Received Mar 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Chills; Fever; Shaking; Seborrhea/increased inflammatory disease/Seborrhea flares; Seborrhea/increased inflammatory disease/Seborrhea flares; Dry eyes; Epidural abscess; Adult patient received 1 ml dose; MSSA bacteremia; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), TREMOR (Shaking), SEBORRHOEA (Seborrhea/increased inflammatory disease/Seborrhea flares), CONDITION AGGRAVATED (Seborrhea/increased inflammatory disease/Seborrhea flares), DRY EYE (Dry eyes), EXTRADURAL ABSCESS (Epidural abscess) and STAPHYLOCOCCAL BACTERAEMIA (MSSA bacteremia) in a 55-year-old male patient who received mRNA-1283 (MNEXSPIKE 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. No Medical History information was reported. On 12-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced EXTRADURAL ABSCESS (Epidural abscess) (seriousness criteria hospitalization and medically significant) and STAPHYLOCOCCAL BACTERAEMIA (MSSA bacteremia) (seriousness criterion medically significant). On 12-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced OVERDOSE (Adult patient received 1 ml dose). On 14-Oct-2025, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and TREMOR (Shaking) (seriousness criterion hospitalization). In October 2025, the patient experienced SEBORRHOEA (Seborrhea/increased inflammatory disease/Seborrhea flares) (seriousness criterion hospitalization), CONDITION AGGRAVATED (Seborrhea/increased inflammatory disease/Seborrhea flares) (seriousness criterion hospitalization) and DRY EYE (Dry eyes) (seriousness criterion hospitalization). At the time of the report, CHILLS (Chills), PYREXIA (Fever), TREMOR (Shaking), SEBORRHOEA (Seborrhea/increased inflammatory disease/Seborrhea flares), CONDITION AGGRAVATED (Seborrhea/increased inflammatory disease/Seborrhea flares), DRY EYE (Dry eyes), EXTRADURAL ABSCESS (Epidural abscess) and STAPHYLOCOCCAL BACTERAEMIA (MSSA bacteremia) had not resolved and OVERDOSE (Adult patient received 1 ml dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: elevated. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that post vaccination the patient experienced at 48 hours chills, fever, severe shaking; at 2 weeks increased inflammatory disease (seborrhea and new onset severe dry eyes). The seborrhea flares resulted in an MSSA bacteremia and epidural abscess, and the dry eye disease has never been resolved. It was reported that for the patient CRP remains elevated after 6 weeks of antibiotics and 8 weeks of follow-up. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Name: CRP; Result Unstructured Data: elevated