Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2003166 | OT |
No adverse event; HCP calling to report AE for a vaccine that was inadvertently administered after a temperature excursion. ? Name of vaccines involved (including lot/exp): ROTATEQ 2003166 9/8/2025 ? Temperature: 1.5C ? Time frame; This spontaneous report was received from a registered nurse and refers to a) 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 14-APR-2025, the patient was inadvertently vaccinated with an improper stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (valid lot #2003166, expiration date reported as 08-SEP-2025, but upon internal validation established as 06-SEP-2025) 2 ml, once, administered by oral route as prophylaxis. The temperature excursion was reported 1.5 degree Celsius with a time frame of 50 minutes. No previous temperature excursion reported. In addition, the reported stated that the patient did not have any reactions or symptoms (no adverse event).