Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 95BJ9 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946595 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y008284 | OT / LA |
No additional AE; patients may have received improperly stored PROQUAD; This spontaneous report was received from a Nurse and refers to an 8-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 01-Oct-2024 FCPH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website. 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. On 05-Dec-2024, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-Oct-2025) administered by Subcutaneous route in Left Arm for prophylaxis with sterile diluent (MERCK STERILE DILUENT) (Product storage error). On the same day, the patient also received Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Left arm), administered by Intramuscular route and Flucelvax quadrivalent (Influenza vaccine inact sAg 4v) (lot #946595) (Right Arm), administered by Intramuscular route. No additional AE. This is one of the several reports received from the same reporter.