Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Knee arthroplasty, Off label use, Poor quality product administered, Product administration error
Clinical narrative: dose 1 Johnson and Johnson/ dose 2 BNT162B2/ dose 3 BNT162B2; dose 1 Johnson and Johnson/ dose 2 BNT162B2/ dose 3 BNT162B2; surgery is for right knee replacement; Pfizer COVID-19 Vaccine Gray Cap was administered after the refrigeration conditions (2 to 8°C)/ BUD was on 05May2022 then administered on 11May2022; Pfizer COVID-19 Vaccine Gray Cap was administered after the refrigeration conditions (2 to 8°C)/ BUD was on 05May2022 then administered on 11May2022; This is a spontaneous report received from contactable reporter (Nurse) from medical information team, Program ID: (159558).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 at 08:30 as dose 3 (booster), 0.3 ml single (Lot number: FP4554) at the age of 79 years intramuscular, in right deltoid for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Janssen COVID-19 vaccine (dose 1, single, Manufacturer: Johnson and Johnson, LOT: 1802068 , EXP: Unknown, Dose and Route: 0.5, route unknown), administration date: 25Mar2021, when the patient was 78-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, Manufacturer: Pfizer , LOT: FE3590, EXP: Unknown, Dose and Route: 0.3; route unknown), administration date: 01Nov2021, when the patient was 79-year-old, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11May2022 at 08:30, outcome "unknown" and all described as "Pfizer COVID-19 Vaccine Gray Cap was administered after the refrigeration conditions (2 to 8°C)/ BUD was on 05May2022 then administered on 11May2022"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "dose 1 Johnson and Johnson/ dose 2 BNT162B2/ dose 3 BNT162B2"; KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "surgery is for right knee replacement".  Additional information: Pfizer COVID-19 Vaccine Gray Cap was administered after the refrigeration conditions (2 to 8°C). The BUD (beyond use date) was on 05May2022. They were supposed to stop giving vaccines on 05May2022, which was the last day of ten weeks for the vaccine but administered on 11May2022. The patient was at facility for pre-op. The patient hasn't for surgery yet, surgery is for right knee replacement on 20Jun2022.; Sender's Comments: There is not a reasonable possibility that the event right knee replacement was related to the vaccination of BNT162B2 in this elderly patient based on the available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. 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