Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Pyrexia, Vaccination site erythema, Vaccination site hypersensitivity
Clinical narrative: vaccination site reaction; fever; redness and itching at the vaccination site; redness and itching at the vaccination site; The vial was punctured yesterday and misplaced. It's been more than 12 hours since puncture outside of the refrigerator; The vial was punctured yesterday and misplaced. It's been more than 12 hours since puncture outside of the refrigerator; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 3 (booster), single (Lot number: GJ2524), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01, Site and Route of injection, Route of administration: intramuscular, Batch/Lot number: Not Available / Provided at Time of Report Completion), administration date: 25Apr2021, for COVID-19 immunization; BNT162b2 (Dose: 02, Date: 11Nov2021, Route of administration: intramuscular, Batch/Lot number: FH8030), administration date: 11Nov2021, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 26Oct2022, outcome "unknown" and all described as "The vial was punctured yesterday and misplaced. It's been more than 12 hours since puncture outside of the refrigerator"; VACCINATION SITE REACTION (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "redness and itching at the vaccination site". The events "vaccination site reaction" and "fever" required emergency room visit. Therapeutic measures were not taken as a result of vaccination site reaction, pyrexia.   Additional information: The expired Pfizer COVID vaccine bivalent gray cap was administered to the patient and wanted to know if they need to repeat the dose. The vial was punctured and misplaced. It had been more than 12 hours since puncture outside of the refrigerator in the vial. Originally stored in refrigerator. The reporter was a healthcare professional (HCP)occupation/ speciality was unknown. The reporter was not the prescribing HCP. The reporter's or a sub-contracted party contact information was available. Start date and stop date of Pfizer covid-19 vaccine was unknown. A clear narrative description, as provided by the reporter, sequence of event(s), diagnosis, treatment, (including dates), and any other relevant details. Include any laboratory tests and/or results provided by the reporter. Medical questions addressed by this program was forwarded/referred to Medical Information. Yes Customer and/or medical inquiry forwarded or referred. Upon Follow-up (20Dec2022), The patient provided information to you regarding the reported adverse event(s) with the use of the product. Patient did not consider the Pfizer product had a causal effect to the adverse event. Prior vaccinations (within 3 weeks) reported as None. Concomitant drugs and Relevant test reported as Unknown. The type of medication error: A dose was given from an opened vial. The vial was opened less than 24 hours prior to vaccination. The stage of medication error (e.g., prescribing, dispensing, preparation, and administration) reported as Dispensing and administration. contributing factor to the medication error reported as An open vial was left at the immunization station. Technician drawn up a dose from the wrong vial and vaccination the patient. The injection was given really high which caused redness and itching at the vaccination site.  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 (30Nov2022): Follow-up attempts are completed. No further information is expected.  Follow-up (20Dec2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent which included that:  Updated information included: Dosage regimen [Start date/time, lot#, dose number, anatomical location]. Vaccine facility information. Historical vaccine info [dose 1, dose 2]. Event onset date/time [The vial was punctured yesterday and misplaced. It's been more than 12 hours since puncture outside of the refrigerator]. New AE [vaccination site reaction, fever, redness and itching at the vaccination site].