Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Pyrexia
Clinical narrative: she had a fever for 2 days after receiving the 4th dose; vaccine given beyond expiration date; vaccine given beyond expiration date; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP) from medical information team.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 14:07 as dose 4 (booster), single (Lot number: FK9729, Expiration Date: Sep2022) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: EW0179, Expiration date: 31Aug2021, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Time: 13:12), administration date: 03Jun2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; , Lot number: FL3197; Expiration date: 01Jun2022, Anatomical site of injection: Right arm, Route of administration: Intramuscular, Time: 12:58), administration date: 06Jan2022, when the patient was 58-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04May2022 at 14:07, outcome "unknown" and all described as "vaccine given beyond expiration date"; PYREXIA (non-serious), outcome "recovered", described as "she had a fever for 2 days after receiving the 4th dose".  Additional information: Caller states evidently, they had given some Covid vaccines beyond the expiration date because, some of the staff were confused because the expiration date was not really on the vial. It just says when it was manufactured. They get the vaccines from their local health department in (withheld). They are only supposed to be stable in the refrigerator for 10 weeks after receiving it. It had been longer than 10 weeks. Caller states that they are trying to figure out how long the product was actually stable. They had given about 40 adult doses past they should have been given. She states she was one of the patients, she and her fiance who received these vaccines. Caller states they received the vaccines and they were shipped to them on 13Jan2022. She guesses, they were only supposed to be giving them until 23Mar2022. Caller states they had the manufacturer date of Sep2021 and believed the EXP to be 31May2022. Upon follow up received on 03Jun2022 and 07Jun2022, We received Pfizer BioNTech Cofid-19 Vaccine Lot # FK9729 on 13Jan2022 and was supposed to expire on 23Mar2022, however the health department had written 31May2022 as the expiration date. We inadvertently kept using the vaccine until 23May2022. Further to your request received on 03Jun2022, we have completed the evaluation regarding BNT162b2 lot FK9729 that was exposed to temperatures out of labelled claims. The product was subjected to storage conditions between 2 C and 8 C before being administered 130 days after being placed in the fridge. Stability assessment. The marketed product stability study analyses for the impacted product are outlined in the table below. Note: The information below is product and batch specific, is based on the information provided by (Name withheld) RN and includes a review of all factors contributing to the batch history prior to and including the deviation outlined. The information cannot be used to assess any other batches or products. The patient did not provide information regarding the reported adverse event(s) with the use of the product. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (end at risk of serious COVID-19 complications). Vaccination facility type: Doctor's Office/Urgent Care. The vaccine was not administered at military facility. Relevant tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. Autopsy information: N/A. Pfizer BioNtech COVID-19 Vaccine administered beyond the recommended date of use 23Mar2022, by mistake on 04May2022. Was this dose valid. Upon follow up on 20Jun2022, it was reported that the caller confirms that doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date. The caller states that the 10 week BUD was on 23Mar2022 and there were doses administered on 09May2022. The caller states that she received correspondence from (Withheld) with Pfizer's SCQ team who provided documentation that this vaccine, specifically lot# FK9729 that was administered past its BUD was not a supported excursion. The caller is asking what the recommendations are for administering an unsupported/invalid dose and would the invalid dose be reflected in the Health Department's records. This AE has been filed previously, however, the caller reports that she and her husband both received doses from this vial. This was the caller's 4th Pfizer COVID-19 vaccine dose. She states that her and her husband both had a fever for 3 days and felt like she was "hit with a mack truck." Later in the call the caller stated that she had a fever for 2 days after receiving the 4th dose. The caller states that she had the exact same side effects to this dose as all of the other doses she had received so she felt like the dose was still valid.   Follow-up (03Jun2022): Follow-up attempts are completed. No further information is expected.  Follow-up (03Jun2022 and 07Jun2022): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included that: Updated Information Included: Expiration Date. Additional reporter added. Vaccination Facility Type and additional information added.  Follow-up attempts are completed. No further information is expected.  Follow-up (14Jun2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter sent via follow-up letter which included that: Updated information includes: Historical vaccine information updated. Vaccination start time, route of administration, anatomical location added. Vaccination facility name, address, city, state, postal code, phone number added. Type updated and additional information.  Follow-up attempts are completed. No further information is expected.  Follow-up (20Jun2022): This is a spontaneous follow-up report received from a contactable nurse.  Updated information includes: Event (Fever), clinical information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200759951 Similar report from same reporter;