Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Intentional dose omission, Pain, Tinnitus
Clinical narrative: Not received the 2nd dose; Tinnitus in both ears/ Started to get significant tinnitus in both ears; Since receiving the vaccine, there is inflammation in body due to the antibodies being present; Weird pains showing up in my body; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus in both ears/ Started to get significant tinnitus in both ears), INFLAMMATION (Since receiving the vaccine, there is inflammation in body due to the antibodies being present), PAIN (Weird pains showing up in my body) and INTENTIONAL DOSE OMISSION (Not received the 2nd dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Ear injury. Concurrent medical conditions included Hearing loss (Some hearing loss in right ear from paintball injury).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced TINNITUS (Tinnitus in both ears/ Started to get significant tinnitus in both ears). 24-Feb-2021, the patient experienced INFLAMMATION (Since receiving the vaccine, there is inflammation in body due to the antibodies being present). In 2021, the patient experienced PAIN (Weird pains showing up in my body). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not received the 2nd dose). At the time of the report, TINNITUS (Tinnitus in both ears/ Started to get significant tinnitus in both ears) had not resolved, INFLAMMATION (Since receiving the vaccine, there is inflammation in body due to the antibodies being present) and PAIN (Weird pains showing up in my body) outcome was unknown and INTENTIONAL DOSE OMISSION (Not received the 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided.  No treatment medications were provided.  The patient felt the inflammation in body due to antibodies present and that the vaccine was in the patient's body. The suspected it as neurological which responded to antibodies and created side effects (inflammation).  After a month of event occurrence, the patient scaled tinnitus as 9 and 8 in right ear and left ear respectively.  After six months, the events were still considered as significant and scaled as 8 and 7 in right ear and left ear respectively. The patient had seen general physician and an ear nose and throat specialist.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non Significant Follow up Information- reporter's address was updated On 16-Aug-2021: Follow-up received -medical history was updated and event Weird pains showing up in my body was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.