Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 2 | U7907AA | RL |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | X026480 | LL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | 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 a medical assistant and referred to multiple patients of unknown ages and genders. Their 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. The administered doses were involved in a temperature excursion (product storage error), they had not had any reports of patients experiencing any medical concerns or symptoms after being administered. Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained an 6-months-old female patient. She did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 13-DEC-2024, the patient was vaccinated with the second 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 second 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) (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: 2265349. 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