Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | U7907AA | RL |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | X026480 | LL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | X023403 | OT |
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 11-DEC-2024, administered doses of vaccines were involved in a temperature excursion (product storage error), they have not had any reports of patients experiencing any medical concerns or symptoms after being administered (no adverse event). Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained a 2-months-old male patient. He did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 12-DEC-2024, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Oral solution, lot#X023403 (expiration date: 03-APR-2025), given orally (dose not provided); with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) suspension for injection, lot#X026480 (expiration date: 12-JAN-2026) in the left thigh; and with the first dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Hae... (VAXELIS) suspension for injection, lot#U7907AA (expiration date: 30-SEP-2026) in the right thigh (doses and routes of administration were not provided), all as prophylaxis, that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccine was viable , and no events occurred to the patient after the administration. The vaccine had been given in private doctor's office/hospital by a medical professional. It was not available for return. This case was previously classified as non-valid, as there were no patient identifiers, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one of 5 reports received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2265350. The previous case ID: 2501USA001924. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
Comments: NONE