Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
muscle aches; Joint aches; fatigue; Injection site pain starting a few hours after vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (muscle aches), ARTHRALGIA (Joint aches), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration) in a 57-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) 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 SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint aches), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration). The patient was treated with Ibuprofen (Advil) 21-Sep-2025 for Muscle pain, Joint pain and Vaccination site pain, at a dose of 400 milligram once and Ibuprofen (Advil) 22-Sep-2025 for Muscle pain, Joint pain and Vaccination site pain, at a dose of 400 milligram once. In September 2025, MYALGIA (muscle aches), ARTHRALGIA (Joint aches) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. The patient received Influenza vaccine at the same time in the opposite arm. It was reported that, the patient's injection site pain started a few hours after vaccine administration, followed by muscle aches, joint aches and fatigue. Improved gradually over the next 48 hours. Currently she had mild injection site pain only. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Medical History/Concurrent Conditions: COVID-19