Received Sep 26, 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 | — | — |
injection site pain; muscle aches; Joint aches; headache; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache) and NAUSEA (nausea) in a 34-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. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 20-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram and dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with Naproxen (oral use) from 21-Sep-2025 to 22-Sep-2025 for Vaccination site pain, Muscle ache and Joint ache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) 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. No concomitant medications provided by the reporter. It was reported that patient was received influenza vaccine at the same time of Moderna COVID-19 vaccination in the opposite arm. It was reported that the patient experienced symptom of injection site pain after vaccination followed by muscle and joint aches, headache, nausea and fatigue. The Patient took treatment medication of Naproxen orally on 21-Sep-2025 and 22-Sep-2025 for symptoms of injection site pain, muscle and joint aches. The patient did not experience any additional symptoms or events.