Symptomtext
No additional AE.; an improperly stored vaccine was administered to a patient / freezer out of temp range; This spontaneous report was received from a registered nurse and refers to a 20-month-old (reported as 19-month-old) female patient. She was a premature baby (36 weeks, 3118 grams birth weight). The patient had no medications, allergies, medical or surgical history. She had no siblings. On 18-OCT-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) 0.5 milliliter via subcutaneous route in right vastus lateralis, lot #W005206, expiration date 14-FEB-2024, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (first dose) via subcutaneous route in left vastus lateralis, lot #U022983, expiration date 22-JUL-2023 (exact dose was not reported), hib vaccine (HIB) (fourth dose) via intramuscular route in left vastus lateralis, lot #335N9, expiration date 25-MAY-2023 (exact dose was not reported), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (fourth dose) via intramuscular route in right vastus lateralis, lot #LS444, expiration date 16-SEP-2023 (exact dose was not reported) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (fourth dose) lot #FMS700, expiration date 31-JUL-2024 (exact dose, injection site, route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 10.8 degrees Fahrenheit (F) for 18 hours 30 minutes. Freezer failed, the vaccines were moved to the back up location. Temperatures out of range multiple times due to odd cycle. The reporter was not aware of excursions until 21-OCT-2022. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse event reported. No prescription drug treatment for the experience was required. The medication error occurred during storage in clinical practice. After excursion found, no further doses were given. The vaccines were not available for evaluation. The single use vaccines were used according to the instruction leaflet and were administered by trained healthcare professional in the private doctor's office/ hospital; purchased with private funds. This is one of several reports received from the same reporter.
