Sex: M
Vaccine: CHIK
Symptoms: Blood sodium decreased, Condition aggravated, Confusional state, Dehydration, Diabetic metabolic decompensation
Clinical narrative: Lethargy; Extreme confusion; Elevated heart rate; Fluid in lungs; Low sodium; Fever (103 - 39 degree Celsius); The following information was downloaded from VAERS official webpage on 08 Mar 2025.  A 86-year-old male vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) on 17 Dec 2024.   Concomitant medication included Levothyroxine, Aliskirn, Amlodipine, Januvia (sitagliptin), Glimepiride, Metformin, Ezetimibe, Rosuvastatin, Omeprazole, Baby Aspirin (acetylsalicylic acid) and Magnesium.  Past drug history included Lisinopril and Sudafed (pseudoephedrine-HCl).  On 20 Dec 2024 he experienced extreme lethargy. On day seven after vaccination extreme confusion started (he had no idea where he was, where his son went, etc.) He also experienced fever up to 103 (39 degree Celsius), elevated heart rate, fluid in lungs and low sodium. Therefore he was hospitalised for seven days.   The outcome of all events was reported as not resolved by time of report to VAERS.; Sender's Comments: Company causality assessment: This case refers to a 86-year-old male vaccinee for whom no medical history was reported. The male vaccinee was treated for (not provided, derived from medication assuming correct indication): hypothyroidism, essential high blood pressure, primary hypercholesteremia,  type II diabetes, atherosclerosis, reflux. No information on his general condition and well-being prior to the vaccination. Concomitant medication included Levothyroxine, Aliskirn, Amlodipine, Januvia (sitagliptin), Glimepiride, Metformin, Ezetimibe, Rosuvastatin, Omeprazole, Baby Aspirin (acetylsalicylic acid) and Magnesium. Information on the dosage of the concomitant medication is missing. Confusion and mood changes have been reported for Amlodipine and Omeprazole in particular, and the advanced age of the vaccinee may also play a role here. He was vaccinated with IXCHIQ (live attenuated viral vaccine) on 17DEC2024. Indication for vaccination, e.g. planned travel not provided. 2-3 days after vaccination (20DEC2024), the patient started with "extreme" lethargy and developed 7 days post-vaccination "extreme" confusion and was admitted to hospital on 24DEC2024, where he stayed for 7 days. Pyrexia (103 F), increased heart rate and pulmonary oedema were diagnosed and decreased blood sodium was measured, timing and severity of the latter three findings was not provided. No information on other findings nor on the therapy provided during the hospital stay. From the existing information the most likely underlying causation of the described symptoms is a dehydration after pyrexia with increased heart rate as general reactions to vaccination with probably a metabolic decompensation (diabetes) and renal excretion impact and interaction of a medication mix after relative accumulation. Pulmonary oedema and decreased blood sodium were reported without timing nor severity (possible impact of rapid re-hydration). Causation of pyrexia and dehydration possible. Outcome: At the time of leaving hospital / report completed on 31DEC2024 judged as "not recovered" without further specification on the condition.