Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Poor quality product administered, Product administration error, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FK9729, Expiration Date: Sep2022) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 09May2022, outcome "unknown" and all described as "vaccine given beyond expiration date"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "felt like she was hit with a truck"; PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fever". Additional information: The caller confirmed that doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after its 10 weeks Beyond Use Date. The caller stated that the 10-week BUD was on 23Mar2022 and there were doses administered on 09May2022. The caller states that she received correspondence from (Name 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 asked what the recommendations are for administering an unsupported/invalid dose and would the invalid dose be reflected in the Health Department's records. The caller reported 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 truck". The caller stated that she had a fever for 2 days after receiving the 4th dose. The caller stated 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. Hello (Withheld), can you please provide an answer to the customer below on the potential need for revaccination. We've assessed their storage deviation and determined that stability data can't support the use of the vaccine. If this isn't the right email to be asking this to, can you please provide the proper email. Hi (Withheld). I have been trying to get in touch with Pfizer Medical for two weeks now without success. I need further clarification on the Letter you sent to me on 07Jun2022. In the letter you have the expiry date listed as Sep2022, but you also have Stability data does not support the use of this product, and then you go on to say that the decision to release the impacted products is my responsibility. Please clarify to me if these patients vaccines are considered valid or not, or if they all need to be revaccinated. If you are saying the expiration is really Sep2022, then all the vaccines given are valid. I personally received the vaccine and had the same reaction with a fever that I did with all my other vaccines, so I believe that the vaccine was still stable. Please advise me on what I need to tell all of these patients. If you have any further questions, please call me on my cell phone at (Withheld). Sender's Comments: Linked Report(s) : US-PFIZER INC-202200759951 Same reporter/drug/event, different patient;