney injury (AKI), and Potassium hyperkalemia, normalizing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with amiodarone was not reported; and treatment with furosemide, and digoxin was withdrawn. The patient recovered from hyperkalemia, bradycardic, EKG showed a prolonged PR interval and scooped ST segments, and EKG showed a prolonged PR interval and scooped ST segments, and was recovering from digoxin toxicity, vomiting, dehydration, drug interactions, abdominal pain, acute onset of confusion, viral-like syndrome, and pre-renal acute kidney injury (AKI). The authors concluded that given digoxin's narrow therapeutic index, small clinical changes such as post covid-19 vaccine flu-like symptoms, dehydration, and medication changes can manifest drug toxicity. Therefore, attentive monitoring of accompanying comorbidities and drug interactions was imperative at preventing catastrophic toxic effects. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220904528-covid-19 vaccine ad26.cov2.s - viral-like syndrome. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220904528-covid-19 vaccine ad26.cov2.s -Dehydration. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS (Furosemide). Therefore, this event(s) is considered not related   20220904528-covid-19 vaccine ad26.cov2.s -pre-renal acute kidney injury (AKI). The case causality is considered NOT RELATED. Rationale: As reported -patient experienced AKI SECONDARY TO DEHYDRATION, provides more plausible explanation.  20220904528-covid-19 vaccine ad26.cov2.s -  Digoxin toxicity, hyperkalemia, bradycardic, EKG showed a prolonged PR interval and scooped ST segments, EKG  showed a prolonged PR interval and scooped ST segments, vomiting, abdominal pain, acute onset of confusion, drug interaction. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS (Digoxin, amiodarone, furosemide). Therefore, this event(s) is considered not related