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 starting a few hours after administration; headache; fatigue; muscle and joint aches; muscle and joint aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Injection site pain starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches) in a 57-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. The patient's past medical history included COVID-19 in August 2024. 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 starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches). The patient was treated with Ibuprofen (Advil) (oral use) on 21-Sep-2025 for Muscle ache and Joint ache, at a dose of 600 milligram. At the time of the report, VACCINATION SITE PAIN (Injection site pain starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches) 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 a few hours after vaccination followed by muscle and joint aches, headache, and fatigue. The patient did not experience any additional symptoms or events.
Medical History/Concurrent Conditions: COVID-19