Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Laboratory test abnormal, Poor quality product administered, Product administration error
Clinical narrative: patient was given the product "out of the window" for the bivalent. The product was previously punctured for greater than 12 hours. Total hours post puncture was 5-6 hours beyond the 12 hours; patient was given the product "out of the window" for the bivalent. The product was previously punctured for greater than 12 hours. Total hours post puncture was 5-6 hours beyond the 12 hours; Labs were drawn yesterday and three came in abnormal 30 minutes after the visit yesterday,; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Jan2023 at 11:30 as dose 5 (booster), 0.3 ml single (Lot number: GJ3274, Expiration Date: 31Jul2023) at the age of 35 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2", start date: 2018 (ongoing); "Hypertension", start date: 2018 (ongoing). The patient's family history included: "Liver disease", start date: 2005 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1 Monovalent Manufacturer: Pfizer, Lot & Exp Unknown), administration date: 01Jan2021, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (Dose 2 Monovalent Manufacturer, LOT: EL9267, EXP: Unknown Dose and Route: 0.3ml injected into right deltoid Time: 09:36), administration date: 20Feb2021, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 Monovalent LOT: EN6202 EXP: Unknown, Dose and Route: 0.3ml and intramuscular injection, injection site is unknown Time: 09:36), administration date: 13Mar2021, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 Monovalent, LOT: FH8028, 0.3ml intramuscular on right deltoid, Time: 09:36), administration date: 16Nov2021, when the patient was 34-year-old, for Covid-19 immunization; flu shot (Dose/Route: 0.5ml injected into left deltoid Lot Number/ Expiry Date: UJ893AA / Expiry date is unknown), administration date: 06Nov2022, for Immunization. The following information was reported: LABORATORY TEST ABNORMAL (non-serious) with onset 11Jan2023, outcome "unknown", described as "Labs were drawn yesterday and three came in abnormal 30 minutes after the visit yesterday,"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Jan2023 at 11:30, outcome "unknown" and all described as "patient was given the product "out of the window" for the bivalent. The product was previously punctured for greater than 12 hours. Total hours post puncture was 5-6 hours beyond the 12 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: As per COVAX: "One was given outside of the time frame and she wants to know if they need to be revaccinated." Caller states a patient yesterday was given the product "out of the window" for the bivalent. The product expired 11:30 PM and was inadvertently given the following AM. The product was previously punctured for greater than 12 hours. Total hours post puncture was 5-6 hours beyond the 12 hours. Max 18 hours of puncture time. Total cumulative time post-puncture: Up to 24 hours at 2 degree Centigrade and 30 degree Centigrade (35 degree Fahrenheit to 86 degree Fahrenheit), depending on storage container Total cumulative time post-puncture cannot exceed 24 hours, regardless of container. Upon follow-up on 12Jan2023, calling from a primary care and wants to give us a call regarding the Pfizer Covid 19 bivalent injection. They had one given outside the timeframe and wanted to see if they needed to revaccinate or what steps they needed to do. Upon follow-up on 12Jan2023 it was reported that a shot of the Covid-19 vaccine Bivalent was administered outside the time frame and the caller wanted to see if they needed to revaccinate the patient or what were the next steps to take. Concomitant Products: All medications were current. They did send in three new medications yesterday for the patient. Labs were drawn yesterday (at the time of report) and three came in abnormal 30 minutes after the visit yesterday, 11Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (12Jan2023): This is a spontaneous follow-up report received from a HCP. This contactable HCP reported for a patient that: Updated information included: Reporter info (Institution). New Reporter (slider#2). Patient details (DOB, age, unit, weight, height, race, gender). Historical vaccine (Dose#1, dose#2, dose#3, dose#4). Relevant Med History (Diabetes type 2, Hypertension and Liver disease). Lab test. Dosage regimen (Start Date/Time, dose no., lot# and Anatomical Location). Vaccine Facility Information. Event onset date. Historical vaccine (Flu shot). New event added (Labs were drawn yesterday and three came in abnormal 30 minutes after the visit yesterday). Concomitant Therapy and additional information.