Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Poor quality product administered, Product storage error
Clinical narrative: booster doses; Patients that were given the vaccine on November 15th; In the freezer temperature range for 20 days; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non-HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101620053 (Pfizer).  A 79-years-old male patient received third dose of bnt162b2 (COMIRNATY, Batch/Lot number: FF2593, Expiration Date: 31Mar2022) administration date 15Nov2021 (age at the time of vaccination was 79-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster doses"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 15Nov2021, outcome "unknown", described as "Patients that were given the vaccine on November 15th"; PRODUCT STORAGE ERROR (non-serious) with onset 15Nov2021, outcome "unknown", described as "In the freezer temperature range for 20 days".  Additional Information: There was a dose administered on 12Nov2021, where the vaccines had been stored in the freezer, temperature range for 17 days and was administered to one patient, a 72-years-old female and then on 15Nov2021, the PFIZER COVID 19 Vaccine was stored in the freezer temperature range for 20 days before it was administered to 3 patients that includes a 72 year female, a 45 year old male and a 79-years-old male. Registered nurse stated, that they had PFIZER purple top vaccines that was removed from ultra-cold on 26Oct2021, it was placed in a vaccine freezer and it was supposed to move on the night to a vaccine refrigerator, to keep up with the cold chain and storage handling, instructions that were provided by PFIZER, they did not pull the vaccine that night, doses were left in the freezer all the way until the morning of 16Nov2021, based on the information they had we were looking for possibly patients, 3 patients that were given the vaccine on 15Nov2021, possibly were given outside the stability, the vaccines were pulled from the vaccine freezer and placed into the refrigerator on the 15th and then given to the patient within the 6th hour but the problem was that they put the vaccine in the freezer at 20 days instead of 14 days. When paraphrased regarding the concern, registered nurse stated, she was just concerned about the stability, she mentioned there was no data specifically about the 20 days in the freezer and she was not sure if they should revaccinate patients. They were no longer using the vaccine and it had been quarantined away, she was just concerned about the patients who have received the vaccine on the 15th. Registered nurse was informed about the PFIZER Medical Information department and provided with the number. The Ethnicity and patient details were withheld. About height and weight, the nurse did not have height and weight of the patient. Date of Vaccination: 15Nov2021. It was the third dose of the COVID-19 Vaccine. Medical history was not available with the nurse.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101621870 same reporter/drug/event, different patient;US-PFIZER INC-202101622130 same reporter/drug/event, different patient;US-PFIZER INC-202101622101 same reporter/drug/event, different patient