Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2117047 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8335AA | — |
No additional AE; Administration of improperly stored vaccines; This Spontaneous report was received from an other health professional and referred to a 6-month-old patient of unknown gender. The patient's medical history, past medications, and concomitant medications were not reported. On 27-Oct-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution at a dose of 2 mL (valid Lot Number: 2117047, Expiration date: 18-May-2026) for prophylaxis and with DTap-IPV-Hib-HepB (Vaxelis) Suspension for injection at a dose of 0.5 mL (valid Lot Number: U8335AA; Expiration date: 31-Oct-2027) for prophylaxis (routes of administration were not reported). It was reported that the vaccines were improperly stored before administration (Product storage error). No additional adverse event. The reporter considered product storage error to be related to suspect vaccines but determined to be not assessed per internal guidelines. This is one of multiple cases received from the same reporter (cross-referenced with case# 2346588).