Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Z00766 | OT |
administration of first dose of ROTATEQ at 4 months of age; No additional AE details. No additional AE reported; This spontaneous report was received from a Medical assistant and refers to a 4-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution, first dose (lot #Z00766, expiration date: 24-Nov-2026) administered by Oral route as prophylaxis. Lot# Z00766 was not a valid lot# for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) or any other company product. The vaccine was administered at 4 months of age with first dose (Drug administered to patient of inappropriate age). No additional adverse reported (no adverse event).