Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | 2096663 | OT |
No adverse event; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child.; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child. The previous 9 tubes did not have any issues. The product was discarded so it can not be returned a; This spontaneous report was received from a nurse and refers to a Child patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-APR-2025, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #2096663, expiration date reported and confirmed as 17-MAY-2026; exact dose not provided) administered by oral route as prophylaxis. On that same day, the nurse reported that near the "neck or side" of the suspect vaccine ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child (syringe issue / accidental underdose). The previous 9 tubes did not have any issues. The product was discarded so it could not be returned. No adverse event reported.