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 | — | — |
joint pain; headache; fatigue; Injection site pain starting a few hours after administration; muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches) in a 24-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. 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. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches). The patient was treated with Ibuprofen (Advil) (oral use) 21-Sep-2025 for Vaccination site pain and Muscle ache, at a dose of 400 milligram once. On 22-Sep-2025, ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches) had resolved. 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 a few hours after vaccination followed by muscle and joint aches, headache, and fatigue. The patient did not experience any additional symptoms or events.