Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Severe sinus infection with green mucous and some came out of the ear; Tinnitus; She could not swallow; Hearing loss in the left ear/ have some hearing loss in the right ear as well but not like the left; COVID 19; Nerve is dead; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS BILATERAL (Hearing loss in the left ear/ have some hearing loss in the right ear as well but not like the left), NERVE INJURY (Nerve is dead) and SINUSITIS (Severe sinus infection with green mucous and some came out of the ear) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID 19). On 08-Jul-2023, the patient experienced DEAFNESS BILATERAL (Hearing loss in the left ear/ have some hearing loss in the right ear as well but not like the left) (seriousness criterion medically significant). In July 2023, the patient experienced NERVE INJURY (Nerve is dead) (seriousness criterion medically significant). On an unknown date, the patient experienced SINUSITIS (Severe sinus infection with green mucous and some came out of the ear) (seriousness criterion medically significant), TINNITUS (Tinnitus) and DYSPHAGIA (She could not swallow). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency and DOXYCYCLINE for Infection, at an unspecified dose and frequency. At the time of the report, DEAFNESS BILATERAL (Hearing loss in the left ear/ have some hearing loss in the right ear as well but not like the left), NERVE INJURY (Nerve is dead), SINUSITIS (Severe sinus infection with green mucous and some came out of the ear), TINNITUS (Tinnitus) and COVID-19 (COVID 19) had not resolved and DYSPHAGIA (She could not swallow) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  On 13-Jan-2021, patient received 1st dose, lot -026L20A. On 19-Feb-2021, patient received 2nd dose, lot -029N20A. On 03-Nov-2021, patient received 3rd dose, lot -939906. On 10-May-2022, patient received 4th dose, lot -005M21A.  On 08-Jul-2023, hearing loss in the left ear started. Nerve was dead. Patient was audiology testing, had MRI and sees ENT. She experienced a severe sinus infection with green mucous and some came out of the ear. She was prescribed Paxlovid other medications as well as doxycycline and other drugs to fight infection. Patient was inquiring if Spikevax had some COVID virus because COVID gave her the hearing loss and want to know if there was a reason for concern. Noise of being underwater, tinnitus, if she run a washing machine, or driving, she hears gurgling and bubbling, and it was constant. Patient had some hearing loss in the right ear as well but not like the left. Patient was not hospitalized but went to the ER because she could not swallow and made 8 visits to urgent care. Patient had in total 5 of vaccines caught COVID after cruise.  Company Comment  This is a Spontaneous case concerning a 80-year-old female patient with no relevant medical history reported, who experienced the serious (per medically significant) unexpected events of Sinusitis (Severe sinus infection with green mucous and some came out of the ear) Nerve injury and Deafness bilateral (Hearing loss in the left ear/ hearing loss in the right ear as well but not like the left) which occurred about 8 months after a dose of mRNA-1273 BIVALENT.222  received as the fifth dose for COVID-19 Vaccination. It was reported that the patient experienced COVID-19 infection and that 6 days later experienced severe sinus infection which was treated with Paxlovid and doxycycline, the patient reported symptoms of tinnitus and hearing loss and performed audiology testing, MRI and sees and ENT. COVID-19 remains as contributory for sinusitis, and sinusitis as contributory with hearing loss and nerve dead, all the events could be in connection.  Patient's advanced age also remains a confounder. The benefit-risk relationship of mRNA-1273 BIVALENT .222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-027289 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027289:Monovalent dose