Age: 58.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Both arms hurt for 3 days; Ringing in his ears came back like gang busters; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in his ears came back like gang busters) and PAIN IN EXTREMITY (Both arms hurt for 3 days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (Both arms hurt for 3 days). In November 2021, the patient experienced TINNITUS (Ringing in his ears came back like gang busters). On 06-Nov-2021, PAIN IN EXTREMITY (Both arms hurt for 3 days) had resolved. At the time of the report, TINNITUS (Ringing in his ears came back like gang busters) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication details were provided.   No Treatment medication details were provided.  Reporter stated that he didn't have any adverse effects after the second shot. 7 months later on 03NOV2021 he received his booster shot.  Just like the first shot, exactly one week after receiving the booster shot the ringing in his ears "came back on like gang busters".  That's awful and so pronounced. He stated that he has been trying to determine what could be causing it. He thought maybe he had eaten something, but he can not link it to anything other than the vaccine.  He stated that  he also received the flu vaccine that day and both arms hurt for three days after receiving the injections.  The flu shot was given in his right arm. He states the ringing is only in one ear and he can not turn his hearing aid up enough to drown out the ringing.    Company Comment: This case concerns a 58-year-old male patient with no relevant medical history, who experienced the unexpected events of Pain in Extremity and Tinnitus. The event occurred around the same month after receiving the third dose of mRNA-1273 Vaccine and Co-Suspect Influenza Vaccine. The rechallenge was not applicable s   This case was linked to MOD-2021-060106 (Patient Link).; Sender's Comments: This case concerns a 58-year-old male patient with no relevant medical history, who experienced the unexpected events of Pain in Extremity and Tinnitus. The event occurred around the same month after receiving the third dose of mRNA-1273 Vaccine and Co-Suspect Influenza Vaccine. The rechallenge was not applicable since the event Tinnitus happened on the first dose however did not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.