Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deafness, Ear disorder, Rhinorrhoea
Clinical narrative: developed water in right ear, tried to clear the water out of ear, the water in right ear was sloshing and squealing; The patient says that the water loosened and came out through her nose several days; hearing loss; This spontaneous case was reported by a nurse and describes the occurrence of DEAFNESS (hearing loss) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (First dose, Lot number 032M20A expiration date is not known, Right arm of administration Patient reported Adverse Reactions of tired, washed out, sore right arm.) on 06-Mar-2021, Moderna Covid-19 vaccine (Second dose, Lot number 031A21A expiration date is not known. Right Arm of administration Patient reported Adverse Reactions of tired, wiped out, went to bed for a couple of days) on 03-Apr-2021, Moderna Covid-19 vaccine (First booster dose, Lot number 017F21A expiration date is not known, right arm of administration Patient reported Adverse Reactions of really tired.) on 23-Dec-2021, Moderna Covid-19 vaccine (Second booster dose, Lot number 059M21A expiration date is not known, right arm of administration Patient reported Adverse Reactions of a sore right arm and and patient was tired.) on 21-May-2022. Past adverse reactions to the above products included Adverse reaction with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On 17-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. In October 2022, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant) and RHINORRHOEA (The patient says that the water loosened and came out through her nose several days). On 18-Oct-2022, the patient experienced EAR DISORDER (developed water in right ear, tried to clear the water out of ear, the water in right ear was sloshing and squealing). At the time of the report, DEAFNESS (hearing loss), EAR DISORDER (developed water in right ear, tried to clear the water out of ear, the water in right ear was sloshing and squealing) and RHINORRHOEA (The patient says that the water loosened and came out through her nose several days) 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.   Concomitant drugs were not reported.  It was reported that the water in patient's right ear was sloshing and squealing to the point where patient's partner could hear the water. It was also reported that patient was going to see the ENT on 07-Nov-2022.  Treatment medications were not provided.  Company Comment: This spontaneous case concerns a 69-year-old female patient, with medical history of adverse reactions after each COVID-19 vaccination,  who experienced the unexpected and serious (medically significant) event of Deafness (reported as hearing loss).  The event occurred on an unknown date after fifth dose of mRNA-1273.222, thus, latency between the event onset and fifth dose vaccination cannot be assessed. The event was described along with two unexpected non-serious events of ear disorder  and rhinorrhea (which were reported as "developed water in right ear, tried to clear the water out of ear, the water in right ear was sloshing and squealing, water loosened and came out through nose several days"). Ear disorder occurred 1 day after the vaccination with mRNA-1273.222, while the exact onset date of rhinorrhea is unknown. The patient planned ENT consultation due to the events. Previous COVID-19 vaccination history included vaccination with mRNA-1273 (primary series and 2 booster doses) with reported adverse events, but none of them included a similar event (fatigue and pain in extremity were reported for first and fourth dose, and fatigue for second and third dose). No further information was provided. The outcome of all events was unknown at the time of the report. Additional information has been requested. The benefit-risk relationship of mRNA-1273.222 is not affected by this report. Event's seriousness was assessed as per the European Medicines Agency list of important medical events.   This case was linked to MOD-2022-663104, MOD-2022-663113, MOD-2022-663121, MOD-2022-663126 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with medical history of adverse reactions after each COVID-19 vaccination,  who experienced the unexpected and serious (medically significant) event of Deafness (reported as hearing loss).  The event occurred on an unknown date after fifth dose of mRNA-1273.222, thus, latency between the event onset and fifth dose vaccination cannot be assessed. The event was described along with two unexpected non-serious events of ear disorder  and rhinorrhea (which were reported as "developed water in right ear, tried to clear the water out of ear, the water in right ear was sloshing and squealing, water loosened and came out through nose several days"). Ear disorder occurred 1 day after the vaccination with mRNA-1273.222, while the exact onset date of rhinorrhea is unknown. The patient planned ENT consultation due to the events. Previous COVID-19 vaccination history included vaccination with mRNA-1273 (primary series and 2 booster doses) with reported adverse events, but none of them included a similar event (fatigue and pain in extremity were reported for first and fourth dose, and fatigue for second and third dose). No further information was provided. The outcome of all events was unknown at the time of the report. Additional information has been requested. The benefit-risk relationship of mRNA-1273.222 is not affected by this report. Event's seriousness was assessed as per the RA list of important medical events.