Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness neurosensory, Deafness unilateral, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: diagnosed with sudden sensoineural hearing loss in her right ear; vertigo goes and comes, mostly feels in the morning; she had a sore throat, and then lost her hearing; achy and tired and slept for 2 hours; muscle pain, achy and tired and slept for 2 hours; Initial information received on 25-Sep-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 48 years old female patient who experienced diagnosed with sudden sensoineural hearing loss in her right ear, vertigo goes and comes, mostly feels in the morning, she had a sore throat, and then lost her hearing, achy and tired and slept for 2 hours and muscle pain, achy and tired and slept for 2 hours, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s) and family history were not provided. The patient's past vaccination(s) included flu vaccine. The patient's had no concomitant medications.  On 21-Sep-2019, the patient received a dose  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left arm.  The patient developed a serious diagnosed with sudden sensoineural hearing loss in her right ear (deafness) <<Unknown latency>> following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient developed a non-serious vertigo goes and comes, mostly feels in the morning (vertigo) <<Unknown latency>> following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious she had a sore throat, and then lost her hearing (oropharyngeal pain) <<Unknown latency>> following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious achy and tired and slept for 2 hours (fatigue) <<Unknown latency>> following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious muscle pain, achy and tired and slept for 2 hours (myalgia) <<Unknown latency>> following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was muscle pain, achy and tired and slept for 2 hours, achy and tired and slept for 2 hours, she had a sore throat, and then lost her hearing, vertigo goes and comes, mostly feels in the morning and diagnosed with sudden sensoineural hearing loss in her right ear.    The patient was treated with PREDNISONE (PREDNISONE).  The patient outcome is reported as Unknown for vertigo goes and comes, mostly feels in the morning, as Recovered / Resolved on an unknown date for achy and tired and slept for 2 hours, as Unknown for she had a sore throat, and then lost her hearing, as Not Recovered / Not Resolved on an unknown date for diagnosed with sudden sensoineural hearing loss in her right ear and as Recovered / Resolved on an unknown date for muscle pain, achy and tired and slept for 2 hours.; Sender's Comments: This case concerns a 42 year old female patient who presented with vertigo which goes and comes, had sore throat, diagnosed with sudden sensoineural hearing loss in her right ear and muscle pain, achy, tired and slept for two hours after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Patient's medical history, condition at time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.