Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
reports beginning to feel, "not well"; sore arm; feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills); feeling "extreme tiredness/"too tired; night sweats; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweats), MALAISE (reports beginning to feel, "not well"), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) in a 95-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Feb-2025, the patient experienced NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired). On 03-Feb-2025, the patient experienced MALAISE (reports beginning to feel, "not well"). At the time of the report, NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold.. mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) had not resolved and MALAISE (reports beginning to feel, "not well") outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no relevant medical history within the past 4 weeks. No concomitant medications were provided. Following the vaccination, patient experienced armed soreness from Saturday through Monday. On Monday, she began to feel unwell, describing sensations of alternating hot and cold, which was later identified as chills. Although this feeling subsided that night, her condition had progressively worsened since then. Additionally, she was experiencing night sweats, necessitating a changed of bedsheets that morning, and expressed feelings of extreme fatigue, stating that she was too tired to visit a doctor. No treatment medication was provided.