Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | C2Y9B | IM / RA |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 1 | W1C831M | SC / LA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 2 | Y006284 | SC / RA |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 4799G | IM / LA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y008284 | OT / RA |
No adverse event; patient may have received improperly stored PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a 10-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component; Tetanus vaccine toxoid (BOOSTRIX), Polio vaccine inact 3v (Vero () IPOL) . On 01-OCT-2024, the facility received a shipment of COVID vaccines that needed to be stored in the freeze. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website and it was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. The dose administered was moved from freezer to refrigerator an 01-OCT-2024 and on 19-NOV-2024, the patient was vaccinated with an improperly stored second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-OCT-2025), dose number 2, administered by Subcutaneous route in Right Arm (Product storage error) and diluent (MERCK STERILE DILUENT), administered by Subcutaneous route in Right Arm (lot # and expiration date were not reported), for prophylaxis. Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/04/2013 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Engerix-B; Boostrix; IPOL