Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
causing tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (causing tinnitus) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (causing tinnitus). At the time of the report, TINNITUS (causing tinnitus) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient probably took the same doses. These shots were causing tinnitus. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:For doctor