Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lipids, Metabolic function test, Poor quality product administered, Product administration error, Vitamin D
Clinical narrative: once the first dose has been given and they are multi dose vial that it is only good for 12 hours from the first dose; administered to a patient; once the first dose has been given and they are multi dose vial that it is only good for 12 hours from the first dose; administered to a patient; Elevated liver enzymes; This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse).  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Jun2023 at 07:30 as dose 5 (booster), 0.3 ml single (Lot number: GJ6743, Expiration Date: 30May2025) at the age of 56 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Lot number: EL3302, NDC# 592671000-1, Expiration Date: 31May2021, Location: Right deltoid, Route: Intramuscular), administration date: 26Jan2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3 ML SINGLE, Lot number: EL9269, NDC# 592671000-1 , Expiration Date: 31May2021, Location: Right deltoid), administration date: 15Feb2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number not reported), administration date: 26Nov2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: SJ4991, Location: Left arm), administration date: 12May2022, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: HEPATIC ENZYME INCREASED (non-serious) with onset 22Jun2023, outcome "unknown", described as "Elevated liver enzymes"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 22Jun2023 at 07:30, outcome "unknown" and all described as "once the first dose has been given and they are multi dose vial that it is only good for 12 hours from the first dose; administered to a patient". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that patient had other conditions. The events were described as "Elevated Liver enzymes' and "once the first dose has been given and they are multi dose vial that it is only good for 12 hours from the first dose; administered to a patient". The reporter stated that the bivalent COVID booster (Clarified as Pfizer COVID 19 Bivalent Vaccine) the 12 and up, the grey cap, the sub zero freezer is at central supply of pharmacy department where it is transferred over and so the dates change a little bit for once they are taken out to coincide with the criteria for how often they can be out of the freezer before they are no longer good. The reporter understood that once the first dose had been given and they are multidose vial and enquired that it was only good for 12 hours from first dose. Stated that the vaccine was given to the patient after taking out from freezer. The reporter stated the details of the historical vaccines. The patient had done her labs. The reporter stated that that the doctor noted that the patient had elevated liver enzymes. The reporter stated that the patient is first seen, the vaccine they need is provided and then patient made to stay 15 minutes and then they go to lab, that is how the process was. No other Pfizer vaccines was given on that day. The patient had not taken any other vaccine 4 weeks prior to it. The reporter further asked if it meant the patient needed another dose since obviously the one given on that day sounds like invalid or considered invalid.