Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | LL455 | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3Z34X | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 2117047 | — |
No symptoms reported; Caller reported AE on behalf of patient that was administered 2 doses of ROTARIX and 1 (extra) dose of ROTATEQ due to user error.; extra, dose of ROTATEQ at 6 months old on 08/11/2025; Caller reported AE on behalf of patient that was administered 2 doses of ROTARIX and 1 (extra) dose of ROTATEQ due to user error.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2025 (at the age of 2 months old), the patient was vaccinated with the first dose of rotavirus vaccine live oral 1v (ROTARIX), lot #LL455, expiration date: 11-OCT-2025 and on 09-JUN-2025 (at the age of 4 months old), the patient was vaccinated with the second dose of rotavirus vaccine live oral 1v (ROTARIX), lot #3Z34X, expiration date: 11-SEP-2026 (for both doses strength, indication and route of administration were not provided). On 11-AUG-2025 (at the age of 6 months old), the patient was vaccinated with 1 (extra) first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, lot #2117047 (which has been verified to be valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent), expiration date reported and upon internal validation establish as 18-MAY-2026, 2 mL administered for prophylaxis (strength and route of administration were not provided) as a third dose due to user error, as it was not needed because the series with ROTARIX was already completed (extra dose administered, interchange of vaccine products, inappropriate schedule of product administration). No symptoms reported (No adverse event). This is one of 3 reports received from the same reporter