Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Product label issue, Pyrexia
Clinical narrative: 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; doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date; doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date; she had a fever for 2 days after receiving the 4th dose; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP) from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FK9729, Expiration Date: Sep2022) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "HLD" (ongoing); "Diabetes" (ongoing); "HTN" (ongoing). Concomitant medication(s) included: SIMVASTATIN oral taken for lung disorder (ongoing); GLIPIZIDE oral taken for diabetes mellitus (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 3, SINGLE, Lot number: FL3197, Expiration date: 01Jun2022, NDC: Unknown), administration date: 20Dec2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0179, Expiration date: 31Aug2021, NDC: Unknown), administration date: 18Jun2021, when the patient was 61-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; 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, outcome "unknown" and all described as "doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date"; PRODUCT LABEL ISSUE (non-serious) with onset 04May2022, outcome "unknown", described as "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"; PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "she had a fever for 2 days after receiving the 4th dose".  Additional information: The reporter confirmed that doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date. The reporter stated that the 10 week BUD was on 23Mar2022 and there were doses administered on 09May2022. Vaccine, specifically lot FK9729,  that was administered past its BUD was not a supported excursion. The patient and her husband both received doses from that vial. That was the patient's 4th Pfizer COVID-19 vaccine dose. The patient stated that she and her husband both had a fever for 3 days and felt like she was "hit with a mack truck." She had a fever for 2 days after receiving the 4th dose.   Follow-Up (03Jun2022): Follow-up attempts are completed. No further information is expected.  Follow-up (03Jun2022): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.   Updated Information Included: Suffix.   Follow-up (07Jun2022): This is a follow-up spontaneous report received in response to the mail.   Updated Information Included: expiry date, new true reporter, vaccination facility details, event-drug taken beyond expiry date, best doctor information.  Follow-up attempts are completed. No further information is expected.  Follow up (13Jun2022): This is a follow up spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter. This case processed as Invalid due to unspecified AE.  Follow-up attempts are completed. No further information is expected.  Follow-up (20Jun2022): This is a Spontaneous Follow-up report received from a contactable Other HCP. This Other HCP reported for a patient.  Update information: Reporter new address. New event fever. Additional information updated.  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;