Symptomtext
No adverse event; PROQUAD was improperly stored on 15-DEC-2021 and administered to a patient; This non-valid spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), (unspecified dose, frequency, route of administration, lot # T032149 has been verified to be a valid lot number, expiration date was reported and established as 20-MAR-2022, lot # U024508 has been verified to be a valid lot number, expiration date was reported and established as 02-FEB-2023, lot # U009261 has been verified to be a valid lot number, expiration date was reported and established as 19-SEP-2022, lot # U026794, expiration date: 26-FEB-2023, vaccination site was not provided) for prophylaxis. It was reported that one dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), was improperly stored on 15-DEC-2021 and was administered to a patient. on an unknown date (product storage error). The vaccine was stored at a temperature of -8.1 Celsius (C) for a time frame of 8 hours and 35 minutes with no previous temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported. This case was considered non-valid due the lack of patient identifiers. Follow-up information was received from the nurse on 01-FEB-2022. Demographics of the patient were provided. The case concerned a female patient of 2 years and 4 months old. Concomitant vaccines administered were diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (PENTACEL) and influenza vaccine (FLUZONE.) On 23-DEC-2021, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous route lot number U024508 (rHA) expiration date 02-FEB-2023 as prophylaxis. The nurse reported that the freezer was found out to be out of range due to a digital data logger. The problem was corrected, however, the vaccine was administered before the problem was reported.