Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nasal congestion, Nervousness, Sleep disorder, Suicidal behaviour, Tension headache
Clinical narrative: altered sleep patterns; weak shaky legs; feel disassociated from body; nasal congestion; memory problem; upset stomach; flu-like symptoms; brain fog; suicidal comments; heaviness in her legs; nervousness; high anxiety; weakness in her legs; head burning sensation with intermittent tightening sensation/Headache; Initial information received on 05-Nov-2019 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 66 years old female patient who experienced brain fog (foggy feeling in head), suicidal comments (Suicidal behavior), heaviness in her legs (limb discomfort), nervousness (nervousness), high anxiety (anxiety), altered sleep patterns (sleep disorder), weak shaky legs (tremor), feel disassociated from body (dissociation), nasal congestion (nasal congestion), memory problem (memory impairment), upset stomach (abdominal discomfort), weakness in her legs (muscular weakness), head burning sensation with intermittent tightening sensation/headache (headache) and flu-like symptoms (influenza like illness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ25388 via unknown route in unknown administration site.  On 28-SEP-2019, the patient developed a serious brain fog (depressed level of consciousness) (Unknown latency) 1 hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On 28-SEP-2019, the patient developed a serious suicidal comments (Suicidal behavior) (Unknown latency) 1 hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On 28-SEP-2019, the patient developed a non-serious heaviness in her legs (limb discomfort), nervousness, high anxiety (anxiety), weakness in her legs (muscular weakness), head burning sensation with intermittent tightening sensation/headache (headache) 1 hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious altered sleep patterns (sleep disorder), weak shaky legs (tremor), feel disassociated from body (dissociation), nasal congestion, memory problem (memory impairment), upset stomach (abdominal discomfort) and flu-like symptoms (influenza like illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included No lab data.)  Final diagnosis was flu-like symptoms, suicidal comments, head burning sensation with intermittent tightening sensation/headache, weakness in her legs, upset stomach, memory problem, nasal congestion, feel disassociated from body, weak shaky legs, altered sleep patterns, high anxiety, nervousness, heaviness in her legs and brain fog.  The patient was treated with PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL [IBUPROFEN]) and MEPYRAMINE MALEATE, PARACETAMOL (EXCEDRIN P.M. [MEPYRAMINE MALEATE;PARACETAMOL]).  The outcome of the event was Unknown for all the events.; Sender's Comments: This case concerns 66 years old female patient who experienced foggy feeling in head, suicidal behavior, limb discomfort, nervousness, anxiety, sleep disorder, tremor, dissociation, nasal congestion, memory impairment, abdominal discomfort, muscular weakness, headache and influenza like illness after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible with the role of the vaccine for foggy feeling in head, limb discomfort, anxiety, muscular weakness and unknown for other events. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.