Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | — | OT |
3-month-old child was admitted with Rotavirus 2/7/2025. Child was supposed to receive ROTATEQ today, but did not; This spontaneous report was received from a Nurse and refers to a 3-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, reported as "ROTATEQ VIAL 2", administered by oral route for prophylaxis (lot # and expiration date were not reported). On 07-FEB-2025, the patient was admitted due to Rotavirus, diagnosed on 20-FEB-2025. Child was supposed to receive Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) that day, but did not. At the reporting time, the outcome of Rotavirus was not known. The action taken with the suspect vaccine regarding the event was not reported but established as not applicable. The causal relationship between the event of Rotavirus and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.