Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | IM |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
sleepy; irritable; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever) in a 6-month-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products RSV vaccine for an unknown indication, Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for an unknown indication and Rotavirus vaccine for an unknown indication. No Medical History information was reported. On 11-Jul-2025, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of RSV vaccine (unknown route) 1 dosage form, dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) (unknown route) 1 dosage form and dose of Rotavirus vaccine (unknown route) 1 dosage form. On 11-Jul-2025, the patient experienced SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever). The patient was treated with Paracetamol (Tylenol infant) in July 2025 at a dose of 2 milliliter every four hours. On 12-Jul-2025, SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever) had resolved. For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that Infant received first dose of Moderna Covid vaccine along with RSV, TDaP, rotavirus, and other standard six-month vaccines. Post vaccination patient was developed fever and patient was sleepy with irritable symptom which was started about two hours after vaccination; side effects were lasted approximately 36 hours. The patient did not experience any additional symptoms or events.