Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Electrocardiogram, Hypotension, Insomnia, Listless
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 28-Sep-2018 from a consumer. This case involves a 91 years old male patient who experienced hypo-tension, systemic inflammatory response syndrome, had chills, diabetes (chronic), acute kidney injury with creatininee of 1.8, he  couldnt sleep, he was Tachyin the 140 s & BP Systolic in the 90 s, lost ability to get up from the chair, became listless, pale with clammy skin and adverse reaction to vaccine, while he received vaccine FLUZONE HIGH DOSE. The patient had the regular flu shot in the past and never had a reaction. Prior in June 2018 creatinine was 1.3. The patients other past medical history, concomitant medications (s), vaccination(s) and family history were not provided. On 26-Sep-2018 at 11:30 am, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a diabetes (chronic) (diabetes mellitus), serious systemic inflammatory response syndrome (systemic inflammatory response syndrome) (Unknown latency) and serious acute kidney injury with creatininee of 1.8 (acute kidney injury) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. On an unknown date, the patient developed a non-serious hypo-tension (hypotension) and had chills (chills) (couple of hours later), he  couldnt sleep (insomnia), he was Tachyin the 140 s & BP Systolic in the 90 s (tachycardia), lost ability to get up from the chair (dysstasia), became listless (listless), pale (pale), clammy skin (clammy) and adverse reaction to vaccine (adverse reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Latency was unknown. The patient went to ER due to events. Other relevant tests included was ECG, BG, Cultures, CXR patchy and CT scan was normal. In ER - systolic BP dropped to 81. Final diagnosis was adverse reaction to vaccine, clammy skin, pale, became listless, lost ability to get up from the chair, his vitals he was tachycardia in the 140 and blood pressure systolic in the 90, he couldnt sleep, acute kidney injury with creatinine of 1.8, diabetes (chronic), had chills, systemic inflammatory response syndrome and hypo-tension. The patient was treated with PARACETAMOL (TYLENOL), CODEINE PHOSPHATE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRY CODEIN) and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) and bolus 1000 cc NS (normal Saline). The patient outcome is unknown for the events. List of documents held by sender: none.; Sender's Comments: This case involves an elder patient who developed reported events following vaccination with Fluzone HD. Time to onset is compatible with the role of vaccine. The patient had the regular flu shot in the past and never had a reaction. Additional information including patients significant medical history, condition at the time of vaccination, details of previous administered flu vaccines, any other concomitant therapies, lab test ruling out other infectious etiology is missing for further assessment of the case. Based on limited information available, the role of vaccine cannot be assessed.