Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; after receiving the 2023 dose patient began a 1 and half year battle with sickness; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced ILLNESS (after receiving the 2023 dose patient began a 1 and half year battle with sickness). On an unknown date, the patient experienced INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues). At the time of the report, INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) had not resolved and ILLNESS (after receiving the 2023 dose patient began a 1 and half year battle with sickness) outcome was unknown. Relevant medical history of the patient was reported as unknown. Concomitant product use was not provided by the reporter. It was reported that patient had sickness 2 weeks after receiving the vaccine on an unspecified date of Sep-2023. Patient was battling with sickness for 1 and a half year. Patient never had covid however vaccine had made him sick. At the time of the reporting patient was suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not provided. Reporter causality was not reported. This case was linked to MOD-2025-782987 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.