Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Deafness bilateral, Ear discomfort, Ear haemorrhage, Ear infection fungal, Ear pain
Clinical narrative: Left year shut down as well; Fungus infection on the ear; Lost hearing from the right ear; This spontaneous case was received on 18-Nov-2020 from other non-health professional (consumer)(reference number: SEQW20-05250) concerned a 68-year-old, male patient.  The patient's concurrent conditions included high blood pressure, pain problems, foot neuropathy and insomnias. The patient's concomitant medications included lisinopril, Percocet (oxycodone hydrochloride; paracetamol), Lyrica (pregabalin) and Ativan (lorazepam) all for an unreported indication.  On 30-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right arm and route of administration: not reported) for influenza prophylaxis. The batch number reported was 283850.  On an unspecified date in Oct-2020, four/five days after receiving Flucelvax QIV, the patient started started feeling tickling in the ear.  On an unspecified date in Oct-2020, one week after receiving Flucelvax QIV, the patient visited a doctor because he had ear pain, blood coming from ear and drainage. The patient was diagnosed with hear infection in his right ear (same side where he received the flu shot, in the right arm) and for that the doctor prescribed antibiotics for three weeks.  On an unspecified date in Oct-2020 (three weeks ago as reported), after receiving Flucelvax QIV, the patient lost hearing from the right ear.   On 08-Nov-2020, reported as ten days ago, the ear doctor collected some draining/fluid from his ear, since the patient did not get any better. The culture revealed the patient had a fungus infection on the ear. The doctor gave him seven days dose of Diflucan (fluconazole) and recommended to clean the ear with vinegar and distilled water. The patient did not get any better after it.   On 17-Nov-2020, reported as last night, the patient's left ear shut down as well. In a scale from 1 - 10, his hearing capacity is at one.  At the time of initial reporting on 18-Nov-2020, the patient had not recovered from the events, the patient reported worsening.  The reporter did not provide causality assessment.  The events of 'ear infection fungal', 'deafness right ear' and 'deafness both ear' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 68-year-old, male patient was administered Flucelvax QIV. Approximately one week after receiving Flucelvax QIV, the patient was diagnosed with hear infection in his right ear and treated with antibiotics. The patient lost hearing from the right ear. The ear doctor collected some draining from his ear, since the patient did not get any better. The culture revealed the patient had a fungus infection on the ear. The patient developed hearing loss in left ear as well. For the events of ear infection fungal, causality is assessed as not related due to biological implausibility. Deafness unilateral and deafness bilateral are assessed as not related since was likely associated with fungal ear infection.; Sender's Comments: A 68-year-old, male patient was administered Flucelvax QIV. Approximately one week after receiving Flucelvax QIV, the patient was diagnosed with hear infection in his right ear and treated with antibiotics. The patient lost hearing from the right ear. The ear doctor collected some draining from his ear, since the patient did not get any better. The culture revealed the patient had a fungus infection on the ear. The patient developed hearing loss in left ear as well. For the events of ear infection fungal, causality is assessed as not related due to biological implausibility. Deafness unilateral and deafness bilateral are assessed as not related since was likely associated with fungal ear infection.