Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U8335AA | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2117047 | OT |
No additional AE; improper vaccine storage; Rotateq dose 0.5 ml; This Spontaneous report was received from medical assistant and referred to a 2-month-old patient of unknown gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 02-Oct-2025, the following vaccines had temperature excursion of 34.3F for 3 hours 57 minutes 30 seconds: Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Batch/Lot Number: 2117047 has been verified to be a valid lot number, Expiration date not reported but upon internal validation established as 18-May-2026) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS) (Batch/Lot Number: U8335AA has been verified to be a valid lot number, expiration date not reported but upon internal validation established as 31-Oct-2027). On 14-Oct-2025, the patient was vaccinated with above mentioned Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (0.50 mL; strength was not provided) (underdose) via Oral and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS) (0.50 mL, route and strength were not reported) for prophylaxis (product storage error). No additional AE (no adverse event) was reported. The Outcome of product storage error was reported as recovered. The action taken with suspect vaccines was Not Applicable. 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 several cases from the same reporter.