Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Impaired work ability, Product dose omission issue, Tinnitus
Clinical narrative: Sounded like wind, so loud could not concentrate; Had to take a week off work; He never received the 2nd dose; High pitch ringing in the same ear of right arm injection site/ constant high pitch ring in the right ear; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (High pitch ringing in the same ear of right arm injection site/ constant high pitch ring in the right ear), DISTURBANCE IN ATTENTION (Sounded like wind, so loud could not concentrate), IMPAIRED WORK ABILITY (Had to take a week off work) and PRODUCT DOSE OMISSION ISSUE (He never received the 2nd dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced TINNITUS (High pitch ringing in the same ear of right arm injection site/ constant high pitch ring in the right ear). 29-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (He never received the 2nd dose). In 2021, the patient experienced DISTURBANCE IN ATTENTION (Sounded like wind, so loud could not concentrate) and IMPAIRED WORK ABILITY (Had to take a week off work). The patient was treated with GABAPENTIN for Ringing in ears, at a dose of 3 mg twice a day; ESCITALOPRAM OXALATE (LEXAPRO) at an unspecified dose and frequency; ALPRAZOLAM (XANAX) at an unspecified dose and frequency and DIAZEPAM (VALIUM) at a dose of UNK, prn. On 29-Dec-2020, PRODUCT DOSE OMISSION ISSUE (He never received the 2nd dose) had resolved. At the time of the report, TINNITUS (High pitch ringing in the same ear of right arm injection site/ constant high pitch ring in the right ear) had not resolved, DISTURBANCE IN ATTENTION (Sounded like wind, so loud could not concentrate) outcome was unknown and IMPAIRED WORK ABILITY (Had to take a week off work) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications also included unspecified multiple steroid doses and a hearing aid.  Patient visited ENTs and family doctor. The patient believed that the tinnitus was due to a autoimmune or inflammatory reaction from the vaccine. The patient stated that about a month ago he weened himself off the gabapentin for 4 days and the ringing came back louder so he resumed taking gabapentin.  This is a case of Product Dose Omission Issue concerning a 44-year-old male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Disturbance in Attention, and Impaired Work Ability. The events occurred the same day after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Product Dose Omission Issue concerning a 44-year-old male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Disturbance in Attention, and Impaired Work Ability. The events occurred the same day after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.