Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: We experienced a fridge temperature excursion which started on Sunday and continued until Wednesday morning when it was finally discovered. The temperature started to slowly rise from 46F to a top temperature of 54.14F on Wednesday when we transferred the vaccines to another fridge. Unfortunately, we had administered vials of both Pfizer (adult purple cap only) and Janssen on Monday and Tuesday before the problem was discovered Wednesday morning. No vials were administered on Wednesday.   On Sunday, starting around 11 am, the temperature started to rise. The min. temperature for Sunday was 44.24F and the max. temperature was 48.02F.  On Monday the min. temperature was 47.84F and the max. was 51.26F. The temperature was above 50.5 on Monday for about 4 hours and 30 minutes. The vaccines for Monday were taken out of the fridge around 8:45am and placed in a temperature-controlled courier up to our vaccination clinic. In total 1 vial of Janssen was pulled (lot # 1822809 - 2 doses administered, 3 wasted) and 3 vials pulled of Pfizer (lot # FF2587 - 13 doses administered, 5 wasted). With the Pfizer pulled 2 vials may have been pulled at the 8:45 am time and 1 vial may have been pulled mid-day.   Patient Information:  0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 2 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 2 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 3 0.5 JSN 1822809 Dose: 1 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 1 0.5 JSN 1822809 Dose: 1 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 3   On Tuesday the min. temperature was 49.64F and the max. was 51.44F. The temperature was above 50.5 on Tuesday for about 8 hours and 2 minutes. The vaccines for Tuesday were taken out of the fridge around 8:45am and placed in a temperature-controlled courier up to our vaccination clinic. In total 1 vial of Janssen was pulled (lot # 1822809 - 3 doses administered, 2 wasted) and 2 vials pulled of Pfizer (lot # FF2587 - 9 doses administered, 3 wasted).   Patient Information 0.5 JSN 1822809 Dose: 1 0.5 JSN 1822809 Dose: 1 0.3 PFR FF2587 Dose: 3 0.3 PFR FF2587 Dose: 1 0.3 PFR FF2587 Dose: 1 0.3 PFR FF2587 Dose: 2 0.3 PFR FF2587 Dose: 2 0.3 PFR FF2587 Dose: 1 0.3 PFR FF2587 Dose: 1 0.5 JSN 1822809 Dose: 1 0.3 PFR FF2587 Dose:1 0.3 PFR FF2587 Dose: 2   On Wednesday min. temperature was 41.54 as the vaccines were transferred into a new fridge around 10:30am and the max. temperature was 54.14F. The temperature was only above 50.5 on Wednesday for about 3 hours and 2 minutes. No vials from the fridge were administered.  I reached out to both Janssen and Pfizer manufacturers and talked to their excursion team and their safety team to relay patient information. Regarding the Janssen doses administered, the documentation provided to me and relayed over the phone from Janssen was thus: ?47F to 50 F ? No restriction in duration if the product is not expired. For 51F to 77F ? Up to 12 hours (cumulative) if the product is not expired?. Our product is not expired and did not meet the ?Up to 12 hours cumulative? when we administered the vaccines. No further steps were taken to reach out to patients. We will dispose of the vaccines we have left in the fridge.   Regarding Pfizer, I submitted a report to their excursion team as well as submitted patient information to their safety team. I received an email stating they had no data regarding stability for the vaccine for the temperature excursion I reported and was directed to call the CDC. I called the CDC, but they said I would need to receive specific information about what to do for patients administered the vaccine from the manufacturer. The CDC also asked me to submit a VAERS report and to receive more information for the patients from VAERS. I am seeking guidance on whether the patients we vaccinated need to be re-vaccinated and what to tell them regarding the vaccination they previously received. Please advise.