Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | AU3834B | — |
reduced hearing loss/ down to about 90% where it was around 50%/right ear; long-term COVID; got covid; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear), POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Niacin. Past adverse reactions to the above products included Drug allergy with Niacin. Concurrent medical conditions included Cancer, Heart disease, unspecified and Drug allergy (Reaction to Niacin). On 28-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. In 2024, the patient experienced POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid). On an unknown date, the patient experienced HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear). At the time of the report, HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear) had not resolved and POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid) outcome was unknown. Concomitant medications were not reported. It was reported that patient have had more vaccines but was reluctant ever since the symptoms happened. Patient's her current symptom was still reduced hearing loss. It was down to about 90% where it was around 50%. It was her right ear that went down, and the other ear didn't go down, her left ear. Patient went to have a flu shot and they had her fill out a form that said if had a reaction to "Niacin. Patient said she had a reaction to this, and they said they could not administer it so she got it done at her doctor's office. It was reported that her reaction was not pertaining to COVID or the flu, it was just. Patient confirmed that her doctor did end up administering the flu vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.
Cancer; Drug allergy (Reaction to Niacin)
Medical History/Concurrent Conditions: Heart disease, unspecified