Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | X027728 | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Y007989 | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Y009551 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012865 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y010466 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X019103 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y009782 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y007623 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2003174 | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2032351 | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2032354 | OT |
Medical assistant reporting an unknown number of administrations of RECOMBIVAX HB, MMR II, GARDASIL 9 and ROTATEQ following a temperature excursion. No symptoms reported and no additional details provided. This agent is adding RECOMBIVAX HB and GAR; no AE; This spontaneous report was received from a medical assistant and refers to unknown number of unspecified patients. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with the following incorrectly stored vaccines: rotavirus vaccine (ROTATEQ) administered orally, lot # 2003174, expiration date 14-SEP-2025; lot # 2032351, expiration date 06-OCT-2025; lot # 2032354, expiration date 12-NOV-2025 (dose, anatomical location were not provided), Human Papillomavirus 9-valent Vaccine (GARDASIL 9) lot # y010466, expiration date 29-OCT-2026; lot # y012865, expiration date 10-OCT-2026 (dose, route of administration, anatomical location were not provided), measles (+) mumps (+) rubella vaccine (MMR II) lot # x019103, expiration date 16-JUL-2025, lot # y009782, expiration date 23-MAY-2026; lot # y007623, expiration date 11-APR-2026 (dose, route of administration, anatomical location were not provided), hepatitis B vaccine (RECOMBIVAX HB) lot # x027728, expiration date 16-OCT-2026; lot # y007989, expiration date 06-DEC-2026; lot # y009551, expiration date 08-DEC-2026 (dose, route of administration, anatomical location were not provided). The suspect vaccines were stored at the temperature of 0.6 degrees Celsius for 5 hours and at 11.1 degrees Celsius for 35 minutes (Product storage error). No adverse events were reported. This is an invalid report due to lack of the patients' identifiers.; Reporter's Comments:
Sterile diluent