Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | OT |
| DTPIHI | DT+IPV+HIB+HEPB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
sleepy; irritable/ cranky; fever; This spontaneous report was received from a Consumer or other non health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported. The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months (same as other vaccines received on 11 Jul-2025). On 11-Jul-2025, the was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form administered by oral route (exact dose, lot # and expiration date were not reported) for prophylaxis (indication reported as unknown but by default changed to prophylaxis). On the same day, the patient started therapy with clesrovimab (ENFLONSIA) (reported as RSV vaccine) prefilled syringe, 1 dosage form administered by unknown route for unknown indication (exact dose, lot # and expiration date were not reported). On the same day, he was vaccinated with a dose of COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) dose 1 administered intramuscularly (lot # and expiration date were not reported) for COVID-19; with a dose of Pneumococcal vaccine conj 20v (CRM197) 1 dosage form administered by unknown route for unknown indication (expiration date, and lot # were not reported); and with a dose of Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine 1 dosage form administered by unknown route for unknown indication (indication, expiration date, and lot # were not reported). It was reported that the patient received first dose of Moderna Covid vaccine at 6-month checkup along with RSV, rotavirus, and other standard vaccines. The patient received the vaccine at noon. On 11-Jul-2025, the patient experienced somnolence (sleepy). On the same day at 5:00 PM, the patient experienced irritability (irritable/ cranky) and pyrexia (fever). On that day at 5:00 PM, body temperature was 101 F. It was also reported that, post vaccination, the patient developed fever and he was sleepy with irritable symptom which started about two hours after vaccination. He was feverish and cranky until mid-day on 13-Jul-2025. The fever never reached over 101 F. From 11-Jul-2025 to 13-Jul-2025, the patient was treated with paracetamol (TYLENOL) (oral use) at a dose of 2.5 milliliter every four hours. Paracetamol (TYLENOL) significantly improved the symptoms. The patient did not experience any additional symptoms or events. On 12-Jul-2025, somnolence had resolved. On 13-Jul-2025, irritability and pyrexia had resolved. The action taken with COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) was unknown (by default changed to not applicable). The action taken with clesrovimab (ENFLONSIA) was not reported. The action taken with Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine, Pneumococcal vaccine conj 20v (CRM197) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not applicable. The causal relationship between the reported adverse events and the suspect therapies was not reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-07-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : MOD-2025-788098 , Central date : 2025-07-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Medical History/Concurrent Conditions: Fever (The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months.); Ill-defined disorder (The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months.); Irritability (The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months.)
Test Date: 202507111700; Test Name: Body temperature; Result Unstructured Data: 101 [degF]