Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid-19.) on 19-May-2025 and Heart attack. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PAIN (body ache) and HEADACHE (headache). On 18-Sep-2025, HEADACHE (headache) had resolved. At the time of the report, PAIN (body ache) had resolved. The concomitant medication was not reported by the reporter. The patient had a headache and body ache. It was unknown if the patient experienced any additional symptoms or events. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data or results available. The treatment medication was not reported by the reporter.
Medical History/Concurrent Conditions: COVID-19 (Patient was diagnosed with Covid-19.); Heart attack