Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
soreness/aches; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness/aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 26-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concomitant products included Sertraline hydrochloride (Sertraline) and Influenza vaccine (Fluzone) for an unknown indication. On 12-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 13-Feb-2025, the patient experienced PAIN (soreness/aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN (soreness/aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no past medical history, no concomitant disease or risk factor. There were no lab data/results available. No treatment information was reported. Reporter did not allow further contact
Sertraline; Fluzone