Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 2124042 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8335AA | — |
No additional AE/No PQC; Medical Assistant reported administration of improperly stored vaccines to multiple patients beginning on 10/2/2025; This spontaneous report has been received from a medical assistant and refers to 5-month-old patient of unreported gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On 04-Oct-2025, the patient was vaccinated with improperly stored vaccines: Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) as prophylaxis in a 3 doses schedule 0.5 mL (dose number, route of administration not reported; lot number 2124042 has been verified to be valid; expiration date not reported but upon internal validation established as: 20 Jun 2026) and with and Hepatitis B [Recombinant] Vaccine (VAXELIS) as prophylaxis 0.5 mL ((dose number, route of administration not reported; lot #U8335AA has been verified to be a valid lot number, expiration date reported as October 2027, but upon internal validation established as 31-OCT-2027). The above-mentioned vaccines were exposed to a temperature excursion (TE). No previous temperature excursions reported. No additional adverse event. No product quality complaints (PQC).