Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
sore back; ear muffled; vision faintness; headache; nausea; various joint pain/Knee; muscle aches; light headedness; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache) and NAUSEA (nausea) in a 17-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. On 21-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (various joint pain/Knee), MYALGIA (muscle aches) and DIZZINESS (light headedness). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (various joint pain/Knee), MYALGIA (muscle aches) and DIZZINESS (light headedness) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that patient experienced nausea, headache, sore back, knees, ear muffled, various joint pain, muscle aches, vision faintness (light headedness). It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.