Sex: U
Vaccine: HPV9
Symptoms: Product measured potency issue, Product storage error
Clinical narrative: *This event involved multiple patients, not just the patient listed above* Temperature excursion occurred on 2/2/22 in one refrigerator in office that houses vaccines (both stock). Temperature was -0.3 degrees Celcius for 44 minutes. Alarm on fridge sounded, police were alerted and called the office. Nurse checked fridge and watched fridge and watched fridge got a couple of minutes as temperature was going back closet to being in range, however nurse was watching temperature on actual fridge instead of data logger that temperatures are suppose to be read by. Vaccines continued to be given out of this fridge. Maintenance came to look at the fridge that day, temperatures were accurate. The manufacturer of the fridge also came to look at it and besides being dusty/dirty near fan had no issues found. On 2/19 our clinical supervisor received email from state that we had a temperature excursion and asked about papers regarding vaccine stability. This was when we reviewed the datalogger information and saw the drop in temperature. Our pharmacy t4ech then did the letters to the manufacturers and we were told by pharmacy tech on 2/22 that all vaccines that were given out of that fridge were stable and that we could continue to give out of that fridge. On 2/25 the letters were received by state and we were told that the vaccines were not stable that had been given an that we should stop using that fridge. From there myself and clinical supervisor called all manufacturers to confirm this and all vaccines in the fridge besides Rotateq vaccine were considered spoiled. (Spoiled vaccinations included: Influenza, Hepatitis B, Pentacel, ActHIB, Hepatitis A, Daptacel, Quadracel, IPV, Tdap, Td, HPV, Menactra, Trumenba, Bexsero) We were told by state that giving a vaccine that has reached a certain cold temperature does not harm the patients that received it, however it effects how well the vaccine works in protecting the patient. We them proceeded to gather lists of all patients who were in the office and received vaccines out of the effected fridge the day of the temperature excursion and after and compiled a list of patients effected by this. From there we called each patient individually and explained the temperature excursion. We were told by state that is is recommended to repeat these vaccinations, however parents could decline and the vaccine initially received would still be on their record and valid. All staff in the office were made aware of this issue, including providers. In response to this excursion we now have ben checking the effected fridge multiple times a day instead of just morning and afternoon. We have started downloading the data logger information every week, we have also reached out to the manufacturer who has come to look at the fridge again and has recommended this fridge be replaced due to temperature excursions that have occurred over the years and due to it being 8 years old. State has also recommended the fridge be replaced. All state vaccines in the fridge were logged and shipped back. All private vaccines in the fridge were also logged and shipped back for possible credit. Staff education was provided in a clinical meeting and one on one education was give regarding data logger.