Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Off label use, Poor quality product administered
Clinical narrative: received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial; Off label use; Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021.; Dose 4 Booster; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2022 10:41 (Lot number: FJ9943, Expiration Date: Aug2021) at the age of 55 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 1), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 2), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 3), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant) with onset 29Mar2022, described as "received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial"; OFF LABEL USE (medically significant) with onset 29Mar2022, described as "Off label use"; EXPIRED PRODUCT ADMINISTERED (medically significant) with onset 29Mar2022, described as "Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021."; IMMUNISATION (medically significant) with onset 29Mar2022, described as "Dose 4 Booster". Therapeutic measures were not taken as a result of poor quality product administered, off label use, expired product administered, immunisation. Clinical Course: Caller stated that a patient received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial. First puncture was yesterday March 28th 2022 at 12:58 pm and the patient received the shot today 29Mar2022 at 10:41 am. Regulatory authority Support CEP 159558 has a pharmacist has a Covid 19 vaccine (gray cap) that expired that they already administered to one of their patients. Stated that they will do a report with VAERS. Is her fourth dose since she is immunocompromised. Stated that she was immunocompromised prior to getting the vaccine. Patient details: Height, weight and ethnicity unknown. Stated that the vaccine was pharmacy prescribed. Product details: Stated that she cannot read the expiration date. Stated that she has the bottle. Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021  No follow-up attempts are possible. No further information is expected; Sender's Comments:  Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.