Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product preparation error, Product temperature excursion issue
Clinical narrative: States this was each patients booster dose; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (Lot number: FE3590) at the age of 44 years as dose number unknown (booster), 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021, outcome "unknown", described as "States this was each patients booster dose"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 14Nov2021, outcome "unknown" and all described as "undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted".  Additional information: Caller stated that he worked in medical clinic and he was a physician reporting a temperature excursion of the Pfizer Covid vaccine (Adult). Caller stated that they had the Pfizer Covid vaccine for ages 12 and up, and they had an incident over the weekend. There was an event outdoors at a church on Sunday 14Nov2021, stated that the clinic he worked at was closed on Sunday. Someone who was going to the event who was going to be administering the vaccines, took the vials of vaccines out of refrigerator on Saturday 13Nov2021 and transported them in a cooler to their own freezer. Caller reported that the vials were placed into the freezer over night and moved back to a cooler on Sunday the day of the event, stated that they were then thawed again to be administered at the event. Caller clarified that the vials were what was stored in the cooler, that they were diluted and drawn up at the time of the event and administration. The undiluted thawed vaccine was moved from the refrigerator to a cooler, then placed in a freezer, stored there for 24 hours, moved back into a cooler where it thawed, then diluted and given to 16 patients. There were some vaccines likely involved in a temperature excursion. Caller wanted to know if the vaccine was stable or do the patients need to be revaccinated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595916 same reporter/SD/AE, different patient.