Received Oct 17, 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 | — | — |
lethargic; vomiting (once)/patient threw up; low grade fever (temporal 99C); This spontaneous case was reported by a non-health professional and describes the occurrence of LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)) in a 24-month-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. On 13-Oct-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 13-Oct-2025 at 5:20 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 14-Oct-2025 at 10:00 AM, the patient experienced LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)). On 15-Oct-2025, LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2025, Body temperature: low grade fever (temporal 99C). The patient had no medical history, concomitant disease or risk factor. No concomitant medications were provided. At 5:20 on 13-Oct-2025, a shot was administered in the leg. At 10A.M, the next day, patient threw up and had low grade fever (temporal 99C). There were no lab data/results available. Patient was administered an unspecified drug 100mg twice. By 15-Oct-2025, all symptoms alleviated. The patient did not experience any additional symptoms/events. Reporter causality was not provided.
Test Date: 20251014; Test Name: Body temperature; Result Unstructured Data: low grade fever (temporal 99C)