Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
mild/grade one tenderness at the injection site; Administration error to study participant; This is a spontaneous report received from a Physician and an Other HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 21Apr2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 23Apr2025, outcome "unknown", described as "Administration error to study participant"; VACCINATION SITE PAIN (non-serious) with onset 23Apr2025, outcome "unknown", described as "mild/grade one tenderness at the injection site". Additional information: On 21Apr2025 a study participant was screened and randomized for an avian flu vaccination study. Study was prepared and ready for administration around the same time for participant (ID withheld), protocol. The drug was given to the study participant in the study in error. The site process, which occurred with this participant, is to prepare per pharmacy manual, label the syringe with the occluding label, participant/study label and place in an opaque box for transport to the exam room for administration. The participant was taken to the exam room and the unblinded team verify the participant's full name and date of birth with the participant and the unblinded study team verify enrollment number syringe label number with the subject chart prior to administration. The double verification of the syringe label enrollment number to the participant chart was done in the preparation area but verification of the syringe to the subject chart again in the exam room was missed. Beginning 22Apr2025, they had placed labels on the opaque box to write the study and participant enrollment number as an additional verification of the contents of the box. The unblinded team would verbally verify the participant enrollment number on the syringe with the chart once in the exam room, prior to administration. This would be done for all studies going forward and all unblinded staff had been retrained to this verification process. The participant, Pl, and the sponsors of both studies were immediately notified of the error. Site would follow the subject for safety purposes which included daily phone contact for 8 days following vaccine administration at least once per month for 6 months following IP administration to document any AEs. The site was awaiting further guidance from Pfizer regarding the participant follow up schedule. The participant did not report any AEs during the 30min post vaccine observation period. The participant was given a copy of the consent for the study IMP they received. Information in email body: Hello - please be advised that per the Clinical team guidance, this erroneous administration of study drug to a non-Pfizer study participant was being reported to Pfizer US Drug Safety. was a blinded study an only the unblinded team was copied on this email as reporter was reporting the unblinded IP assignment for their reference, below. Please note that this participant received only the Pfizer IP (BNT162b8 monovalent (Omicron KP.2) 100 mcg/mL Vial 0.3 mL) - no IP for the other sponsor study they were enrolled in was administered and no safety concerns/reactions had been reported to date. Reporter had attached NTF/summary from the PI/site for your reference. On 23Apr2025: Drug Safety, In follow up to the initial email below, the participant reported mild/grade one tenderness at the injection site and no other symptoms on 23Apr2025. Reporter had included the unblinded site pharmacist/site director on this email who reported this and would report any further safety follow up updates. On 24Apr2025: Please be advised that (patient ID withheld) did not experience the AE or the dosing error. The participant who did does not have an ID as patient was not enrolled in a Pfizer trial but rather another sponsor trial, but received our IP. Apologies for any confusion on this. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.