Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: the temperature went out of range 4 different times, one time being 03Mar2022; vaccines have been administered on 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022; The initial case was missing the following minimum criteria: ICH-Unspecified number of patients. Upon receipt of follow-up information on (13May2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 14-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2022 at 16:21 as dose 1, single (Lot number: FE3594), on 11Mar2022 at 10:43 as dose 2, single (Lot number: FE3594) and as dose 3 (booster), single (Lot number: FE3594), all intramuscular for covid-19 immunisation. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Caller stated the vaccines have been administered on 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "the temperature went out of range 4 different times, one time being 03Mar2022".  Additional information: It was reported that the "Below is the attached temp for the freezer & refridge during the last 3 months. We only had Pfizer covid injections our last covid 19 was on 16Mar2022. Was advised to send in information regarding temps during the last 3 months due to temp log." Outbound callback attempt 1 performed on 22Apr2022 at 1639 EST. Outbound disclaimer provided. Caller was seeking 3 months worth of data recorded from the digital logger, in which the state is requesting, for the undiluted/unpunctured Pfizer Covid-19 vaccine, purple cap vials. Caller stated that they have not been able to download the data from the logger. Due to the caller not being able to access the data logger report, the state proceeded with their manual handwritten documentation in which the state highlighted that the temperature went out of range 4 different times, one time being 03Mar2022. Caller stated the vaccines have been administered on 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022, however the caller did not know how many patients received the vaccines nor did they have any information about the patients. Caller provided that the last time they have had Pfizer Covid-19, purple cap vaccines were on 19Mar2022 in which they were not administered and had been discarded. Caller stated that she has contacted controlant and was waiting to hear back from them with the data report. Caller believes the temperatures were mistakenly recorded wrong by her technicians in which they did not put a "negative" sign for temperatures such as 10C, 9C, and 8C. Caller stated the other incident was her technician writing 23C on the freezer log, rather than the refrigerator log. E-transmitting potential duplicate AE /information. Transferred. Request Name: REQ-765411. Product: Comirnaty. Question: Due to the caller not being able to access the data logger report, the state proceeded with their manual handwritten documentation in which the state highlighted that the temperature went out of range 4 different times, one time being 03Mar2022. Caller stated the vaccines have been administered on 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022, however the caller did not know how many patients received the vaccines nor did they have any information about the patients. Caller requested for stability information for undiluted, unpunctured, Pfizer Covid-19 vaccine, purple cap vials to provide to the state and showing that Pfizer has been contacted. Caller asked if Pfizer could evaluate when an excursion occurred by the manual log that was attached with her original submission. Number of COVID-19 Vaccines: 59267105504. Expiry Date of COVID-19 Vaccines: 31Mar2022. Warm transfer from (Name withheld) with Pfizer Medical Information, GRACE: INT. Agent reports she had a pharmacist on line calling about the Pfizer COVID-19 vaccines in which the purple cap adult is in question. Caller reported she had a state inspection in which the state found potentially 4 times the vaccines were out of range however the caller claims inaccuracies were user error that the tech did not right a negative sign in front of the temperature. Agent reports however the COVID-19 vaccines were administered on 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022. Agent reports caller no patient information was provided and unknown the number of patients that received the COVID-19 vaccines. Agent reported the caller did provide that the data logger has not provided any data. Caller stated the data logger was not able to download the data that the state was requesting for the 3 months they wanted which is why the caller referred to the manual temperature logger that her  co-workers are writing down. Agent reports she is filing a product quality complaint for the data logger. Caller clarified details provided by transfer agent. Caller stated as far as the COVID-19 Vaccines being administered she states no. Caller states those were the days that the temperature was found to be out of range. Caller stated on 19Mar2022 was the last time they gave the vaccine and the temperature was in range that day. Caller stated she would have to dig through her records to find if she administered the COVID-19 vaccines on the dates the temperatures were out of range. Caller placed the call on hold for a moment. Product Details: Caller provides the manufacturer date as Nov2021. Caller stated she was given the expiration date of 31Mar2022. Caller clarified that 19Mar2022 was the last day that she gave a shot. Caller confirms that 03Mar2022, 09Mar2022, 15Mar2022, and 17Mar2022 were the dates provided that the temperature was out of range, but she does not know if any vaccines were administered on those dates. Caller asks if the Feb dates are needed as well. Caller provides on 03Feb2022 the temperature recorded was 9 degrees Celsius, and on 07Feb2022, 08 Feb2022, and 15Feb2022 the temperature recorded was 8 degrees Celsius. It was not provided if any vaccines were administered on these dates. Caller asked is this the Safety department. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No adverse events were reported with the use of the product. Vaccination Facility Type was Pharmacy or Drug Store. No prior vaccinations, concomitant drugs, medical history and relevant tests were reported. No specific relevant test For Thromboembolic Events with Thrombocytopenia.   Comments/Narrative: The following questions were answered: Please clarify the type of medication error. Freezer temp; Please provide the stage of medication error (e.g., prescribing, dispensing, preparation, and administration). Prep; Please provide contributing factors to the medication error. Temp control; Please clarify if the medication error affected the patient or consumer with clinical consequences. No; Please provide specific patient information and the number of patients involved in above reported events.  Follow-up attempts are completed. No further information is expected.