Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Vertigo
Clinical narrative: Caller states she normally has hearing loss; Caller states she normally has hearing loss, but it is worse; Increase in vertigo/The vertigo is also kind of weird; Ringing in ear the noise is so much more to where is uncomfortable/the ringing affecting both ears\ringing is louder and stronger than what  had experienced in the past/the ringing in ear is so much worse and the vertigo; Pain in her right ears which happens off and on; Had a fever of 103 degrees, and chills, which lasted for about 8 hours and was fine.; Had a fever of 103 degrees, and chills, which lasted for about 8 hours and  was fine.; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Caller states she normally has hearing loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears (Ringing is louder and stronger). Concurrent medical conditions included Hearing loss.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHILLS (Had a fever of 103 degrees, and chills, which lasted for about 8 hours and was fine.) and PYREXIA (Had a fever of 103 degrees, and chills, which lasted for about 8 hours and  was fine.). On an unknown date, the patient experienced DEAFNESS (Caller states she normally has hearing loss) (seriousness criterion medically significant), HYPOACUSIS (Caller states she normally has hearing loss, but it is worse), VERTIGO (Increase in vertigo/The vertigo is also kind of weird), TINNITUS (Ringing in ear the noise is so much more to where is uncomfortable/the ringing affecting both ears\ringing is louder and stronger than what  had experienced in the past/the ringing in ear is so much worse and the vertigo) and EAR PAIN (Pain in her right ears which happens off and on). In March 2021, CHILLS (Had a fever of 103 degrees, and chills, which lasted for about 8 hours and was fine.) and PYREXIA (Had a fever of 103 degrees, and chills, which lasted for about 8 hours and  was fine.) had resolved. At the time of the report, DEAFNESS (Caller states she normally has hearing loss), HYPOACUSIS (Caller states she normally has hearing loss, but it is worse), VERTIGO (Increase in vertigo/The vertigo is also kind of weird), TINNITUS (Ringing in ear the noise is so much more to where is uncomfortable/the ringing affecting both ears\ringing is louder and stronger than what  had experienced in the past/the ringing in ear is so much worse and the vertigo) and EAR PAIN (Pain in her right ears which happens off and on) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 degree celsius (High) 103 degree Celsius.         Concomitant medications were not reported.  After receiving second dose, about 22 hours patient had a fever of 103 degrees and chills which lasted for about 8 hours and patient was fine. The patient had a new strange side effect that had been gradually increasing, increase in vertigo and, ringing in ear; the noise is so much more to where is uncomfortable and reporter states that the patient normally has a hearing loss, but it is worse the ringing in ear is so much worse and the vertigo. Patient had not seen doctor and the ringing affecting both ears but had pain in her right ears which happens off and on. Ringing was louder and stronger than what patient had experienced in the past.  Treatment medications were not reported.  Company Comment : This case concerns a  66 year old female patient with medical history of hearing loss and ringing in ears, who experienced the unexpected event of deafness. The event deafness occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. Patient's history of hearing loss is a confounder. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-324335 (Patient Link).; Sender's Comments: This case concerns a  66 year old female patient with medical history of hearing loss and ringing in ears, who experienced the unexpected event of deafness. The event deafness occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. Patient's history of hearing loss is a confounder. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.