Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Amylase normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal
Clinical narrative: Vertigo; Initial information received on 10-Sep-2024 regarding an unsolicited valid  serious courtesy case received from a physician.  This case involves a 68 years old female patient (83.8 kg) who had vertigo after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical history included Postmenopause in 2007 with Current Condition. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Hypertension on 10-NOV-2010 with Current Condition, Type 2 diabetes mellitus on 14-NOV-2012 with Current Condition, Obesity with Current Condition and Chronic obstructive pulmonary disease on 10-NOV-2010 with Current Condition.  Concomitant medications included Hydrochlorothiazide (Hydrochlorothiazide); Amlodipine (Amlodipine); Insulin human (Humulin r); Aspirin and Tozinameran (Pfizer BioNTech COVID-19 vaccine).  On 12-Oct-2023, the patient received a  dose of 0.7 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot UT8079BA via intramuscular route in unknown administration site. On 12-Oct-2023 she also received a  dose of vaccine  with an unknown batch number via intramuscular route in unknown administration site. for prophylactic vaccination (Immunization)  On 21-OCT-2023 the patient developed a serious vertigo 9 days following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. The patient was hospitalized for this event. Relevant laboratory test results included: Activated partial thromboplastin time - In October 2023:  [normal] Alanine aminotransferase - In October 2023:  [normal] Amylase - In October 2023:  [normal] Aspartate aminotransferase - In October 2023:  [normal] Blood alkaline phosphatase - In October 2023:  [normal] Blood chloride - In October 2023: 106  Blood creatinine - In October 2023: 2.10  Blood glucose - In October 2023: 281  Blood potassium - In October 2023: 4.7  Blood pressure measurement - On 21-Oct-2023: 205/102 [205/102, elevated]; in October 2023: 132/76. Blood sodium - In October 2023: 137  Blood urea - In October 2023: 30  Body temperature - On 21-Oct-2023: 96.6  Brain natriuretic peptide - In October 2023:  [normal] Carbon dioxide - In October 2023: 19  Computerised tomogram head - On 22-Oct-2023:  [no acute intracranial abnormality]; on 24-Oct-2023:  [1. no large vessel occlusion or visible aneurysm along the major intracranial arteries.There were areas of calcific atherosclerosis along the cavernous and clinoid segmentsof the bilateral internal carotid arteries (ICAs) with areas of moderate stenosis along thecavernous segments and up to moderate to severe stenosis along the clinoid segmentsbilaterally. The remainder of the major intracranial arteries were grossly normal incaliber.2. Trace bilateral mastoid fluid. This may have reflected Eustachian tube dysfunction,however, correlate clinically to exclude the possibility of mastoiditis in the appropriateclinical setting.] Echocardiogram - In October 2023:  [findings are consistent with hypertensive heart disease] Glomerular filtration rate - In October 2023: 28  Haemoglobin - In October 2023: 12.3  Heart rate - On 21-Oct-2023: 103 ; in October 2023: 87  Lipase - In October 2023:  [normal] Myocardial necrosis marker - In October 2023:  [normal] Oxygen saturation - On 21-Oct-2023: 92 %; in October 2023: 95 % Platelet count - In October 2023: 586  Prothrombin time - In October 2023:  [normal] Respiratory rate - On 21-Oct-2023: 22  Troponin - In October 2023:  [normal] Ultrasound kidney - On 27-Oct-2023:  [left renal cysts, no hydronephrosis] White blood cell count - In October 2023: 17.8   Reportedly "Her chiefcomplaints included nausea, vomiting, diarrhea and dizziness. She denied abdominal pain. The subject had prior ER visits for nauseaand vomiting. The subject was admitted to the hospital with admitting diagnosis of vertigo ambulatory dysfunction. "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Vertigo).  At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2023 for the event vertigo.  On 01-NOV-2023, the subject was discharged from the hospital with prescribed oral meclizine 25 mg as needed indicated for vertigoprophylaxis.   Follow-up visit with primary care physician was recommended in 2-3 days. Blood pressure medications were unchangedat discharge (no worsening of blood pressure control).   No new BP medicines were prescribed.On 30-APR-2024, the subject completed the study.  The investigator assessed the event, vertigo, as related to Fluzone HD+ mRNA-1345 + placebo, and not related to the procedure.   Asper the investigator, it was a precautionary decision to mark this event as related to investigational product (IP), furthermore medicalrecords were pending.  Follow-up received on 28-NOV-2023 included updated causality assessment to study drug (from not related to related) with rationalefor this assessing and procedure (from related to not related). AESI criterion was updated to non-AESI and event term updated fromworsening vertigo to vertigo.  Follow-up received on 04-JAN-2024 included updated event onset date, event stop date, event outcome, date of hospital discharge,event treatment, laboratory tests, action taken with study drug and medical history.  Follow-ups received on 24-JAN-2024 included results of CT brain without contrast and renal US, added circumstances leading toaction taken with study drug, updated medical history of COPD.  Follow-ups received on 01-FEB-2024 clarified that stool culture was not performed and that the subject did not have renal failurebased on lab results.  Follow-up received on 07-FEB-2024 included updated medical history of the subject and action taken with suspected drug.  Follow-up received on 26-FEB-2024 included updated concomitant medication details (dose of insulin human), added date of dosingdiscontinuation.  Follow-up received on 16-APR-2024 included updated the subject's medical history details (obesity).  Follow-up received on 08-MAY-2024 included new information about the study completion.  Follow-up received on 08-JUL-2024 included updated treatment details (meclizine continuation).; Sender's Comments: Sanofi Company Comment dated 10-Oct-2024 : This case involves a 68-year-old female patient (83.8 kg) who had vertigo after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD].Further information regarding Past medical treatment, vaccination excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. Further, the patient medical history would be cofounding factor for this event.