Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Pyrexia, Tinnitus, Vaccination site pain
Clinical narrative: Arthritis in left hand; insomnia; Now more than ever I'm scared; With less strength; headache; tiredness; After second dose he had a sore arm and fever for a while during the night; After second dose he had a sore arm and fever for a while during the night; Strong ringing in the left ear; Malaise in the right temple; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Strong ringing in the left ear), MALAISE (Malaise in the right temple), ARTHRITIS (Arthritis in left hand), INSOMNIA (insomnia) and FEAR (Now more than ever I'm scared) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced MALAISE (Malaise in the right temple). On an unknown date, the patient experienced TINNITUS (Strong ringing in the left ear), ARTHRITIS (Arthritis in left hand), INSOMNIA (insomnia), FEAR (Now more than ever I'm scared), ASTHENIA (With less strength), HEADACHE (headache), FATIGUE (tiredness), VACCINATION SITE PAIN (After second dose he had a sore arm and fever for a while during the night) and PYREXIA (After second dose he had a sore arm and fever for a while during the night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TINNITUS (Strong ringing in the left ear), MALAISE (Malaise in the right temple), ARTHRITIS (Arthritis in left hand), INSOMNIA (insomnia), FEAR (Now more than ever I'm scared), ASTHENIA (With less strength), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown and VACCINATION SITE PAIN (After second dose he had a sore arm and fever for a while during the night) and PYREXIA (After second dose he had a sore arm and fever for a while during the night) had resolved.            The patient was a veteran. No relevant concomitant medications were reported. Reportedly, the patient had first and second dose. After the second dose he had a sore arm and fever for a while during the night. One or two weeks after the second dose, the patient started with the ringing in his ear and headache, that came and go every 15-20 days. He did not pay much attention to it. But since July, the ringing and headache have been constant during the mornings, when everything was quiet. In the Hospital (where he worked and got the doses), he was diagnosed with Tinnitus. He was also diagnosed with arthritis in his left hand. Associated to the ringing in his ears, he had insomnia and he was tired. He also felt tiredness as a general corporal thing as well as with less strength. The patient also reported that he was scared more than ever.  The patient visited the otorhinolaryngologist and traumatologist in the same hospital where he worked. Action taken with mRNA-1273 in response to the events was not applicable. Reporter's causality assessment is not provided.   This case was linked to MOD-2021-334623 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 28 Sep 2021 with updated Address , Date of birth and age,gender,with updated start date and batch/lot numbers and anatomical site of suspect product, Treatment  is also added.; Sender's Comments: This case concerns a  53-year-old, male patient with no relevant medical history, who experienced the unexpected events of tinnitus, malaise, arthritis, insomnia, asthenia and fear, as well as expected events of pyrexia, headache, vaccination site pain and fatigue. The events of tinnitus and headache occurred approximately one or two weeks after the second dose of Moderna COVID-19 Vaccine. These events came and go every 15-20 days, however, since July, the ringing and headache have been constant during the mornings. The exact start date for the remaining events was not specified at the time of the report. The rechallenge was not applicable having in mind that the events developed after the second dose. The events pyrexia, headache, vaccination site pain and fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.