Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 72RF2 | IM / RA |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | T5727 | IM / RA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | X024650 | IM / RA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y013579 | SC / RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y013579 | OT / RA |
No adverse effects; "was stored in the refrigerator for months; This spontaneous report was received from a Nurse and refers to a 9-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included (Gardasil 9) Human Papillomavirus 9-valent Vaccine, Recombinant, Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v), IPOL (inactivated polio virus), Engerix b (Hepatitis b vaccine rHBsAg (yeast)), Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) . On 01-Oct-2024, the facility receievd 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 FD website with title "Package insert refrigerator stable formulation Proquad". Unware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) products licensed by the FDA, it was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and both state and priavte Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenhelt) until administration. On 13-Nov-2024, the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the patient arrived to the facility and was refrigerated until administration day. On 06-Jan-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013579 has been verified to be a valid lot number, expiration date: 03-Feb-2026; dose and strength were not provided) by Subcutaneous route in right arm for prophylaxis (product storage error). No adverse effects (no adverse event) were reported.
Havrix; Gardasli 9; Fluarix Quadrivalent; IPOL; Engerix B; Boostrix; Sterile Diluent