Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 3 | 2096656 | OT |
No symptoms reported; ROTATEQ which underwent a temperature excursion was administered; This spontaneous report was received from a physician and referred to a 7-month-old Male patient. The patient's medical history, past medications and concomitant medications were not reported. On 13-Nov-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) VIAL 2 (units not reported) (2.00 mL total, lot number: 2096656 with expiration date: 19-Apr-2026) via oral for prophylaxis at private doctor's office/hospital. Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent a temperature excursion below 9.1 degree Celsius for 0 hours 47 minutes 0 seconds (product storage error). No symptoms reported (no adverse event). A temperature excursion occurred as a result of a reading from a digital data logger. This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [withheld]@merck.com , Index date : 2025-12-29 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Sod , Central date : 2025-12-29 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :