Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Poor quality product administered, Product administration error, Pyrexia
Clinical narrative: vaccine given beyond expiration date; vaccine given beyond expiration date; he had a fever for 2 days after receiving the 4th dose; felt like she was hit with a mack truck; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FK9729, Expiration Date: 31May2022) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HLD" (ongoing); "A fib" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for hyperlipidaemia (ongoing); ASA oral taken for atrial fibrillation (ongoing). Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Date: 01Oct2021, Time: 09:23, Anatomical Site of injection: L Arm (Left arm), Route of administration: Intramuscular, Batch/Lot Number: EW0183), administration date: 01Oct2021, when the patient was 62-year-old, for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete, unknown manufacturer, Given else where), for Covid-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 18Apr2022, 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 mack truck"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "he had a fever for 2 days after receiving the 4th dose".  Additional information: Caller was a Registered Nurse. She was notified yesterday (24May2022) by a health department that some doses of Pfizer-BioNTech COVID-19 Vaccine (gray cap) were expired. The original expiry date that they were told was 31May2022 and then they were notified that the real expiry date was 23Mar2022. The manufacture date of these vaccines printed on the vial was Sep2021. The vaccines were being stored in a refrigerator since 13Jan2022. According to the 10 week storage time and according to the caller, the expiry date would be 24Mar2022. Then, some doses of this vaccine were administered since 13Mar2022 until 23May2022. The product was subjected to storage conditions between 2 degree C and 8 degree C before being administered 130 days after being placed in the fridge. Vaccination Facility Type was Doctor's Office/Urgent Care. Vaccine was not Administered at Military Facility. No Prior Vaccinations (within 4 weeks). No Relevant Tests were done. No Specific relevant test for thromboembolic events with thrombocytopenia. This caller states that she has been trying to get in touch with someone from Pfizer USMI for the past 2 weeks regarding case #. 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 (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 was asking what the recommendations are for administering an unsupported/invalid dose and would the invalid dose be reflected in the Health Department's records. Regulatory Authority: Potential Duplicate AE reporting. 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. URL withheld Dose administered past the expiration/ beyond-use date Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval).  No follow-up attempts are possible. No further information is expected.  Follow-Up (03Jun2022): Follow-up attempts are completed. No further information is expected.  Follow up (03Jun2022): This is a spontaneous follow-up report received from a contactable nurse. This nurse reported for a patient that: Updated information: Reporter information  Follow-up (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: Updated information included: No new information updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (13Jun2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported in response to HCP letter sent included that:  Updated Information Included: Historical vaccine information. RMH. Anatomical Location. Vaccine Facility Information. Conmed.  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. This nurse reported for a patient that: The updated Information: New Reporter slider# 02 was added and event "Pyrexia and feeling abnormal added.  Follow-up attempts are completed. No further information is expected.