Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Deafness, Influenza like illness, Poor quality sleep
Clinical narrative: lost hearing in right ear; pretty severe flu like reaction; waking in the middle of the night; may have received the full dose instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing in right ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 016M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (he was taking blood pressure medication.) and Cholesterosis (he was taking cholesterol medications.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEAFNESS (lost hearing in right ear) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (pretty severe flu like reaction), POOR QUALITY SLEEP (waking in the middle of the night) and ACCIDENTAL OVERDOSE (may have received the full dose instead of the half dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DEAFNESS (lost hearing in right ear), INFLUENZA LIKE ILLNESS (pretty severe flu like reaction), POOR QUALITY SLEEP (waking in the middle of the night) and ACCIDENTAL OVERDOSE (may have received the full dose instead of the half dose) outcome was unknown.            No concomitant medication information was provided. It was reported that, it did not list on the card the dosage level for the booster of Moderna. They did not list the mL amount. They felt like because of his age and artery condition that was strange, hard to explain and undiagnosed, he wanted to be aggressive about getting the booster and the doctor agreed with him getting the dose at the time. They thought they may had received the full dose instead of the half dose because the booster dose was not out yet when he got the 3rd shot  Company comment: This case concerns a male patient, of unknown age, with no reported relevant medical history, who experienced unexpected, serious (medically significant) event of Deafness, unspecified days after receiving mRNA-1273 vaccine as a third dose.  Dose 1 and Dose 2 were given with a 28-day interval, with the second dose given approximately 6 months before receiving the third dose of mRNA-1273 vaccine.  The patient was started with Ibuprofen on an unspecified date, of unknown dose and frequency. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Follow up information was received on include no new information.; Sender's Comments: This case concerns a male patient, of unknown age, with no reported relevant medical history, who experienced unexpected, serious (medically significant) event of Deafness, unspecified days after receiving mRNA-1273 vaccine as a third dose.  Dose 1 and Dose 2 were given with a 28-day interval, with the second dose given approximately 6 months before receiving the third dose of mRNA-1273 vaccine.  The patient was started with Ibuprofen on an unspecified date, of unknown dose and frequency. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report