Sex: F
Vaccine: FLUX
Symptoms: Diabetic ketoacidosis, SARS-CoV-2 antibody test negative, Type 1 diabetes mellitus, Urine ketone body present
Clinical narrative: Diabetic ketoacidosis; Chest pain; Diabetes Mellitus Type 1; This clinical trial case from country, initially received on 12-Mar-2024 with additional information received on 22-Mar-2024 (processed together), was reported by a health professional and concerns an elderly female subject. Weight: 58.96 kg; Height: 152.4 cm  The subject was enrolled in the study   Past medical history included Deep Vein Thrombosis to left lower extremity. At the time of the event the subject had Heartburn, High Cholesterol, Pre-diabetes, Anxiety, Bipolar, Osteopenia. Concomitant medications included Crestor (rosuvastatin calcium) for high cholesterol, Prevacid (lansoprazole) for heartburn and lithium carbonate for bipolar. The subject's historical vaccine included influenza prophylaxis vaccine (brand not specified) received on an unspecified date in Oct-2022, for unreported indication. The subject's last menstrual period was in 2005..  Administration of company suspect drug: On 12-Dec-2023, at 12:56, the subject was vaccinated with the blinded study vaccine aQIVc HD vs QIVr vs aQIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid) for prophylaxis of influenza. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 24-Feb-2024, 75 days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV, the subject experienced diabetic ketoacidosis (DKA). The subject was admitted to the hospital. On the same date, the result of the anion gap was 27 (high), the result of carbon dioxide (CO2) was 15 (low), and urinalysis showed ketones in urine. The subject must have developed type one diabetes prior to hospitalization for diabetic ketoacidosis and this indicated a new type one diabetes diagnosis. The subject had never been on insulin or had taken an antidiabetic medications.  On unspecified date in Feb-2024, the subject tested for COVID antibodies, and the lab results were negative. There was no positive COVID diagnosis. Confirmatory type 1 labs (antibodies) pending.  On 28-Feb-2024, the subject recovered from the event of diabetic ketoacidosis and was discharged home on insulin glargine 35 units qd subcutaneously, insulin lispro ten units tid subcutaneously, and metformin 500 mg bid orally all received for diabetic ketoacidosis.   On 07-Mar-2024, 87 days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV, the subject experienced chest pain and hyperglycemia. The subject called 911 due to chest pain. The subject reported medics did accucheck and blood glucose was 435. The subject was hospitalized.   On 10-Mar-2024, after three days, the subject recovered from the event of chest pain and was discharged from the hospital.  At the time of follow up reporting, on 25-Mar-2024, the subject had not recovered from the event of 'type 1 diabetes mellitus'.  Reporter's assessment: The Investigator assessed the event of diabetic ketoacidosis as severe and the event of chest pain as moderate, both serious due to the seriousness criteria of hospitalization and life-threatening, and the event of 'type 1 diabetes mellitus' as moderate and non-serious adverse event of special interest (AESI). The Investigator reported that it was possible that IP contributed to hospitalization with DKA, but most likely it was from COVID. The events of diabetic ketoacidosis and 'type 1 diabetes mellitus' were assessed as possibly related to the study vaccine and the alternative cause for the event of diabetic ketoacidosis was reported as concomitant disease, for the events of chest pain and 'type 1 diabetes mellitus' was reported as other.  The subject remained blinded in the study.  Additional information was received on 25-Mar-2024: Blinding status was broken by the Sponsor. No changes in the narrative.   Additional information was received on 25-Mar-2024 with additional information received on 26-Mar-2024 (being processed together) from Investigator: Pre-diabetes added as historical condition. Metformin was added as a treatment medication. Stop date was added as '28-Feb-2024', hospitalization end date was updated from '29-Feb-2024' to '28-Feb-2024', life-threatening criterion was added, and AESI criterion was removed for the event of 'diabetic ketoacidosis'. Intensity added as 'moderate', stop date added as '10-Mar-2024', outcome updated from 'Not reported' to 'Recovered / Resolved', life-threatening criterion added, and As Reported Causality changed form 'related' to 'not related' for the event of chest pain. The event of 'hyperglycaemia' removed. The event of 'Type 1 diabetes mellitus' added. Four lab findings were added. Alternative cause for the events was added. Narrative and case comment were amended accordingly.  Additional information was received on 28-Mar-2024 from Investigator: On Patient tab, onset date for medical condition of pre-diabetes added and amended from historical condition to current condition. Narrative was amended accordingly.   Additional non-significant  information was received on 03-Apr-2024 from Investigator: Verbatim of historical condition Deep vein thrombosis updated to Deep Vein Thrombosis to left lower extremity. Anxiety, bipolar and osteopenia added as current condition. Lithium carbonate added as concomitant. Treatment medication insulin recoded to insulin glargine and treatment medication insulin lispro added. Dosage regimen, indication and route of administration added for all treatment medications. Narrative was amended accordingly.   Additional information was received on 05-Apr-2024 from Investigator: The Investigator reported that it was possible that IP contributed to hospitalization with DKA, but most likely it was from COVID. Confirmatory type 1 labs (antibodies) pending. The reporter noted the patient had a history of pre-diabetes, so this was a new diabetes diagnosis (Dx). Narrative was amended accordingly.; Reporter's Comments: A 68-year-old subject developed diabetic ketoacidosis and was hospitalized 75 days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV. Ketoacidosis was suspected to have developed due to new onset diabetes mellitus type I. After five days the subject was discharged from the hospital. The subject also experienced chest pain, and was hospitalized again, 87 days after vaccination. After three days the subject was discharged from the hospital. Concurrent condition was significant for pre-diabetes (unspecified time prior to event onset). Laboratory data was pending at time of the report. The subject received an influenza vaccine one year prior, without events reported. The Investigator assessed the events of Diabetic ketoacidosis and Type 1 diabetes mellitus as possibly related to the study vaccine, but for the event of diabetic ketoacidosis alternative cause was reported as concomitant disease. The Investigator reported that it was possible that study vaccine contributed to hospitalization with DKA, but most likely it was from COVID (however discrepantly reported that there was no positive COVID diagnosis). As per investigator chest pain was not related. In line with investigator's assessment the sponsor considers chest pain as not related due to implausible temporal relationship. The Sponsor assessed the events Diabetic ketoacidosis and Type 1 diabetes mellitus as possibly related to the study vaccine with the currently available information. Patient had pre-diabetes, high cholesterol and was overweight which are confounding factors.