Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Poor quality product administered, Product administration error
Clinical narrative: vaccines outside of the 10 week age of the vaccine /vaccines were kept in fridge for longer than the allowable time; they were kept anywhere from 13 to 73 days after; vaccines outside of the 10 week age of the vaccine /vaccines were kept in fridge for longer than the allowable time; they were kept anywhere from 13 to 73 days after; sore arm; redness; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "vaccines outside of the 10 week age of the vaccine /vaccines were kept in fridge for longer than the allowable time; they were kept anywhere from 13 to 73 days after"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ERYTHEMA (non-serious), outcome "unknown", described as "redness".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Got a RN on the line, they had vials of the Pfizer COVID 19 vaccine both purple and orange cap on the orange cap she does not know if it is the monovalent or Bivalent, she does not have this in her information at this point, so we have a lot of AE at one side there were 116 and at the other side there was 105. Basically, what happened is that the vaccines were kept in fridge for longer than the allowable time and I know the difference between the orange and purple I am not sure of purple anymore, but I know the orange is for 10 weeks, but they were kept anywhere from or given to patients anywhere from 13 to 73 days after the allowable time in the refrigerator. I do have some LOT# for the purple cap it looks like FM0698. She did give the same LOT for some of the orange cap I said that it is unusual that would be the same, so she is going to double check for the paperwork. I do have the another orange cap LOT# as well FT1551 and she mentioned with that LOT# there are about 15-20 patients that got the vaccine or dose of that vaccine just a day or two after got approval so they were wanting to ask about that, that to me does not seem to fall out of any labelled guidelines but I want to mention in case she says something. and I have email address if you like those so the first one is for the work one and that is [Email] (clarified and captured) and the other is [Email] and she has got lot of information so am sure she will give you a lot more details but that is all I have got for now. When paraphrased the concern reporter stated, Reporter stated, I have 5 different LOT and one of them the state report actually said that it was the same LOT one dose is orange and one was purple, the others, one LOT was all orange, another one was all orange, another one was all purple. The first one LOT FM0698. One was orange and all the others were purple cap. The orange cap was given 13 days over the allowed 10 weeks after receiving the vaccine date. The purple cap, the charting from state report shows that some doses were given anywhere from 13 all the way out to 73 days after that 10-week expiration date. Next one is LOT FL8095. All of them that were given wrong were orange cap and they were given anywhere from one day over all the way out to 56 days over. Reporter further stated, "I have more LOT#. Next FL8094, they were all orange caps, and they went anywhere from three days over out to 33 days over. And then I have 2 more, the next one is LOT FM7553, that is purple cap and that one is anywhere from 6 to 56 days over. Last LOT FP4554, purple top and that was anywhere from 1 day over the expiration date out to 54 days, so we have 5 LOT. When probed for the patient details: Reporter stated, Yeah, but it is going to take couple of hours there are 216 plus patient. So, we are just looking for whether or not Pfizer has any data for the vaccines viability outside the 10-week expiration date or not. When confirmed for further probing reporter stated, "Well it depends where you take it once you have the question, she said that she is going to send me a form that will be filled out and returned back to the supply chain quality team and they will (incomplete sentence). It is 216 and patients I can't give you, it will be midnight. When confirmed if previous department has provided the resolution: Reporter stated, "No. They are trying to find who has any data that can extrapolate something and give us a final report. You know what, our call is done. I have been 4-5 hours with Pfizer and its going circle, it is not your fault. I am done, and I will deal the set of forms that will go to supply chain committee, we will go from there, you will document everything and still not have a resolution answer for me, so I think we have to back track and see what CDC says because they said that even out of (Incomplete sentence). I will let you go. Thanks. Caller says what happened is back in November they had the vaccine program, which they do every two years, audit them. The COVID vaccines were shipped from (name withheld) to their offices, and the medical assistants said there used to be a form in there that said from this particular shipment date for expiration date is, which used to be a lot longer but eventually went down to 10 weeks, and those forms never came in the boxes anymore. When they did the audit in both offices of two offices, vaccines were given to a number of children, both primary and booster doses, were given out of ten weeks range. They had almost 200 and something children given the vaccine out of appropriate date. They called you guys and sent reports out of appropriate dates and were told that the doses couldn't be considered viable. The information provided would be the same stuff for an excursion. She has gotten additional paperwork from the Drug Safety Unit, and there is probably 6-8 pages worth, so she is hoping to get information from them on not doing 10 pages on 200 patients. It has taken this long to get the VAERS reports done. Per their Public Health immunologists and epidemiologists and the Hospital in (name withheld), they consulted and said they don't have to repeat any of the doses, and they should do reports to VAERS. Not one family reported any adverse events outside of the regular sore arm or redness that happened, they have no adverse events. She needs them to know they are not going to fill out these forms they gave them times 200 some odd patients.  Follow-up (12Jan2023): This is a follow-up report combining information from duplicate reports 202201293716 and 202201293456. The current and all subsequent information will be reported under manufacturer report number 202201293456.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200101648 same reporter/event/drug, different patient;