Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Poor quality product administered, Product temperature excursion issue
Clinical narrative: questioning lack of efficacy; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FH8030, Expiration Date: 28Feb2022) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021 10:00, outcome "unknown", described as "questioning lack of efficacy"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 22Dec2021 10:45, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2021, outcome "unknown" and all described as "administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days". Patient did not receive any treatment for the events. Stated that she is not aware of any antipyretic use around the date of vaccination. On 22Dec2021, administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days. Pfizer Adult purple top vial a Pfizer product administered on 22Dec2021. Reporter is a registered nurse at withheld who called and spoke with withheld regarding sending an email for next steps to take with a temperature excursion. Stated that she reported that it was in the freezer too long. Stated that it was supposed to be in the freezer for 14 days and was in 21 days past 14 days. Stated that it was stored within normal temperature in the fridge. Stated that it was in the refrigerator for seven days before it was administered during a vaccination clinic to eight separate patients as a booster dose. Provided a case number of 524685. Stated that she did not know a lot of fine details but through root cause analysis that she has come up with a lot more information. Stated that she did not complete reports on the patients. Clarified that the vaccine came from district health, and they put it in their freezer, and it is kept between 25 degrees below Celsius and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days per Pfizer from the other phone call. Count for which of the 8 patients received the Pfizer purple top vial paediatric dose not provided. Later clarified that they were not all booster doses. Event details: Stated that the efficacy of the vaccine is more important than any adverse events. Seriousness is not significant. Stated that she has not spoken with the patient. Questioned lack of efficacy on 28Dec when they discovered the mistake. Stated that they stopped questioning efficacy after they called Pfizer. Later clarified that she is still questioning the efficacy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of Drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200010841 as same reporter/drug/event, different patient.