Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052155 | IM |
rash; severe headache; fatigue; fever; arm swelling/swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling/swelling), RASH (rash), HEADACHE (severe headache), FATIGUE (fatigue) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052155) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052155) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: MNEXSPIKE PFS (Dose 1) on 08-Sep-2025. Past adverse reactions to the above products included No adverse effect with MNEXSPIKE PFS. On 25-Mar-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 26-Mar-2026, the patient experienced PERIPHERAL SWELLING (arm swelling/swelling), HEADACHE (severe headache), FATIGUE (fatigue) and PYREXIA (fever). On 27-Mar-2026, the patient experienced RASH (rash). On 27-Mar-2026, PYREXIA (fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swelling/swelling), RASH (rash), HEADACHE (severe headache) and FATIGUE (fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2026, Body temperature: 101 degree Fahrenheit. Concomitant medication was not provided. It was reported that within 12 hours of vaccination, patient developed a fever. She also experienced other symptoms which interfered with her ability to perform daily activities. On the third day, she developed a rash along with the swelling and a picture was provided. It was stated that none of these symptoms had occurred following her previous dose of mNEXSPIKE administered on 08-Sep-2025. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Date: 20260326; Test Name: body temperature; Result Unstructured Data: 101 degree Fahrenheit