Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2124042 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8335AA | — |
No adverse event; Improper storage of product in use; This spontaneous report was received from a healthcare professional regarding a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 31-OCT-2025, the patient was vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL administered as a 3 dose schedule for prophylaxis (lot number reported as 2124042, which has been verified as valid, expiration date not reported but validated as 20-JUN-2026) (vaccination scheme and route of administration were not reported); and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS) at a dose of 0.5 mL (lot number reported as U8335AA, which has been verified as valid, expiration date reported as October 2027 and validated as 31-OCT-2027) (vaccination scheme, route and anatomical site of injection were not reported). The administered doses were exposed starting on 02-OCT-2025 to several temperature excursions: 34.3 F for 3 hours 57 minutes and 30 seconds; 34.7 F for 7 hours and 45 minutes; and 34.8 F and 35 F for an unknown period (Product storage error). No additional adverse event was reported. This is one of several reports received from the same reporter.